Title: Drugs.com - New Drug Approvals, Description: New drug approvals news from Drugs.com. Comprehensive and up-to-date drug news for both consumers and healthcare professionals., By: Feedage Forager, ID: 893552, Grade: 97, Type: RSS091
The LiMAx® test is now commercially available in the UK. Humedics GmbH, a specialist in real-time measurement of individual liver function at bedside, today announced that the company has received the first Marketing Authorization for its diagnostic agent LiMAxetin®, which is needed to perform the LiMAx® test.. CE Mark for the LiMAx system was obtained in 2015, and application for Marketing Authorization for the diagnostic agent via the Decentralized Procedure in the UK, Austria and Germany, with Germany being the Reference Member State, was submitted in April 2016. Marketing Authorization for the diagnostic agent LiMAxetin® 4mg/ml solution for injection has now been granted by the UK healthcare authority, MHRA (Medicines and Healthcare Products Regulatory Agency), and additional marketing authorizations in Germany and Austria are expected to follow in short order.. Karsten Damgaard-Iversen, CEO of Humedics GmbH, stated: "This approval is a major milestone not only for Humedics, but also for ...
Contestants in TheStreet's FDA Drug Approval Contest think well of Sarepta, Navidea and Biogen, less so about Arena, Aveo and Delcath....ARNA
We included all new drugs approved for use in the USA, Europe and/or Canada from 2001 to 2010, identified in a prior study.5 To be clear, this sample was limited to approvals of new molecular entities or novel biological drugs and excluded reformulations of previously approved active pharmaceutical ingredients, combination therapies of active pharmaceutical ingredients that had been approved previously, and generic drug approvals. We then used the public websites of the governing regulators for each market, the FDA, the European Medicines Agency (EMA) and Health Canada, respectively, to ensure that all drugs conformed to the original papers inclusion criteria and reconfirm FDA approval dates for all drugs unapproved by the FDA in the original data set (using a cut-off date of 1 May 2016). In addition, we updated Health Canada approval dates using the Notice of Compliance (NOC) database, which provides the most accurate timing for Canadian market access.6. Drugs first approved outside the USA ...
Pharmacia & Upjohn Has Exclusive Rights in Europe. Foster City, CA -- May 1, 1997. Gilead Sciences, Inc. (NASDAQ:GILD) announced today that it has received marketing authorization for VISTIDE (cidofovir injection) from the European Commission (EC). This authorization allows the product to be marketed in all 15 countries of the European Union as an intravenous treatment for cytomegalovirus (CMV) retinitis in patients with AIDS. CMV retinitis is a rapidly progressing viral infection that may affect a patients vision over time and may ultimately lead to blindness in patients with late-stage AIDS. The ECs action follows a December 1996 recommendation for approval from the Committee for Proprietary Medicinal Products (CPMP). Pharmacia & Upjohn (P&U) has exclusive marketing rights for VISTIDE outside the United States. In Europe, an amendment will be filed to transfer the marketing authorization from Gilead to P&U. P&U will then begin making the product available throughout the European Union on a ...
TY - JOUR. T1 - Glioblastoma survival in the United States improved after Food and Drug Administration approval of bevacizumab. T2 - A population-based analysis. AU - Johnson, Derek R.. AU - Leeper, Heather E.. AU - Uhm, Joon H.. PY - 2013/10/1. Y1 - 2013/10/1. N2 - BACKGROUND Bevacizumab received US Food and Drug Administration approval for use in recurrent glioblastoma based on promising radiographic response data, but without clear evidence that it prolongs survival. A population-based analysis was conducted to determine whether bevacizumab approval was associated with improved glioblastoma survival in the United States. METHODS Surveillance, Epidemiology, and End Results (SEER) Program data were used to compare survival of glioblastoma patients who died in 2006, 2008 (both prior to approval of bevacizumab), and 2010 (after approval of bevacizumab). RESULTS The SEER database contained 1715 patients with glioblastoma who died in 2006, 1924 who died in 2008, and 1968 who died in 2010 who met ...
