Regulatory Filings and Submissions

The agency has approved Retacrit (epoetin alfa-epbx) by Pfizer’s Hospira, which is a biosimilar to Amgen’s anemia drug, Epogen/Procrit (epoetin alfa).

Barriers impede biosimilar market entry into the United States despite the Biologics Price Competition and Innovation Act.

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

The agency is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval and for violating cGMP requirements.

The data and analytics company reports on the anticipated uptake of Humira (adalimumab)‎‎ biosimilars in the EU once they are launched in 2018.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

The European approval marks the first approval for a biosimilar in that region resulting from the companies’ joint portfolio.

The agency has release a report providing an overview of steps taken to enhance benefit-risk assessment in the review of drugs.

The agency has accepted AstraZeneca’s biologics license application for an investigational leukemia drug candidate and granted it priority review.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The agency’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

Drug manufacturers can improve use of quality agreements in contract manufacturing.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

The agency has approved a new HIV treatment for patients with "limited treatment options".

Biologic new molecular entities (NMEs) accounted for 26% of total NME approvals in 2017.

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.