Nov 06, 2020 09:41 AM IST
The possibility of positive developments on the product pipeline front and restructuring initiatives can accelerate earnings growth for Lupin
- Sep 03, 2020 12:37 PM IST
Hyderabad, Sep 3 : The US Food and Drug Administration has issued a Warning Letter to Mylan Laboratories Limited's plant in Telangana for signific..
- Jul 20, 2020 02:36 PM IST
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
- Jan 09, 2020 11:08 AM IST
"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.
- Dec 02, 2019 06:42 PM IST
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.
- Nov 18, 2019 02:44 PM IST
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.
- Sep 29, 2019 12:55 PM IST
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.
- Jul 29, 2019 01:24 PM IST
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
- Feb 20, 2019 02:54 PM IST
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
- Dec 19, 2018 04:03 PM IST
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.
- Jun 28, 2018 03:20 PM IST
The introduction of biosimilars is an important mechanism to help increase access to more affordable biologics treatments.
- Mar 29, 2018 12:06 PM IST
Biocon and its partner Mylan on Thursday said they have received approval for insulin glargine in Europe and Australia
- Mar 28, 2018 08:25 PM IST
Biotechnology major Biocon and Mylan today said their co-developed biosimilar insulin glargine has received marketing authorisation approval from the European Commission (EC).
- Mar 28, 2018 09:29 AM IST
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.
- Jan 19, 2018 12:28 PM IST
The company is trying to combine forces with companies who have been successful in biosimilars, said Kiran Mazumdar Shaw, CMD, Biocon.
- Oct 05, 2017 10:05 AM IST
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.
- Oct 04, 2017 03:15 PM IST
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.
- Sep 05, 2017 05:44 PM IST
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.
- Apr 26, 2017 05:50 PM IST
- Apr 13, 2017 08:59 PM IST
During the inspection, the FDA investigator observed specific violations such as the quality system not fully ensuring data integrity, the regulator said.
- Mar 27, 2017 09:21 AM IST
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.
- Mar 15, 2017 05:07 PM IST
Feel better product launch visibility and first movers advantage to aid its financials; largely maintain buy call on the stock
- Mar 15, 2017 10:33 AM IST
Global healthcare company Mylan has inked a settlement pack with Genentech and Roche in relation to patents for cancer drug Herceptin (Trastuzumab).
- Mar 03, 2017 11:26 AM IST
Biocon Chief Kiran Mazumdar Shaw says India is not an outsourced services country anymore, it is an innovation and knowledge partner.
- Mar 02, 2017 07:00 PM IST
"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.