• Atossa Therapeutics is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology. (atossatherapeutics.com)
  • Fate Therapeutics, Inc. is a clinical-stage biopharmaceutical company. (stockhouse.com)
  • Previously, Mr. Glover was Co-Founder and Chief Business Officer of Coherus BioSciences, a commercial biologics platform Company focused on delivering biosimilar therapeutics and novel immuno-oncology products which went public in 2014. (tmcnet.com)
  • TAIPEI , Sept. 18, 2023 /PRNewswire/ -- Caliway Biopharmaceuticals (Caliway), a biopharmaceutical company focusing on breakthrough medical aesthetics and inflammatory medicine discovery of small-molecule therapeutics, announced the completion of subject recruitment in the CBL-0201EFP Phase 2-stage 2 study. (wkrn.com)
  • Protagonist Therapeutics, Inc. is a biopharmaceutical company. (marketscreener.com)
  • The company specializes in RNA interference therapeutics for genetically defined diseases. (investmentu.com)
  • Another company focused on cancer and immune disorders, Fate Therapeutics (Nasdaq: FATE) focuses on cellular therapy. (investmentu.com)
  • AUTO-1/22 is under clinical development by Autolus Therapeutics and currently in Phase II for Hairy Cell Leukemia. (pharmaceutical-technology.com)
  • Autolus Therapeutics (Autolus), formerly Autolus Therapeutics is a clinical-stage biopharmaceutical company. (pharmaceutical-technology.com)
  • vTv Therapeutics Inc, a clinical-stage biopharmaceutical company, focuses on the development of orally administered treatments for diabetes. (etfdailynews.com)
  • Receive News & Ratings for vTv Therapeutics Daily - Enter your email address below to receive a concise daily summary of the latest news and analysts' ratings for vTv Therapeutics and related companies with MarketBeat.com's FREE daily email newsletter . (etfdailynews.com)
  • BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics. (globenewswire.com)
  • BOTHELL, Wash., Aug. 20, 2015 -- (Healthcare Sales & Marketing Network) -- Alder BioPharmaceuticals, Inc. ("Alder") (ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, autoimmune and inflammatory diseases, today announced the appointment of Paul B. Cleveland to its Board of Directors. (salesandmarketingnetwork.com)
  • Landos Biopharma is a clinical stage biopharmaceutical company focused on the development of first-in-class, oral therapeutics for patients with autoimmune disease. (wreg.com)
  • Biomed Industries™, Inc. is a bio-pharmaceutical company committed to the development and commercialization of new drug therapeutics for unmet needs. (webnewswire.com)
  • Caliway Biopharmaceuticals (Caliway), is a Taiwan -based, clinical-stage biopharmaceutical company driven to breakthrough drug discovery of novel small-molecule therapeutics to help patients suffering from illness or life-threatening diseases. (mywabashvalley.com)
  • PARIS, FRANCE / ACCESSWIRE / June 8, 2023 / Abivax SA (Euronext Paris: FR0012333284 - ABVX), a Phase 3 clinical-stage biotechnology company focused on developing therapeutics that modulate the immune system to treat patients with chronic inflammatory diseases, today announces the appointment of Ida Hatoum as Chief People Officer. (bignewsnetwork.com)
  • Abivax is a Phase 3 clinical stage biotechnology company, focused on developing therapeutics that modulate the immune system to treat patients with chronic inflammatory diseases. (bignewsnetwork.com)
  • Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the appointment of Jim Kelly as Executive Vice President, Chief Financial Officer (CFO) and Treasurer, and Nasir Egal, Ph.D. as Senior Vice President, Quality Assurance. (pharmiweb.com)
  • Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved health globally through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. (pharmiweb.com)
  • PALO ALTO, Calif., Jan. 8, 2018 -- (Healthcare Sales & Marketing Network) -- Eiger BioPharmaceuticals, Inc. (Nasdaq: EIGR), focused on the development and commercialization of therapies for rare diseases, announced today the appointment of Eldon Mayer to its Board of Directors. (salesandmarketingnetwork.com)
  • TEL AVIV, Israel , July 7, 2022 /PRNewswire/ -- Galmed Pharmaceuticals Ltd. (Nasdaq: GLMD) ("Galmed" or the "Company"), a clinical-stage biopharmaceutical company for liver, metabolic, fibrosis and inflammatory diseases, announced today results showing significant effects of Aramchol in pre-clinical model of both lung and gastrointestinal (GI) fibrosis. (prnewswire.com)
  • GAITHERSBURG, Md. and BASEL, Switzerland, Nov. 10, 2020 (GLOBE NEWSWIRE) -- Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it entered into an agreement with Lonza for the manufacturing of AdCOVID ™ , Altimmune's next-generation, single-dose intranasal vaccine candidate for COVID-19. (yahoo.com)
  • BOSTON, Sept. 19, 2023 (GLOBE NEWSWIRE) -- HilleVax, Inc. (Nasdaq: HLVX), a clinical-stage biopharmaceutical company focused on developing and commercializing novel vaccines, today announced that it intends to offer and sell, subject to market and other conditions, $100.0 million of shares of its common stock in an underwritten public offering. (wfla.com)
  • SAN DIEGO, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced its participation in the upcoming Cantor Global Healthcare Conference 2023 being held in New York. (abc4.com)
