Regulatory Filings and Submissions

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

The European Union is collaborating with the Pharmaceutical Inspection Co-operation Scheme to develop similar guides for evaluating inspectorates’ competency.

The company received a complete response letter from FDA in response to the biologics license application for a proposed trastuzumab biosimilar.

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.

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.

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

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.

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".

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

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

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.

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

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

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 US Government Accountability Office released a report stating that FDA should make its plans to release guidance regarding nonbiological complex drugs public.

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.

FDA looks to achieve near-record level of new drug approvals following slowdown in 2016.

Bio/pharma professionals manage expectations amid industry uncertainty.