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Galapagos and MorphoSys signed an exclusive development and commercialization deal with Swiss-based Novartis.
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The Chinese biopharma market is booming as more and more companies eye breaking into that rich market. Christophe Weber, chief executive officer of pharma giant Takeda, views its China programs as its second-biggest business behind the United States.
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Roche’s Tecentriq Sees Mixed Results in Interim Phase III Lung Cancer Analysis, Study to Continue
7/19/2018
Roche’s Tecentriq, in combination with chemotherapy, hit its co-primary endpoint of progression-free survival in a Phase III trial for non-small cell lung cancer patients. But, the Swiss pharma giant said the combination has so far failed to achieve statistical significance in overall survival, a... -
Patient Death: Mersana Shares Plunge
7/19/2018
Shares of Mersana Therapeutics have plunged nearly 40 percent this morning after the company announced the FDA placed a partial clinical hold on its Phase I antibody drug conjugate XMT-1522 following the death of a patient. -
In a speech given at the Brookings Institution preceding the release of the U.S. Food and Drug Administration (FDA)’s Biosimilars Action Plan, FDA Commissioner Scott Gottlieb unloaded on big pharma.
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Kite, a Gilead company based in Santa Monica, California, signed an agreement with Utrecht, Netherlands-based Gadeta BV. The companies will work on discovering and developing novel cancer immunotherapies based on gamma-delta T-cell receptors (TCRs).
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In 2012, the U.S. Food and Drug Administration (FDA) created Breakthrough Therapy designation. The Washington Post reports on a new study conducted by Yale School of Medicine researchers and published in the Journal of the American Medical Association that looks at the designation and the drugs t...
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Allergan and Molecular Partners Announce Two Positive Phase 3 Clinical Trials for Abicipar pegol ...
7/19/2018
Allergan plc, a leading global pharmaceutical company and Molecular Partners, a clinical-stage biopharmaceutical company developing a new class of drugs known as DARPin® therapies, today announced the release of two positive clinical trials. -
Merck Reinforces Commitment to Responsible Pricing
7/19/2018
Merck (NYSE:MRK), known as MSD outside the United States and Canada, has a long history of responsible pricing. In 2017, Merck issued its second annual Pricing Action Transparency Report, which showed that net prices across Merck’s U.S. product portfolio declined by 1.9 percent...
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PTC Therapeutics to Acquire Agilis Biotherapeutics
7/19/2018
PTC Therapeutics, Inc., today announced that it has entered into an agreement to acquire Agilis Biotherapeutics, Inc., a biotechnology company advancing an innovative gene therapy platform for rare monogenic diseases that affect the central nervous system (CNS). The transaction was approved by the Boards of both companies.
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FDA Approves New Indications for ZOMACTON® (somatropin) as Ferring Plans Launch of Needle-Free Delivery System
7/19/2018
Ferring Pharmaceuticals, Inc.. today announced that the U.S. Food and Drug Administration (FDA) has approved ZOMACTON (somatropin) for injection in four additional pediatric indications:
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HedgePath Pharmaceuticals Granted Exclusive Option to License UCONN's Patented Chemical Analogues of Itraconazole
7/19/2018
HedgePath Pharmaceuticals, Inc. (OTCQB: HPPI), a clinical stage biopharmaceutical company that discovers, develops and plans to commercialize innovative therapeutics for patients with cancer, announced today that it has signed an exclusive option agreement with the University of Connecticut (UConn) related to patents and patent applications covering certain chemical analogues of the Food and Drug Administration (FDA) approved anti-fungal drug itraconazole.
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ACADIA Pharmaceuticals Announces Appointment of Austin D. Kim as Executive Vice President, General Counsel and Secretary
7/19/2018
Acadia Pharmaceuticals Inc., a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders, today announced that Austin D. Kim has joined ACADIA as Executive Vice President, General Counsel and Secretary.
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AVEO Oncology Issues Statement Regarding Revised TIVO-3 Trial Guidance
7/19/2018
AVEO Oncology today issued the following statement regarding its recently revised guidance on the timing of topline data from the TIVO-3 study, its Phase 3 trial of tivozanib as a third-line treatment for advanced renal cell carcinoma.
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Ocular Therapeutix™ Announces FDA Acceptance of NDA Resubmission for DEXTENZA®
7/19/2018
July 19, 2018 12:00 UTC Ocular Therapeutix™ Announces FDA Acceptance of NDA Resubmission for DEXTENZA® PDUFA date is set for December 28, 2018 BEDFORD, Mass.--( BUSINESS WIRE )-- Ocular Therapeutix™, Inc. (NASDAQ: OCUL), a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has received acknowle
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FDA Issues New Biosimilar Action Plan (BAP) Accepting Recommendations made by Sarfaraz Niazi, CEO of Pharmaceutical Scientist to Modernize Regulatory Approval Process of Biosimilars
7/19/2018
The FDA has just-issued a Biosimilar Action Plan (BAP) that considers most of the recommendations made by Sarfaraz Niazi.
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Innovative Alzheimer's Treatment from China Concludes Phase 3 Clinical Trials
7/19/2018
Green Valley plans to submit the application for treatment to the China National Drug Administration this Year
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Ipsen and BioLabs to open new Innovation Center in Cambridge (U.S.) to foster development of new therapies for patients
7/19/2018
Ipsen Innovation Center – BioLabs to be located in Ipsen’s new and third global hub in the heart of Cambridge, Massachusetts
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New Phase 3 Data Show Investigational Subcutaneous Formulation of Vedolizumab Meets Primary Endpoint in Achieving Clinical Remission at Week 52 in Patients with Moderately to Severely Active Ulcerative Colitis
7/19/2018
Data to be discussed with global health authorities, including the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA)
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Synteract Augments Executive Team with Cheryl Murphy as Senior Vice President, Clinical Development
7/19/2018
Synteract, an innovative contract research organization (CRO) providing full-service, Phase I-IV services enabling biopharma companies to bring new medicines to market, has added Cheryl Murphy as senior vice president, Clinical Development to its executive team.