Tue,24Apr2018

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  • The European Medicines Agency issued a warning letter to Indian drugmaker Theon Pharmaceuticals, citing the company 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.

  • U.S. regulators knocked back Pfizer's biosimilar version of Roche's breast cancer stalwart Herceptin, the drug giant's second biosim knockoff to fall short at the FDA. The delay will put Pfizer even farther behind Mylan and Biocon, which nabbed an FDA green light in December.

  • With a generics pricing squeeze hitting the entire copycat drug industry, Mylan is laying off about 500 employees in Morgantown, West Virginia. The cuts will simplify the site—among pharma's largest—which is now too complex, the company said.

  • Pfizer’s first ad campaign for over-the-counter Viagra in the U.K. uses comparisons to illustrate the relative commonplace incidence of erectile dysfunction. Print and out-of-home ads begin with the fact that “4.3 million men in the U.K. experience erectile problems.” The text-heavy ads then note comparisons such as, “That’s more men than there are cabs in the whole of the U.K.” or “That’s enough men to fill every major British football stadium.”

  • Protection against the dominant H3N2 flu strain offered by the coming season’s flu vaccine will again be far from optimal—putting it mildly. That's thanks to the widely used manufacturing process based on eggs, according to a new study.

  • ​​​​​​​The word "gamification" gets tossed around a lot in marketing and loyalty programs, but for Boehringer Ingelheim it’s more than just a buzzword. The pharma company recently expanded its RespiPoints online rewards program because it works. Today, four of its respiratory drugs to treat COPD and asthma are in the program, run in conjunction with HealthPrize Technologies.

  • Luminary Labs has run innovation challenges for Sanofi, Merck, Janssen and many more since 2011, giving out more than $5 million in prizes along the way. But where are those gold-star ideas now?

  • The third time wasn’t the charm for Takeda in its attempts to swallow Shire—but the fourth time might be. On Friday, the Dublin drugmaker said Japan’s largest pharma offered £47 per share, almost half of that in cash, or about £44 billion ($61.6 billion).

  • Novartis is hoping its multiple sclerosis candidate siponimod’s performance in secondary progressive patients can help secure it a blockbuster approval. And now it has more data to put toward that case.

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