Sat,26May2018

RPS-Strategy Redefined - Clinical Trials Asia

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  • Novartis has been looking to jettison some assets in its North American generics business, but as it turns out, a manufacturing facility in Canada will be sold off first. Its buyer, Avara, will add the Sandoz plant to a series of Big Pharma pickups over the past year.

  • BioMarin finally won FDA approval for Palynziq to treat the rare inherited blood disorder phenylketonuria, but with a dreaded black box warning on the label—and an estimated average cost of $192,000—analysts are already wondering whether the product will be the blockbuster it's expecting.

  • Merck & Co. was expecting big things from Eisai’s Lenvima in March, when it agreed to shell out up to $5.8 billion on half of the liver cancer drug’s sales. But in the first expansion bid since that deal, Lenvima has hit a snag.

  • AstraZeneca’s immunotherapy Imfinzi already has an FDA approval for inoperable lung cancer patients who've responded to chemo and radiation—and that's something none of its rivals will be able to say for a while. Friday, it hit another key benchmark to stretch out that lead.

  • With MERS and Lassa fever projects already funded, the Coalition for Epidemic Preparedness Innovations is ready to put a check mark beside the third disease on its priority list. The outbreak-focused alliance is granting up to $25 million to two partners developing a vaccine against the bat-borne disease Nipah.

  • Astellas will cut 600 positions in Japan in an R&D and sales reorg; a GSK infectious disease veteran launches wins $260 million to launch a China-focused biotech; Sun Pharma wins an FDA green light for its knockoff version of Johnson & Johnson's prostate cancer drug Zytiga; and more.

  • Targeted by the Justice Department in an industrywide copay assistance investigation, Pfizer has now agreed to a $23.85 million settlement with the feds. The deal will resolve allegations that its contributions to an assistance fund were kickbacks.

  • AbbVie’s Imbruvica growth strategy in chronic lymphocytic leukemia centers on expanding use of the drug among previously untreated patients. And it now has some new data that should help it do that.

  • Eli Lilly is leaning on oncology as a key pillar for growth going forward, but with news that its president of the business, Sue Mahony, is retiring, the drugmaker will need to find new leadership for the unit.

  • Merck & Co.'s effort to take its Fosamax appeal to the Supreme Court just got a boost with backing from the U.S. Solicitor General. If the high court hears the appeal, its decision could ripple across the drug business, because at its heart is the question of whether FDA decisions supersede certain legal challenges.

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