In view of the controversy regarding the diabetes drug Avandia, generic name rosiglitazone, an insight to the drug approval process might be in order. The question is how can this potentially serious adverse effects, (heart attack, stroke and the potential identified increased fracture rate), just now, (after more than 6 million people worldwide have taken Avandia since it came on the market in 1999 to treat type 2, the most common form of diabetes), come to light. About 1 million Americans are
Teva seeking EU regulatory approval for anti-CGRP therapy for the prevention of migraine JERUSALEM--(BUSINESS WIRE)--Feb. 2, 2018--, European Medicines Agency (EMA) Accepts Fremanezumab Marketing Authorization Application
DR ANTHONY MELVIN CRASTO, Worlddrugtracker, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India, in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now sSanofi, Searle India ltd, now Rpg lifesciences, etc. he is now helping millions, has million hits on google on all organic chemistry websites. His New Drug Approvals, Green Chemistry International, Eurekamoments in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 25 year tenure, good knowledge of IPM, GMP, Regulatory aspects, he has several international drug patents published ...
DR ANTHONY MELVIN CRASTO Ph.D , Born in Mumbai in 1964 and graduated from Mumbai University, Completed his PhD from ICT ,1991, Mumbai, India in Organic chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues,. Currently he is working with GLENMARK- GENERICS LTD, Research centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India.. Prior to joining Glenmark, he worked with major multinationals like Hoechst Marion Roussel, now Sanofi Aventis, & Searle India ltd, now Rpg lifesciences, etc. He has worked in Basic research, Neutraceuticals, Natural products, Flavors, Fragrances, Pheromones, Vet Drugs, Drugs, formulation, GMP etc. He has total 25 yrs exp in this field, he is now helping millions, has million hits on google on all organic chemistry websites.. His New Drug Approvals , Green Chemistry International, Eurekamoments in Organic Chemistry , Organic Chemistry by Dr Anthony, WIX BLOG , are some most read chemistry blogs. He has hands on ...
A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index , the SPDR S&P Biotech ETF ...
Newron Pharmaceuticals Release: Safinamide Marketing Authorization Application (MAA) Submitted To The European Medicines Agency - read this article along with other careers information, tips and advice on BioSpace
CTI BioPharma Announces European Medicines Agency Validation of Pacritinib Marketing Authorization Application for Patients with Myelofibrosis who have Thrombocytopenia
CTI BioPharma Announces European Medicines Agency Validation of Pacritinib Marketing Authorization Application for Patients with Myelofibrosis who have Thrombocytopenia
BASEL, Switzerland, Aug. 21, 2014-- Basilea Pharmaceutica Ltd. announces today that the European Medicines Agency has accepted its isavuconazole Marketing Authorization Application for review. Ronald Scott, Basileas CEO, stated: We are very pleased with the EMAs acceptance of our MAA for review.
WASHINGTON, June 3, 2014 /PRNewswire/ -- European Medicines Agency Accepts HETLIOZ™ (tasimelteon) Marketing Authorization Application for Non-24-Hour...
Santhera Submits Marketing Authorization Application to the European Medicines Agency for Puldysa® (Idebenone) in Duchenne Muscular Dystrophy - News & Meetings- DuchenneXchange
Dear Diana, Thank you so very much for that information. Doesnt it seem strange and sometimes disheartening, a smaller, much smaller country than ours is so far ahead in research for certain diseases. I just cant understand it. But, I am glad that there are many countries involved in seeing and researching to goals of wellness. God Bless and thank you for that. marty LINHILLIS wrote: , , Dear All , , FYI and file , Diana , , --------------------------------------------------------------- , , Subject: SciClone Obtains First European Marketing Approval and... , Date: Tue, 21 Apr 1998 13:30:26 EDT , From: AOL News ,[email protected], , Organization: AOL (http://www.aol.com) , , SciClone Obtains First European Marketing Approval and New Drug Application , For ZADAXIN(R) Thymosin Alpha 1 , , - Deal Positions the Company for a U.S. and , , Pan European Partnering Arrangement - , , SAN MATEO, Calif., April 21 /PRNewswire/ -- SciClone Pharmaceuticals (Nasdaq: , SCLN) today announced the signing of an ...