  • NEW YORK, Nov. 21, 2023 (GLOBE NEWSWIRE) -- Landos Biopharma, Inc. (NASDAQ: LABP), a clinical-stage biopharmaceutical company developing novel, oral medicines for patients with autoimmune diseases, today announced a peer-reviewed publication describing the safety, tolerability, pharmacokinetic and clinical efficacy results for the NX-13 Phase 1b trial in patients with ulcerative colitis (UC) in the Journal of Crohn's and Colitis . (wreg.com)
  • Mr. Finn joined the Company as a director in November, 2023. (atossatherapeutics.com)
  • Eiger BioPharmaceuticals, Inc.'s ISS Governance QualityScore as of September 1, 2023 is 9. (yahoo.com)
  • The Company anticipates the FDA will file the rolling NDA by mid-November 2023. (itbusinessnet.com)
  • The Company initiated the rolling submission of the NDA in May 2023 based on data from the FIREFLY-1 trial with a data cutoff as of December 22, 2022. (itbusinessnet.com)
  • An updated Clinical Study Report (CSR) was submitted to the FDA with an additional six months of safety and efficacy data through June 5, 2023. (itbusinessnet.com)
  • FARON ), a clinical-stage biopharmaceutical company focused on tackling cancers via novel immunotherapies, announces that the extraordinary general meeting (the "EGM") of the Company took place today, September 22, 2023 in Turku, Finland. (streetinsider.com)
  • LONDON, Nov. 15, 2023 (GLOBE NEWSWIRE) -- Myricx Bio ('Myricx'), a UK biotech company focused on the discovery and development of a completely novel class of antibody-drug conjugate (ADC) payloads. (globenewswire.com)
  • LONDON, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Myricx Bio ('Myricx'), a UK biotech company focusing on the discovery and development of a completely novel class of selective cytotoxic payloads for. (globenewswire.com)
  • San Francisco, California, USA, Aug. 31, 2023 (GLOBE NEWSWIRE) -- US Capital Global has been engaged by PlantForm Corporation ("PlantForm" or the "Company") as its strategic financial advisor on a. (globenewswire.com)
  • First Patient Dosed in Phase Ⅲ Study of JSKN003 for the Treatment of Advanced HER2-Low Breast Cancer Share: SUZHOU, China, Dec. 4, 2023 /PRNewswire/ -- Alphamab Oncology (stock code: 9966.HK) announced the first patient has been dosed in the phase III clinical study (JSKN003-302) of anti-HER2 bispecific antibody-drug conjugate JSKN003 for treatment of advanced HER2-low breast cancer. (cbinsights.com)
  • Its lead product candidate is Lonafarnib, an orally bioavailable, small molecule, which is in Phase III clinical trials to treat hepatitis delta virus infection. (yahoo.com)
  • and Avexitide for the treatment of congenital hyperinsulinism, as well as has completed Phase II clinical trials to treat post-bariatric hypoglycemia. (yahoo.com)
  • Novavax is conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. (pharmiweb.com)
  • The company also will produce batches for Phase III trials and commercial supply. (genengnews.com)
  • This agreement will speed our ORALAIR® Bet v 1 project towards late-stage clinical trials and registration while securing the supply of active ingredients for commercial batches," remarks Albert Saporta, chairman and CEO of Stallergenes. (genengnews.com)
  • Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval. (pharmaceutical-technology.com)
  • These latest results further suggest the potential of this investigational therapy to bring transformational benefit to eligible patients living with severe hemophilia A, if confirmed in ongoing clinical trials," said Seng H. Cheng, Senior Vice President and Chief Scientific Officer, Pfizer Rare Disease. (pharmiweb.com)
  • Currently, the company has four products on the market, four in late-stage clinical trials and six in development. (investmentu.com)
  • Strong results from clinical trials and a huge potential market for therapy makes ALX Oncology Holdings Inc. a bright prospect as an oncology-focused investment. (investmentu.com)
  • The company has four products in its pipeline, in varying stages of clinical trials. (investmentu.com)
  • The company has a strong and promising pipeline, with five products in first-stage clinical trials and several more in preclinical stages. (investmentu.com)
  • An examination of how clinical trials have changed in Australia over the past 15 years has identified challenges such as. (biospectrumasia.com)
  • According to a February 2022 report by Research and Markets, the clinical trials market in India was estimated to be val. (biospectrumasia.com)
  • Agilex Biolabs, the leading bioanalytical laboratory supporting Australian clinical trials, has established its first sa. (biospectrumasia.com)
  • The PPD clinical research business of Thermo Fisher Scientific Inc. and Matrix Clinical Trials, a Matrix Medical Ne. (biospectrumasia.com)
  • Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed two Phase 2b clinical trials. (salesandmarketingnetwork.com)
  • This press release contains forward-looking statements, including statements regarding the further development of ALD403 and ALD1613, our expectations for the initiation of future clinical trials and studies, availability of clinical trial data, patient enrollment and the potential of ALD403, ALD1613 and clazakizumab to address the unmet medical needs of patients. (salesandmarketingnetwork.com)
  • He continued, "Our massive data set on dementia, culled from over 3,000 clinical trials as well as over 7,000 published papers on the topic will empower deep analysis of the state-of-the-art in the field and to focus our considerable AI and machine learning capabilities to rapidly accelerate new drug development. (webnewswire.com)
