Rise and shine, another busy day is on the way. And here on the Pharmalot campus, where clouds are hovering and leaves are falling, we are coping with our mandatory cup of stimulation. Our to-do list is so crammed, in fact, that posting may be sporadic over the next day or two as we complete some more involved efforts than usual. Meanwhile, here is the usual, although lengthy, items of interest. Hope you have a successful day and do keep in touch…
US prosecutors plan to ask the Canadian and British governments to extradite officials with an online pharmacy on charges of smuggling $78 million worth of mislabeled, unapproved and counterfeit cancer drugs into the country to sell to doctors, the says. Canadadrugs.com and its chief executive, Kristjan Thorkelson, are accused of spearheading the conspiracy.
Valeant Pharmaceuticals chief executive Michael Pearson warned that the impact of ending its relationship with Philidor Rx Services, the mail-order pharmacy, would meaningfully affect its dermatology business, which makes up almost a fifth of total revenue, Bloomberg News writes. On a conference call, he said the company is working to forge better relationships with insurers and create a new program to ensure patients can get and afford its products.
Federal prosecutors in at least four states are mounting investigations into what they describe as widespread fraud by compounding pharmacies in claims to the Tricare health-insurance program that covers 9.5 million US military members and their families, The Wall Street Journal reports. Four Florida pharmacies last month agreed to pay $12.8 million combined to settle civil allegations that they falsely billed the insurance program.
A jury ordered Johnson & Johnson to pay $1.8 million to a Maryland man who developed female breasts while taking the company’s Risperdal antipsychotic drug, the third verdict in thousands of lawsuits filed over the side effect, Bloomberg News tells us. J&J failed to properly warn doctors and patients that Risperdal, used to treat schizophrenia and bipolar disorder, could spark abnormal male breast development.
Complaints about quality issues at Indian drug makers are part of a “turf war” with Western companies. “These are struggles for market share,” said Rita Teaotia, Department of Commerce Secretary told InPharma Technologist. “If someone is able to compete at more aggressive pricing, then it hurts them. And part of this overreaction to minor infringements, maybe, comes from this.” Meanwhile, Regulatory Focus reviewed 50 FDA inspection reports issued to Indian companies over the past two years and found “a slew of detailed quality concerns.”
Mallinckrodt stock plummeted by more than 25 percent yesterday after Andrew Left of Citron Research, the short seller, tweeted the drug maker has “more downside” than Valeant Pharmaceuticals, Bloomberg News writes. The issue is getting insurers to pay for drugs that have undergone big prices, notably H.P. Acthar Gel, which costs about $35,000 a vial. The company bought the medicine in 2005, when the cost was $1,235 a vial.
Tax inversions would be curbed under legislation introduced in Congress, as Pfizer pursues such a deal with Allergan, according to Reuters.
The White House rejected a suggestion from Senate Finance Committee Chairman Orrin Hatch (R-Utah) to renegotiate biologics exclusivity provisions in the Trans-Pacific Partnership treaty, BioCentury writes.
Republican presidential candidates are belatedly starting to float their ideas for reining in drug costs and play catch up on an issue that Democrats have embraced, Stat reports.
AstraZeneca’s experimental lupus drug, anifrolumab, significantly cut disease activity in a mid-stage clinical trial, boosting hopes the medicine can become a $1 billion-a-year seller, Reuters writes.
Astellas Pharma agreed to buy Ocata Therapeutics, which is developing regenerative medicines for eye diseases, in all-cash deal worth $378 million, Xconomy reports.
MannKind is selling stock in Israel as part of a needed survival move now that its Afrezza inhaled insulin shows further signs of being a dud, TheStreet tells us.
Sanofi was accused in a lawsuit of stalling development of its Lemtrada multiple sclerosis drug to avoid paying out at least $708 million to rights holders under a 2011 agreement to acquire Genzyme, Reuters reports.
The fate of the UK’s Cancer Drug Fund will be decided by the Prime Minister’s office and not by the Department of Health or NHS England, PharmaPhorum tells us.
Unnecessary use of stents to clear blockages in diseased coronary arteries fell by about 50 percent between 2010 and 2014, and the drop came after new practice guidelines were issued in 2009, The Wall Street Journal says.
Johnson & Johnson licensed global rights, excluding China and South Korea, to develop and market Hanmi Pharmaceutical’s oxyntomodulin-based therapies in a deal worth up to $915 million, Pharma Times writes.Print This Post