Ever wonder why medications are so expensive? The FDA approval process is long and arduous for many pharmaceutical companies. The investments are massive and the time needed to conduct the appropriate rounds of testing can take years, even decades. Granted, the FDA is invested in the safety and efficacy of medication-and rightly so. Join us on a peek behind the curtain on how a drug gets approved.
The ASCO Post article, "Ibrutinib CLL Trial: Where is the Equipoise?" published in May 2013, inaccurately conveyed that the Food and Drug Administration (FDA) requires an improvement in overall survival for chronic lymphocytic leukemia (CLL) drug approval and opposes allowing crossover in the RESONATE trial. To the contrary, the FDA recognizes the needs of patients with cancer and encourages drug companies to provide earlier patient access to promising therapies.. The FDA understands the challenges of showing an overall survival improvement in CLL, given the long natural history of the disease and availability of multiple therapies. Therefore, while we may request drug companies to collect overall survival data to ensure there is no detrimental effect on overall survival and to observe any potential improvement, an improvement in overall survival is not necessary for approval in CLL.. Recent FDA approvals for a CLL indication (bendamustine [Treanda] and rituximab [Rituxan]) were based on ...
Our research indicates that the FDA has exercised considerable flexibility in the approval of oncology drugs over the past decade. We found that the accelerated approval program has been used consistently in this time period, showing that sponsors interest in the program and the FDAs willingness to grant accelerated approvals have not waned. Indeed, in 2012, the FDA granted accelerated approval to five oncology drugs, matching its second-highest single-year total in the past 10 years. We also found that extension of OS, while still considered the gold standard by the FDA, is by no means required for approval in oncology. Even the conversion of accelerated approval to regular approval has frequently taken place without demonstration of an improvement in OS. Our research is consistent with a 2003 study conducted by the FDA, which found that 68% of drugs were approved on the basis of endpoints other than survival (29), as well as with a 2011 study that showed the FDAs flexibility in approving ...
Regulatory News: ERYTECH Pharma (Paris:ERYP) (ADR:EYRYY), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating therapeutic drug substances inside red blood cells, today announced that it has resubmitted to the European Medicine Agency (EMA) its Marketing Authorization Application (MAA) for eryaspase (GRASPA®) for the treatment of patients with relapsed or refractory (R/R) acute lymphoblastic leukemia (ALL). The MAA resubmission includes the data from ERYTECHs GRASPALL 2009-06 Phase 2/3 clinical trial in children and adults with R/R ALL as well as additional data to address the outstanding questions of the Committee for Medicinal Products for Human Use (CHMP) of the EMA. The GRASPALL Phase 2/3 trial, showed positive efficacy and safety results with GRASPA in combination with chemotherapy as compared to native L-asparaginase in patients with R/R ALL. The patients treated with GRASPA experienced a mean duration of L-asparaginase activity that was al
May 7, 2014 Santhera Pharmaceuticals announced todaythat it has re-filed with the European Medicines Agency (EMA) a Marketing Authorization Application (MAA) for Raxone® (idebenone) in the treatment of Lebers Hereditary Optic …. ...
Shares of Cempra (NASDAQ: CEMP) are down 5% mid-morning after the company said that it has withdrawn its marketing authorization application (MAA) seeking European Medicines Agency (EMA) approval of oral capsule and intravenous formulations of solithromycin for the treatment of community-acquired pneumonia in adults. The decision to withdraw was made based off of the Day…
CRANBURY, N.J., June 3, 2015-- Amicus Therapeutics, a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, has submitted a marketing authorization application to request full approval of the oral small molecule pharmacological chaperone Galafold for Fabry patients who have amenable genetic mutations.
