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Congress Presses FDA to Do More to Combat Drug Shortages
Legislators have requested that FDA do more to prevent drug shortages.
Celltrion Resubmits to FDA Its Proposed Biosimilar to Roche’s Herceptin
The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.
Sanofi Completes $4.8-Billion Ablynx Acquisition
The acquisition is expected to strengthen Sanofi’s R&D strategy with Ablynx’s nanobody technology platform.
Roche to Acquire Foundation Medicine for $2.4 Billion
The acquisition is expected to strengthen Roche’s personalized healthcare strategy.
New Immunotherapy Method Brings Complete Regression of Hard-to-Treat Breast Cancer
Researchers at the National Cancer Institute have developed a new approach to immunotherapy that led to the complete regression of breast cancer in a patient who was unresponsive to all other treatments.
Research Shows Promise for Syphilis Vaccine
Microbiologists from the University of Connecticut have pinpointed exterior proteins on syphilis-causing bacteria that could serve as vaccine targets for syphilis.
FDA Commissioner Outlines Agency's Efforts for Patient-Focused Drug Development
FDA Commissioner Scott Gottlieb, MD, released a statement on new agency efforts to involve the patient voice in medical product development and FDA regulatory decision-making.
Bayer Completes Monsanto Acquisition for $63 Billion
Bayer completed its acquisition of Monsanto, the largest in Bayer’s history.
Gilead Sciences, Hookipa in $410-Million Partnership for HIV, Hepatitis B Immunotherapies
The companies will partner in research for HIV and hepatitis B immunotherapies, and Hookipa will manufacture arenavirus-based vectors for clinical development by Gilead.
WuXi Biologics to Build US Biologics Production Facility
WuXi Biologics will invest $60 Million to establish a biologics production facility in Massachusetts.
Alexion, Complement Partner to Treat Neurodegenerative Disorders
Alexion Pharmaceuticals and Complement Pharma will partner to develop a preclinical C6 complement inhibitor to treat neurodegenerative disorders.
Sartorius Stedim Biotech and Siemens Collaborate on Automation
Siemens will become a preferred supplier for Sartorius Stedim Biotech’s automation solutions, and SSB will create a globally standardized automation platform for its biopharmaceutical manufacturing systems.
Global Standard for Managing Post-Approval Changes Moves Forward
Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.
MilliporeSigma Opens Technical Support Center
MilliporeSigma targets emerging biotechs with US development center and global grants.
FDA Launches Overhaul of New Drug Review Program
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
Report Shows Bioscience Industry Has $2-Trillion Economic Impact
A new report released at the BIO International Convention shows that the US bioscience industry has had a $2-trillion economic impact and has accelerated venture capital investment and job growth.
GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory
The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.
Vetter Launches Use-Centered Approach to Improve Injections
Vetter anounced the Open Innovation Challenge to examine the applicability of digital trends to injection systems.
ISPE Field-Tests Quality Program
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
AAPS Announces 2018 Slate of Candidates
The American Association of Pharmaceutical Scientists (AAPS) board of directors announced the candidates for the 2018 AAPS board.
FDA Approves First Biosimilar to Amgen’s Neulasta
The agency has approved Mylan’s Fulphila (pegfilgrastim-jmdb) as the first US-approved biosimilar to Amgen’s Neulasta (pegfilgrastim) to reduce infection risk during cancer treatment.
Gottlieb Proposes Modernization of Drug Review Office
The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.
EMA Recommends Approval of Migraine Biologic
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Hospira Recalls Naloxone Hydrochloride
The company is recalling two lots of Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL, Carpuject Single-use cartridge syringe system due to particulate matter on the syringe plunger.
EMA Recommends Four Biosimilars for Approval
The agency has recommended approval of three biosimilar adalimumab products from Novartis, referencing AbbVie’s Humira, and a biosimilar trastuzumab from Pfizer, referencing Roche’s Herceptin.
New Research Hub Tackles Access to Vaccines
The Future Vaccine Manufacturing Hub will work with CPI as well as other UK institutions to address challenges of vaccine production and distribution so that the spread of new diseases can be effectively tackled.
Lonza Expands Cell Portfolio for In Vitro Testing
Lonza has added four liver cell types to its hepatocytes portfolio for testing of in vitro drug models.
Lonza to Manufacture TxCell Product
TxCell announces manufacturing agreement with Lonza for its HLA-A2 CAR-Treg cellular product.
Anti-methamphetamine Antibody Moves to Clinic
Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.
Alcami Announces Deal with New Investors
Madison Dearborn Partners will acquire a majority ownership position in CDMO Alcami.
