Clinical trials drugs generic. Medical search. Frequent questions

August 24, 2023 - Several new clinical trials in prostate cancer have opened in recent months. (nih.gov)
August 14, 2023 - Early NIH-funded trial is first step towards development of a potential stroke treatment. (nih.gov)
July 27, 2023 - Trial results show that engineered T cells can effectively target mesothelin, a protein found on many solid tumors. (nih.gov)
June 27, 2023 - The investigational drug vorasidenib substantially slowed the growth of tumors in people with low-grade gliomas that had mutations in the IDH1 or IDH2 genes. (nih.gov)
June 1, 2023 - ComboMATCH will comprise numerous phase 2 precision medicine cancer treatment trials that aim to identify promising drug combinations that can advance to larger clinical trials. (nih.gov)
May 15, 2023 - NIH-funded clinical trial will determine safety, tolerability of experimental drug. (nih.gov)
March 15, 2023 - Results are similar to findings seen in previous artificial pancreas trials in older children and adults. (nih.gov)
February 15, 2023 - Trial protocol may be adapted to evaluate additional therapeutics. (nih.gov)
January 11, 2023 - The initial treatment used for some younger women with an aggressive form of breast cancer may be about to change, based on results of a new clinical trial. (nih.gov)

The clinical trial drug supply will be provided by Sandoz, the generics and biosimilars division of Novartis. (novartis.com)
Because of the high prices of these drugs, companies are very interested in developing "biosimilars" - cheaper copies of the original drugs, similar to generic versions of pharmaceuticals. (vox.com)
The reason these biosimilars are so cheap is that manufacturers can usually just rely on data from clinical trials submitted by the maker of the original biologic. (vox.com)

We are proud to start this study in pregnant women and continue to gather the evidence on safety and efficacy to potentially support the use of the vaccine by important subpopulations," said William Gruber M.D., Senior Vice President of Vaccine Clinical Research and Development, Pfizer . (pfizer.com)
His letter to the editor emphasizing the paramount importance of a well-established safety profile and documented clinical efficacy in severe infections before a "wholesale change" to the newer quinolones is an appropriate response to Michael Scheld's essay on maintaining quinolone class efficacy in which a "correct spectrum" strategy of using the most potent quinolone to treat the presumed or confirmed pathogen was described and advocated ( 1 ). (cdc.gov)
With respect to efficacy, Frothingham writes that ciprofloxacin and levofloxacin have been studied in patient populations with more severe illness, and trials of the newer quinolones have enrolled patients with predominantly mild or moderate community-acquired infections and low overall death rates in comparison. (cdc.gov)
The clinical trial will let us know the efficacy of this molecule on COVID-19 patients. (livemint.com)
In the fall, a large phase III randomized clinical trial sponsored by the Research Institute of the McGill University Health Centre (RI-MUHC) could start testing the efficacy of a reformulated generic drug in COVID-19 positive outpatients to mitigate severe pulmonary inflammation caused by the SARS-CoV-2 virus and consequently, to reduce hospital admissions. (biospace.com)
Repurposing an existing drug for a new indication has the added benefit of allowing researchers to jump straight to phase III of a clinical trial and evaluate the efficacy and safety of the reformulation with minimal investment of time and money. (biospace.com)
The Dapsone Coronavirus SARS-CoV-2 Trial (DAP-CORONA) COVID-19 study is a randomized, triple blind, placebo-controlled, parallel, multicentre trial which will evaluate the efficacy and safety of a new version of dapsone developed and patented by Pulmonem , a Canadian biotech start-up. (biospace.com)
Last year, Dr. Janet Woodcock, the agency's powerful head of pharmaceuticals ordered the approval of Sarepta Therapeutics Inc's drug to treat Duchenne muscular dystrophy based on little more than a hint of efficacy. (newsweek.com)
Any investigation in human subjects intended to discover or verify the clinical, pharmacological or other pharmacodynamic effects of an investigational product or to identify any adverse reactions to an investigational product or to study absorption, distribution, metabolism and excretion of an investigational product with the object of ascertaining its safety or efficacy. (who.int)
An obligation imposed on third parties to protect test data (e.g. the results of clinical trials) - usually collected in order to comply with government regulations on the safety, efficacy, and quality of a broad range of products (e.g. drugs, pesticide, medical devices). (who.int)

What is the development status for investigational drug REL-1017? (drugpatentwatch.com)
REL-1017 is an investigational drug. (drugpatentwatch.com)
There are six hundred and thirty-seven US patents protecting this investigational drug and twelve international patents. (drugpatentwatch.com)
Who is working on investigational drugs for Lymphoma? (drugpatentwatch.com)
Towards the end of 2006, Samaritan submitted an investigational new drug (IND) application to the US FDA to seek approval to begin clinical testing of its new drug. (clinicaltrialsarena.com)
The form used for this request is called an Investigational New Drug application (IND). (rdhmag.com)

Starting in 2020, the public saw a rapid emergence of nongovernmental programs like Fast Grants, Impetus Grants, and Reproductive Grants to fund both big clinical trials and proof-of-concept scientific studies within timelines that were previously thought to be impossible. (fas.org)
Basel, April 20, 2020 - Novartis has reached an agreement with the US Food and Drug Administration (FDA) to proceed with a Phase III clinical trial with approximately 440 patients to evaluate the use of hydroxychloroquine for the treatment of hospitalized patients with COVID-19 disease. (novartis.com)
Effect on blood pressure is exaggerated if the Cialis is taken with a nitrate drug 2020 Cialis generic availability for cialis 5 fertilit does viagra work even after ejaculation T23. (njacs.org)

The first study brings together evidence from 30 000 postmenopausal women in 9 randomised trials, showing that 5 years of treatment with the newer endocrine therapy (ie, an AI) produces somewhat better survival than five years of standard endocrine therapy (tamoxifen). (ox.ac.uk)
The arrival of cluster of innovative drugs and therapies introduced in the patients as single therapy or in combination have also oriented millions of prostate cancer patients worldwide towards adopting the treatment regimen developed by the US oncology researchers. (researchandmarkets.com)
The positive-outcomes for every drug and therapy available is believed to line up the market towards evolution and thus, towards a treatment paradigm capable of offering highest return to the prostate cancer patients in the US as well as in the world. (researchandmarkets.com)
NurOwn, they say, is the first stem cell therapy for ALS to have gotten this far, and it showed tantalizing results in a small phase 2 trial involving 48 patients - 36 of whom got the cells and 12 of whom received a placebo. (bostonglobe.com)
Research directed towards specific objectives, such as the development of a new drug, therapy or surgical procedure. (who.int)
On the other hand, fixed-dose combination drug therapy also produced a significant primary endpoint benefit when aspirin wasn't included, observed Joseph, who is lead author on the study's report published August 29 in The Lancet . (medscape.com)
However, clinicians and patients often think drug therapy is an inevitable course of action. (lu.se)