  • Based in Paris and Montpellier, Abivax's lead drug candidate, obefazimod (ABX464), is in Phase 3 clinical trials for the treatment of ulcerative colitis. (bignewsnetwork.com)
  • In the two trials combined, more than 55% of patients on continuous bimekizumab achieved HiSCR75 at week 48 in the observed case analysis, according to a news release from biopharmaceutical company UCB. (medscape.com)
  • It is further discussed how these contribute to an improved and flexible DP development through the acceleration of the iterative build-measure-learn cycle in laboratories and clinical trials. (bvsalud.org)
  • Eiger BioPharmaceuticals, Inc., a commercial-stage biopharmaceutical company, focuses on the development and commercialization of targeted therapies for rare and ultra-rare diseases in the United States and internationally. (yahoo.com)
  • Eiger BioPharmaceuticals, Inc. was founded in 2008 and is headquartered in Palo Alto, California. (yahoo.com)
  • NGM Biopharmaceuticals (NGM) delivered earnings and revenue surprises of 13.46% and 166.31%, respectively, for the quarter ended December 2022. (barchart.com)
  • Paris - 18 February 2022 - Euronext today congratulates Aelis Farma, a biopharmaceutical company specialising in the treatment of brain diseases, on its listing on Compartment B of Euronext's regulated market in Paris (ticker code: AELIS). (euronext.com)
  • Philochem is a fully owned subsidiary of the Philogen Group, a Swiss-Italian clinical-stage biotechnology company listed on the Italian Stock Exchange. (biospace.com)
  • Having co-founded and led multiple successful biotechnology companies and drug development initiatives spanning the breadth of biotech's most prominent therapeutic areas, Steve's skillset is perfectly aligned to lead the next phase of Ambrx's growth and clinical development. (tmcnet.com)
  • About Aelis Farma Aelis Farma is a biotechnology company founded in 2013 that has developed a new class of drugs, the signalling specific inhibitors of the CB1 receptor (CB1-SSi), of which two compounds are at clinical stage. (euronext.com)
  • China's Clover Biopharmaceuticals, a global clinical-stage biotechnology company developing novel vaccines and biol. (biospectrumasia.com)
  • SAN DIEGO , July 8, 2011 /PRNewswire/ -- HUYA Bioscience International, a leader in globalizing China 's biopharmaceutical innovations, today announced a strategic partnership with the Liaoning (Benxi) Bio-pharmaceutical Industry Base. (biospace.com)
  • While the company's stock has suffered recently, it remains a contender in the immuno-oncology biopharmaceutical space. (investmentu.com)
  • Mr. Finn is also a Founding Partner of Scientia Ventures, a manager of venture capital funds that invest in companies targeting computational biology and chemistry, the digitization of medicine, digital therapies, and traditional drug development businesses at the cutting edge of the life sciences industry. (atossatherapeutics.com)
  • He currently serves as director of Verigraft AB, a regenerative medicine venture, Rose Pharma LLC, a development stage specialty pain company and Solör Bioenergy Holdings AB, a bioenergy business. (atossatherapeutics.com)
  • Together, we will help promote the acceleration and development of China 's emerging biopharmaceutical industry. (biospace.com)
  • His broad industry and operational background will be invaluable as we prepare for late stage clinical development and begin commercial planning across the entire Eiger pipeline. (salesandmarketingnetwork.com)
  • I am very pleased to join Eiger's Board at this exciting point in the Company's evolution to late stage development, and look forward to working closely with the other Board members and Eiger's management team to advance a diverse set of exciting clinical stage orphan disease programs in therapeutic areas of high unmet medical need," said Mr. Mayer. (salesandmarketingnetwork.com)
  • Eiger is a clinical-stage biopharmaceutical company focused on the development and commercialization of targeted therapies for orphan diseases. (salesandmarketingnetwork.com)
  • The new findings, together with the robust anti-fibrotic effects demonstrated in clinical studies of patients with NASH and advanced fibrosis could potentially enable Galmed to quickly transition to Phase 2/3 clinical studies with Aramchol in indications with unmet need and faster development pathways. (prnewswire.com)
  • Galmed Pharmaceuticals Ltd. is a clinical stage drug development biopharmaceutical company for liver, metabolic and inflammatory diseases. (prnewswire.com)
  • This new collaboration will focus on the development and commercialization of a small molecule for imaging applications, which promises to improve the diagnosis, staging and monitoring of response-to-treatment for cancer patients. (biospace.com)
  • Both companies are committed to the development of the product and making it available to patients who may benefit from it. (biospace.com)
  • The company is focused on the development and delivery of human antibodies and cytokine responses to the treatment of cancer. (morningstar.com)
  • The company is actively engaged in the development of Pritumumab which would be used for the treatment of brain cancer and pancreatic cancer. (morningstar.com)
