Novartis was granted fast-track reviews of its cell therapy Kymriah for blood cancers in the United States and Europe.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
While the nation’s media was focusing on the unsuccessful attempts by Republicans to pass a successor to Obamacare, a fascinating sideshow has developed in nearby White Oak, Maryland, home of the Food and Drug Administration.
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
A lot can happen in 20 years. When the FDA Modernization Act (FDAMA) was passed in 1997, a mere 217 of its ~40,000 words were allocated to the presentation of healthcare economic information (HCEI). Those 217 words resided within Section 114 of the Act, giving birth to the abstract universe many of us now commonly refer to as FDAMA 114. Fast-forward to January 2017, and the FDA’s release of its Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers – Draft Guidance for Industry and Review Staff. Now 7,000+ words, this document is likely to significantly alter the way pharmaceutical manufacturers engage with the audience who increasingly holds the keys to its commercial success … payers such as health plans, pharmacy benefits managers (PBMs) and hospital systems.
Overall, the prospects for the sector remain strong, linked to the expected growth in healthcare. There is a strong case for investment in particular segments, subject to appropriate valuation and due diligence. This report highlights some of the trends that should be in the minds of CEOs, CFOs and investors.
The U.S. FDA issued a warning letter to Imprimis Pharmaceuticals Inc. accusing it of making false or misleading claims that its compounded eye medications had the agency’s approval.
The U.S. FDA expects a shortage of intravenous saline fluids for hospitals due to damage to key manufacturing facilities in Puerto Rico to improve over the coming weeks and months.
The U.S. FDA and Department of Defense launched a program to speed up the development of drugs that could be used by military personnel.
The U.S. FDA approved a supplemental NDA for Gilotrif (afatinib) for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor receptor mutations as detected by an FDA-approved test.
Trisenox (arsenic trioxide) injection was approved in combination with tretinoin for treating adults with newly diagnosed low-risk acute promyelocytic leukemia.
The European Commission granted Marketing Authorization for Shire’s ADYNOVI [Antihemophilic Factor (Recombinant), PEGylated], for on-demand and prophylactic use in patients 12 years and older living with hemophilia A.
The U.S. Food and Drug Administration approved expanded use of AstraZeneca Plc’s cancer drug Lynparza.
GSK receives FDA approval for expanded indication for Fludriarix Quavalent for persons 6 months and older
GSK announced it received approval from the U.S. FDA’s Center for Biologics Evaluation and Research expanding the indication for FLUARIX QUADRIVALENT (Influenza Vaccine) to include use in persons 6 months and older.
The European Union approved Roche’s multiple sclerosis medicine Ocrevus, one of the Swiss company’s key new drugs.
The U.S. Food and Drug Administration issued a warning letter to Becton Dickinson (BD) & Company that cited several violations of federal law.
Merck & Co. and development partner Eisai Co. snagged Breakthrough Therapy Designation from the FDA for a combo renal cell carcinoma (RCC) treatment.
Amgen Inc. said the U.S. FDA approved its drug Xgeva to prevent fractures in patients with multiple myeloma.
Shares of Belgium-based TiGenix NV shot up after Japan’s Takeda Pharmaceutical opted to acquire the company for $630 million.
Promacta received breakthrough therapy designation from the FDA for first-line treatment of SAA.
Novartis’ Kisqali (ribociclib) won U.S. Food and Drug Administration breakthrough therapy designation for treating some breast cancer patients.
FDA Accepts Supplemental Biologics License Application and Grants Priority Review for Adcetris in Frontline Advanced Hodgkin Lymphoma
Normal immune cells that live near milk ducts in healthy breast tissue may play a key role in helping early breast cancer cells leave the breast for other parts of the body, researchers say.
U.S. drug approvals hit a 21-year high in 2017, with 46 novel medicines winning a green light — more than double the previous year — while the figure also rose in the EU.
The FDA approved Mylan’s Estradiol Vaginal Cream USP 0.01%, the first generic version of Allergan’s Estrace.
The U.S. Food and Drug Administration issued a warning letter to Fresenius Kabi AG of Germany for its plant in India.