Good morning, everyone, and welcome to another working week. We hope the weekend respite, which was extended on this side of the pond, was delightful and invigorating. Of course, that break is now in the rearview mirror as the usual routine of meetings, deadlines, and whatnot has returned. Are you ready? Try coping with a cup of stimulation, if need be. Meanwhile, here are some tidbits. Hope you have a smashing day and do keep in touch …
Johnson & Johnson confirmed it is talking to Actelion about a potential takeover, Bloomberg News tells us. A deal would be unusual for J&J, which has grown pharmaceutical sales 40 percent since 2010 almost entirely through in-house product development and licensing deals to become the health company’s biggest unit. Actelion has brought to market two new lung medicines that are poised to become blockbusters over the next three years.
House and Senate leaders announced late last week that they had finally reached a deal on the 21st Century Cures Act, STAT tells us. The landmark legislation is designed to speed federal approval of new drugs and devices and boost funding of medical research. But what Republican lawmakers are calling the final version of the bill is actually still in negotiation with Senate Democrats.
Last June, Pfizer raised the list price of Viagra by 13 percent, and less than a week later, Eli Lilly increased the price of its competing Cialis pill by the same amount, the Wall Street Journal writes. For years, in fact, the drug makers took price increases on their erectile-dysfunction drugs within weeks of each other, sometimes even on the same day, keeping the list price of each pill within a few dollars.
Biobucks are not always as they appear, STAT tells us. In 2014, about 18 percent of the total deal value was paid out in cash on signing, but that dropped to 11 percent in the first nine months of this year, as biotech stocks have slumped. And of nearly 700 biotech licensing deals inked over the past four years, on average, just 14 percent of the total announced value was paid out upon signing.
The UK’s National Institute for Health and Care Excellence agreed to recommend Johnson & Johnson’s Imbruvica pill for treating chronic lymphocytic leukemia after the drug maker offered an undisclosed discount, PharmaTimes reports. The drug costs about $68,000, and NICE had previously determined the drug was not cost-effective for certain subsets of the CLL patient population.
Indian drug regulators alleged that 27 medicines — which are sold by 18 major drug makers, including Abbott India, GSK India, Sun Pharma, Cipla, and Glenmark Pharma — are of “substandard” quality, the Indian Express informs us. The regulators cited false labeling, incorrect number of ingredients, discoloration, moisture formation, and failing dissolution and disintegration tests.
A new HIV vaccine, which will be tested in a trial in South Africa, could be “the final nail in the coffin” for the disease if it is successful, the Associated Press reports. The study aims to enroll 5,400 sexually active men and women aged between 18 and 35 at 15 sites and will be the largest and most advanced HIV vaccine clinical trial to take place in the country, where more than 1,000 people a day are infected with HIV.
GlaxoSmithKline has started pivotal trials of an experimental anemia drug, chasing AstraZeneca in the race to develop a medicine that mimics the body’s response to high altitudes, Reuters writes.
The Food and Drug Administration cleared Lupin to restart production of drugs for the US market at its plant in Goa after the firm fixed quality-control problems, InPharma Technologist tells us.
GlaxoSmithKline filed its Shingrix shingles vaccine in Europe, one month after a US filing for the drug, which analysts believe could hit peak annual revenues of $1.5 billion, Pharmaphorum reports.
The UK’s NICE recommended Bristol-Myers Squibb’s Opdivo as an option for previously treated advanced renal cell carcinoma in adults, PharmaTimes says.
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