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Government Agencies FDA

  • Abemaciclib, which was granted U.S. Food and Drug Administration breakthrough therapy status for breast cancer in 2015, is also being tested for use in lung cancer. After skin cancer, breast cancer is the most common cancer in women in the United States, according to the U.S. Centers for Disease Control and Prevention. About 40,610 women will die from breast...

  • LONDON, March 17- U.S. regulators have dealt a fresh blow to AstraZeneca's new medicine to treat high potassium levels, indicating it still has concerns over the manufacturing process of the drug. The intervention-- the second in the United States for this drug-- came after an inspection of the manufacturing facility in Texas. "AstraZeneca and ZS Pharma are...

  • March 16- U.S. stocks slipped on Thursday pressured by healthcare shares after proposals in President Donald Trump's budget signaled higher regulatory costs for the sector and a cut in federal funding for medical research. For 2018, the Trump administration has budgeted over $2 billion in fees to be collected by the U.S. Food and Drug Administration from the...

  • Emflaza has been available outside the United States for decades to treat DMD, a devastating muscle-wasting disease that mainly affects young boys. Last month, the U.S. Food and Drug Administration approved Emflaza for use in the United States. But Translarna, which is designed to treat a specific subset of DMD patients, was rejected by the FDA last year and is...

  • March 16- PTC Therapeutics Inc said on Thursday that it would buy the rights to Marathon Pharmaceuticals Llc's controversial Duchenne muscular dystrophy drug, Emflaza, for $140 million upfront. The U.S. Food and Drug Administration in February approved the steroid for the devastating muscle-wasting disease that mainly affects young boys.

  • The FDA has been criticized by lawmakers for not being quick enough at approving drugs, and President Donald Trump told Congress earlier this year that he aimed to speed up the approval of drugs. The FDA has been charging companies to review their products since 1992. Most of the user fees collected are for prescription drugs- around $866 million estimated in...

  • There are currently no therapies for this form of MG approved by the U.S. Food and Drug Administration. Catalyst said it intends to discuss a plan with the FDA to take Firdapse into a pivotal study. Catalyst's shares jumped 17 percent to $1.37 before the bell on Wednesday.

  • March 14- The benefits of Endo International Plc's long-acting opioid painkiller no longer outweigh its risks, an independent panel to the U.S. Food and Drug Administration concluded on Tuesday. However, data shows that while nasal abuse has reduced with the reformulation, rates of intravenous abuse increased, FDA staff noted in their review on Thursday,...

  • March 14- The benefits of Endo International Plc's long-acting opioid painkiller no longer outweigh its risks, an independent panel to the U.S. Food and Drug Administration concluded on Tuesday. The Centers for Disease Control and Prevention estimates at least 91 Americans succumb every day to opioid overdose. Data shows that while nasal abuse has reduced...

  • March 14- The benefits of Endo International Plc's long-acting opioid painkiller no longer outweigh its risks, an independent panel to the U.S. Food and Drug Administration concluded on Tuesday. The drug, Opana ER, is a long-acting variation of oxymorphine that is intended to treat pain severe enough to require daily, around-the-clock, long-term opioid...

  • *Consensus forecasts point to sales of $1.5 bln by 2022. ZURICH, March 14- Novartis has won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women who have a difficult-to-treat form of breast cancer, challenging U.S. rival Pfizer's Ibrance. British biotech company Astex Pharmaceuticals, now part of Otsuka, will receive undisclosed...

  • The legislation from Senators Chuck Grassley, an Iowa Republican, and Debbie Stabenow, a Michigan Democrat, would add the secretaries of the Agriculture Department and Health and Human Services, which oversees the Food and Drug Administration, to a panel that reviews mergers and other deals to ensure that transactions do not harm national security.

  • *Sun shares rise as much as 6.8 pct in Mumbai. MUMBAI, March 14- India's largest drugmaker Sun Pharmaceutical Industries said U.S. regulators plan to lift a ban on its Mohali plant in northern India, paving the way for a resumption of exports to the company's biggest market after four years. Sun's shares surged as much as 6.8 percent in Mumbai on Tuesday to a...

  • MUMBAI, March 14- India's largest drugmaker Sun Pharmaceutical Industries Ltd said on Tuesday that U.S. regulators plan to lift a ban on its Mohali plant in northern India, allowing the company to restart supplies from there after four years. Sun gained the plant along with its acquisition of Ranbaxy Laboratories in 2015 and has been attempting to fix quality...

  • March 13- Novartis AG said on Monday that the U.S. Food and Drug Administration had approved the company's experimental drug, kisqali, as a first-line treatment for a type of breast cancer in postmenopausal women, in combination with another breast cancer drug. The approval is based on a late-stage data, which showed that kisqali, along with letrozole, met the main...

  • Gottlieb choice broadly positive for the industry: Pro

    Barbara Ryan, Barbara Ryan Advisors, discusses the biotech and pharmaceutical industry's view of President Trump's pick of Scott Gottlieb to head the FDA.

  • Pres. Trump nominates Dr. Scott Gottlieb to run FDA

    CNBC's Meg Tirrell takes a closer look at President Trump's FDA pick Dr. Scott Gottlieb, and what this nomination means for the health care sector. With “Fast Money Halftime Report” traders.

  • Scott Gottlieb

    Trump wants to deregulate the Food and Drug Administration. He chose the right guy for the job, Vox reports.

  • Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, the White House said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and tobacco.

  • Scott Gottlieb, a conservative health policy expert with deep ties to the pharmaceutical industry, to lead the U.S. Food and Drug Administration, a White House official said on Friday. If confirmed by the Senate, Gottlieb would be in charge of implementing Trump's plan to dramatically cut regulations governing food, drugs, cosmetics, dietary supplements and...