Top News
NCI Director Named as Acting FDA Commissioner
Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.
Fujifilm to Acquire Large-Scale Biologics Manufacturing Site from Biogen in $890-Million Deal
The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.
FDA Takes Steps to Refine Biosimilar Naming Convention
FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.
Biogen to Acquire Gene-Therapy Company Nightstar in $800-Million Deal
The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.
FDA Commissioner Scott Gottlieb, MD, Resigns
The FDA commissioner plans to leave the agency in April.
Roche to Acquire Spark Therapeutics
The $4.3-billion acquisition is expected to strengthen Roche’s gene therapy pipeline.
Danaher to Acquire GE’s Biopharma Business
The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.
FDA Big Winner in Final Congressional Budget Agreement
FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.
GSK, Merck KGaA Partner in $4.2-Billion Cancer Immunotherapy Deal
The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.
FDA Seeks Participants in DSCSA Pilot Program
Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.
Janssen, MeiraGTx Partner on Eye-Focused Gene Therapy
Janssen and MeiraGTx will collaborate on the development and commercialization of gene therapies for treating inherited retinal diseases.
AstraZeneca Announces Organizational Changes
Company to focus on innovation, growth, and productivity with creation of new units.
GSK Acquires TESARO for $5.1 Billion
The acquisition of biopharmaceutical company TESARO is expected to strengthen GSK’s oncology pipeline and commercial footprint.
Lilly to Acquire Loxo Oncology
The $8-billion acquisition will broaden Lilly's oncology portfolio in precision medicines and treatments that target cancers caused by specific gene abnormalities.
Bristol-Myers Squibb to Acquire Celgene in $74-Billion Deal
Merger cites combined strengths in oncology, immunology and inflammation, and cardiovascular disease.
Critical FDA Functions Continue as US Government Shutdown Hits the One-Week Mark
Core functions and those funded by fiscal year 2018 user fees are continuing, and 59% of the agency’s staffers are being retained.
GSK and Pfizer Merge Consumer Healthcare Businesses
The proposed $12.7-billion deal includes the spinoff of GSK and Pfizer consumer brands to a new UK-listed company.
Takeda, Shire Shareholders Approve Proposed Acquisition
The $62-billion acquisition of Shire by Takeda Pharmaceutical was approved by both sets of shareholders.
FDA Hits Valsartan Manufacturer with Warning Letter
FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.
FDA Answers Data Integrity Questions
New FDA guidance developed to identify lapses in data integrity and promote best practices.
WuXi Biologics Begins Construction of Major Biologics Center in China
The new center will integrate biologics drug discovery, development, clinical manufacturing, and commercial manufacturing.
Novartis to Acquire Endocyte in Deal Worth $2.1 Billion
Novartis plans to acquire Endocyte, a biopharmaceutical company, to accelerate the development of innovative radioligand technology for treating cancer.
Amgen Launches Adalimumab Biosimilar in Europe
Amgen’s biosimilar to AbbVie’s Humira (adalimumab) is the first inflammation biosimilar from Amgen's portfolio to launch in Europe.
Sandoz Humira Biosimilar Patent Dispute Resolved
Novartis’ Sandoz has reached a global patent resolution for Hyrimoz (adalimumab), its biosimilar to AbbVie’s Humira (adalimumab).
Janssen, Arrowhead Enter $3.7-Billion Partnership to Treat Hep B
The companies will develop and commercialize ARO-HBV, a Phase I/II subcutaneous, ribonucleic acid interference therapy candidate being investigated for the treatment of chronic hepatitis B viral infection.
Novartis to Sell Parts of Sandoz in $1-Billion Deal
Novartis will sell selected portions of its Sandoz United States portfolio to Aurobindo Pharma USA for $900 million in cash, plus $100 million in potential earn-outs.
UK Outlines Potential Pharma Changes Post-Brexit
Guidances for regulatory changes, batch testing, and reporting address situations resulting from “no-deal” Brexit scenario.
DHSC Directs Pharma to Stockpile Medicines
As a contingency against border delays resulting from a “no-deal” Brexit, the Department of Health and Social Care (DHSC) directs pharma companies to stock extra medicines.
FDA Approves First-of-its-Kind RNA Therapy
The new drug, Onpattro (patisiran), by Alnylam Pharmaceuticals, is in a new class of drugs called small interfering ribonucleic acid (siRNA) treatment.
EMA Scales Back Activities to Prepare for Brexit
The European Medicines Agency (EMA) will temporarily scale back activities as it copes with “significant staff loss” and prepares for the next phase in its continuity plan.
