Topic:

Regulatory

Latest Headlines

Latest Headlines

Cost watchdogs demand efficacy data on new Bayer cancer drugs

German pharma giant Bayer got back-to-back bad news on two of its newest drugs, from two different countries, no less.

Eyeing rival mAb mob, Novartis touts PhIII secukinumab psoriasis data

Investigators for Novartis pumped out more positive Phase III data for its psoriasis therapy secukinumab over the weekend, adding some patient satisfaction scores on the self-injected treatment as the company positions this new product against a host of rivals that promise to quickly crowd the field.

Celgene wins FDA approval for its blockbuster arthritis contender apremilast

Celgene picked up the FDA's blessing for the much-debated apremilast, winning approval to market the oral drug as a treatment for psoriatic arthritis in step one of its blockbuster plan.

J&J, Medivir get EU nod for their hep C drug Olysio

The horse race for oral treatments of chronic hepatitis C entered another turn today as the European Union recommended approval of Olysio, the Johnson & Johnson and Medivir entry in the high-stakes derby, Bloomberg reports.

Novartis' vaccine unit gets a badly needed booster from the U.K.

The U.K.'s Joint Committee on Vaccination and Immunization (JCVI) is revising its stance on Novartis' meningitis B vaccine Bexsero. The jab, originally left off Britain's routine vaccination schedule, has gained the JCVI's nod, supplying a needed boost for the Swiss company's flailing vaccine unit.

Yes, U.S. med tech recalls have doubled since 2003--but so has the market

"Medical device recalls nearly doubled in a decade," proclaims The Wall Street Journal 's headline--a bit of data the FDA is expected to release Friday that seems likely to travel far on social media. Critics are already making hay, questioning the rigor of pre-market vetting at the FDA.

J&J's Velcade cleared by U.K. for first-line myeloma treatment in about-face

The U.K.'s National Institute for Health and Care Excellence has come around on Johnson & Johnson's Velcade as a first-line treatment for the blood cancer multiple myeloma. It approved the drug for the new use today, four months after initially saying it was unconvinced the benefits of the drug outweighed its costs.

Wockhardt plants cited by Indian regulators

In a move that seems to heed FDA Commissioner Margaret Hamburg's call to expect higher standards from their drugmakers, state drug regulators in India have taken action against two Wockhardt plants that the U.S. FDA banned months ago.

EU smiles on Lilly and Boehringer's FDA-rejected diabetes drug

European regulators are recommending approval for Boehringer Ingelheim and Eli Lilly's latest diabetes offering, shrugging off a manufacturing issue that spiked the drug's FDA approval and putting the pair in line for third place in a new class of treatments.

Novo says Tresiba's down but not out of the blockbuster diabetes race

Last year's stinging FDA rejection for Novo Nordisk's Tresiba wiped billions off the drugmaker's market cap, but, despite getting bogged down with new safety studies, the company believes it can still get its long-acting insulin on the market before its rivals can settle in.