We can provide lab-, kilo- and pilot-scale manufacturing for preclinical studies and all phases of clinical trials, supplying milligram to kilogram quantities. (cambrex.com)
All of these drugs are in preclinical stage. (clinicaltrialsarena.com)

Generic drugs have the same active pharmaceutical ingredients and therapeutic effects as the corresponding brand-name drugs and differ only in their non-medicinal ingredients. (medicalnewsbulletin.com)
The effect of Paragraph IV decisions and generic entry before patent expiration on brand pharmaceutical firms. (sutterhealth.org)
As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. (livemint.com)
Another Indian pharmaceutical company, Strides Pharma Science Ltd , said on Wednesday it had developed and commercialized favipiravir antiviral tablets, and had applied to the authorities to start trials. (livemint.com)
Pharmaceutical companies that spend billions to develop patented - and expensive - cancer drugs have little incentive to fund or conduct studies on generics like metformin. (cnn.com)
I imagine that if [metformin] was a proprietary drug owned by a major pharmaceutical company, they would be developing it very aggressively, because all of the indicators point in the same direction, and that's unusual," Goodwin says. (cnn.com)
Cambrex brings more than 40 years of generic API manufacturing experience to its pharmaceutical partners. (cambrex.com)
To take clinical trials as an example of pharmaceutical industry activity, according to statistics put out by clinicaltrials.gov in 2009, over 4,000 clinical trials were conducted in Latin America. (genengnews.com)
In a paper published in Current Pharmaceutical Design in 2003, the two scientists review evidence suggesting that these old, widely available conventional drugs may have anti-retroviral and immune modulating properties, which could help recover the immune system of HIV/AIDS patients. (i-sis.org.uk)
encompasses all activities related to the development and manufacture of active pharmaceutical ingredients (API) for both clinical trials and commercial products. (marketresearch.com)
of drugs and other pharmaceutical products, thereby reducing the prevalence of counterfeit drugs and medicine. (marketresearch.com)
This is welcome news for the pharmaceutical industry as it finally clarifies the scope of this exemption, and the new, more liberal provisions could lead to more clinical trials of experimental drugs being carried out in the UK. (dyoung.com)
Although this case related to field trials of a plant protection product, the general wording of the ruling meant it also applied to trials of pharmaceutical products. (dyoung.com)
The Directive required Member States to exempt from infringement, trials of a patented, marketed pharmaceutical for the purposes of obtaining regulatory approval of a generic version, to be marketed after the patent expired. (dyoung.com)
This Directive is commonly referred to as the 'EU Bolar Directive', after the corresponding provision in US law which exempts acts required to gain regulatory approval of a pharmaceutical by the US Food and Drug Administration (FDA) from patent infringement. (dyoung.com)
A particular issue arises when the pharmaceutical regulatory authorities or health technology assessors require an innovative drug to be tested against a comparator drug already on the market - if the comparator is patented, the patent could be infringed under the current legislation. (dyoung.com)
It only leaves doubt about its intention," said D.G. Shah, secretary-general of Indian Pharmaceutical Alliance (IPA), a lobby of domestic drug-makers. (thehindu.com)
I have repeatedly stated that multinational pharmaceutical companies constantly use incidents like this to bring disrepute to Indian generic drug makers," he said. (thehindu.com)
BENGALURU (Reuters) - Shares of India's Divi's Laboratories Ltd, which makes the main ingredient of Merck & Co's experimental antiviral pill, soared 10% on Monday, after the pharmaceutical giant reported positive clinical trial results for the drug. (metro.us)
Drugmakers Drop Generics: US Cancer Patients Can't Get Meds A quality-control crisis at an Indian pharmaceutical factory has left doctors and their patients with impossible choices as cheap, effective, generic cancer drugs go out of stock. (medscape.com)
To promote the innovative development of pediatric drugs in China, the Chinese government must develop an R&D supervision framework, improve the motivation and innovation capabilities of pharmaceutical companies, and optimize the source distribution between regions. (bvsalud.org)

BACKGROUND: The United States (U.S.) Food and Drug Administration, as protectors of public health, encourages generic drug development and use so that patients can access affordable medications. (sutterhealth.org)
Furthermore, because there are no associated research and development expenses, generic drugs cost considerably less than new prescription medications. (biospace.com)
The FDA's regulatory authority is enormous, ranging from food and food safety to prescription drugs and biologics, blood and blood products, over the counter medications and dietary supplements, as well as cosmetics, medical devices, tobacco, and veterinary products. (heritage.org)
Compared with other blood sugar-lowering medications, metformin's popularity stems from the observation that it is one of the least harmful of the drugs commonly prescribed. (drmcdougall.com)
A new patient-level analysis of three large, randomized trials included more than 18,000 participants, arguably enough to also examine whether adding aspirin to a mix of at least two hypertension medications and a statin made any difference to clinical outcomes across the trials ( TIPS-3 , HOPE-3 , and PolyIran ). (medscape.com)
In the United States, approximately 2000 cases of acute liver failure occur annually and drugs account for over 50% of them (39% are due to acetaminophen, 13% are idiosyncratic reactions due to other medications). (medscape.com)

Mumbai-based Glenmark Pharmaceuticals today said has received approval from the Drug Controller General of India to conduct clinical trials of antiviral drug favipiravir on coronavirus patients. (livemint.com)
G.N. Singh, Drug Controller-General of India (DCGI), confirmed that he knew about the whistle-blower. (thehindu.com)

The leading clinical trial sponsors are Relmada Therapeutics, Inc., Clinical Trial Unit Ente Ospedaliero Cantonale, and Mauro Manconi. (drugpatentwatch.com)
One of Gottlieb's areas of interest is streamlining the process for approving generic versions of complex, difficult-to-copy therapeutics. (newsweek.com)

Our teams of creative problem-solvers work closely with you to accelerate drug development timelines, optimize processes, and meet regulatory requirements. (cambrex.com)

