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Rise and shine, everyone, a busy day is on the way. It is also a very cold one here on the Pharmalot campus, where we are brewing another hot cup of stimulation in our shiny, new coffee kettle. Nothing like single-digit temperatures, yes? We hope things are warmer where you are. Meanwhile, we have assembled the usual menu of interesting items to help you along. Have a wonderful day and do keep in touch …

The Food and Drug Administration approved 45 new drugs — or new molecular entities — in 2015, which was the largest number since 1996, the Associated Press says. The tally reflects an increasing industry focus on medicines used to treat rare and complicated diseases, which often involved so-called accelerated or priority regulatory reviews, extra patent protections, and higher price tags.

Drug makers face new fees for regulatory submissions in India. The Ministry of Health and Family Welfare has proposed notable fee increases for clinical trials, product registrations, manufacturing, and product licenses, according to The Economic Times. For instance, the increases proposed for site registrations for importing drugs would climb to $10,000 from $1,500, while fees for product registrations will rise to $5,000 from $1,000.


To combat high prices for drugs without patent protection, the FDA should consider temporarily permitting compounding of the drug or importing versions approved for sale outside the US, former FDA deputy commissioner Joshua Sharfstein and two other researchers argue in an essay in the Journal of the American Medical Association. They cited the price for Daraprim, which Martin Shkreli raised by 5,000 percent, as an example of the problem.

Johnson and Johnson is looking for a buyer for its Noramco unit, which makes active pharmaceutical ingredients, Reuters writes, adding that the division could be valued for as much as $800 million. Noramco manufactures active ingredients in painkillers, such as oxycodone.


The FDA granted a priority review of a combination of two Gilead Sciences hepatitis C treatments, The Wall Street Journal reports. The combination includes the older Sovaldi medication and an experimental drug known as velpatasvir. The agency is expected to decide whether to approve the combination therapy by June 28.

Baxalta agreed to pay up to $1.6 billion to Symphogen for the rights to co-develop six experimental cancer treatments, according to The Wall Street Journal.

Teva Pharmaceutical and Active Biotech are ending higher doses of an oral drug that is being tested in two trials for treating multiple sclerosis due to non-fatal cardiovascular events in eight patients, Reuters reports.

There are now 10 multiple myeloma treatments available, including three that won FDA approval during an unusual 15-day stretch in November, The Wall Street Journal informs us.

Pfizer, Merck, and Syndax formed a clinical trials arrangement to evaluate a combination of their cancer drugs in patients who have pre-treated, recurrent ovarian cancer, Pharma Times says.

Sumitomo Dainippon Pharma plans to spend about $18.4 million to establish a facility to produce induced pluripotent stem cell-derived drugs by 2017, Nikkei Asian Review writes.

Richter-Helm BioTec’s teriparatide, a biosimilar version of Amgen’s Prolia for osteoporosis, is expected to debut in Europe once the patent expires, Portfolio Hu reports.