Ranbaxy said today that the FDA has withdrawn its 6-month exclusivity for Valcyte. It also said it had lost its tentative approval for AstraZeneca's heartburn blockbuster Nexium. Nexium went off patent in May and Valcyte went off patent last year.
Sanofi, which bought controlling interest in Dubai's Globalpharma in June, will kick off production there with generics of 6 of its drugs. Sanofi is now managing the facility.
Gilead Sciences is presenting a huge gift to Mylan and half a dozen Indian generics makers. It is transferring the manufacturing technology for its biggest product and its blessing to go make cheap copies in 91 markets.
Usually, it's the smaller drugmakers that take advantage of opportunities that present themselves when manufacturing problems arise at another company. But Novartis CEO Joe Jimenez is not above trying to drum up some business for his Sandoz generic drug unit by pointing out problems with some of the big drugmakers in India.
Texas oral drug delivery specialist Neos Therapeutics pulled in $15.5 million in a Series C round of financing to help propel its line of ADHD controlled-release treatments to the market.
European regulatory authorities gave Teva a positive opinion for its DuoResp Spiromax inhalation powder, designed to treat asthma and chronic obstructive pulmonary disease. With the recommendation from the Committee for Medicinal Products for Human Use, Teva hopes to have final approval within a few months.
Forest will discontinue its original Namenda pill in August, pushing current patients onto Namenda XR--and hoping they won't bother to switch back when generics appear next April.
With the FDA's all-clear under its belt, AMRI's once-troubled Burlington, MA, "money pit" is poised to push the Albany, NY, company into new markets, the company's new CEO reportedly told investors at the J.P. Morgan Healthcare Conference last week. The former Teva executive said he's eyeing generics and high-tech drug delivery among potential expansion areas.
The company is investing substantially in plant expansions and manufacturing improvements over the next few years so it can produce more drugs more efficiently.
With sequestration currently in place to rein in government spending across the board, much of the $1 billion that user fees bring in over 2013 will be frozen, with the FDA unable to tap the funding. But now, those funds are the target of the FDA Safety Over Sequestration Act--or FDA SOS Act--a bipartisan bill that would exempt user fees from the mandatory budget cuts.