A U.S. District Court has upheld the validity of a Teva (TEVA +0.1%) patent that covers methods of treating Parkinson's disease and is related to the company's Azilect treatment.
The ruling came after Teva sued Mylan (MYL -1.5%) for infringing the IP, and the Israeli company expects the court to prevent Mylan from launching its generic version of Azilect until Teva's patent expires in 2017.
Teva has also filed a lawsuit suit against Sandoz, which has agreed to abide by the verdict in the case against Mylan. (PR)
Mylan (MYL +4.6%) hits another fresh high as the FDA's guidance regarding generic versions of Glaxo's (GSK) Advair strikes optimism that the generic-drug maker will one day get clearance to sell its own soon.
Up to now, no generic competitor to Advair has emerged because it's been unclear what would be required by regulators in order to win approval.
The FDA’s new guidelines now make it possible for Advair rivals to hit the market by 2016 or 2017.
MYL is considered one of the most viable companies to develop an Advair competitor.
Mylan (MYL +1.3%) says its proposed acquisition of the Agila injectables businesses from Strides Arcolab has received approval from India's Foreign Investment Promotion Board.
The deal also received approval from the Cabinet Committee on Economic Affairs.
The approval comes as a relief for MYL, as India had frozen the deal earlier this year, and was considering a change to its foreign investment laws to protect the country's supply of cheap, lifesaving drugs.
The Indian government is considering a change to its foreign investment rules for pharmaceutical companies in order to protect the country's supply of cheap, lifesaving drugs.
In July, it froze Mylan's (MYL) proposed acquisition of Indian drugmaker Agila Specialties, over concern that its drugs would be exported to more lucrative markets abroad and reduce the domestic supply.
"There are some concerns, particularly in regard to oncology," says India's trade minister Anand Sharma, noting that India wants to ensure that foreign companies don't limit the country's domestic supply of affordable cancer drugs.
The government also worries that acquisitions could grant foreign companies control over the local industry, making it difficult for it to control prices.
Sharma also voiced concern that if foreign companies did acquire Indian firms, they could refuse to produce cheap generics.
Foreign companies have already invested $1.1B in India's pharmaceutical industry over the last fiscal year ended March 31.
Mylan (MYL) settles litigation with Orion regarding an ANDA filing for a generic version of Stalevo. MYL says the terms of the agreement allow it to "launch an authorized generic version of STALEVO immediately and its own ANDA product upon receiving final FDA approval." (PR)
Mylan (MYL +0.2%) settles patent litigation with OSI, Pfizer, and Genentech related to a generic version of the pancreatic cancer treatment Tarceva. Terms and conditions of the settlement are confidential, although MYL does say that all pending litigation is dismissed. (PR)
Mylan (MYL) has gained another legal victory against Teva (TEVA), with a U.S. District Court finding that the Israeli company's generic version of Mylan's Perforomist Inhalation Solution breaches one of the latter's patents. Teva's abbreviated new drug application for generic Perforomist hasn't yet received FDA approval. The trial on the remaining issues in the case is due to start later this month. (See Copaxone verdict) (PR)
Mylan (MYL +0.1%) says a U.S. district court has dismissed a lawsuit filed by Teva (TEVA -1.5%) regarding the alleged patent infringement occasioned by MYL's ANDA filing for a generic version of Copaxone. (PR)