Top News
Novartis to Acquire Takeda Eye-Care Drug in Deal Worth Up to $5.3 Billion
Novartis will acquire assets associated with Takeda Pharmaceuticals’ Xiidra (lifitegrast ophthalmic solution) 5%, an eye-care drug.
Novartis Appoints New Sandoz CEO
Sandoz’s new CEO will assume responsibilities no later than Aug. 1, 2019.
Catalent to Acquire Paragon Bioservices for $1.2 Billion
Catalent’s acquisition of Paragon Bioservices will provide expertise and in expanding gene and cell therapy markets.
Novartis Completes Alcon Eye-Care Spin-Off
With the spin-off, Alcon will operate as a standalone company, and Novartis will focus on its core innovative medicines.
Novartis, Amgen in Legal Dispute Over Migraine Partnership
Amgen issued a notice of termination of its migraine collaboration agreements with Novartis, against which Novartis filed a lawsuit in response.
Thermo Fisher Scientific to Acquire Brammer Bio
A $1.7-billion acquisition CDMO Brammer Bio establishes Thermo Fisher Scientific in viral vector manufacturing.
Novartis Changes Sandoz Leadership, Sandoz CEO Steps Down
Richard Francis will step down as CEO of Sandoz, effective March 31, 2019.
Administration Acts Fast to Smooth Transition to New FDA Commissioner
Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.
FDA Only Winner as New Budget Battle Begins
The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.
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.
Latest ARB Recall Triggered by New Impurity
Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.
FDA to Miss Gottlieb’s Leadership
Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.
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.
Charles River to Acquire Citoxlab in $510-Million Deal
The acquisition would strengthen Charles River’s contract research capabilities.
SK Biopharmaceuticals, Arvelle Partner on Anti-Epileptic Drug for Europe
In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.
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 FY 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.