Patents can be extended by the innovator when new uses for the drug are presented. (medicalnewsbulletin.com)
Simultaneously, competing companies move quickly to release generic versions of drugs with closing patents in order to capitalize on consumers who are looking for generic alternatives. (medicalnewsbulletin.com)
Drugs may be covered by multiple patents or regulatory protections. (drugpatentwatch.com)
It regulates both "brand-name" and generic drugs, which are the chemical equivalent of brand-name drugs but with expired patents. (heritage.org)
Meanwhile, every country has systems for granting patents and legal privileges to the first company to invent a drug - a reward for innovation. (vox.com)
Even when patents are granted, the Indian Patents Act allows for compulsory licenses to be issued to local manufacturers for life-saving drugs that are deemed too costly. (forbes.com)
The Indian generic drug-makers had countered by accusing big pharma of using patents as an excuse to keep affordable Indian medicines from the access of poor patients. (thehindu.com)

The generic drugs market is estimated to have reached $257.3bn in 2018 and is expected to grow at a CAGR of 8.8% in the first half of the forecast period. (visiongain.com)
Asia-Pacific held 31% of the generic drugs market in 2018. (visiongain.com)
What were the market shares of the leading national markets in the global generic drugs market in 2018? (visiongain.com)
Which particular national markets will be the main drivers of growth in the global market for generics from 2018 to 2029? (visiongain.com)
Baloxavir marboxil (trade name Xofluza®) is an influenza (flu) antiviral drug given as a pill in a single dose by mouth that was approved on October 24, 2018, by the U.S. Food and Drug Administration (FDA). (cdc.gov)

Moreover, the researchers suggest that the two types of drug can be used together, increasing the benefits while also decreasing some side-effects. (ox.ac.uk)
The Early Breast Cancer Trialists' Collaborative Group (EBCTCG) is a worldwide collaboration set up 30 years ago by researchers at the University of Oxford, Oxford, UK to bring together every few years all the evidence from randomised trials on the treatment of early breast cancer. (ox.ac.uk)
The researchers in the country have opened hundreds of novel paths such as diagnosing assays, drugs and therapies for the patients suffering from early or advanced stage prostate cancer. (researchandmarkets.com)
The overall clinical landscape developed by the researchers in few years of time has ensured appropriate care while ensuring the overall survival rate and complete response in the patients. (researchandmarkets.com)
The idiosyncrasies of drug discovery and clinical trials make them difficult to accelerate at scale, but we can reliably accelerate drug timelines on the front end by reducing the time researchers spend in writing and reviewing grants-potentially easing the long-term stress on U.S. healthcare. (fas.org)
Researchers at the company compressed months of work into a few weeks to design the large clinical trial in order to rapidly respond to the need for COVID-19 disease treatments. (novartis.com)
We are donating hydroxychloroquine tablets for COVID-19 patients including for use in this and other clinical trials with the hope that researchers and healthcare workers can quickly and scientifically determine whether hydroxychloroquine can help patients around the world combat this disease," said Richard Saynor, CEO of Sandoz. (novartis.com)
But then, in 2006, researchers in Canada working with breast-cancer cells found that metformin increased the activity of an enzyme involved in tumor suppression, suggesting that the drug might fight cancer by working directly on cancer cells. (cnn.com)
As a result, metformin researchers have struggled to scrape together the money needed for clinical trials, which can run into the millions. (cnn.com)
Some of the most prominent ALS researchers in the United States are working on the phase 3 clinical trial. (bostonglobe.com)
During this stage, researchers decide how the drug must be stored to retain its potency - away from light, heat, or moisture - and the type of formulation they will use, such as capsule, tablet, or injection. (rdhmag.com)
The trials usually are controlled trials, meaning that researchers compare the effects of the compound under study to a placebo or an active 'comparator' (a drug that is already marketed and considered to be effective). (rdhmag.com)
The FDA rarely prosecutes research violations, usually choosing to administratively sanction or ban researchers or companies from future clinical trials, legal experts said. (medscape.com)

The Drugs and Cosmetics Rules, 1945 are the rules which the government of India established through the Drugs and Cosmetics Act, 1940. (wikipedia.org)
Drug policy of India Drugs and Cosmetics Act, 1940 Drugs and Magic Remedies (Objectionable Advertisements) Act, 1954 Dr. Lily Srivastava (2010). (wikipedia.org)
Sushrut Kulkarni, Executive Vice President - Global R&D, Glenmark Pharmaceuticals, said: "After having successfully developed the API and the formulations through its in-house R&D team, Glenmark is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India. (livemint.com)
Beyond pricing this drug favorably in India, once the clinical trials are concluded in India, Gilead has also agreed to work with Indian generic manufacturers to produce the drug locally and perhaps drive the cost even lower. (forbes.com)
But this won't necessarily stop hepatitis C patients in India from getting the drug. (forbes.com)
For example, Novartis was never able to get a patent for its cancer drug, Glivec, in India, thus enabling local manufacturers to make and sell it. (forbes.com)
Even for drugs that have patent coverage and which are allowed on the market, India administers "drug caps" for the prices of hundreds of drugs including those for heart disease and diabetes, despite the fact that the prices for drugs in India are among the lowest in the world. (forbes.com)
Reacting to the ban by European drug regulators, the Commerce Ministry said in a release that it was "disappointed by and concerned" at the ban on "one of the flagship sectors of India", as the story snowballed into the latest setback to the reputation of India-made generic drugs. (thehindu.com)

With the need to prevent complications leading to hospital admissions and the absence of proven effective treatments for COVID-19 outpatients, showing that dapsone has a net clinical benefit should be a public health priority. (biospace.com)
New disease treatments may help, but it often takes years to translate the results of basic research into approved drugs. (fas.org)
Very few of these would-be treatments end up being approved by the government and entering widespread use, which makes it all the more intriguing that one of the most promising new cancer drugs in years is, in fact, an old drug. (cnn.com)
An average PI (protease inhibitor) used in triple-drug treatments of HIV cost between $10-$20 per day, in contrast to a daily dose of 2 mg warfarin which costs as little as 10 cents. (i-sis.org.uk)
Over the past five years, at least 100 clinical trials of potential ALS treatments have failed. (bostonglobe.com)
How does the costs of clinical study compare to that of standard treatments? (mesotheliomasymptoms.com)
The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments," said Kathleen Uhl, director of the Office of Generic Drugs in the FDA's Center for Drug Evaluation and Research, in a press release. (pharmacytimes.com)

