Hello, everyone, and how are you today? We are fine, thank you, especially with a warm, shiny sun and cool breeze wafting about the Pharmalot campus. Although the short people are sleeping in, we are quite busy, as usual, and getting ready for a round of meetings with the home office. While we prepare, here are a few items of interest to get you going. Hope you have a smashing day and do keep us in mind when you hear something interesting …
Valeant Pharmaceuticals is reorganizing into three segments: branded drugs; Bausch + Lomb and international products; and US diversified products, including generics. And despite investor expectations, the beleaguered drug maker maintained earnings forecasts for the year in a bid to restore investor confidence after facing a year of sustained criticism over its pricing and accounting practices. Valeant stock jumped in pre-market trading.
AstraZeneca suffered a setback when an experimental cancer drug called selumetinib failed to meet its goal in a late-stage trial for lung cancer, Reuters tells us. Hopes for the medicine had already been lowered after it failed in another study last year for treating a rare cancer of the eye. The drug maker is relying on oncology treatments for a revival following a wave of patent expirations.
The Zika virus may have grabbed global attention, but the biggest drug makers are mostly hanging back from developing a vaccine, STAT reports. Of the vaccines under development, only two projects involve a major drug company. And in one case — a partnership between GlaxoSmithKline and the National Institute of Allergy and Infectious Diseases — the approach planned is new, untested, and not likely to race to market.
A troubled plant here, a troubled plant there: The US Food and Drug Administration ordered Adaptimmune to halt a trial of its liposarcoma therapy and asked for more information about how the drug is made, InPharma Technologist says. The FDA also found quality problems at a Rhode Island plant where Alexion Pharmaceuticals makes Soliris medication. And the agency banned products from a third Indian manufacturing plant run by Wockhardt.
Eisai says the FDA confirmed there is sufficient data to start Phase 3 studies of a drug it is codeveloping to treat early Alzheimer’s disease, Reuters writes.
Gedeon Richter and Allergan are proceeding with an antipsychotic drug despite its failure in a Phase 3 trial for major depressive disorder, Genetic Engineering & Biotechnology News says.