Hello, everyone, and how are you today? We are just fine, thank you, especially now that the Pharmalot campus has settled down. The shortest of the short people has left for the local schoolhouse and the official mascots have descended into a deep snooze. We, however, must remain wide awake, which calls for a few cups of stimulation. As always, we invite you to join us. Meanwhile, here are the tidbits. Have a lovely day and do keep in touch …
GlaxoSmithKline named Emma Walmsley to succeed Andrew Witty as chief executive when he retires next March. Walmsley, who will become the only woman to head a global brand-name drug maker, currently runs the Glaxo consumer health business, a unit that Witty has emphasized following a deal last year that created a joint venture with Novartis as part of a strategic realignment.
Janet Woodcock, who heads the drug review division at the US Food and Drug Administration, won a huge and consequential power struggle this week when she successfully pressed the agency to approve a controversial new drug for treating Duchenne muscular dystrophy — even though there is scant evidence it works, STAT writes. “She’s tough as nails,” said Marc Boutin, who heads the National Health Council, a coalition of patient groups and drug makers.
Bayer is considering dropping the Monsanto name to avoid “sullying its reputation,” Bloomberg News reports. The drug and chemical conglomerate wants to avoid association with a corporate name known for making the herbicide Agent Orange that was used in the Vietnam War and for tangling with environmental groups over genetically modified crops.
Regeneron Pharmaceuticals and Teva Pharmaceuticals will jointly develop and market an experimental pain drug with a new mechanism of action that, if approved, could make it a non-addictive alternative to opioids, Reuters says. The injectable drug, called fasinumab, blocks Nerve Growth Factor, a protein involved in transmission of pain signals. Eli Lilly and Pfizer plan by 2018 to seek approval for a similar medicine.
Australia’s Therapeutics Goods Administration plans to allow drug makers to submit reports from international regulators as one of several steps to speed the approval process for new drugs, according to BioCentury. The TGA estimates that the changes could shorten the approval time by as much as four months. Among the pathways will be an accelerated assessment and consideration of surrogate endpoints.
Allergan agreed to buy Tobira Therapeutics in a deal worth up to nearly $1.7 billion, its second major acquisition in less than a week. Several days ago, Allergan agreed to purchase Vitae Pharmaceuticals for $639 million to bolster its dermatology product pipeline. The latest deal moves Allergan into treatments for nonalcoholic steatohepatitis, or NASH, and other liver diseases.
The US Food and Drug Administration banned products from Laxachem Organics, a maker of active pharmaceutical ingredients, due to a bacterial outbreak, the Economic Times tells us. In July, the Centers for Disease Control and Prevention and the FDA began investigating a multi-state outbreak and, in one state, traced the problem to contaminated Docusate Sodium, an active ingredient supplied by Laxachem.
The European Medicines Agency recommended banning all nonessential drugs made by Pharmaceutics International in the US due to manufacturing problems, according to this notice.
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