Wed,25Apr2018

RPS-Strategy Redefined - Clinical Trials Asia

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  • Branded drugmakers have balked at the U.S. Patent and Trademark Office's inter partes review system almost since its inception seven years ago. One reason? "It's unconstitutional," the companies contend. On Tuesday, the U.S. Supreme Court disagreed.

  • It’s been a painful few years for Orexigen Therapeutics in the obesity arena, and the company is finally ready to bow out. The San-Diego based drugmaker has inked a pact with Nalpropion Pharmaceuticals—a new company funded in part by specialty drugmaker Pernix Therapeutics—to sell worldwide rights to obesity med Contrave and other assets for $75 million in cash.

  • AstraZeneca has come up short in another lung cancer trial of its immuno-oncology combo, this time in patients who've failed on two prior treatments. But investors shouldn’t use the outcome to predict the forthcoming results of a closely watched first-line study, analysts say.

  • It's been a good news-bad news 24 hours for Eli Lilly. Its closely watched RA prospect baricitinib didn't exactly sail through Monday's FDA committee meeting. But Tuesday morning, Lilly rolled out Q1 results that beat sales and earnings expectations. Upshot? Analysts are still worried about a baricitinib approval.

  • Biogen's Spinraza sales increased only modestly, but the newly launched rare disease drug has tough numbers to top after last year's monster rollout, CEO Michael Vounatsos said Tuesday. And a new marketing campaign could help. But what about those MS numbers?

  • Takeda may just go unchallenged after all in its quest to swallow Shire. With a fifth offer from the Japanese drugmaker on the table, the companies are nearing a tie-up pact, sources tell Bloomberg, and they may have a preliminary agreement to announce as soon as Tuesday.

  • Regeneron had a big year in 2012, and R&D head George Yancopoulos won big kudos for it. He also nabbed a special stock award—500,000 shares—worth $57 million. Now, Yancopoulos has put those shares in his pocket, thanks to their vesting last year. Value now? $193 million.

  • The government-funded Cell and Gene Therapy Catapult opened its $83.8 million manufacturing plant in Stevenage, U.K., designed to support the global gene therapy industry.

  • Indian drugmaker Theon Pharmaceuticals was cited for falsifying records and inadequate quality control systems.

  • A year after inking its $4.3 billion Akorn buyout agreement, Fresenius plans to scrap the deal, citing "material breaches of FDA data integrity requirements." Akorn, though, isn’t having it, and analysts are skeptical, too. The upshot? A “legal battle royale” could be on the horizon.

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