Generic drugs are a cheaper alternative to brand name drugs. (parkinson.org)
Based on his published record, he favors accelerated approval of cheaper generic drugs, and the streamlining of drug approvals generally. (heritage.org)
Do cheaper and less toxic drugs exist? (i-sis.org.uk)
After these expire, other companies can apply to get their cheaper "generic" copies of these drugs on the market. (vox.com)
Critics believe these provisions will likely to limit the availability of cheaper generics. (vox.com)

In his article, Frothingham reminds us that serious adverse drug effects in patients led to the withdrawal or restriction of 4 quinolones in the last decade and that safety may differ substantially among the quinolones discussed in Scheld's review (ciprofloxacin, gatifloxacin, levofloxacin, moxifloxacin) ( 2 ). (cdc.gov)
Recently in the past few months, post the outbreak of COVID-19, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US," Glenmark said. (livemint.com)
In another development, preliminary results from a US government trial showing that patients given Gilead Sciences Inc's experimental antiviral drug remdesivir recovered faster than those given a placebo. (livemint.com)
The U.S. Food and Drug Administration said it has been in discussions with Gilead about making remdesivi r available to patients as quickly as possible, but the agency declined to comment on any plans to grant the drug regulatory approval. (livemint.com)
The healthcare applications related with the market drugs and therapies is stemming the entire treatment regimen towards solving the unmet needs of the patients and gradually cause an upregulation in the market share and size. (researchandmarkets.com)
In the past few years, it can be observed that the overall reliability of the prostate cancer patients on the available drugs and therapies has increased, leading to the phase where clinical pipeline of the market has received unlimited approvals and launches by the regulatory bodies. (researchandmarkets.com)
We recognize the importance of answering the scientific question of whether hydroxychloroquine will be beneficial for patients with COVID-19 disease," said John Tsai, Head of Global Drug Development and Chief Medical Officer at Novartis. (novartis.com)
Patients in the trial will be randomized into three groups. (novartis.com)
As part of its research and development commitment, Novartis has formed a clinical investigation team to provide rapid access for approved clinical requests and support of clinical evaluation of its medicines to be repurposed and address the needs of patients with COVID-19 infections. (novartis.com)
In addition to hydroxychloroquine, Novartis plans to sponsor or co-sponsor clinical trials to study ruxolitinib and canakinumab for hospitalized patients with COVID-19 infections. (novartis.com)
In patients who had he is ovoid without quite sure the fact generic levitra online must cease immediately. (njacs.org)
The first hint that metformin might also have anticancer properties came a decade later, when two research teams separately reported that diabetes patients were less likely to develop cancer, and less likely to die from the disease, if they were taking the drug. (cnn.com)
The National Cancer Institute (NCI), for instance, is funding dozens of clinical trials that are currently under way or recruiting patients. (cnn.com)
In the new larger trial, 200 patients will be given three doses over two months and then be monitored for several months. (bostonglobe.com)
To preserve the integrity of the trial, patients aren't told whether they are receiving cells or a placebo. (bostonglobe.com)
As a result, patients are given the opportunity to take part in clinical trials as well. (mesotheliomatreatmentcenters.org)
While curing hepatitis C saves lives and prevents a lot of downstream healthcare costs for patients who, without this drug, could ultimately develop liver cancer or require a liver transplant, payers and politicians are in an uproar for a variety of reasons, not the least of which is that the drug is priced much higher in the U.S. than in the rest of the world. (forbes.com)
The lower price of generic drugs makes them more affordable for health service providers and patients compared with brand-name drugs. (britannica.com)
Both the American Cancer Society and the American Society of Clinical Oncology encourage patients to write down their questions before meeting with doctors and patient advocates. (mesotheliomasymptoms.com)
Trials often are 'double blind,' which means both the patient and the investigator running the study do not know which patients are taking the actual drug being studied. (rdhmag.com)
Drugs entering this phase are expected to mimic real life for the condition being studied, which usually means that the requirements for patients to enter the study become less restrictive. (rdhmag.com)
In clinical trials for Crestor, the most common adverse effects among the patients taking the drug were headache, pain in muscles, abdominal pain, weakness, and nausea. (pharmacytimes.com)
The Product and Administration Co-pay Programs are valid ONLY for patients with commercial (private or non-governmental) insurance who have a valid prescription for a Food and Drug Administration (FDA)-approved indication of a Genentech medicine. (lucentis.com)
The Drug Co-pay Program is not available or valid for patients receiving free medicine from the Genentech Patient Foundation. (lucentis.com)
We found that 70% of patients were aware of the availability of generic medicines, 60% understood the terms "generic" and "branded" in relation to medicines and 64% were conscious of generic substitution practice. (who.int)
Nearly half (47%) the patients stated they would refuse generic substitution of ciclosporin when it became available if this was just to save the health authority money. (who.int)
In our opinion, random generic substitution should not be implemented because there is still uncertainty and lack of knowledge among patients. (who.int)
RÉSUMÉ La présente étude a examiné les connaissances et la compréhension actuelles des patients en matière de substitution par des génériques. (who.int)
À notre avis, la substitution par des génériques ne doit pas être mise en œuvre de manière aléatoire en raison de l'incertitude et des faibles connaissances des patients. (who.int)
New Trials in Gynecological Cancers Enrolling Now Perhaps one of your patients could benefit from clinical trials now looking for patients with gynecological cancers. (medscape.com)
In randomized clinical trials , there was evidence of development of reduced susceptibility in some patients treated with baloxavir. (cdc.gov)
Drugs account for 2-5% of cases of patients hospitalized with jaundice and approximately 10% of all cases of acute hepatitis. (medscape.com)
Bromfenac (Duract), a nonsteroidal anti-inflammatory drug (NSAID), was introduced in 1997 as a short-term analgesic for orthopedic patients. (medscape.com)
Cost-effectiveness analysis of genotyping for HLA-B*15:02 in Indonesian patients with epilepsy using a generic model. (cdc.gov)
Bergqvist J, Iderberg H, Mesterton J, Bengtsson N, Wettermark B, Henriksson R. Healthcare resource use, comorbidity, treatment and clinical outcomes for patients with primary intracranial tumors: a Swedish population-based register study. (janusinfo.se)
Schmidt-Mende K, Andersen M, Wettermark B, Hasselström J. Educational intervention on medication reviews aiming to reduce acute healthcare consumption in elderly patients with potentially inappropriate medicines -A pragmatic open-label cluster randomized controlled trial in primary care. (janusinfo.se)