First-of-its-Kind Product Further Adds to Allergans Robust Eye Care Portfolio. DUBLIN, April 25, 2017 /PRNewswire/ - Allergan plc, (NYSE: AGN) today announced that it has been granted marketing authorization from the U.S. Food and Drug Administration (FDA) for TrueTear™ Intranasal Tear Neurostimulator, the first and only FDA-cleared device developed to temporarily increase tear production during neurostimulation in adult patients.. TrueTear™ is a handheld stimulator with daily disposable tips that is inserted into the nasal cavity to induce the production of tears. There have been two clinical studies showing positive safety and effectiveness of the device in the increase of tear production completed with 145 aqueous deficient dry eye adult patients.. "TrueTear™ represents a technological breakthrough for eye care professionals as it delivers an effective, non-invasive and drug-free way to temporarily increase tear production," said David Nicholson, Chief R&D Officer, at Allergan. "As an ...
Brain tumor news: Guilford Pharmaceuticals Receives European Marketing Authorization for Expanded Use of GLIADEL(R) Wafer - GLIADEL(R) Approved to Treat Newly-Diagnosed Patients with Malignant Glioma
Teva Pharmaceutical Industries Ltd., (NYSE:TEVA) announced today that the European Commission has granted marketing authorization for DuoResp Spiromax
The European Commission has granted marketing authorization for Zydelig® (idelalisib), 150 mg tablets, a first-in-class oral treatment for two incurable...
Alnylam Announces Filing for Marketing Authorization of ONPATTRO® (patisiran) in Brazil for the Treatment of Hereditary ATTR Amyloidosis with Polyneuropathy - read this article along with other careers information, tips and advice on BioSpace
/PRNewswire/ -- Merck, a leading science and technology company, today announced that the European Medicines Agency (EMA) has accepted for review the Marketing...
droxidropa CHARLOTTE, N.C., Oct. 9, 2013 (GLOBE NEWSWIRE) -- Chelsea Therapeutics International, Ltd. today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that the New Drug Application (NDA) seeking approval to market Northera (droxidopa), an orally active synthetic precursor of norepinephrine, for the treatment of symptomatic neurogenic orthostatic hypotension (NOH)…
Gleevec (imatinib mesylate): Oral therapy for the treatment of chronic myeloid leukemia. New approved drug details including side effects, uses and general information.
Stivarga (regorafenib): For the treatment of gastrointestinal stromal tumor. New approved drug details including side effects, uses and general information.
Glucarpidase injection (Voraxaze) for the treatment of toxic plasma methotrexate concentrations (, 1 μmol/L) in patients with delayed methotrexate clearance due to impaired renal function ...
The European Commission has granted conditional marketing approval in the EU to pharmaceutical giant Pfizers (NYSE:PFE) lung cancer drug Xalkori, Pfizer stated in a press release Wednesday.. A conditional marketing authorization is renewable annually. The European Commission will consider converting it to a standard marketing authorization after Pfizer submits data from a recent trial to the European Medicines Agency.. Xalkori was approved in the U.S. in 2011 and has been approved in countries including Switzerland, Canada, South Korea, and Japan. Pfizer has submitted it for regulatory review in several other countries.. According to Pfizer: Xalkori is an oral, anaplastic lymphoma kinase (ALK) inhibitor. By inhibiting the ALK fusion protein, Xalkori blocks signaling in a number of cell pathways that are believed to be critical for the growth and survival of tumor cells, which may lead to growth inhibition or regression of tumor.. ...
