Mylan

The marketing and supply agreement is for a period of five years for India only, to enhance distribution and in clinic presence of the two products.

Biocon's arm to acquire Viatris’ biosimilars for $3.3 billion

Biocon is calling the deal a transformational acquisition creating a world-leading biosimilars enterprise.

Exclusive | Biocon in talks with Mylan to merge biosimilar businesses, plans IPO after merger: Sources

xxBiocon and Mylan are in advanced talks for combining their biosimilar businesses to create a large company in which Biocon seeks to hold a controlling majority stake, sources told Moneycontrol

Lupin: Covid opportunity strengthens US business

The possibility of positive developments on the product pipeline front and restructuring initiatives can accelerate earnings growth for Lupin

FDA issues warning Letter to Mylan's Telangana plant; Company says no impact

Hyderabad, Sep 3 : The US Food and Drug Administration has issued a Warning Letter to Mylan Laboratories Limited's plant in Telangana for signific..

COVID-19 treatment | Mylan launches generic version of Remdesivir in India

The drug is approved for treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalised with severe presentations of the disease, Mylan said in a statement

Solara Active Pharma to conduct internal probe on Nizatidine API amid Mylan recall

"We understand from Mylan NV's press release dated January 8, 2020, that Mylan Pharmaceuticals has initiated a voluntary recall of three lots of Nizatidine Capsules, USP (150 mg and 300 mg strengths) due to detected trace amounts of impurity...," Solara Active Pharma Sciences in a filing to BSE.

Biocon and Mylan launch Trastuzumab biosimilar Ogivri in USA

Ogivri was the first biosimilar of Herceptin to be approved by USFDA two years ago, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer.

USFDA pulls up Mylan for manufacturing violations at Andhra plant

In a warning letter issued to the company's CEO Heather Bresch, the US Food and Drug Administration (USFDA) said inspectors during May 27 to June 5, this year found significant deviations from standard manufacturing practices at the company's Unit 8 in G Chodavaram village in Vizianagaram.

Mylan to invest $1 billion in India on capex in 6 years

Mylan Global President and Executive Director Rajiv Malik said the company had been investing close to about $400 million or $450 million towards Capex every year and half of it in India.

Corporate Corridor | Pfizer’s Upjohn and Mylan combining forces holds lessons for Indian pharma majors

The merger of Pfizer’s Upjohn division and Mylan may not only attempt to solve their problems in the US market but also make inroads into emerging markets, particularly China

Dr Reddy’s Suboxone launch: Why investors shrugged it off

Dr Reddy’s generic Suboxone launch is set to be a reality. A much-awaited event, a mounting threat from competitors may limit its benefits

Mylan recalls 1.2 mn bottles of 'made in India' BP drug from US due to cancer risk

The finished products were manufactured by Mylan Pharmaceuticals Inc. and Mylan Laboratories Limited. And these batches were distributed in the US between March 2017 and November 2018, Mylan said.

Mylan to commercialise Lupin's etanercept biosimilar

The introduction of biosimilars is an important mechanism to help increase access to more affordable biologics treatments.

We expect roll out of insulin glargine in Europe to start in second half of 2018, says Biocon

Biocon and its partner Mylan on Thursday said they have received approval for insulin glargine in Europe and Australia

Biocon, Mylan get European Commission nod to market biosimilar insulin glargine

Biotechnology major Biocon and Mylan today said their co-developed biosimilar insulin glargine has received marketing authorisation approval from the European Commission (EC).

Biocon gets Europe and Australia approval to sell insulin glargine

Insulin glargine is a biosimilar version of Sanofi's top selling Lantus. Insulin glargine is a long acting insulin that renoves patients from administering multiple injections in a day.

Partnership with Sandoz is for the future wave of biosimilars: Biocon

The company is trying to combine forces with companies who have been successful in biosimilars, said Kiran Mazumdar Shaw, CMD, Biocon.

Mylan surges, Teva slumps after FDA approves Copaxone copy

The approval late on Tuesday by the U.S. Food and Drug Administration came earlier than both companies had expected. It was issued a day after the health regulator said it would introduce measures to speed to market generic versions of complex drugs like Copaxone to help address the rising cost of pharmaceuticals.

FDA nod to Natco's marketing partner Mylan for generic Copaxone

The news gave fillip to the shares of Natco which hit the upper circuit of 20 per cent (Rs 954.35) a piece on BSE today.

Pharma major Mylan puts Andhra Pradesh plant on sale

Sources told CNBC-TV18 that the plant is not garnering enough interest from buyers. A number of them had come and reviewed the plant without any concrete outcome.

USFDA issues warning letter to Mylan for Nashik facility

During the inspection, the FDA investigator observed specific violations such as the quality system not fully ensuring data integrity, the regulator said.

EU regulator recommends suspending 300 drugs tested by Indian CRO firm

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.

Analysts cheer Mylan-Roche settlement, upbeat on Biocon

Feel better product launch visibility and first movers advantage to aid its financials; largely maintain buy call on the stock