Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and relaxing because the never-ending routine of meetings, deadlines, and the like has now returned. Such is life, as they say. To cope, yes, we are quaffing cups of stimulation — fanciful blueberry for those keeping track — and invite you to do the same. Meanwhile, here are some tidbits. Have a smashing day and do keep in touch …
Immunotherapy drugs have been hailed as a breakthrough in cancer treatment, but doctors are finding that what makes them effective is also what poses serious risks, the New York Times reports. In cancer clinics around the world and in clinical trials, side effects are appearing. And studies are finding that severe reactions occur nearly 20 percent of the time with some drugs, and in more than half of patients when certain drugs are used in combination.
A Novartis drug eliminated an aggressive form of blood cancer in 82 percent of patients treated with modified immune cells in a mid-stage trial, PMLive writes. Novartis plans to seek regulatory approval in early 2017, which may calm jitters about the potential of CAR-T, an emerging technology that relies on modified immune cells that are engineered to attack and destroy malignant cells. A Juno Therapeutics trial was halted recently after two patient deaths.
Aetna agreed to cover the Sarepta Therapeutics drug for Duchenne muscular dystrophy, according to its latest clinical policy bulletin, which states the treatment is “medically necessary” for people who have demonstrated a response to therapy as evidenced by remaining ambulatory. UnitedHealthcare, Humana, and Cigna are also covering the treatment, although Anthem declined to do so.
The CRISPR patent dispute reaches a much-awaited milestone on Tuesday, when the case’s first and only oral arguments take place, STAT tells us. The case, which pits the University of California against the Broad Institute of Harvard and MIT for rights to key patents on CRISPR genome-editing, is being closely watched, although the arguments are slated to last less than an hour for a patent potentially worth billions of dollars.
AstraZeneca plans to move an undisclosed number of back office jobs from the UK to Costa Rica, Poland, and Malaysia in a bid to lower expenses, the Guardian tells us. Earlier this year, the drug maker said it hoped to bring down annual costs by about $1 billion by the end of 2017, through a series of cost-cutting measures. At the time, the company indicated most job cuts would on the UK would be minimal.
Amgen and Allergen have filed with European regulators what they believe is the first biosimilar candidate of Roche’s cancer blockbuster Avastin, according to PharmaTimes.
More than 300 civil society groups asked Asia Pacific region negotiators to reject attempts to adopt Trans-Pacific Partnership texts into the Regional Comprehensive Economic Partnership, PharmaBiz says.
Two patients with hemophilia B experienced adverse autoimmune reactions to a Spark Therapeutics gene therapy, requiring treatment with steroids and causing lower levels of factor IX, TheStreet says.
The FDA approved a new indication for Eli Lilly and Boehringer Ingelheim’s Jardiance to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and cardiovascular disease.