Gottlieb, a physician and former deputy FDA commissioner during the George W. Bush administration, is seen as competent and knowledgeable. But critics worry about his ties to the pharmaceutical industry.
Tagrisso is designed to help cancer patients with certain genetic mutations that are very common in China and the regulatory green light boosts the British drugmaker's prospects in a key therapy area.
The US drug regulator off late, has been a cause of headaches for many domestic pharmaceutical companies. Today, shares of Divis Laboratories tanked 20 percent after an import alert was issued its on Vizag unit. The Dr Reddy's Laboratories shares also hit a 52-week low after the company's Duvvada plant received 13 observations which included repeats from a November, 2015 warning letter.
The drug firm received establishment inspection report (EIR) from the US Food and Drug Administration on closure of inspection of its Ankleshwar plant in Gujarat.
The US drug regulator had inspected its Baroda unit between March 6 and 10 and issued no Form 483s for the same.
The US drug regulator gave a tentative nod for the company's Olmesartan Medoxomil tablets, which is used to treat blood pressure.
Of the total 18 observations, 9 from July 2015 and another 9 from March 2016 inspection, the former ones relating to equipment and warehousing have been closed. Nine observations are still outstanding for the company.
In an interview to CNBC-TV18, Sanjiv Bhasin of IIFL shared his reading and outlook on the market.
This is depite the fact that exports revival in its US and institutional businesses seems distant as the US- Food and Drug Administration (FDA) regulatory issues are likely to remain unresolved in the next two years.
The Lupin Pharmaceuticals duo MD Nilesh Gupta and CEO Vinita Gupta say current business conditions only permit revenue visibility of USD 3.5 billion, although their aspiration is to hit USD 5 billion soon. They are among the 50 contenders vying for the World Entrepreneur Award currently being hosted by E&Y at Monte Carlo.
Sameer Baisiwala, pharmaceutical and property analyst at Morgan Stanley, feels pharmaceuticals space is a good bet given the recent EIRs issued to domestic pharma companies by the regulator.
Of the total food samples inspected last year, 105 were found to be sub-standard and 30 unfit for human consumption.
Malvinder and Shivinder Singh had sold their stake in Ranbaxy Laboratories to Daiichi way back in 2008, following which Daiichi-led Ranbaxy was forced to pay the US Department of Justice a sum of USD 500 million over non-compliance with US Food and Drug Administration's testing norms.
Thermo Fisher Scientific Inc., the world leader in serving science, today announced that it has received 510(K) clearance from the U.S. Food and Drug ...
Bedaquiline, known as the 'miracle drug' is the first TB drug to be approved by Food and Drug Administration (FDA) in over 40 years. The drug will be made available in six public hospitals in Delhi, Mumbai, Chennai, Guwahati and Ahmedabad.
The company's subsidiary has received final approval for Imatinib Mesylate from Food and Drug Administration (FDA) in December 2015.
Prabhat Awasthi, head of India equities, Nomura, says Bank of Japan's move to go into negative interest rate zone was more of a rate signal and not a liquidity tool for markets
Abhishek Sharma, Pharma Analyst at IIFL recommends buying Glenmark Pharma and likes Lupin and Dr Reddy's Labs.
The company has received received the final approval from the United States Food and Drug Administration (FDA) to market Fyavolv tablets, Lupin today said in a statement. "Lupin's US subsidiary, Lupin Pharmaceuticals Inc shall commence promoting the product in the US shortly," it added.
Pandorum Technologies Pvt. Ltd., the Bangalore-based biotechnology startup working on tissue engineering, announced today that it has developed ...
Reiterating that its MAGGI Pazzta is 100 percent safe, Nestle India said that Lucknow-based National Foods Analysis Laboratory and its reports can not be relied upon.
Pazzta samples were collected from Nestle distributor - Sriji Traders at Mau on June 10 and were sent to a Lucknow-based government laboratory.
The product is a generic version of Forest Laboratories' Namenda tablets in the same strengths, it added.
Unichem's product is therapeutically equivalent to Forest Laboratories Inc's Namenda tablets, it added.
In an exclusive interview to CNBC-TV18, Commerce Minister Nirmala Sitharaman, says among most sectors, Indian pharma sector has already made its impact in the global market.