Cangrelor, AR-C69931MX [dichloro-[[[(2R,3S,4R,5R)-3,4-dihydroxy-5-[6-(2-methylsulfanylethylamino)-2-(3,3,3-trifluoropropylsulfanyl)purin-9-yl]oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-hydroxyphosphoryl]methyl]phosphonic acid N-[2-(Methylthio)ethyl]-2-[(3,3,3-trifluoropropyl)thio]-5¢-adenylic acid monoanhydride with (dichloromethylene)bis[phosphonic acid] 163706-06-7 cas no Also known as: AR-C69931XX, 163706-06-7, Cangrelor (USAN/INN), Cangrelor [USAN:INN:BAN], UNII-6AQ1Y404U7, cangrelor (AR-C69931MX), Molecular Formula: C17H25Cl2F3N5O12P3S2 Molecular Weight: 776.359196 Cangrelor UPDATE Company: The Medicines Company Approval Status: Approved June 2015 Specific Treatments: For reducing periprocedural thrombotic events Therapeutic Areas Cardiology/Vascular Diseases, Company: The Medicines Company Approval…
On May 17, 2012, Osiris Therapeutics announced that Canadian health regulators approved Prochymal, its drug for acute graft-versus host disease in children who have failed to respond to steroid treatment. Prochymal is the first stem cell drug to be approved anywhere in the world for a systemic disease. Graft-versus-host disease, a potentially fatal complication from bone marrow transplant, involves the newly implanted cells attacking the patients body. Until now, there have been no approved treatments for the disease. Prochymal is designed to control inflammation and promote tissue regeneration. Since the drug is made up of bone marrow stem cells derived from an adult donor, it circumvents ethical concerns that are raised by the use of stem cells derived from embryos. The Canadian approval is contingent on Osiris conducting further post-market testing-and its anticipated that if the FDA approves the drug when marketing authorization is sought later this year, similar conditions would be imposed.
Healthcare Sales & Marketing Network: Medigus Announces Marketing Approval from the Israeli Ministry of Health (MEA) for SRS(TM) System for the Treatment of Gastroesophageal Reflux Disease (GERD)
Another key factor in the Biotech Industrys success has been the "patent cliff" major pharmaceuticals have faced in 2012. Major drug manufacturers have looked to biotech companies to help offset major revenue losses from expiring patents as it is less time consuming than developing new drugs through R&D. Five Star Equities releases regular market updates on the Biotech Industry so investors can stay ahead of the crowd and make the best investment decisions to maximize their returns. Take a few minutes to register with us free at www.FiveStarEquities.com and get exclusive access to our numerous stock reports and industry newsletters. Affymaxs mission is to discover, develop and deliver innovative therapies that improve the lives of patients with kidney disease and other serious and often life-threatening illnesses. The companys first marketed product, OMONTYS (peginesatide) Injection, was approved by the FDA in March 2012. SIGA Technologies is a pharmaceutical company specializing in ...
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Carfilzomib is a second generation, non-competitive, irreversible proteasome inhibitor. It contains the unusual (for drugs) epoxide group responsible for the irreversible binding to the target. It is differentiated from the first generation proteasome inhibitor bortezomib (boron-based) in this irreversible inhibition mechanism, which is believed to contribute to overcoming bortezomib resistance. Additionally, clinical trials have showed that carfilzomib is associated with fewer incidences of Peripheral Neuropathy (NP) (incidence reported 14% of patients with 1% having Grade 3 NP) in comparison with bortezomib (36% and 24% Grade 3). Epoxides are quite reactive, and can react with many proteins in a biological system ...
Latest solutions, case studies, interviews, practical articles for clinical trials operations, data management, technology, investigative sites and services.
Ibrutinib. Ibrutinib was approved by the FDA in February 2014 for the treatment of patients with CLL whose disease did not respond to at least one prior therapy.. Ibrutinib is an irreversible Bruton tyrosine kinase (BTK) inhibitor, leading to the decreased activity of downstream signaling events and, ultimately, the proliferation of leukemic cells.4,5. Furthermore, ibrutinib has been shown to suppress the expression adhesion proteins in the bone marrow microenvironment, impairing B-cell homing.6. The efficacy of ibrutinib in relapsed and heavily pretreated patients with CLL was demonstrated in a multicenter, nonrandomized, open-label, phase 1b/2 trial.7. In this trial, the overall response rate was 71% in both the 420-mg and 840-mg arms. Importantly, the response rate among patients with a 17p deletion was similar at 68%; however, patients with a mutated immunoglobulin variable-region heavy-chain (IGHV) gene had a significantly lower response rate (P=0.005).. The PFS and OS rates were 75% and ...
