Hello, everyone, and welcome to the middle of the week. And congratulations are in order for having made it this far. On that note, why not forge ahead? After all, consider the alternatives. This calls for a nice cup of stimulation and, as always, you are invited to join us. Remember, no prescription is required. And now, onward. Here are some tidbits to get you going. Hope you conquer the world and do drop us a line when you run across something fascinating …
Pfizer and Allergan called off their $160 billion merger after the US Treasury Department this week issued new rules to thwart tax inversions. The deal was designed to lower their corporate tax rate from about 24 percent to 17 percent, and save roughly $35 billion in taxes. The decision is a big victory for the Obama administration, whose rules were more aggressive than many tax experts had expected. Pfizer will pay Allergan a $150 million breakup fee.
The US Food and Drug Administration approved Inflectra, a biosimilar version of Johnson & Johnson’s Remicade, to treat Crohn’s disease, ulcerative colitis, rheumatoid arthritis, and psoriasis, Reuters writes. The new version is made by Celltrion and will be marketed by Pfizer’s Hospira unit. This is only the second biosimilar approved by the FDA. Analysts expect the drug to become available later this year.
The New England Journal of Medicine is coming under attack, ProPublica writes. Some physicians are questioning whether the publication is losing relevancy and reputation. The journal and its top editor have resisted correcting errors and lag other journals in an industry-wide push for more openness in medical research. Some have also complained that the journal dismisses dissent with a “paternalistic arrogance.”
A Florida jury ruled that Tyco Integrated Systems was not liable for the theft of more than $60 million worth of prescription drugs from an Eli Lilly warehouse in Connecticut six years ago, the Associated Press reports. Lilly’s insurer, the National Union Fire Insurance, alleged Tyco failed to adequately report security weaknesses at the warehouse. The insurer said thieves obtained information from a Tyco report and used it to break into the building.
A Valeant Pharmaceuticals board committee did not find additional accounting issues that would require more restatements, Bloomberg News says, adding the drug maker plans to file its annual report on or before April 29. The board examined how the drug maker accounted for revenue through the Philidor Rx Services mail-order pharmacy, which Valeant allegedly used to boost prescriptions and circumvent some insurance reimbursements.
FDA medical staffers supported the use of an Intercept Pharmaceuticals drug as a monotherapy in patients with liver disease who did not respond to standard treatment, Reuters reports. The drug is being reviewed for use in patients with primary biliary cirrhosis, a rare liver disease caused by an autoimmune destruction of the bile ducts. An FDA advisory panel meets Thursday to review the medication.
The FDA is being warned to regulate medical device cybersecurity more firmly, according to Regulatory Focus. The warning comes after the US Department of Homeland Security issued an advisory about more than 1,400 cybersecurity vulnerabilities that affect versions of an automated supply cabinet used in hospitals and other health facilities to dispense medicines.
Johnson & Johnson is making a renewed push in Africa to boost sales of new drugs to fight HIV/AIDS and other illnesses, The Wall Street Journal writes. And J&J will invest $50 million in Tesaro and license a potential prostate cancer drug from the company, the paper adds.
The US Centers for Medicare & Medicaid Services will delay enforcement of a rule that changes the way state Medicaid agencies reimburse pharmacies for prescription medicines, Modern Healthcare reports.
European regulators backed the use of an Eisai breast cancer drug called Halaven to treat liposarcoma, according to Pharma Times.
The new FDA draft guidelines for labeling requirements for biosimilar medicines will become a burden for Indian generic drug makers, TwoFour Insight says.
Samsung Bioepis and Biogen filed a lawsuit in the UK against AbbVie over its strategy of filing patents designed to block biosimilar versions of its Humira rheumatoid arthritis treatment, Reuters reports.