Regulatory Filings and Submissions

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

Paratek has completed submission of two new drug applications for oral and intravenous omadacycline, a new antibiotic for pneumonia and skin infections.

CRLs put the brakes on drug development and damage corporate reputation and stock prices. Upfront investment and better sponsor oversight are ways to prevent them.

The latest continuing resolution funds the government for three weeks.

Non-essential activities and new regulatory submissions are on hold until a federal government funding agreement is reached.

The agency has expanded the indication of AstraZeneca’s anti-cancer drug to include treatment for breast cancer with a certain inherited genetic mutation.

FDA noted in a recent inspection that American CryoStem was receiving and processing adipose tissue into a product called Atcell, and then marketing the product without agency approval.

The agency published draft guidance on good practices for submitting abbreviated new drug applications.

Scientific advances and renewed investment may infuse biopharma for growth.

Gene therapies highlight FDA new drug approvals in 2017.

The biotechnology company has filed for FDA approval of a new plasma manufacturing facility in Covington, GA, to support its immunology franchise.

FDA has approved a new gene therapy for treating patients born with a rare, inherited vision loss.

Sanofi Genzyme and its partner, Alnylam Pharmaceuticals, has filed a marketing authorization application with EMA for an investigational RNAi therapeutic for treating a genetic-based disease.

FDA has approved a Pfizer biosimilar to J&J’s top-selling anti-inflammatory biologic, Remicade.

The draft guidance gives recommendations on how certain oral drug products should be labeled regarding gluten.

The approval for Admelog (insulin lispro injection) marks the first short-acting insulin approved as a “follow-on” product.

The European Medicines Agency has granted Samsung BioLogics approval to manufacture a monoclonal antibody at the company’s second facility in Songdo, Incheon, South Korea.

The agency has approved Nucala (mepolizumab) to treat Eosinophilic Granulomatosis with Polyangiitis (EGPA) to GlaxoSmithKline. This indication is the first FDA-approved therapy specifically to treat EGPA.

FDA has accepted for review Eli Lilly and Company’s biologic drug candidate that is in development for treating migraine.

Biopharma majors are among the industry stakeholders who have commented and raised questions about FDA’s recently proposed draft guidance for analytical assessment of similarity in biosimilars.

FDA has approved Mylan’s biosimilar to Roche’s blockbuster anti-cancer biologic, Herceptin.

New gene therapies and combination products require innovative regulatory approaches.

The agency has approved a biologic-based new molecular entity for treating hemophilia A and has expanded the indication for a leukemia drug to now treat a common form of non-Hodgkin lymphoma.

Commissioner Scott Gottlieb, MD, outlined a plan to support innovation of regenerative medicines while ensuring public safety.

Two of the medicines recommended for approval are orphan drugs.