  • Stallergenes and CMC Biopharmaceuticals inked an agreement for development and supply of recombinant Bet v 1 (rBet v 1) purified bulk. (genengnews.com)
  • Mr. Glover has extensive experience building successful biopharmaceutical companies, with a focus on pharmaceutical business strategy, corporate development, product development, commercialization, and business optimization. (tmcnet.com)
  • His strategic and operational experience, which covers most therapeutic classes of biopharmaceuticals, includes strategic planning, corporate development, operations management, product development, and clinical and regulatory oversight. (tmcnet.com)
  • ZyVersa is a clinical stage biopharmaceutical Company advancing a dynamic pipeline of drug candidates with multiple programs built around two proprietary technologies - Cholesterol Efflux Mediator™ VAR 200 in development to ameliorate renal lipid accumulation that damages the kidneys' filtration system in patients with glomerular kidney disases, and Inflammasome ASC Inhibitor IC 100, targeting damaging inflammation associated with numerous CNS and other inflammatory diseases. (tmcnet.com)
  • Prior to joining Precigen, Mr. Shah spent more than a decade in scientific positions focused on the development of protein, antibody, gene and cell therapy drugs at Zyngenia, Teva Biopharmaceuticals USA, CoGenesys, and Human Genome Sciences. (bio.org)
  • UCART-22 is under clinical development by Cellectis and currently in Phase II for B-Cell Acute Lymphocytic Leukemia (B-Cell Acute Lymphoblastic Leukaemia). (pharmaceutical-technology.com)
  • The company carries out research and development in the field of oncology and gene editing. (pharmaceutical-technology.com)
  • GlobalData's Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). (pharmaceutical-technology.com)
  • Stelis BioSource® is an outsourcing partner for process development, current good manufacturing practice (cGMP) production and aseptic filling of biopharmaceutical products. (pharmaceutical-business-review.com)
  • The company is the contract development manufacturing organisation (CDMO) division of Stelis Biopharma, a pure-play, independent biopharmaceutical company. (pharmaceutical-business-review.com)
  • With its end-to-end capabilities, Stelis handles development stages ranging from pre-clinical to commercial for recombinant proteins expressed in both microbial and mammalian systems. (pharmaceutical-business-review.com)
  • Set up in 2014 with 22,000ft 2 of lab space, Stelis BioSource's modern research and development (R&D) facility in Bangalore offers a wide range of capabilities and employs scientists with the competency and experience necessary to develop biopharmaceuticals to regulated market standards. (pharmaceutical-business-review.com)
  • The company's early stage development offerings include cell banking and characterisation. (pharmaceutical-business-review.com)
  • We are excited about the potential of our AdCOVID vaccine candidate and are actively focused on expanding our network of strategic manufacturing partners to ensure Altimmune's commercial readiness to supply vaccine in 2021 should our clinical data support this advancement," said Dr. Vyjoo Krishnan, Ph.D., Vice President of Product Development for Altimmune. (yahoo.com)
  • The Company uses its peptide-based chemical entities rusfertide and JNJ-2113 in different stages of development, all derived from its proprietary discovery technology platform. (marketscreener.com)
  • Its lead clinical asset, rusfertide (PTG-300), is an injectable hepcidin mimetic in development for the treatment of erythrocytosis, iron overload and other blood disorders. (marketscreener.com)
  • HilleVax intends to use the net proceeds from the proposed offering to fund the clinical development of HIL-214, including certain manufacturing activities, and for working capital and general corporate purposes. (wfla.com)
  • The Company works on innovation and new product development for global markets. (business-standard.com)
  • Sun Pharmaceutical Advanced Research Company Ltd was incorporated on March 1 2006 as an innovative and development company. (business-standard.com)
  • The company is currently developing two new drug candidates in clinical development, AEF0117, for the treatment of cannabis use disorders, and AEF0217, for the treatment of cognitive disorders including those linked to trisomy 21. (euronext.com)
  • AEF0217, which targets cognitive disorders such as those caused by Down syndrome, recently entered phase 1 clinical development. (euronext.com)
  • As a follow-up to this blog we posted last year, PhRMA is excited to share new data that provides a fresh look at the significant investment of America's biopharmaceutical companies make in R&D. In 2015, PhRMA member companies invested an estimated $58.8 billion in research and development (R&D), up 10.3 percent from 2014. (phrma.org)
  • This week on Fact Check Friday, we're getting to the heart of the biopharmaceutical industry's investment and role in research and development (R&D) of new medicines. (phrma.org)
  • We are currently focused on advancing the clinical development of NX-13 in UC. (wreg.com)
  • These risks, contingencies and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates. (bignewsnetwork.com)
  • Special consideration should be given to the potential hurdles of clinical and pharmaceutical development including further assessment by the company and regulatory agencies and IRBs/ethics committees following the assessment of preclinical, pharmacokinetic, carcinogenicity, toxicity, CMC and clinical data. (bignewsnetwork.com)
