Bio/Pharma News
Sanofi Pasteur, Translate Bio in $805-Million Deal to Develop mRNA-Based Vaccines
The three-year collaboration will focus on developing vaccines for up to five infectious disease pathogens.
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.
J&J Accepts $2.1-Billion Offer for Diabetes Solutions Business
Johnson & Johnson has accepted an offer from Platinum Equity to acquire diabetes solutions business LifeScan for $2.1 billion.
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.
GE Healthcare Equips China Cell Therapy Manufacturing Plant with FlexFactory
The company will provide the first FlexFactory manufacturing platform for cell therapy manufacturing.
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.
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.
EMA Recommends Approval of Migraine Biologic
EMA has recommended marketing authorization for Aimovig (erenumab), a new treatment for migraine.
Anti-methamphetamine Antibody Moves to Clinic
Catalent’s GPEx technology was used to develop antibody for anti-methamphetamine clinical study.
Bayer Gets US Approval for $66-Billion Acquisition of Monsanto
Bayer received conditional approval from the Antitrust Division of the United States Department of Justice to acquire Monsanto in a deal worth $66 billion.
GE and CCRM Partner with DiscGenics on New Cell Therapy
GE Healthcare and the Centre for Commercialization of Regenerative Medicine (CCRM) will support scale-up efforts by DiscGenics for a new cell therapy intended to treat back pain.
Novartis Gains EC Approval for Infliximab Biosimilar
The European Commission has approved Zessly (infliximab), a biosimilar to Johnson & Johnson’s blockbuster Remicade (infliximab).
Novartis’ AveXis to Invest $55 Million in New Gene Therapy Manufacturing Facility
The gene therapy company is expected to invest $55 million in a new manufacturing facility that will produce therapies for rare neurological genetic diseases.
WuXi Biologics to Invest $60 Million in New Singapore Biomanufacturing Facility
WuXi Biologics will build a biologics manufacturing facility in Singapore that will use both fed-batch and continuous perfusion-based single-use bioreactors.
FDA Approves AstraZeneca’s Hyperkalemia Treatment
The new drug offers rapid and sustained control of patients’ potassium levels.
Allergan Acquires Anti-Depressant Drug Candidate
Allergan will buy a potential depression treatment from Aptinyx.
Vectalys, FlashCell Merge to Form Gene Therapy Company
The new company will develop proprietary RNA-based therapeutics and will provide broad lentiviral development and manufacturing expertise and support.
Gilead’s Kite Expands Cell Therapy Facilities in US, Europe
The company has leased and purchased facilities in the United States and Europe to expand its cell therapy pipeline.
FDA Approves First Preventive Treatment for Migraine
The agency approved Amgen and Novartis’ Aimovig (erenumab-aooe), the first FDA-approved preventive treatment for migraine in adults.
Lilly to Acquire AurKa Pharma in Deal Worth Up to $575 million
The acquisition of AurKa Pharma will help strength Eli Lilly’s oncology pipeline.
FDA Approves Pfizer’s Epoetin Alfa Biosimilar
The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).
Novartis Acquires AveXis for $8.7 Billion
The acquisition is expected to strengthen Novartis’ gene therapy pipeline.
Lilly to Acquire ARMO BioSciences for $1.6 Billion
Eli Lilly will acquire ARMO BioSciences to strengthen Lilly's immuno-oncology program.
GlobalData Reports on Barriers Impeding Biosimilar Entry into US Market
Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.
Merck, Moderna Expand mRNA Cancer Vaccines Partnership
The companies expanded their partnership to develop and commercialize messenger RNA (mRNA) cancer vaccines to include shared-antigen mRNA cancer vaccines such as mRNA-5671.