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Biotech and Pharmaceuticals Life Sciences

  • *Head and neck cancer studies resume patient recruitment. LONDON, Nov 22- U.S. officials have given a green light for two clinical trials testing AstraZeneca's immunotherapy drug durvalumab in head and neck cancer to resume recruiting patients, lifting a hold imposed following cases of bleeding. Shares in AstraZeneca gained around 1 percent on Tuesday as the...

  • LONDON, Nov 22- U.S. officials have given a green light for two clinical trials testing AstraZeneca's cancer immunotherapy drug durvalumab in head and neck cancer to resume recruiting patients, lifting a hold imposed following cases of bleeding. The British drugmaker said on Tuesday that one of the late-stage Phase III trials had already re-opened for new...

  • BRIEF-GSK FILES REGULATORY SUBMISSION OF CANDIDATE VACCINE@. *GSK files regulatory submission of candidate vaccine for prevention of shingles in Canada. *Says regulatory submission for candidate shingles vaccine is based on a comprehensive phase III clinical trial program.

  • The companies are racing rivals including Eli Lilly, Alder Biopharmaceuticals, Allergan and Teva Pharmaceuticals to have a new, more effective migraine treatment approved by U.S. and European regulators. Jefferies analyst Jeffrey Holford, in a note on Thursday, forecast $1.5 billion in peak sales for the drug, with estimates for Novartis reaping about $440...

  • *Says will meet with FDA "as soon as possible". Dynavax Chief Executive Eddie Gray said on Monday the company would meet with the FDA "as soon as possible" to discuss concerns raised by the agency in a "complete response letter." The company said the FDA, in its letter, sought information about certain "adverse events" during clinical trials, among other clarifications.

  • *Says to meet with FDA "as soon as possible". The drug developer said on Monday it received a "complete response letter" from the FDA, seeking information about certain "adverse events" during clinical trials, among other clarifications. Dynavax Chief Executive Eddie Gray said the company would meet with the FDA "as soon as possible" to discuss the letter.

  • The drug developer said it received a "complete response letter" from the FDA, seeking information about certain "adverse events" during clinical trials, among other clarifications. Dynavax said there was no request from the FDA for additional clinical trials and there were no apparent concerns about rare serious events. Dynavax Chief Executive Eddie Gray...

  • Nov 14- Dynavax Technologies Corp said on Monday the U.S. Food and Drug Administration had rejected the marketing application for its hepatitis B vaccine Heplisav-B, sending the company's shares tumbling 44 percent in premarket trading. The drug developer said it received a "complete response letter" from the FDA, seeking information about certain "adverse...

  • SAN FRANCISCO, Nov 9- U.S. companies reacted on Wednesday with caution to businessman Donald Trump's victory in the U.S. presidential election and pointed to uncertainty over his lack of clear policy proposals. Following campaign promises by Trump to renegotiate global trade agreements and make U.S. companies move factories back to the United States, over...

  • SAN FRANCISCO, Nov 9- U.S. companies reacted on Wednesday with caution to businessman Donald Trump's victory in the U.S. presidential election and pointed to uncertainty over his lack of clear policy proposals. Following campaign promises by Trump to renegotiate global trade agreements and make U.S. companies move factories back to the United States, over...

  • NATIONAL INSTITUTES OF HEALTH SAYS TESTING OF INVESTIGATIONAL INACTIVATED ZIKA VACCINE IN HUMANS BEGINS; 1 ST OF 5 PLANNED CLINICAL TRIALS TO TEST ZPIV VACCINE.

  • BOSTON, Nov 1- Billionaire hedge fund manager Daniel Loeb on Tuesday told clients that "idiosyncratic opportunities" have helped boost returns this year as a string of constant surprises has shaped markets, adding that more may be in store. With next week's U.S. presidential election looming large, Loeb's Third Point hedge fund wrote to clients in a letter seen by...

  • Nov 1- Pfizer Inc scrapped its high-profile cholesterol fighter after its effectiveness waned over time in large clinical trials, sending its shares 2 percent lower and prompting the company to trim its 2016 earnings forecast. Chief Executive Ian Read said in an interview that the effectiveness of Pfizer's drug waned in a significant number of patients...

  • Oct 28- German chemicals and pharmaceuticals company Merck KGaA is exploring a sale of its biosimilars unit, according to people familiar with the matter, as that business faces fierce competition from larger players in the sector. Stefan Oschmann, however, who took over as Merck's CEO earlier this year, has been focused on finding ways to safeguard his...

  • LONDON, Oct 27- AstraZeneca's high hopes for cancer immunotherapy were dented on Thursday as the recruitment of new patients with head and neck cancer into two clinical studies was put on hold, following instances of bleeding. The drugmaker said the U.S. Food and Drug Administration had placed a partial hold on enrolment into the final-stage Phase III trials...

  • *Fiocruz tie-up follows partnership deal with U.S. Army. The deal with the Fiocruz public health centre follows a tie-up in July between Sanofi and a U.S. Army research institute, which gave the drugmaker access to one of the furthest advanced vaccines in development. "It only makes sense for the pursuit of public health that we combine our expertise and resources...

  • Oct 27- Sanofi has struck a collaboration deal with a leading Brazilian research institute to speed development of a Zika vaccine, consolidating the French drugmaker's leading position in the race to defeat the mosquito-borne virus. The deal with the Fiocruz public health centre follows a tie-up in July between Sanofi and a U.S. Army research institute, which...

  • *Consensus forecasts point to $1.05 billion sales in 2021. LONDON, Oct 24- GlaxoSmithKline has filed its shingles vaccine Shingrix for U.S. regulatory approval, the drugmaker said on Monday, bringing the potential $1 billion- a-year seller a step closer to market. The company, which will see Emma Walmsley take over as chief executive in 2017, is seeking to...

  • Honoree Bob Dylan speaks onstage at the 25th anniversary MusiCares 2015 Person Of The Year Gala honoring Bob Dylan at the Los Angeles Convention Center on February 6, 2015 in Los Angeles, California.

    American winners of the prize will find that they're making less than any winner since 1988.

  • Oct 10- New data is likely to prompt doctors to abandon Bristol-Myers Squibb's immunotherapy Opdivo in favor of Merck& Co's rival Keytruda in a large segment of the lucrative lung cancer market, analysts said on Monday. It generated $840 million of sales in the second quarter, more than double those of Keytruda. Details of the trial unveiled at the European...