Abeona Therapeutics, a Dallas, Texas-headquartered clinical-stage biopharmaceutical company, has opened a commercial GMP manufacturing facility for gene and cell therapies in Cleveland, Ohio called The Elisa Linton Center for Rare…
FDA Issues Draft Guidances to Facilitate Generic-Drug Development and Approval
The US Food and Drug Administration (FDA) has issued two draft guidances to improve the Risk Evaluation and Mitigation Strategy (REMS) process to facilitate generic-drug development and approval. REMS is…
Celltrion Progresses Biosimilars of Roche’s Rituxan and Herceptin
Celltrion, an Incheon, South Korea-based life-sciences company, has resubmitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of its biosimilar candidate that references…
Construction Begins on New EMA HQ in Preparation for Brexit
In preparation for the UK’s exit of the European Union (EU) (i.e Brexit), the European Medicines Agency (EMA) has begun construction for its new headquarters building in Zuidas, Amsterdam, the…
Allergan Issues Voluntary Recall of One Lot of Oral Contraceptive
Allergan has issued a voluntary nationwide recall in the US of one lot of the oral contraceptive, Taytulla (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) 1 mg/20…
Allergan Plans To Sell Women’s Health, Infectious Disease Businesses
Allergan said it plans to sell its women’s health and infectious disease businesses following a strategic review and will focus on four main therapeutic areas (medical aesthetics, central nervous system,…
Senate Health Committee Announces Hearing on Drug Pricing
The US Senate Committee on Health, Education, Labor and Pensions (HELP) plans to hold a hearing on June 12, 2018 with Secretary of the Department of Health and Human Services…
Private-Equity Firm MDP To Acquire Majority Stake in Alcami
Alcami, a contract development and manufacturing organization of active pharmaceutical ingredients (APIs) and drug products, has reached an agreement to be acquired by Madison Dearborn Partners, LLC (MDP), a Chicago-based…
Bayer Gets Conditional US OK for $66-Billion Acquisition of Monsanto
Bayer has obtained approval from the Antitrust Division of the US Department of Justice (DOJ) for its proposed $66-billion acquisition of Monsanto, an agrochemical and seed company, conditioned upon certain…
Fujifilm Diosynth Biotechnologies, a contract development and manufacturing organization of biologic-based drugs, has extended its gene therapy and viral vaccine fill / finish capabilities to provide services in support of…
