Business in Brief
Valeant’s CEO steps down, Bayer and Regeneron team up again, and the FDA issue marketing approval for Triggerfish
- Valeant’s CEO Michael Pearson stepped down amid accounting problems at the Canadian pharmaceutical company, such as revenue forecast misstatements and a congressional probe into drug price hiking. Bill Ackman, Pershing Square Capital Management’s CEO has been appointed to Valeant’s board of directors, joining his colleague Stephen Fraidin (Pershing Square’s vice chairman).
- However, Valeant’s officers, including Ackman, have received cease trade orders from one of Canada’s securities regulators,Autorité des marchés financiers, tied to the company’s failure to meet deadlines for filing its annual report and other documents.
- Bayer and Regeneron join forces to develop a new combination therapy that consists of Bayer’s aflibercept, plus Regeneron’s angiopoietin2 antibody, nesvacumab. The combination, administered via a single intravitreal injection, is currently under Phase II clinical evaluation for wet AMD (NCT02713204), and DME (NCT02712008) – this is in addition to their existing Phase II evaluation of aflibercept plus REGN2176-3 (a PDGF-β antibody) in patients with wet AMD (NCT02418754, NCT02061865).
- The FDA has issued de novo marketing approval to SensiMed’s eye volume monitoring (a surrogate marker of IOP) contact lens, Triggerfish, for adults aged ≥22 years, under the supervision of a healthcare professional.
- Retina Implant AG has secured €26 million in private funding – from both existing and new investors – and will be used to establish new clinical centers around the world, and to help the company initiate reimbursement applications for its Alpha IMS subretinal microchip in key markets.
- The Pfizer-Allergan merger is off – see here for more.
I spent seven years as a medical writer, writing primary and review manuscripts, congress presentations and marketing materials for numerous – and mostly German – pharmaceutical companies. Prior to my adventures in medical communications, I was a Wellcome Trust PhD student at the University of Edinburgh.