Dr. Rajesh Pahwa of the University of Kansas, a Parkinson's Foundation Center of Excellence, describes how generics compare to brand name products and what to look for, and look out for, when getting a generic or making the switch. (parkinson.org)
He has conducted more than 100 clinical trials related to Parkinson's disease and other movement disorders. (parkinson.org)
Although the use of SP-233 has been focused principally on the treatment of Alzheimer's disease, Samaritan claims that the drug can potentially treat Parkinson's disease and neurological disorder. (clinicaltrialsarena.com)

Taken separately, previous clinical trials of bisphosphonates in early breast cancer have shown mixed results, but taking all their results together, a clearer picture emerges. (ox.ac.uk)

Today, the majority of the countries in the region have local regulations aligned with the Declaration of Helsinki, Council for International Organizations of Medical Sciences, and International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines, and all of these countries have a regulatory agency responsible for pharmaceuticals, medical devices, and clinical research. (genengnews.com)
Gottlieb is well-known on Capitol Hill, where he has testified multiple times on hot-button health issues, including complex drug pricing matters, and is viewed favorably by the pharmaceuticals industry. (newsweek.com)
In this case, while some other EU countries implemented the EU Bolar Directive broadly, to exempt all clinical trials of both innovative and generic pharmaceuticals from patent infringement, the UK implemented it narrowly and applied it only to trials of generic drugs. (dyoung.com)

Clopidogrel pharmacogenomics: next steps: a clinical algorithm, gene-gene interactions, and an elusive outcomes trial. (sutterhealth.org)
The fast pace of progress in endometrial cancer has taken a step forward with two trials underlining the benefit of immunotherapy plus chemo, while suggesting adding a PARP inhibitor could further boost outcomes. (medscape.com)
Sveréus S, Larsson K, Rehnberg C. Clinic continuity of care, clinical outcomes and direct costs for COPD in Sweden: a population based cohort study. (janusinfo.se)

One of the biggest sticking points in the negotiations had to do with data protection for biologic drugs. (vox.com)

Since the drug development process can span over 15 years, drugs that have been approved by Health Canada and the FDA are awarded a 20-year patent that provides the manufacturer exclusive rights to sell the drug (referred to as market exclusivity) and to make back some of the money they spent before other companies can enter the market with a generic version. (medicalnewsbulletin.com)
Innovator drug companies strive to maintain their market share and recoup costs associated with the development process, while generic companies fight to remain competitive in the industry. (medicalnewsbulletin.com)
Forces influencing generic drug development in U.S. (sutterhealth.org)
Forces influencing generic drug development in the United States: a narrative review. (sutterhealth.org)
MAIN RESULTS: Generic drug manufacturers make decisions regarding development of products based on expected profitability, influenced by market forces, features of the reference listed drug, and manufacturing capabilities, as well as regulatory restrictions. (sutterhealth.org)
Barriers to the development of generic drugs include the challenge of demonstrating bioequivalence of some products, particularly those that are considered to be complex generics. (sutterhealth.org)
CONCLUSIONS: We present here a focused review describing the influences on generic manufacturers who are prioritizing drugs for generic development. (sutterhealth.org)
We also review proposed strategies that regulators may use to incentivize generic drug development. (sutterhealth.org)
In addition to this, the association of the entire market with numerous investments on their back has led to the profound identification and development of potential clinical products having numerous healthcare applications such as no major side effects and very less chances of cancer recurrence. (researchandmarkets.com)
With respect to understanding the entire mechanism of action of the cancer at early as well as advanced stage have completely shifted the market towards paradigmatic development of immunotherapies, several different chemotherapeutic agents and small molecule cancer drugs. (researchandmarkets.com)
This is not a cancer drug development story like any other," says Pollak, who led the 2006 study on metformin and enzymes. (cnn.com)
If you're looking to outsource drug product development to a CDMO, you need a collaborative partner who will engage you deeply to understand the unique needs of your project. (cambrex.com)
Biopharma companies at all stages of development, rely on our expertise and broad capabilities to produce the clinical trial supply of drug products they need, when they need them. (cambrex.com)
We understand that the commercial phase of drug development can be challenging, especially when it comes to manufacturing at scale and meeting changing market demands. (cambrex.com)
After drugs that target cholinergic neurotransmission, anti-amyloid therapies represent the next largest group of compounds in development for AD. (clinicaltrialsarena.com)
In addition to caprospinol (SP-233), Samaritan Pharmaceutical's pipeline also contains two other drugs in development for AD, SP-004 and SP-008, and two stem cell neuron differentiation therapies SP-sc4 and SP-sc7. (clinicaltrialsarena.com)
He is expected to encourage the agency to increase flexibility in the clinical trial development process. (newsweek.com)
various elements, including expanding Research and development ventures, the rising number of clinical preliminaries, and the ascent of FSP outsourcing in drug improvement. (marketresearch.com)
Generic drugs tend to be sold at a much lower price than brand-name drugs, because the companies that manufacture generics bypass the expense of research and development , clinical trials, regulatory approval, and marketing associated with brand-name drugs. (britannica.com)
Phase III trials are the next step in development. (rdhmag.com)
In China, the focus of drug research and development has gradually shifted from generic to innovative drugs. (bvsalud.org)
The goal of this work was to better understand the characteristics of and historical changes in innovative pediatric drug research and development (R&D) in China and to provide effective data support for policy makers and other stakeholders. (bvsalud.org)
The decision to include a boxed warning was based on the FDA's review of postmarketing safety reports and meetings held with the American Thyroid Association, the National Institute of Child Health and Human Development, and the pediatric endocrine clinical community. (medscape.com)
Even so, the agency is empowered to pursue as a crime the unauthorized development of vaccines and drugs - and sometimes goes after such cases to send a message. (medscape.com)
Genotyping HLA alleles to predict the development of Severe cutaneous adverse drug reactions (SCARs): state-of-the-art. (cdc.gov)

Theoretically, other companies could conduct their own trials to create a biosimilar, but because this is so expensive, it defeats the point. (vox.com)

Why was there a need for a different antiviral drug for flu? (cdc.gov)
More information regarding antiviral resistance is available on the Influenza Antiviral Drug Resistance webpage. (cdc.gov)
CDC's Influenza Division has taken specific actions in the laboratory to incorporate the antiviral drug baloxavir into routine virologic surveillance. (cdc.gov)

Extensive placebo-controlled clinical trials will be needed before metformin can be used as a standard cancer treatment. (cnn.com)

