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  • Lupin: Covid opportunity strengthens US business Nov 06, 2020 09:41 AM IST

    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 Sep 03, 2020 12:37 PM IST

    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 Jul 20, 2020 02:36 PM IST

    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 Jan 09, 2020 11:08 AM IST

    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 Dec 02, 2019 06:42 PM IST

    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 Nov 18, 2019 02:44 PM IST

    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 Sep 29, 2019 12:55 PM IST

    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 Jul 29, 2019 01:24 PM IST

    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 Feb 20, 2019 02:54 PM IST

    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 Dec 19, 2018 04:03 PM IST

    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 Jun 28, 2018 03:20 PM IST

    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 Mar 29, 2018 12:06 PM IST

    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 Mar 28, 2018 08:25 PM IST

    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 Mar 28, 2018 09:29 AM IST

    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 Jan 19, 2018 12:28 PM IST

    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 Oct 05, 2017 10:05 AM IST

    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 Oct 04, 2017 03:15 PM IST

    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 Sep 05, 2017 05:44 PM IST

    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.

  • India's antitrust watchdog orders probe into Roche cancer drug Apr 26, 2017 05:50 PM IST

    India's antitrust watchdog orders probe into Roche cancer drug

  • USFDA issues warning letter to Mylan for Nashik facility Apr 13, 2017 08:59 PM IST

    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 Mar 27, 2017 09:21 AM IST

    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 Mar 15, 2017 05:07 PM IST

    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

  • Mylan deal removes uncertainty over launch of Trastuzumab biosimilar: Biocon Chief Mar 15, 2017 10:33 AM IST

    Mylan deal removes uncertainty over launch of Trastuzumab biosimilar: Biocon Chief

    Global healthcare company Mylan has inked a settlement pack with Genentech and Roche in relation to patents for cancer drug Herceptin (Trastuzumab).

  • To cut healthcare costs, US must partner India: Biocon's Shaw Mar 03, 2017 11:26 AM IST

    To cut healthcare costs, US must partner India: Biocon's Shaw

    Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.

  • Biocon, Mylan breast cancer drugs approved by DCGI: HC told Mar 02, 2017 07:00 PM IST

    Biocon, Mylan breast cancer drugs approved by DCGI: HC told

    "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.

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