OR WAIT null SECS
April 02, 2018
New therapies and tighter budgets challenge bio/pharma to think outside the industry.
Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.
March 29, 2018
Congress passed a $1.3-trillion omnibus budget bill March 22, 2018 that increases federal support for biomedical research and health programs for fiscal year 2018.
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).
March 23, 2018
The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.
The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.
March 20, 2018
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 sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.
The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.