December 2004 marked 5 years since the Food and Drug Administration approved gatifloxacin and moxifloxacin and 8 years since the approval of levofloxacin. (cdc.gov)
Metformin, a diabetes drug, was approved by the Food and Drug Administration in 1995, and since then tens of millions of Americans with diabetes have taken it daily to control their blood sugar. (cnn.com)
A couple weeks ago, President Donald Trump nominated Dr. Scott Gottlieb to be commissioner of the powerful Food and Drug Administration. (heritage.org)
Cimetidine was developed as part of a research effort led by Nobel laureate Sir James Black, and was the first H2-antagonist to receive approval from the FDA (Food and Drug Administration) in 1977. (i-sis.org.uk)
The White House is expected as early as Friday to nominate Dr. Scott Gottlieb, a physician and conservative health policy expert, to lead the U.S. Food and Drug Administration, sources familiar with the matter said. (newsweek.com)
If confirmed by the Senate, Gottlieb would be in charge of implementing President Donald Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco. (newsweek.com)
If the trial is successful, the company plans to seek Food and Drug Administration approval to sell the treatment. (bostonglobe.com)
Out of those, only one might be approved for marketing by the Food and Drug Administration (FDA). (rdhmag.com)
Once the company thinks it has enough information from the animal testing, it applies to the Food and Drug Administration for approval to study the drug in humans. (rdhmag.com)
Between January and October 2013, the whistle-blower sent 15 emails to the United States Food & Drug Administration (USFDA), the World Health Organization (WHO), the Austrian Agency for Health and Food Safety (AGES) and the National Agency for Medicines and Health Products Safety (ANSM), requesting them to audit the facility. (thehindu.com)
In the last few years, the US Food and Drug Administration (FDA) has withdrawn 2 drugs from the market for causing severe liver injury: bromfenac and troglitazone. (medscape.com)
The Food and Drug Administration (FDA) concluded that the overall risk of liver toxicity from pemoline outweighs the benefits. (medscape.com)
These recommendations do not represent approval by the Food and Drug Administration (FDA) or approved labeling for the particular products or indications in question. (cdc.gov)
The Food and Drug Administration has launched a criminal investigation into research by a Southern Illinois University professor who injected people with his unauthorized herpes vaccine, Kaiser Health News has learned. (medscape.com)
Under a Supreme Court ruling , a corporate official may be prosecuted for a criminal misdemeanor offense under the Federal Food, Drug and Cosmetic Act even without proof that the official acted with intent or actual knowledge of the offense. (medscape.com)

In July, privately held Hetero Labs said it was also seeking a domestic emergency use nod for the experimental treatment, after interim data from its late-stage trial showed molnupiravir helped reduce hospitalisations in mild cases of COVID-19. (metro.us)

NOTE: The expectation is that the data generated as an outcome of this research award, including but not necessarily limited to any individual replicate/subject-level data (not just summary results), any model constructs/code and data sets that represent an outcome of the award will be shared with the FDA Office of Generic Drugs (OGD) prior to the completion of the award period. (nih.gov)

The notable Schedules and their summary: Schedule G: Most of these drugs are hormonal preparations. (wikipedia.org)

This way, manufacturers can move quickly to infiltrate the generic drug market with little to no competition before other generic companies have time to produce their products. (medicalnewsbulletin.com)
Multisource drug products listed under the same heading. (njacs.org)
clinical and nonclinical stage products. (marketresearch.com)
It is noted that the proposed changes will not apply to plant protection products, so Monsanto v Stauffer will still prohibit all UK field trials of such products for regulatory review. (dyoung.com)
Counterfeiting can apply to both branded and generic products. (who.int)
All imported products were 2 to 3 times more expensive than the locally produced generic products. (who.int)
Although the majority of generic products met the dissolution specification requirement that 80% of the drug must dissolve in 30 minutes, 1 generic product failed. (who.int)

When a drug patent expires, all other companies are free to produce their own generic versions. (medicalnewsbulletin.com)
Drug companies often scramble to find new uses so that they can extend their patent life and be the sole providers of the drug for a longer period of time. (medicalnewsbulletin.com)
Once the patent on a branded drug expires, other companies are free to apply for approval of a generic version - a drug that acts in the body largely the same as the branded one. (parkinson.org)
The U.S. patent on metformin expired in 2002, so the drug is now available in various generic versions that cost just pennies per pill. (cnn.com)
On 26 February 2013, the UK Government announced a proposal to change UK patent law to exempt clinical trials of innovative drugs, for both regulatory approval and health technology assessments, from patent infringement. (dyoung.com)
The question of whether research into a patented drug infringes the patent has been a controversial one in the UK for many years. (dyoung.com)
As this decision has never been overruled by a higher UK Court, this strict interpretation of the exemption has put the UK out of step with other EU countries, notably Germany, which exempted some clinical trials from patent infringement. (dyoung.com)
The combined effects of the above provisions have meant it has long been uncertain whether clinical trials of patented, innovative medicines in the UK constitute patent infringement. (dyoung.com)
The Government has accepted the need to change UK patent law to exempt from patent infringement activities involved in preparing or running clinical trials involving innovative drugs for the purpose of gaining regulatory approval in any country. (dyoung.com)
At the moment, it's up to countries to decide whether things like a small change in a drug molecule should warrant a patent extension. (vox.com)
To put it simply, this would directly target a country's ability to define its own patent law and put a higher standard on when generics can become available. (vox.com)
The manufacture of a generic drug is legal when the patent for the brand-name drug has expired, a patent was never issued, the patent will not be infringed, or the patent is not enforceable in the country where the generic drug is manufactured and sold. (britannica.com)
A company may also manufacture a generic drug if it can verify that the original brand-name drug patent was invalid or unenforceable. (britannica.com)
In anticipation of patent expiration, many companies with brand-name drugs create a generic product of their own or license the product to generic companies. (britannica.com)

Gottlieb is taking over the FDA at the very time that there is deep concern in the White House, Congress, and the nation over rising prescription drug prices. (heritage.org)
Gottlieb, like the president, believes that the current drug markets are dysfunctional and wants to intensify competition. (heritage.org)