  • About Alphamab Oncology Alphamab Oncology is a biopharmaceutical company dedicated to the discovery, development manufacturing and commercialization of world-class innovative biotherapeutics for cancer treatment. (cbinsights.com)
  • To make cancer manageable and curable Alphamab Oncology has always been guided by clinical value and patient needs, and focuses on the development of innovative, safe and affordable anti-tumor drugs to benefit patients in China and around the world. (cbinsights.com)
  • Among them, The world's first subcutaneous PD-L1 inhibitor injection (Envafolimab) has been obtained the market approval by the Chinese National Medical Products Administration, several varieties have entered the critical clinical stage in China and the United States, 2 varieties were selected into the national special project of ' New Drug Development', and 3 varieties were granted 4 orphan drug qualifications by FDA. (cbinsights.com)
  • Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. (aap.com.au)
  • In this Perspective, a review of ideas/techniques along with supporting technologies that can be applied at each stage of DP development is shared. (bvsalud.org)
  • Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease. (prnewswire.com)
  • Ida will be responsible for Abivax's growth strategy in the United States and Europe, ensuring the appropriate staffing of the Company to successfully conduct the ongoing Phase 3 clinical program of obefazimod in ulcerative colitis as well as its subsequent commercialization and market access, provided the drug candidate obtains the required regulatory approvals. (bignewsnetwork.com)
  • While solutions to these common problems exist at large pharma companies, and are typically proprietary, the selection of tools for smaller biotech companies is limited. (torx-software.com)
  • Zosano Pharma Corp is a clinical-stage biopharmaceutical company. (gurufocus.com)
  • Sun Pharma Advanced Research Company Ltd. (SPARC) is a clinical stage bio-pharmaceutical company engaged in creating new drugs and delivery systems. (business-standard.com)
  • of India approval for Paclitaxel Injection Concentrate for Nanodispersion (PICN).On 1 December 2014 Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops. (business-standard.com)
  • On 4 March 2015 Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for ELEPSIA XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg). (business-standard.com)
  • The product will be manufactured by Sun Pharmaceutical Industries Ltd at its Halol (Gujarat) facility in India.On 9 June 2015 Sun Pharma Advanced Research Company Ltd. (SPARC) and Sun Pharmaceutical Industries Ltd. announced that SPARC has licensed out Xelpros (Latanoprost BAK-free eye drops) to a subsidiary of Sun Pharma for the US market. (business-standard.com)
  • On 1 August 2015 Sun Pharma Advanced Research Company Ltd. (SPARC) announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Xelpros Latanoprost BAK-free eyedrops. (business-standard.com)
  • SPARC had recently out-licensed this product to a subsidiary of Sun Pharmaceutical Industries Ltd (SPIL).On 25 September 2015 Sun Pharma Advanced Research Company Ltd. announced that the U.S. Food and Drug Administration (USFDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Elepsia XR (Levetiracetam extended-release tablets 1000 mg and 1500 mg). (business-standard.com)
  • Covington's client, Merck, agreed to acquire Acceleron Pharma, an American clinical stage biopharmaceutical company, in an $11.5 billion merger. (cov.com)
  • Prior to joining Abivax, Ida was Senior Vice President and Head of People Talent and Culture at CinCor Pharma, where she successfully managed and lead the recruitment strategy and organizational design of the company during a period of strong growth. (bignewsnetwork.com)
  • The figure demonstrates that the biopharmaceutical industry invested more on R&D than the entire operating budget of the National Institutes of Health (NIH), which totaled $30.3 billion. (phrma.org)
  • HUYA is one of the first companies to have recognized China 's potential to help meet the global need for new preclinical and clinical stage compounds. (biospace.com)
  • In addition, Ambrx has preclinical and clinical collaborations with multiple partners on drug candidates generated using Ambrx technology. (tmcnet.com)
  • Alphamab Oncology is a clinical-stage biopharmaceutical company that develops and markets biotherapeutics for cancer treatment. (cbinsights.com)
  • received grants for clinical research from Baxter Healthcare, CSL Behring, Talecris Biotherapeutics, Nabi Biopharmaceuticals. (cdc.gov)
  • As we near the cusp of a breakthrough in gene editing technology, companies in this sector become increasingly appealing. (investmentu.com)
  • Secondary endpoints include ORR by Response Assessment in Pediatric Neuro-Oncology Low-Grade Glioma (RAPNO-LGG), progression-free survival (PFS), duration of response (DOR), time to response, clinical benefit rate and safety. (itbusinessnet.com)
  • Dr. Reardon, currently Clinical Director of the Dana-Farber Cancer Institute (DFCI), Center for Neuro-Oncology and Professor of Medicine at Harvard Medical School, is board-certified in both Neuro-Oncology and Pediatric Hematology/Oncology. (globenewswire.com)
