Good morning, everyone. Another busy day is on the way. We can tell because the shortest of short people raced out the door for the bus to the local schoolhouse and Mrs. Pharmalot is indulging us by brewing yet another cup of stimulation in the coffee kettle. All of which means it is time to get cracking. So, as always, here are some items of interest to help you along. Hope you conquer the world today and, of course, keep us in mind for juicy tips …
Valeant Pharmaceuticals was sued by former Sprout Pharmaceuticals investors who claim the drug maker botched the marketing of the Addyi female libido pill after acquiring it in a $1 billion buyout last year, Bloomberg News reports. The lawsuit claims Valeant violated terms of the deal by overcharging for Addyi and failed to make promised investments to market the drug, shortchanging them former Sprout shareholders on royalty payments.
Meanwhile, Valeant is exploring a sale of its eye-surgery equipment business for perhaps $2.5 billion as part of an effort to unload assets and pare $30 billion in debt, the Wall Street Journal reports. Earlier in the week, the drug maker was reportedly talking to Takeda Pharmaceuticals about selling its Salix unit for about $10 billion. While some investors are buoyed, the potential deals underscore the magnitude of the problems that Valeant faces.
Roche says that four patients suffered serious adverse events in a clinical trial of an experimental hemophilia drug, Reuters informs us. The problems relate to thrombosis, or blood clots, with two thromboembolic events and two cases of thrombotic microangiopathy. Deutsche Bank analyst Richard Parkes believes the problems suggested patients were still experiencing breakthrough bleeds despite getting the medicine.
Early human and animals trials of a Merck drug found it effectively “switched off” production of toxic amyloid proteins that lead to the sticky plaques seen in the brains of Alzheimer’s patients, the Guardian writes. Samples taken from the fluid surrounding the brain showed the drug reduced levels of two compounds known to be building blocks for abnormal amyloid proteins. The results of a Phase 3 trial are due to be reported in July 2017.
The Centers for Medicare and Medicaid Services is proceeding with a national test of Medicare coverage for a YMCA diabetes prevention program over the objections of the pharmaceutical industry, USA Today tells us. Trade groups representing hospitals and doctors support the plan, but the Pharmaceutical Research and Manufacturers of America called it a “flawed precedent” based on “preliminary” evidence.
The UK’s National Institute for Health and Care Excellence issued a draft guidance recommending an Eisai breast cancer drug called Halaven after the drug maker offered an undisclosed price reduction and updated clinical trial data, according to Reuters. NICE is reappraising all the drugs covered by the UK’s Cancer Drugs Fund and requiring they meet tough cost-effectiveness targets.
Gilead Sciences quietly ended development of two drugs, Pharmafile writes. One was in Phase 2 development for treating alcoholic hepatitis, NASH, and pulmonary arterial hypertension. As recently as last month, the company said it planned to proceed through Phase 3 development despite less-than-expected efficacy. The other was a monoclonal antibody for treating ulcerative colitis, Crohn’s disease, rheumatoid arthritis, gastric cancer, and cystic fibrosis.
PTC Therapeutics says there is a “higher degree of uncertainty” around the fate of its Duchenne muscular dystrophy drug in the European Union. The drug maker is waiting to hear whether marketing authorization for the drug, known as Translama, will be renewed or if the medicine will be removed from the market. The drug had been given conditional approval. The company, meanwhile, is appealing regulatory rejection in the US.
The Indian government may disband the National Pharmaceutical Pricing Authority and assume power to set prices of essential medicines, the Economic Times reports. The move comes in response to concerns that excessive controls were stifling innovation and competitiveness of the sector. The revamped policy will also delink price controls from the list of essential medicines. Right now, a drug is subject to price controls as soon as it is added to the list.