It is worth noting that the saturation of clinical trial sites in Latin America as compared to the U.S. and Western Europe stands in stark contrast: the number of clinical trial sites per million in Latin America was 2, as compared to 82 in the U.S. and 11 in Western Europe. (genengnews.com)
Such lack of saturation in the region, coupled with high enrollment rates and growing regulations, make the growth of clinical trials in Latin America likely to continue all that much more in the future. (genengnews.com)
However, while the clinical trial application process in Latin America is seemingly straightforward, the process is not without its land mines. (genengnews.com)
These six countries represent over two-thirds of the population in Latin America and account for approximately 70% of the clinical trials there. (genengnews.com)

Tongkat Ali has no known severe interactions with other drugs. (rxlist.com)
This resulted in more than 50 cases of severe hepatic injury, and the drug had to be withdrawn in 1998. (medscape.com)
Updates on the immunopathology and genomics of severe cutaneous adverse drug reactions. (cdc.gov)
A Comprehensive Review of HLA and Severe Cutaneous Adverse Drug Reactions: Implication for Clinical Pharmacogenomics and Precision Medicine. (cdc.gov)
Pharmacogenetic Testing for Prevention of Severe Cutaneous Adverse Drug Reactions. (cdc.gov)
Genetic testing for prevention of severe drug-induced skin rash. (cdc.gov)

The National Institute on Drug Abuse also was crucial to the approval by forming a public-private partnership by designing and conducting the clinical trials required to determine that the intranasal formulation delivered naloxone as quickly and as effectively as an injection. (medscape.com)

December 28, 2022 - A clinical trial led by NCI has resulted in FDA approval of the immunotherapy drug atezolizumab (Tecentriq) to treat advanced alveolar soft part sarcoma. (nih.gov)
Prescription drug testing and approval is the agency's biggest headline-grabbing task. (heritage.org)
The administration is going to be pushing for quicker approval of drugs for all sorts of diseases with similar, vociferous patient populations who are crying out for a solution. (newsweek.com)
If approval is given, the compound moves on to the 'clinical testing' stage. (rdhmag.com)
A GVK Bio whistle-blower's personal crisis led to EU suspending approval for its generic drugs. (thehindu.com)
A legal protection that data collected (e.g. the results of clinical trials) for the purpose of obtaining marketing approval may not be used for a specified period by the regulatory authorities to grant approval to a generic equivalent. (who.int)
Specifically, the terms ``safe'' and ``effective'' are not synonymous with the FDA-defined legal standards for drug approval. (cdc.gov)

Schedule J: Contains a list of various diseases and conditions that cannot be treated under any drug currently in market. (wikipedia.org)
No drug may legally claim to treat these diseases. (wikipedia.org)
In some cases, clinicians are evaluating drugs that have been approved for other diseases, hoping that these will also work against COVID-19. (novartis.com)
Some countries have also allowed their manufacturers to produce generic drugs to treat major diseases when the health services of those countries have not been able to fund the cost of brand-name drugs. (britannica.com)
As such, it stabilizes the drug-abusing lifestyle, reducing criminal behaviors, and also reducing needle sharing and promiscuous behaviors leading to transmission of HIV and other diseases. (medscape.com)
Under the umbrella of the Innovative Medicines Initiative (IMI), we are generating new data and knowledge to facilitate tailored lifestyle and drug therapies, for the prevention and treatment of complex cardiometabolic diseases. (lu.se)

Two new studies, both published in The Lancet , suggest that two different classes of drugs, aromatase inhibitors (AIs) and bisphosphonates, can each improve survival prospects for postmenopausal women with early breast cancer. (ox.ac.uk)
Requests for investigator-initiated trials have been granted for COVID-19-related clinical studies of ruxolitinib, canakinumab, imatinib mesylate, secukinumab, hydroxychloroquine and valsartan. (novartis.com)
The drug hydroxychloroquine has garnered interest in the medical community after showing preliminary promise in small clinical studies, including one with co-administration with the antibiotic azithromycin. (novartis.com)
Phase I clinical studies yet to be started. (clinicaltrialsarena.com)
He also works as a surgery professor at the Mayo Medical School and has authored a number of peer reviewed studies, including clinical trials. (mesotheliomatreatmentcenters.org)
Studies in the biomedical area that are typically designed to expand scientific knowledge of human biology, disease mechanisms and processes, as well as to understand how drugs work. (who.int)
A proposed change to recommendations for cardiovascular disease (CVD) prevention, along with studies on associations between aspirin and other conditions, resulted in this week's top trending clinical topic. (medscape.com)

As the Brookings Institution explains, biologics are much more structurally complex than regular "small-molecule drugs" and are therefore more difficult and expensive to make, costing on average 22 times more than nonbiologic drugs. (vox.com)

However, 32% did not know if they were taking generics and 31% felt that generics were not equivalent or only sometimes equivalent to branded medicines. (who.int)
Cars T, Lindhagen L, Malmström R, Neovius M, Schwieler J, Wettermark B, Sundström J. Effectiveness of Drugs in Routine Care: A Model for Sequential Monitoring of New Medicines using Dronedarone as Example. (janusinfo.se)

The second study brings together evidence from another 20 000 women in 26 randomised trials, showing that 2-5 years of treatment with a class of drugs called bisphosphonates, which are usually used to treat osteoporosis, reduces the risk of breast cancer recurring in post-menopausal women, and also significantly extends survival. (ox.ac.uk)
The clinical management associated with the market such as teams offering novel healthcare strategies are also inclining the market towards splendid growth and a memento for superior treatment facilities. (researchandmarkets.com)
The clinical trial complements a commitment by Novartis, through Sandoz, to donate up to 130 million tablets of hydroxychloroquine to supply global clinical research efforts in the event the medicine is proven beneficial for treatment of COVID-19. (novartis.com)
Phillips RJ, cialis Fast Free Shipping to Australia Glyceryl trinitrate GTN nitroglycerin Filgrastim Ryder JE'Helping you get an erection Diphenhydramine Aldesleukin Coadministration of Viagra and other drugs for erectile dysfunction treatment should be avoided Many m This stimulation. (njacs.org)
More recently, warfarin is used as an anti-coagulating drug in the treatment of heart disease and stroke. (i-sis.org.uk)
According to the authors, this is an exceptional drug index that cannot be matched by any drugs currently used in the treatment of HIV/AIDS. (i-sis.org.uk)
Richard Vinci, with his wife, Michelle Geoffrion-Vinci, at Massachusetts General Hospital, where he is taking part in a late-stage clinical trial of a treatment for amyotrophic lateral sclerosis. (bostonglobe.com)
Antiviral drugs for flu treatment are not sold over the counter. (cdc.gov)

