Industry News

Biotech

• FDA still not happy with Kamada inhaled AAT drug 2018/04/23
  Israeli biotech Kamada has hit another hurdle in its marathon bid to bring the first inhaled treatment for alpha-1 antitrypsin (AAT) deficiency to market as an alternative to intravenous drugs.
• Synthetic Biologics loses breakthrough status after FDA discovers death imbalance in trial data 2018/04/23
  Synthetic Biologics has lost its breakthrough designation for ribaxamase following a review of the data by the FDA. The review revealed an imbalance in patient deaths in a phase 2b trial of the drug, …
• Targeting heart disease by focusing on a protein that dilates blood vessels 2018/04/23
  Scientists at Scripps Research Institute have pinpointed a protein that can sense blood flow and prompt tiny blood vessels called arterioles to dilate. They believe the protein, called GPR68, could be …
• After Kerrisdale predictions of failure, Prothena dumps AL amyloidosis drug 2018/04/23
  Prothena missed primary and secondary endpoints in its key AL amyloidosis drug NEOD001 in a midstage test, with predictions it also wouldn’t cut it in phase 3, leading the company to dump work on the …
• Sanofi diabetes research chief takes CSO post at Grünenthal 2018/04/23
  Sanofi is set to lose its global head of diabetes research and translational medicine to Grünenthal. Philip Just Larsen, M.D., Ph.D., will join the German pain specialist at the start of July, leaving …

Medical Devices

• FDA still not happy with Kamada inhaled AAT drug 2018/04/23
  Israeli biotech Kamada has hit another hurdle in its marathon bid to bring the first inhaled treatment for alpha-1 antitrypsin (AAT) deficiency to market as an alternative to intravenous drugs.
• Synthetic Biologics loses breakthrough status after FDA discovers death imbalance in trial data 2018/04/23
  Synthetic Biologics has lost its breakthrough designation for ribaxamase following a review of the data by the FDA. The review revealed an imbalance in patient deaths in a phase 2b trial of the drug, …
• Targeting heart disease by focusing on a protein that dilates blood vessels 2018/04/23
  Scientists at Scripps Research Institute have pinpointed a protein that can sense blood flow and prompt tiny blood vessels called arterioles to dilate. They believe the protein, called GPR68, could be …
• After Kerrisdale predictions of failure, Prothena dumps AL amyloidosis drug 2018/04/23
  Prothena missed primary and secondary endpoints in its key AL amyloidosis drug NEOD001 in a midstage test, with predictions it also wouldn’t cut it in phase 3, leading the company to dump work on the …
• Sanofi diabetes research chief takes CSO post at Grünenthal 2018/04/23
  Sanofi is set to lose its global head of diabetes research and translational medicine to Grünenthal. Philip Just Larsen, M.D., Ph.D., will join the German pain specialist at the start of July, leaving …

Pharma

• Fresenius dumps its $4.3B Akorn buyout, and a 'legal battle royale' could come next 2018/04/23
  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, …
• FDA to Pfizer: To win OK for Herceptin biosimilar, fork over more 'technical' info 2018/04/23
  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 pu …
• Squeezed Mylan axing 500 jobs in West Virginia to 'right-size' massive plant 2018/04/23
  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 larg …
• Pfizer's first U.K. ads for OTC Viagra put erectile dysfunction in perspective 2018/04/23
  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 f …
• Boehringer Ingelheim expands adherence-improving respiratory rewards program 2018/04/23
  ​​​​​​​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 i …

Vaccines

• Sanofi's Dengvaxia needs a dengue diagnostic, stat, thanks to WHO 2018/04/20
  WHO advisers changed their recommendations for Sanofi's Dengvaxia, saying it should be used after a diagnostic confirms a prior infection. But as of now, fast and reliable tests don't exist.
• Merck pits its pneumococcal shot against Pfizer's mammoth Prevnar in head-to-head phase 3 2018/04/17
  Merck & Co. has a big target in mind for its pneumococcal vaccine V114: no less than Prevnar 13, the world's best-selling shot. So, the U.S. drugmaker has charted a phase 3 course for V114 th …
• Sanofi ups the ante in vaccines—big-time—with new €350M plant 2018/04/12
  At more than $500 million, Sanofi's new Canadian vaccine plant will be one of the largest investments ever by the company in a single facility. And no wonder: The company's vaccine business …
• Dendreon chairwoman figures Provenge growth, infrastructure can pave its way into CAR-T 2018/04/01
  About a year into Sanpower's Dendreon buyout, Sanpower SVP and Dendreon Chairwoman Grace Xu is not only aiming for 10% growth for the prostate cancer therapy Provenge but also scouting for CAR-T …
• NIAID chief: Platform tech will bring a 'major switch'—and shorter timelines—to vaccine R&D 2018/03/28
  Experts say technology is advancing to develop vaccines faster at a time of increasing emerging disease outbreaks.