  • His clinical and research efforts have been recognized on multiple occasions, receiving the R. K. Rundles Award for Excellence in Clinical Oncology Research in 2007 as well as the 2015 and 2016 Awards for Excellence in Clinical Research granted by SNO. (globenewswire.com)
  • Tina Runk, EVP of Clinical Operations and Director enthusiastically commented, "We are very pleased that Dr. Reardon has joined our esteemed Neuro-Oncology Medical Advisory Board. (globenewswire.com)
  • Vivacitas Oncology is a private clinical-stage biopharmaceutical company focused on tough-to-treat cancers. (globenewswire.com)
  • The company focuses on targeted therapies, immune-oncology and autoimmunity-markets rife with potential. (investmentu.com)
  • Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. (abc4.com)
  • Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. (aap.com.au)
  • The Company is focused on developing a pipeline of programmed cellular immunotherapies for patients with cancer and autoimmune disorders. (stockhouse.com)
  • The Company is advancing a pipeline of iPSC-derived, chimeric antigen receptor (CAR)-targeted natural killer (NK) and T-cell product candidates. (stockhouse.com)
  • This technology has generated a strong proprietary pipeline of clinical-stage products and preclinical compounds in an array of disease indications. (biospace.com)
  • We welcome Jim's broad finance and strategic leadership as Novavax quickly matures into a global commercial company," said Mr. Erck. (pharmiweb.com)
  • We look forward to Mr. Mayer's strategic insights and contributions to the Board and Company. (salesandmarketingnetwork.com)
  • Steve's corporate leadership experience and seasoned oversight of Ambrx's strategic direction will be an invaluable asset to both the Company and its shareholders," said Daniel J. O'Connor, Chief Executive Officer of Ambrx. (tmcnet.com)
  • He brings a high level of combined clinical research and medical experience and expertise to help Vivacitas in further developing our lead asset, AR-67 in this challenging therapeutic area. (globenewswire.com)
  • I am extremely grateful for the commitment of our clinical investigators and their patients, and proud of the Aerovate team's dedication and ongoing execution of the trial, as this furthers our goal of developing meaningful therapeutic options for PAH patients as quickly as possible. (wkrn.com)
  • Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. (salesandmarketingnetwork.com)
  • Bexmarilimab is being investigated in a Phase I/II clinical trial as a potential therapy for patients with hematological cancers in combination with other standard treatments. (streetinsider.com)
  • and Arecor , a biopharmaceutical company offering treatments for diabetics. (growthbusiness.co.uk)
  • The CBL-0201EFP Phase 2-stage 2 study (NCT05836779) is an open-label trial that will evaluate the efficacy, safety, and tolerability of CBL-514 with up to two treatments, larger treated areas, and higher total doses, compared to the stage 1. (wkrn.com)
  • As the prospect of intravenous gene therapy gains momentum, this is one company that's poised to have treatments vetted and approved by the time the market comes into its own. (investmentu.com)
  • The company focuses on broad quality of life treatments for those afflicted with Parkinson's disease, Tourette syndrome, and congenital adrenal hyperplasia. (investmentu.com)
  • From the abstract: 'Rare and ultra-rare diseases have been central to the field of gene therapy since its earliest stage, and we are now witnessing more and more effective treatments entering the clinical realm for patients in need. (cdc.gov)
  • Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety in multiple cancer indications, including ARX517, its proprietary antibody-drug conjugates (ADC) targeting the prostate-specific membrane antigen (PSMA) and ARX788, its proprietary ADC targeting HER2. (tmcnet.com)
  • The company pioneer's gene editing company, deploying core proprietary technologies to develop off-the-shelf immunotherapies to target and eradicate cancer cells. (pharmaceutical-technology.com)
  • It has also developed proprietary viral vector and semi-automated cell manufacturing processes, which are used in clinical-stage programs. (pharmaceutical-technology.com)
  • The publication, titled " The Safety, Tolerability, Pharmacokinetics and Clinical Efficacy of the NLRX1 agonist NX-13 in Active Ulcerative Colitis: Results of a Phase 1b Study ", reports the results of the Phase 1b trial which included 38 patients randomized to placebo (n=5), 250mg immediate release (IR) of NX-13 (n=11), 500mg IR of NX-13 (n=11) or 500mg delayed release NX-13 (n=11). (wreg.com)
  • Its clinical programs fall into two categories of diseases: hematology and blood disorders, and inflammatory and immunomodulatory diseases. (marketscreener.com)
  • The primary endpoint was HiSCR50, signifying a 50% reduction from baseline in abscess and inflammatory nodule count on the Hidradenitis Suppurativa Clinical Response (HiSCR) assessment tool. (medscape.com)
  • The company focuses specifically on CD47: a surface cell protein that helps cancer evade the immune response. (investmentu.com)
  • America's biopharmaceutical companies conduct the vast majority of R&D to bring new medicines to patients. (phrma.org)
  • While government research supports basic research, America's biopharmaceutical companies conduct the critical R&D needed to bring new medicines to patients and bear the associated costs and risks. (phrma.org)
