[1]pic thx to noel pennington on flickr creative commons
Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that all-too-familiar routine of meetings, deadlines and what-not has returned. To cope, we are relying, as always, on that mandatory cup of stimulation. Southern Pecan is our choice today and, of course, we invite you to join us. Meanwhile, here is the usual menu of tidbits. Have a good day and keep in touch…
Johnson & Johnson defeated a lawsuit claiming it had improperly designed its Tylenol pain reliever, in the first case to go to trial over the link between the widely used over-the-counter drug and liver damage, Bloomberg News [2] says. The jury ruled she couldn’t prove she had actually taken Extra Strength Tylenol, and didn’t rule on the merits of her claim the pain medication was defectively designed, which may give hope to other plaintiffs.
The FDA declined to approve a dry-eye drug being developed by Shire, dealing a blow to its most important pipeline medicine. The agency wants results from a Phase III trial as a condition of approval, which Piper Jaffray analyst David Amsellem notes does not jib with the “sanguine outlook” expressed recently by Shire execs that the drug could be approved without the data. Wall Street has pegged the drug, called lifitegrast, as a $1 billion-plus annual seller.
The FDA approved an antidote to Pradaxa, the Boehringer Ingelheim bloodthinner, to reverse the effects of the treatment during emergency situations, such as uncontrollable hemorrhages. The move comes five years Pradaxa was approved, during which time the agency was criticized for failing to ensure an antidote was readily available, according to the Project on Government Oversight.
The Competition Commission of India extended a deadline for submitting bids to run a detailed study of the pharma and healthcare services sector, The Economic Times [3] reports. The anti-trust regulator wants to understand whether there are unfair practices as part of larger efforts to clamp down on anti-competitive business practices. Separately, some of India’s biggest drug makers discussed ways to clean up marketing practices [4] and restore the industry’s image.
The head of a group representing drug makers in Greece warned that a pending bill to open up the country to generic drugs was the result of a conspiracy between Germany and Jewish groups, The Times of Israel [5] tells us. Dimitris Giannakopoulos, who heads the Hellenic Association of Pharmaceutical Companies, said 11,000 Greek jobs would be lost and blamed the measure on pressure from Jewish groups in order to benefit Israeli generic drug makers.
A Novartis drug used for treating leukemia may also work for patients with Parkinson’s disease, judging from one small and early clinical test, Bloomberg News [6] says.
The non-profit International AIDS Vaccine Initiative is teaming with CureVac to accelerate the development of AIDS vaccines, using immunoges from IAVI and others to be delivered by CureVac technology, The Economic Times [7] says.
Moderna chief scientist and head of R&D, Joseph Bolen, has quietly left after two years on the job, just as the biotech attempts to transform its financial backing into real products, Fierce Biotech [8] tells us.
GlaxoSmithKline is selling its Romanian subsidiary Europharma Distribution, saying distribution is not a core offering, according to Outsourcing Pharma [9].
An Irish compounding pharmacy, Fannin, has recalled several batches of chemotherapy medicines because of a sterility alert, The Irish Times [10] reports.
Addyi, the female sexual dysfunction pill became available over the weekend, and its arrival may spur more drug development, the predicts.
Regeneron Pharmaceuticals plans to create 200 new jobs in Ireland as part of plan to investing $350 million in facilities in Limerick, The Irish Independent [11] writes.