Internationally, data on the incidence of adverse hepatic drug reactions in the general population remain unknown. (medscape.com)
Genetic Variants Associated with T-Cell Mediated Cutaneous Adverse Drug Reactions: A Prisma-Compliant Systematic Review - an EAACI Position Paper. (cdc.gov)

Central Drugs Standard Control Organization. (wikipedia.org)

Besides the recommendations for CVD prevention, the USPSTF also changed the previous recommendation of aspirin for prevention of colorectal cancer, given evidence generated from large primary CVD prevention trials. (medscape.com)
Pharmacogenomic Advances in the Prediction and Prevention of Cutaneous Idiosyncratic Drug Reactions. (cdc.gov)

generic drug , therapeutic substance that is equivalent to a brand-name drug with respect to its intended use, its effects on the body, and its fate within the body. (britannica.com)

Le dosage en paracétamol a également été mesuré. (who.int)

ABSTRACT This survey examined current patient awareness and understanding of generic substitution. (who.int)

The meta-analysis included individual patient data on 18 766 women in 26 randomised trials, comparing between two and five years of bisphosphonates versus no bisphosphonate. (ox.ac.uk)
In doing so she overrode the recommendation of a panel of outside advisors and top scientists at the agency and set what some say is a precedent for approving drugs based on minimal data. (newsweek.com)
But, of course, the maker of the original drug doesn't want everyone using its data and making cheap knockoffs. (vox.com)
The FDA can't approve a similar drug that relies on the original data during this time. (vox.com)
Melissa Walton-Shirley, MD, a clinical cardiologist in Nashville, Tennessee, says that although she has no issue with the data, the public statement is incomplete at best and dangerous at worst. (medscape.com)
The data showed that, although some progress has been made in the R&D of innovative pediatric drugs in China, many factors limiting this progress still exist, such as concentrated R&D areas, inadequate pediatric participants, and unbalanced source distributions. (bvsalud.org)
Rational Vaccines has said it considered the 2016 trial a success - though it is unclear what data it used to support that claim. (medscape.com)

We also stock Generic Sildenafil, cialis is a medication approved by the FDA to treat erectile dysfunction. (njacs.org)

The most recent clinical trial was a Phase 2 trial, which was initiated on March 30th 2021. (drugpatentwatch.com)

It has also accepted that the proposed exemption should also apply to activities involved in health technology assessments, such as those carried out by the UK National Institute for Health and Clinical Excellence (NICE), which is the authority which decides whether the UK National Health Service (NHS) pays for an approved drug. (dyoung.com)

That refers to fixed-dose combinations of inexpensive generic cardiovascular drugs, whether or not in a single pill. (medscape.com)

After extensive testing and clinical trials, the FDA must approve drugs for their safety and effectiveness. (heritage.org)
Critics say moves to water down clinical trials could jeopardize patient safety. (newsweek.com)
Drug Safety. (lu.se)

The repurposed drug will be administered at the early stages of the disease in symptomatic outpatient adults to tone down what is known as the cytokine storm triggered by COVID-19. (biospace.com)

Images Quizzes Meningitis Quiz, if a study is submitted that demonstrates bioequivalence to a specific listed drug product. (njacs.org)
The regulation of generic drugs is based mainly on their bioequivalence (degree of similarity) to the original brand-name agents. (britannica.com)

Using the Chinese Clinical Trials Registry and Information Transparency Platform, we retrospectively analyzed clinical trials of innovative pediatric drugs conducted in mainland China over the last decade. (bvsalud.org)
This study included 198 innovative pediatric drug clinical trials. (bvsalud.org)
The level of innovative pediatric drug R&D in China currently lags behind the global level and has not kept pace with anti-neoplastic drug R&D in China. (bvsalud.org)

How is the global market for generic drugs evolving? (visiongain.com)
From our sites in Italy, Sweden, and the USA, we are a leading global supplier of generic APIs. (cambrex.com)
Coverage and Leading Companies) The global clinical trials market is on an impressive growth trajectory, with forecasts indicating a significant rise from its 2022 valuation of US$52.5 billion to an estimated US$79.9 billion by 2030. (marketresearch.com)
The GVK staffer wrote to global drug authorities raising doubts on clinical trials. (thehindu.com)

As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. (livemint.com)
Visiongain's study is intended for anyone requiring commercial analyses for the Generic Drugs Market. (visiongain.com)
In December 2006, the FDA requested Samaritan to present more information pertaining to the drug before taking up the first phase of clinical study. (clinicaltrialsarena.com)
The clinical trial and clinical study are synonymous. (who.int)
Real-time clinical note monitoring to detect conditions for rapid follow-up: A case study of clinical trial enrollment in drug-induced torsades de pointes and Stevens-Johnson syndrome. (cdc.gov)

New Trials in Prostate Cancer: Could Your Patient Benefit? (nih.gov)

Based on the anonymous emails received, a joint inspection was triggered by various International Regulatory Authorities at GVK Biosciences, Hyderabad, Clinical Unit between June 25 and July 4, 2012. (thehindu.com)

Anatomy1

Diseases30

Chemicals and Drugs42

Analytical, Diagnostic and Therapeutic Techniques and Equipment106

Psychiatry and Psychology11

Phenomena and Processes16

Disciplines and Occupations14

Anthropology, Education, Sociology and Social Phenomena12

Technology, Industry, Agriculture4

Humanities7

Information Science15

Named Groups4

Health Care94

Geographicals5

20239

Biosimilars3

Efficacy10

Investigational6

20203

Therapy7

Preclinical2

Pharmaceutical21

Medications6

Controller General of India2

Therapeutics2

Accelerate drug development1

Patents7

20185

Researchers13

India8

Treatments7

Cheaper5

Patients36

Parkinson's3

Mixed results1

Pharmaceuticals3

Outcomes3

Biologic Drugs1

Development25

Conduct1

Antiviral drug3

Placebo-controlled1

Food15

Experimental1

Office of Generic Drugs1

Preparations1

Products7

Patent14

Gottlieb2

Latin America4

Severe6

Formulation1

Approval7

Diseases6

Studies7

Small molecule1

Medicines2

Treatment8

Adverse2

Organization1

Prevention2

Therapeutic1

Dosage1

Substitution1

Data7

Erectile dysfunction1

20211

Excellence1

Inexpensive generic1

Safety3

Adults1

Bioequivalence2

Pediatric3

Global4

Study5

Prostate cancer1

Regulatory authorities1