  • Located between Benxi and Shenyang , Liaoning (Benxi) Bio-pharmaceutical Industry Base is now the northeast pharmaceutical center and has attracted both domestic and foreign pharmaceutical companies and research institutions to assemble at this base, including Shenyang Pharmaceutical University, Liaoning Analytical Science Research Institute, and Liaoning TCM Research Institute. (biospace.com)
  • Philogen has signed agreements with several major pharmaceutical companies. (biospace.com)
  • This work led to the award of $1.5 million dollar grant from the Ben and Catherine Ivy Foundation as well as additional funding from pharmaceutical companies. (globenewswire.com)
  • Antibiotics are a precious resource, and preserving their usefulness will require cooperation and engagement by healthcare providers, healthcare leaders, pharmaceutical companies, veterinarians, the agricultural industry, and patients. (cdc.gov)
  • Scale up the manufacturing of GMP purified recombinant Bet v 1 will be undertaken by CMC Biopharmaceuticals. (genengnews.com)
  • Between the years 2009-2011 Shiloah sold his shares in the company to the global McCann Erickson Worldgroup. (wikipedia.org)
  • HUYA has established a series of collaborations with leading universities and research institutions throughout China and has pioneered in-licensing clinical stage compounds from the country, utilizing its expertise to advance these compounds for global markets. (biospace.com)
  • Prof. Dr. Dario Neri, Member of the Board of Philochem and CEO of the Philogen Group, commented: "We are extremely pleased to establish a new collaboration with Bracco Imaging, a leading global company in the image diagnostics field. (biospace.com)
  • Lonza is a leading global biopharmaceutical manufacturing company with facilities in Europe, North America, and South Asia. (yahoo.com)
  • I am thrilled to join the Abivax team during this exciting period of strong growth and internationalization and to contribute to the success of the Company, establishing a global team and a common company culture. (bignewsnetwork.com)
  • JSKN003-302 is a multicenter, randomized, controlled phase III clinical study in patients with unresectable locally advanced or metastatic HER2 low-expressing breast cancer. (cbinsights.com)
  • NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults and will be advanced for regulatory submission. (pharmiweb.com)
  • Based on clinical experience with Altimmune's vaccine platform technology, AdCOVID is expected to provide durable immunity of up to a year or more following a single dose and to have an excellent tolerability and stability profile. (yahoo.com)
  • Our agreement with Lonza expands on our current clinical and commercial manufacturing strategy for AdCOVID, aligning us with leaders in vaccine manufacturing and positioning Altimmune for commercial-readiness in 2021. (yahoo.com)
  • A substance or combination of substances used in conjunction with a vaccine antigen to enhance (for example, increase, accelerate, prolong and/or possibly target) or modulate a specific immune response to the vaccine antigen in order to enhance the clinical effectiveness of the vaccine. (who.int)
  • Nearly all of the lab abnormalities had no clinical manifestations and did not require clinical intervention or change in study treatment. (itbusinessnet.com)
  • The clinical need for cellulite treatment remains unmet. (wkrn.com)
  • Aelis Farma is a clinical-stage biopharmaceutical company which is developing a new generation of innovative drugs for the treatment of brain disorders. (euronext.com)
  • Alder's lead clinical candidate, ALD403, inhibits a well validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. (salesandmarketingnetwork.com)
  • Biomed is a leading innovator, having discovered a new family of drugs which are in the clinical stage for the treatment of Alzheimer's disease. (webnewswire.com)
  • Preliminary results from a Phase I clinical study in Australia for the treatment of advanced solid tumors have observed initial efficacy and good tolerability. (cbinsights.com)
  • Principal Investigator for the STARSTRUCK study, Professor Nat Lenzo , GenesisCare Group Clinical Director Theranostics said, "The treatment of advanced cancer can be extremely challenging. (aap.com.au)
  • The Phase 3 AFFINE clinical trial of giroctocogene fitelparvovec in patients with hemophilia A has started and is over 50% enrolled. (pharmiweb.com)
  • Following the observation of FVIII levels greater than 150% in some treated patients, Pfizer voluntarily paused screening and dosing of additional patients in the trial to implement a protocol amendment to provide clinical management guidance for elevated FVIII levels. (pharmiweb.com)
  • The company collaborates with leading academic institutions and industry partners to develop and deliver programmed T cell product candidates for cancer patients. (pharmaceutical-technology.com)
  • The majority of patients treated with NX-13 for four weeks showed consistent and rapid clinical improvement in total Mayo score and in symptoms relief (as measured by rectal bleeding and stool frequency). (wreg.com)
  • We would like to thank Prof. Lenzo and his clinical team at GenesisCare Murdoch, as well as the patients who will contribute to this important study. (aap.com.au)
