Mylan Inc

Global pharma major Mylan Inc, and Biocon have confirmed the efficacy and safety of MYL-1401O, a proposed biosimilar trastuzumab co-developed by the firms, in comparison to Roche's branded Herceptin used for treatment of cancer

Natco Pharma's partner MylanInc gets USFDA nod for cancer drug

The company's marketing partner Mylan Inc has received a tentative approval from the United States Food and Drug Administration (USFDA) for abbreviated new drug application (ANDA) for Sorafenib tablets in the strength of 200 mg, Natco Pharma said in a filing to BSE.

Natco Pharma gains 9% on USFDA tentative nod for cancer drug

The company's marketing partner, Mylan Inc., has received a tentative approval for its abbreviated new drug application (ANDA) for Sorafenib Tablets, 200mg, with the USFDA.

Mylan gets warning letter from USFDA for lapses at 3 units

The US regulator said its inspectors found "significant violations" in the three manufacturing facilities in Bengaluru of the company, which is an arm of US-based Mylan Inc

Govt clears FDI proposals worth Rs 10,379 crore

The investment proposals were approved following the recommendation for the same by the Foreign Investment Promotion Board (FIPB), headed by Finance Secretary Rajiv Mehrishi.

Natco Pharma at record high; partner Mylan files ANDA

"Marketing partner in the USA, Mylan Inc has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection, 40 mg/ml) and has been accepted by the US Food and Drug Administration (US FDA)," said the company in its filing.

Roche gets break in case against India sales of cancer drug

The Delhi High Court (HC) has thrown a wrench into plans of Biocon and Mylan to market a breast cancer drug that goes by the scientific name Trastuzumab.

Special dividend of Rs 500/share to cost us $525mn: Strides

Strides Arcolab has a fairly strong organic growth strategy in place at the moment, says Group CEO & VC Arun Kumar.

FDI in pharma doubled during Apr-Aug

Faced with rush of multinationals to acquire Indian pharma firms, the Commerce and Industry Ministry is proposing to tighten the FDI policy for the sector by incorporating conditions like mandatory investment in R&D and non-compete clause in the shareholders pact.

Natco Pharma Q1 net up 28% at Rs 21.78cr

Drug firm Natco Pharma today reported 27.59 per cent rise in consolidated net profit to Rs 21.78 crore for the quarter ended June 30, 2013 mainly on account of robust exports.

Without Patented Drugs, there's no generics Inds: Mylan CEO

Novartis‘ and Bayer‘s patent battles in India reflect the increasing legal nature of the globalising pharma industry, Mylan Inc CEO Heather Bresch tells Forbes India.

Mylan to buy Agila Specialties from Strides for $1.6bn

Generic drugmaker Mylan Inc said it would buy Agila Specialties from Strides Arcolab Ltd for USD 1.6 billion to expand its injectable drugs business.

Gilead signs deals with Indian cos for low-cost HIV drug

Gilead Sciences Inc signed deals with three Indian companies to drive sales and reduce manufacturing costs of low-cost generic versions of its HIV drug, Emtricitabine in developing countries.

Mylan Inc to rename Matrix Laboratories as 'Mylan'

US-based drug firm Mylan Inc today said it plans to rename its Hyderabad-based subsidiary Matrix Laboratories as 'Mylan'.

Mylan to enter India with prescription drugs in 1-yr

Drugmaker Mylan Inc said on Friday it plans to enter the Indian commercial market with its own prescription drugs in the next 12 months, the chairman told reporters on Friday.

USFDA opposes Mylan's injunction on Ranbaxy's Lipitor

Ranbaxy is in focus again as the US Foods and Drugs Administration (USFDA) has filed an opposition to US-based pharmaceutical firm Mylan Inc's preliminary injunction on the launch of Ranbaxy's cholesterol treatment drug, which is a generic version of Pfizer's Lipitor, reports CNBC-TV18's Ekta Batra quoting sources.