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UCB’s Cimzia may soon be added to the list of arthritis drugs provided under England and Wales’ National Health Service, following a final draft recommendation by the UK’s healthcare cost watchdog. Read More
The FDA is clarifying its definition of “established conditions” to ensure drugmakers properly report postapproval chemistry, manufacturing and control changes in NDAs, ANDAs and BLAs. Read More
FDA approval of Pfizer subsidiary Wyeth’s Rapamune for lymphangioleiomyomatosis may be the light at the end of the tunnel for sufferers of the extremely rare lung disease. Read More
The FDA on Wednesday approved Patheon Pharmaceuticals’ Viberzi and Salix Pharmaceuticals’ Xifaxan for the treatment of irritable bowel syndrome with diarrhea in adult patients. Read More
A federal judge dealt Otsuka a blow, dismissing claims that the FDA is precluded from approving generic versions of its blockbuster antipsychotic Abilify until its orphan exclusivity runs out in December 2021. Read More
Sponsors looking to determine whether their drugs have impurities that might lead to cancer-causing mutations in human DNA should conduct two toxicology assessments using mathematical models that base this probability on the drug’s chemical structure. Read More
Germany’s healthcare cost watchdog has recommended against paying for Celgene’s Otezla, citing a lack of evidence that the psoriasis drug offers added benefit over available therapies. Read More
The FDA has granted Cerulean Pharma’s investigational nanoparticle drug conjugate CRLX101 orphan status for the treatment of relapsed ovarian cancer, guaranteeing the drugmaker seven years added exclusivity if the product is approved. Read More
Six years after promising a web-based alternative to its electronic submissions gateway, the FDA has launched a drug safety reporting portal for companies with a small number of adverse event reports. Read More
German drugmaker Boehringer Ingelheim has won FDA approval for Stiolto Respimat, the fourth inhaled drug that the FDA has allowed the company to market for chronic obstructive pulmonary disease. Read More