The Indian government has revealed details of its plan to establish itself as a supplier of low-cost, high-quality generic medicines. Instead of relying on the big beasts of Indian generics production, the government is to source its drugs from small and medium-sized players.
Generics drugmaker InvaGen Pharmaceuticals and AlphaMed Bottles, both co-owned companies, said they will build two separate manufacturing facilities in Central Islip, located on Long Island, NY.
Ranbaxy said today that the FDA has withdrawn its 6-month exclusivity for Valcyte.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.