On June 22, 2017, the U.S. Food and Drug Administration granted regular approvals to dabrafenib and trametinib (TAFINLAR® and MEKINIST®, Novartis Pharmaceuticals Inc.) administered in combination for patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.. These are the first FDA approvals specifically for treatment of patients with BRAF V600E mutation-positive metastatic NSCLC.. The FDA today also approved the Oncomine™ Dx Target Test (Thermo Fisher Scientific), a next generation sequencing (NGS) test to detect multiple gene mutations for lung cancer in a single test from a single tissue specimen. This test detects the presence of BRAF, ROS1, and EGFR gene mutations or alterations in tumor tissue of patients with NSCLC. This test can be used to select patients with NSCLC with the BRAF V600E mutation for treatment with the combination of dabrafenib and trametinib. This is the first NGS oncology panel test approved by the FDA ...
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that we may not file a marketing authorization for R/F/TAF in the European Union in the currently anticipated timelines. In addition, there is the possibility that the FDA and other regulatory authorities may not approve F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF or other F/TAF-based regimens in the currently anticipated timelines or at all, and marketing approvals, if granted, may have significant limitations on their use. As a result, F/TAF, E/C/F/TAF, R/F/TAF, D/C/F/TAF and other F/TAF-based regimens may never be successfully commercialized. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are ...
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including the risk that Genvoya may not be approved by other regulatory authorities and the marketing applications for F/TAF and/or R/F/TAF may not be approved by the EMA, and marketing approvals, if granted, may have significant limitations on their use. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. The reader is cautioned not to rely on these forward-looking statements. These and other risks are described in detail in Gileads Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, as filed with the U.S. Securities and Exchange Commission. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such ...
2015 was a good year for innovation in medicine in both the EU and the US, according to data published on Monday (4 January).. The European Medicines Agency (EMA) recommended 93 new products, including generics, up from 82 in 2014. Across the Atlantic, the Food and Drug Administration (FDA) approved 45 novel drugs, four more than in 2014 and the most since the all-time record of 53 set in 1996.. But despite the rosy statistics and the prospect for further progress in 2016, the pharmaceuticals industry faces challenges, with increased political focus on drug pricing having punctured both biotech and specialty pharma valuations in recent months.. The prospect of Hillary Clinton becoming president of the United States could further undermine confidence in the sectors profitability in 2016, given her pledge to rein in drug costs. But any changes in the US pricing model are likely to be gradual, according to Bernstein analyst Tim Anderson.. Big pharmaceutical companies, meanwhile, are still ...
The World Health Organization (WHO) is the United Nations leading regulatory authority for international public health. According to WHO, access to essential and quality medicines is a basic human right.1 Because of the unique way the pharmaceutical industry impacts human health and well-being, WHO plays an important role in regulating international drug approval and marketing. Quality, safety and efficacy (QSE) are the fundamental requirements for marketing a drug in any country. Any new drug must meet adequate quality standards and have sufficient clinical evidence to demonstrate its safety and effectiveness before it can enter the market.2 New drug approval is a highly complex process that requires a high level of expertise and resources, and large, well-trained, experienced multidisciplinary teams with the capability to review and evaluate all aspects of new products. Only a few regulatory agencies, mainly in welldeveloped, industrialized countries, are competent to effectively evaluate new ...
While the bill has the support of Republicans, Democrats, some medical groups, patient groups, and the drug industry, it has also attracted criticism.. For one thing, its not clear that this legislation can solve the problem thats really at the heart of why more lifesaving drugs arent making it onto the market - the lack of promising treatments in the pipeline. A faster approval process cant fix a dearth of innovation from labs themselves.. "If theres a shortfall in drug development, it is mostly because the companies have lost their verve in their ability to discover new drugs. You cant legislate that away," Jerry Avorn, a professor of medicine at Harvard Medical School, told the Washington Post.. "Lowering FDA standards for approving drugs and antibiotics without evidence of clinical benefit - I dont think thats going to help, but it could also harm patients. What we dont need is more drugs approved based on lab tests instead of patient benefit.". Critics of the bill have also ...