September 01, 2014 09:59 (IST)
Wockhardt' two drugs WCK 771 and WCK 2349 has received QIDP status from US FDA. These two drugs will enter global phase-3 clinical trials early next year. Wockhardt is the first Indian company to get the QIDP status.
New Delhi | September 01, 2014 09:16 (IST)
Two drugs -- WCK 771 and WCK 2349 -- have received QIDP status, which allows fast-track review of the drug application by the US Food and Drug Administration (USFDA), Wockhardt said in a statement.
Barcelona | September 01, 2014 08:18 (IST)
The Swiss drugmaker impressed doctors at the European Society of Cardiology meeting in Barcelona at the weekend by unveiling strikingly good clinical trial results for the drug, known as LCZ696, in a keenly awaited clinical trial.
August 31, 2014 18:58 (IST)
Drug maker Wockhardt on Sunday said two of its anti-infective drugs have received the qualified infectious disease product (QIDP) status from the US Food and Drug Administration (FDA).
New Delhi | August 30, 2014 19:11 (IST)
Drug firm Natco Pharma today said its marketing partner in America, Mylan Inc has filed an ANDA for generic Copaxone used in treatment of multiple sclerosis and expects 180 days of marketing exclusivity.
August 29, 2014 14:44 (IST)
The Competition Commission of India (CCI), which has put the multi-billion dollar Sun-Ranbaxy deal for public scrutiny, on Friday said the major issue is whether the combination would result in high market concentration of certain molecules.
August 25, 2014 17:14 (IST)
India's pharmaceutical market will see continued strong growth at a more favourable rate than its global peers and even if the country's GDP growth were to slow down, it would still represent a better growth opportunity, Moody's Investors Service said in a report.
August 25, 2014 08:51 (IST)
The Swiss drugmaker said on Sunday it would pay $74.00 a share through a tender offer for InterMune, representing a premium of 38 per cent to the closing price on August 22.
August 21, 2014 15:12 (IST)
Drug firm Claris Lifesciences has received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for its newly commissioned plant in Ahmedabad.
New Delhi | August 20, 2014 18:38 (IST)
Glenmark Pharmaceuticals SA, a wholly-owned unit of Glenmark, announces the discovery and initiation of studies of a novel clinical development candidate, GBR 1302, the company said in a statement.
Hyderabad | August 20, 2014 15:16 (IST)
The Indian drug major said in a filing with US Securities and Exchange Commission (SEC) that the issue is related to compliance with requirements of special packaging for child resistant blister packs for six products sold by the company in the United States from 2002 through 2011.
New Delhi | August 20, 2014 14:57 (IST)
The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, Zydus Cadila said.
August 20, 2014 12:39 (IST)
Nearly 5 million equity shares of FDC changed hands in multiple block deals on BSE, Thomson Reuters data shows.
August 20, 2014 10:31 (IST)
A filing with the US Securities and Exchange Commission on Monday shows market share gains in key drugs in the US market, analysts say.
August 19, 2014 22:48 (IST)
With many drugs going off patent in the US, Indian pharma companies would continue to experience strong growth in American market, credit rating agency Icra has said.
August 18, 2014 23:02 (IST)
The government has extended the deadline to affix barcodes on mono cartons (ointments, eye/ear drops) by pharmaceutical companies to April 2015.
Hyderabad | August 15, 2014 10:55 (IST)
According to a notification by the USFDA, the recall of the 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles is voluntarily initiated by the company through a letter to the regulator in June under Class-II classification.
August 13, 2014 18:33 (IST)
India's top 20 pharmaceutical companies would increase capital expenditure by 40 per cent to more than Rs 50,000 crore by fiscal year 2018, credit rating agency Crisil said on Wednesday.
August 13, 2014 16:22 (IST)
Drug firm Merck today reported a 25.83 per cent rise in its standalone net profit to Rs 20.99 crore for the second quarter ended June 30, 2014, mainly on robust sales.
San Francisco | August 12, 2014 16:39 (IST)
Apple Inc. has been discussing how its "HealthKit" service will work with health providers at Mount Sinai, the Cleveland Clinic and Johns Hopkins as well as with all scripts, a competitor to electronic health records provider Epic Systems, people familiar with the discussions said.