Latest Headlines

Latest Headlines

Lupin hopes for more U.S. approvals as earnings drop 35%

Indian drug giant Lupin said it hopes to see more of its drugs approved by the U.S. FDA before the end of the year, according to a report by Reuters.

J&J's Ethicon partners with Fogarty Institute to back next-gen device innovation

Nonprofit incubator Fogarty Institute for Innovation is partnering with Johnson & Johnson's surgical device specialist Ethicon to develop next generation medical devices. Ethicon will sponsor the Institute to support its educational programs as well as offer leadership and mentorship to its resident med tech innovators.

FDA says industry responded positively to pilot inspection program

The FDA just released a report describing the results of the Case for Quality Inspection Pilot program. It focused on implantable devices that contain batteries.

J&J's Yondelis finally captures FDA nod, but path to big sales could be steep

Once upon a time, analysts thought the cancer-fighting prospect Yondelis could hit $1 billion in sales by 2010. But that timetable went poof years ago--and so did the forecast--as the drug failed to win the FDA's approval, and eventually ended up in a partnership between Spain's Zeltia and Johnson & Johnson's Janssen unit.

PE firm KKR backs Cohera in $50M for internal surgical adhesive launch

Private equity group KKR is leading a new $50 million round for Cohera Medical, which this year nabbed an FDA approval for its TissuGlu Surgical Adhesive as well as a CE mark for its Sylys Surgical Sealant, which the FDA has designated as an Expedited Access Pathway device given its potential to address unmet patient needs for the prevention of gastrointestinal leaks after surgery.

Cipla runs into FDA concerns for plant in India, as well as one it will buy in U.S.

While many of India's other large drugmakers have run afoul of the FDA for plant problems, Cipla has mostly avoided such entanglements. But suddenly the company is facing some FDA issues at two plants, one in India, and one in the U.S. that it intends to buy to gain a foothold in U.S. manufacturing. 

FDA bans API plant of India's Megafine Pharma

The FDA last week added Megafine Pharma's plant in Lakhamapur, Maharashtra, in India to its import alert list, banning all of its drug products from entering the U.S.

FDA finds mystery 'deficiencies' with Neos' long-acting Ritalin on the eve of approval

Neos Therapeutics got an ominous note from the FDA just weeks ahead of the expected approval date for its long-acting ADHD treatment, clouding the future of the company's lead asset.

Pacira sues for free speech; FDA pulls off-label warning letter. What gives?

On second thought, Pacira Pharmaceuticals, the FDA might just take it back. As Law360 reports, the agency has unpublished a warning letter to the company, issued last September, that took issue with the company's marketing practices.

Shire hit with another setback as FDA rejects top pipeline drug

Shire CEO Flemming Ornskov has yet another setback to grapple with as his company winds toward the end of a strange year. The FDA has rejected the company's application for the dry-eye drug lifitegrast, a key drug that the biotech has billed as a blockbuster earner, despite its mixed record in the clinic.