  • About 50% of patients in BE HEARD I and 60% of patients in BE HEARD II had Hurley stage 3 disease, which is the most severe of the three stratifications. (medscape.com)
  • From the abstract: 'The purpose of this is study it to evaluate the diagnostic utility of publicly-funded clinical exome sequencing (ES) for patients with suspected rare genetic diseases (RGDs). (cdc.gov)
  • Subsequently, Dr. Reardon joined the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke University School of Medicine as an adult Neuro-Oncologist, where he led daily clinical/translational research operations as Associate Deputy Director (2000-2011). (globenewswire.com)
  • Thermo Fisher Scientific has expanded its clinical research operations with the opening of a state-of-the art bioanalyti. (biospectrumasia.com)
  • The company has become a champion of guiding China 's biomedical innovations to the worldwide marketplace. (biospace.com)
  • Lexicon has clinical-stage drug programs for diabetes, carcinoid syndrome, and other indications, all of which were discovered by Lexicon's research team. (prnewswire.com)
  • Philogen is headquartered in Siena, Italy, and has research activities at its subsidiary company Philochem near Zurich, Switzerland. (biospace.com)
  • He helped to significantly expand the clinical research portfolio at DFCI. (globenewswire.com)
  • With plenty of funding to go around and promising research on iPSC-based NK-cell and T-cell immunotherapies, the company should have a strong runway for growth. (investmentu.com)
  • Southern Star Research, an Australian contract research organisation (CRO) specialising in clinical trial acceleration w. (biospectrumasia.com)
  • Combining Real World Evidence (RWE) extracted from government adverse event databases and social media with scientific data from published medical research (meta-analysis), the Company provides unprecedented business intelligence to support regulatory filings, competitive analysis, and marketing messaging. (webnewswire.com)
  • Mr. Kelly brings more than twenty-five years of industry experience in both commercial and clinical-stage companies to Novavax. (pharmiweb.com)
  • Paul's extensive experience in finance and corporate strategy in our industry will be extremely valuable as we continue to advance our lead clinical candidate, ALD403, for the prevention of migraine toward the market. (salesandmarketingnetwork.com)
  • The CBL-0201EFP Phase 2-stage 2 study is an open-label trial that will evaluate the efficacy, safety, and tolerability of CBL-514 in treating subjects with moderate to severe cellulite. (wkrn.com)
  • The CBL-0201EFP study is a two-stage Phase 2 trial evaluating the efficacy, safety, and tolerability of CBL-514 in treating subjects with cellulite. (wkrn.com)
  • We plan to commence a clinical study of AdCOVID in the fourth quarter, with a data readout from this study anticipated in the first quarter of 2021. (yahoo.com)
  • While the FDA did not seek any additional information for supporting clinical data it sought additional information on certain labeling and other deficiencies for processing the NDA. (business-standard.com)
  • SPARC submitted a response to an earlier CRL it had received from the USFDA wherein no additional preclinical or clinical data was required. (business-standard.com)
  • MedAware Systems is a growth stage, next generation medical data and analytics company. (webnewswire.com)
  • We will also expand our current work with pharmaceutical and medical device companies under the aegis of a much larger organization to accelerate market penetration and revenue growth. (webnewswire.com)
  • The acquisition gave Merck access to Acceleron's rare-disease drug candidate sotatercept, which is in a late-stage study to treat pulmonary arterial hypertension, a type of high blood pressure. (cov.com)
  • Alder plans to initiate additional advanced clinical studies for ALD403 in high frequency migraines in 2015 and chronic migraines in 2016. (salesandmarketingnetwork.com)
  • This clinical-stage biopharmaceutical company's chemistry engine combined in-house medicinal chemistry design with external synthesis capabilities. (torx-software.com)
  • Dose number (Do) is a simple metric to predict whether a compound will be reasonably absorbed based on solubility at an expected clinical dose and represents a valuable parameter to the medicinal chemist defining a clinical candidate. (bvsalud.org)
  • Ambrx is a clinical stage biopharmaceutical company using an expanded genetic code technology platform to discover and develop next generation antibody drug conjugates (ADCs) and other engineered therapies to modulate the immune system. (tmcnet.com)
  • J.P. Morgan Securities, LLC and Goldman, Sachs & Co. will be acting as joint book-runners for the offering and Needham & Company, LLC and Stifel, Nicolaus & Company, Incorporated will be acting as co-managers for the offering. (prnewswire.com)
  • Companies with ratings are not formally covered by a Morningstar analyst, but are statistically matched to analyst-rated companies, allowing our models to calculate a quantitative moat, fair value, and uncertainty rating. (morningstar.com)
  • Shiloah is chairman of Silenseed, a clinical stage biopharmaceutical company. (wikipedia.org)
  • Mr. Glover has over 32 years of biopharmaceutical and life sciences experience. (tmcnet.com)
  • With decades of experience supporting companies on thousands of transactions, we ensure your transformational projects turn out as planned. (dlapiper.com)