GlaxoSmithKline's Advair is not your average off-patent blockbuster. It's difficult to copy, which has held off any major generic competition to date. Now, Novartis' generics unit Sandoz and its partner, Vectura, have won their first approval for a copy of the top-selling lung med--a reminder that the clock is ticking on Advair's turn at the top.
Sandoz, the generic drug division of Novartis, has pulled two batches of tuberculosis drugs from the market in India after some packages were found to have improper doses in strips of medications.
Sandoz, the generics arm of drug giant Novartis, launched a Phase III study for its biosimilar of Enbrel with great fanfare today, boasting of a market-leading slate of 7 late-stage biosimilar studies on 5 molecules.
Novartis has received another letter from the FDA regarding its Sandoz generic drugs unit. This time, it is for a plant in Austria that Novartis picked up in its $1.3 billion buyout of Ebewe Pharma, a specialist in generic cancer drugs.
Any drug manufacturer that fails to take instructions from FDA is inviting trouble, and that is what Novartis got by releasing products from a Sandoz Ebewe plant after the agency said they had been manufactured using unapproved inspection procedures.
Generic drugmaker Sandoz is recalling two lots of an injectable drug, making yet another manufacturing problem for its parent, Novartis.
A worker at an Amgen research facility in South San Francisco has been hospitalized after a "flash fire" involving hazardous materials.
After taking a $500 million charge against 2012 earnings for Yaz and Yasmin-related litigation, Bayer has lost its patent fight with three generics makers intent on selling their own copycats.
The news on the biosimilar R&D front has been all bad in recent months--at least for the biggest players in the business. Merck, Teva and Samsung have all experienced severe setbacks, scrapping follow-on programs for some of the biggest biologic targets now on the market.
Johnson & Johnson ($JNJ) and Novartis ($NVS) are the latest pharma companies to feel the ire of EU antitrust regulators. European Commission officials have accused the two drugmakers of delaying a generic version of the painkiller fentanyl--and violating competition laws in the process.