During the inspection, the FDA investigator observed specific violations such as the quality system not fully ensuring data integrity, the regulator said.
The European Medicines Agency (EMA) said that the suspension has been ordered for all drugs for which the bioequivalence studies were conducted by Micro Therapeutic Research Labs at two sites in India.
Feel better product launch visibility and first movers advantage to aid its financials; largely maintain buy call on the stock
Global healthcare company Mylan has inked a settlement pack with Genentech and Roche in relation to patents for cancer drug Herceptin (Trastuzumab).
Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.
"Once the designated authority has given approval, you cannot say prima facie you have case over that. Till that (approval) is disturbed by an order of the court, it will remain," a bench of justices Badar Durrez Ahmed and Sanjeev Sachdeva said.
The Delhi High Court today told Swiss pharma major Roche that it "cannot hang on to" breast cancer drug Trastuzumab, innovated by it, for the rest of its life after having enjoyed the fruits of its patent.
Biocon shares gained 2.6 percent to hit a record high of Rs 1,123 after the US health regulator USFDA has accepted pharma major Mylan's biologics licence application (BLA) for MYL-1401H, a proposed biosimilar Pegfilgrastim.
Biocon Thursday announced the US Food and Drug Administration has accepted Mylan‘s Biologics License Application (BLA) for biosimilar chemotherapy drug Pegfilgrastim for review. Sharing details on the development with CNBC-TV18 Biocon Chairperson and Managing Director Kiran Mazumdar Shaw said, "This is a very important acceptance."
Pharma major Lupin today said it has received final approval from the US health regulator to market its generic version of Mylan's triamcinolone acetonide cream used for treatment of skin disease.
Natco and Mylan believe that they are the first companies to have filed a substantially complete abbreviated new drug application containing a Para-IV certification for a 3 times per week Glatiramer Acetate Injection 40 mg/mL, and expect 180 days of marketing exclusivity in the US.
"The United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents related to Copaxone 40 mg/mL invalid based on obviousness," Natco Pharma said in a BSE filing.
Biocon shares touched a record high of Rs 1,049.50 on Thursday, up nearly 5 percent intraday after the US health regulator has accepted biosimilar application for its proposed cancer drug.
The proposed biosimilar trastuzumab is one of the six biologic products co-developed by Mylan and Biocon for the global marketplace, the two companies said in a statement.
Following US president-elect Donald Trump‘s explosive speech last night where he lambasted the domestic pharma companies for outsourcing work, pharma stocks are likely to be in limelight today.
Bengaluru-based biopharmaceutical firm Biocon on Wednesday said US drug regulator has accepted its partners Mylan‘s biologics license application (BLA) for the proposed biosimilar of breast cancer drug Trastuzumab through the 351(k) pathway.
This study was the last major step of a multiple-phased programme to demonstrate that proposed biosimilar trastuzumab meets the criteria for equivalence in comparison to branded trastuzumab.
Lupin shares climbed nearly 2 percent intraday Wednesday after receiving approval from the US health regulator for Nuvigil tablets that improves wakefulness.
Pharma stocks, especially which have large exposure to United States, saw knee-jerk reaction on Friday after a media report indicated that US prosecutors are undertaking an investigation into the suspected price collusion.
Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease, Biocon said in a regulatory filing.
Strides had completed the sale of its Agila Specialties division to Mylan Inc for a total consideration of up to USD 1.75 billion in December 2013.
There was some regulatory overhangs post Strides-Mylan Agila transaction, says Arun Kumar, Executive VC & MD of Strides Shasun.
Drug prices have come under scrutiny in recent months after Mylan received public backlash for the sharp price increases the Epipen, an injection device to treat fatal anaphylactic shocks from food allergies or insect bites. The price of a two-pack Epipen has risen to nearly USD 600, from just USD 100 in 2007.
The brokerage house believes high contribution of Fortamet & Glumetza is underappreciated, and therefore, weakness of base profits is still not fully realised.