Good morning, everyone, and how are you today? Have you begun adjusting to the new realities that await? We hope so. To help us along, though, we are quaffing more cups of stimulation and enjoying the sunny view of the Pharmalot campus. Whether the glass is half full or half empty, we must persevere. Meanwhile, here are some items of interest. Hope your day goes well and do keep us in mind when something intriguing occurs. We accept secret documents …
Pfizer is evaluating the potential sale or spin-off of its consumer health division that could value the unit at as much as $14 billion, Reuters reports. The possibility comes less than two months after the drug maker decided against splitting itself into two companies — one for its patent-protected drug business and one containing its generics business. However, Pfizer did say at the time that still other operations may be shed at some point.
Mylan Pharmaceuticals disclosed that, as part of a Department of Justice investigation, “certain employees and a member of senior management” received subpoenas seeking additional information about the marketing, pricing, and sale of four drugs — “generic Cidofovir, Glipizide-metformin, Propranolol and Verapamil products” — and any communications with competitors, according to page 58 of a regulatory filing.
And on page 57, Mylan also disclosed receiving a document request last month from the Division of Enforcement at the Securities and Exchange Commission seeking communications with the Centers for Medicare and Medicaid Services and documents concerning products sold to the Medicaid Drug Rebate Program. The company recently agreed to pay $465 million for shortchanging Medicaid over rebates for its EpiPen emergency allergy device.
Meanwhile, Mylan also reported that it is working to finalize that settlement with the Justice Department. The deal, which some lawmakers say is insufficient, took a toll on Mylan finances. The drug maker booked a quarterly loss due to a charge related to the settlement. And wholesalers are buying fewer EpiPens as they anticipate the arrival of an authorized generic version that Mylan plans to sell at half the price.
The Indian Patent Office denied a patent for the Xtandi prostate cancer drug, paving the way for a generic version, the Economic Times reports. The patent was opposed on grounds of “lack of inventive step, lack of novelty, and lack of clarity and sufficiency.” The drug is the subject of a battle in the US, where consumer groups are urging federal officials to allow lower-cost versions to be made and exported to other markets.
The UK’s National Institute for Health and Care Excellence is recommending Novartis’s Afinitor for certain breast cancer patients and Pfizer’s Xalkori lung cancer treatment after the drug makers offered undisclosed larger discounts, PMLive writes. The move comes as NICE reappraises all drugs covered by the Cancer Drugs Fund, which was overhauled earlier this year.
Valeant Pharmaceuticals received an investigative subpoena from the California Department of Insurance in September over its ties to pharmacies and marketing, Reuters informs us.
US public health programs will use lower-dose vaccines administered over longer periods from 2017 if President elect Donald Trump adheres to a plan he outlined last year, inPharma-Technologist says.
The Senate plan to pass its version of the 21st Century Cures Act and speed new drugs and devices to market may get derailed now that President-elect Donald Trump is entering the White House, STAT writes.
All India Drug Action Network went to court to block a government plan to dismantle the National Pharmaceutical Pricing Authority and remove or dilute price controls on essential medicines, the Economic Times reports.
Chinese regulators released guidance for the investigational new drug review process that is expected to speed approvals, according to FDA News.
The UK’s NICE rejected Amgen’s Kyprolis in second line multiple myeloma treatment in first draft guidance, citing uncertainties over long-term survival benefits, Pharmaphorum tells us.
An experimental HIV vaccine from Johnson & Johnson combined with an immune system booster from Gilead Sciences showed promise at keeping the virus at bay in monkeys even after treatments had stopped, Reuters says.