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Biotech and Pharmaceuticals Pharmaceuticals

  • *FDA turns down Hikma application, needs' major' amendment. The FDA has already delayed approval of Mylan's version. Hikma and Mylan have received so-called complete response letters from the FDA that were categorised as major.

  • The FDA has already delayed approval of Mylan's version. Both Hikma and Mylan have received so-called complete response letters from the FDA that were categorized as major. Dealing with a major amendment to a generic drug application means a delay of 10 months for an FDA response, according to agency guidelines.

  • LONDON, May 11- Hikma Pharmaceuticals said on Thursday that U.S. regulators had decided not to approve its generic copy of GlaxoSmithKline's blockbuster lung drug Advair at this time, due to' major' issues with its application. The company said there was a low likelihood of approval this year. The U.S. Food and Drug Administration has already delayed approval of...

  • Mad Money Lightning Round

    Jim Cramer speeds through his take on caller favorite stocks, including one pharmacy giant.

  • NEW YORK, May 10- U.S. drugmaker Pfizer Inc said on Wednesday it reached an agreement with Sangamo Therapeutics Inc for rights to its gene therapy programs to treat the rare blood-clotting disorder hemophilia A, under which Pfizer will pay $70 million upfront. Shares of Sangamo jumped 41 percent to $6.15 in after-the-bell trading. Michael Goettler, global...

  • Mylan President Rajiv Malik said the FDA was asking it to comply with standards set out in draft guidance the agency issued, but that it believes it is not required to do so. An FDA spokeswoman declined to comment, saying she was prohibited by law from discussing a pending application. Malik said the company could not comment further on the length of the delay for...

  • BOSTON, May 10- Billionaire investor William Ackman is making money on one of his new investment ideas, but he declined on Wednesday to identify the portfolio company, which has gained 30 percent since he first bought it. One makes up roughly 5 percent of Pershing Square Capital Management's $11 billion of capital and has gained about 30 percent, Ackman said.

  • BOSTON, May 10- Billionaire investor William Ackman is making money on one of his new investment ideas, but he declined on Wednesday to identify the portfolio company, which has gained 30 percent since he first bought it. One makes up roughly 5 percent of Pershing Square Capital Management's $11 billion of capital and has gained about 30 percent, Ackman said.

  • Boxes of Eli Lilly & Co. Humalog medication sit on a pharmacy shelf in Provo, Utah.

    The increases fit a pattern of drugmakers making single-digit percentage hikes once or twice a year, despite political pressure.

  • Mylan President Rajiv Malik said the FDA was asking it to comply with standards set out in draft guidance the agency issued, but that it believes it is not required to do so. Malik said the company could not comment further on the length of the delay for approval until it meets with the FDA to discuss their disagreement, but that the FDA had designated it as requiring...

  • Mylan EpiPen

    EpiPen maker Mylan said on Wednesday first-quarter profit more than quadrupled, as the maker of generic drugs benefited from strong demand outside the U.S.

  • Mylan's affirmation of its 2017 forecast may be comforting to some following the U.S. Food and Drug Administration's recent rejection of the company's generic version of GlaxoSmithKline Plc's blockbuster Advair asthma treatment, Goldman Sachs analysts said. So far, Mylan has provided no details of the FDA's concerns or how long the product might be delayed.

  • Pharmacist Pharmacy medication

    The high cost of health care in the US is nothing compared to the markup on some prescription medicines. We reveal the most expensive drugs.

  • Mylan has come under fire for steep price increases for EpiPen, its life-saving allergy shot, and also for classifying the treatment as a generic rather than a branded product, leading to smaller rebates to state Medicaid programs. Mylan said net income surged to $66.4 million, or 12 cents per share in the first quarter ended March 31, from $13.9 million, or 3 cents...

  • May 10- EpiPen maker Mylan NV said on Wednesday first-quarter profit more than quadrupled, as the maker of generic drugs benefited from strong demand outside the United States. The company said net income rose to $66.4 million, or 12 cents per share in the first quarter ended March 31, from $13.9 million, or 3 cents per share, a year earlier. Revenue rose to $2.69...

  • *Analysts say failure puts approval at risk. ZURICH, May 10- Roche's Tecentriq immuno-oncology drug failed a late-stage follow-up trial against advanced bladder cancer, the Swiss drugmaker said on Wednesday, raising questions about whether regulators could scale back their approval of the medicine. Roche, the world's biggest maker of cancer drugs, had won...

  • ZURICH, May 10- Roche's Tecentriq drug has failed a late-stage trial in people with previously treated advanced bladder cancer, the Swiss drugmaker said on Wednesday, a setback in its plans to expand use of the immunotherapy. "While these results are not what we had expected, we believe that Tecentriq will continue to play an important role in the treatment of...

  • Cramer Remix: Where the money leaving retail stocks could be headed

    Jim Cramer pointed to consumer spending on vacations and travel as a possible pull from retail purchases.

  • Jim Cramer

    Jim Cramer pointed to consumer spending on vacations and travel as a possible pull from retail purchases.

  • Scott Gottlieb, a health policy expert and venture capitalist, as commissioner of the Food and Drug Administration, which regulates everything from food and drugs to tobacco, cosmetics and dietary supplements. The Senate voted 57-42 in favor of Gottlieb, a conservative physician and former deputy FDA commissioner under George W. Bush, who supporters say is...