- HHS releases proposed rule to import drugs from Canada to lower the price for consumer (healthcarefinancenews.com)Trump proposes rule for importing drugs from Canada; industry says it won't cut costs (reuters.com)Trump plan would allow states to import drugs from Canada (politico.com)Sally Pipes: Canadian drug imports are a dose of bad medicine (sunjournal.com)
The Department of Health and Human Services has released a proposed rule this morning that proposes to lower the price of drugs for consumers by allowing pharmaceutical manufacturers to import certain prescription drugs from Canada...In addition, the Administration has announced the availability of a new draft guidance for the industry that describes procedures drug manufacturers can follow to facilitate importation of prescription drugs, including biological products, that are FDA-approved, manufactured abroad, authorized for sale in any foreign country, and originally intended for sale in that foreign country...READ MORE
- Sackler-owned opioid maker pushes overdose treatment abroad (apnews.com)
The gleaming white booth towered over the medical conference...advertising a new brand of antidote for opioid overdoses. “Be prepared. Get naloxone. Save a life,” the slogan on its walls said...Some conference attendees were stunned when they saw the company logo: Mundipharma, the international affiliate of Purdue Pharma — the maker of the blockbuster opioid, OxyContin, widely blamed for unleashing the American overdose epidemic...Here they were cashing in on a cure...“You’re in the business of selling medicine that causes addiction and overdoses, and now you’re in the business of selling medicine that treats addiction and overdoses?”...“That’s pretty clever, isn’t it?”...“end-to-end provider” — opioids on the front end, and addiction treatment on the back end...READ MORE
- Industry ‘resistance’ to disruption by advanced therapeutics (biopharma-reporter.com)
Speaking at,,,the Pharma Integrates conference...Ettore Cucchetti, CEO of ACG Inspection, stated that the industry shows signs of ‘resistance’, which obstructs the resolution of challenges in the supply chain...“There is a fear among pharmaceutical companies facing the disruption that the advanced medicine have brought to the industry, and the changes required in the supply chain,”...According to Cucchetti, “Due to the existing profit model, leaders of big companies prefer to keep the focus on R&D and productivity,” and do not prioritize investment in the supply chain, even though “there is a lot of room for improvement.”...READ MORE
- Disruptor of the Year: The Federal Trade Commission (biopharmadive.com)
In 2018, $198 billion worth of acquisitions took place in the life sciences sector, which includes pharma and biotech, up by $20 billion over 2017 but well below big years between 2014 and 2016...The FTC's close scrutiny of potential antitrust violations in biopharma acquisitions seems to have cast a shadow over transactions large and small, from megamergers like Bristol-Myers Squibb-Celgene and AbbVie-Allergan to comparatively small plays like Alexion-Achillion and UCB-Ra...At its root is the regulators' concern that big pharma wants to hold onto overlapping projects to hedge against the risk of failure or market competition, which could have a detrimental effect if enough promising medicines don't get developed...READ MORE
- Attorney misconduct allegations crop up in Johnson & Johnson, Gilead cases (fiercepharma.com)
Two high-profile cases in the pharma world have featured similar headlines this month—and they're not flattering to the legal profession...In both instances, allegations of attorney misconduct have cropped up, shifting focus from the lawsuits themselves to the people arguing them...First, HIV advocates battling Gilead Sciences say a U.S. Patent & Trademark Office official harbored a pro-industry bias. And second, J&J lawyers say their counterparts in talc litigation stonewalled questions about expert testimony and otherwise played foul with the rules...READ MORE
- This Week in Managed Care: December 13, 2019 (ajmc.com)
Laura Joszt, Managing Editor at The American Journal of Managed Care. Welcome to This Week in Managed Care from the Managed Markets News Network
- Opinion: Why you should worry about drug companies’ reliance on Chinese ingredients (latimes.com)2019 REPORT TO CONGRESS of the U.S.-CHINA ECONOMIC AND SECURITY REVIEW COMMISSION (uscc.gov)
China has become the world’s largest producer and exporter of “active pharmaceutical ingredients,”...China’s dominance puts both the health of Americans and our national security at risk...a new report from the U.S.-China Economic Security Review Commission...China’s pharmaceutical industry “is not effectively regulated by the Chinese government” and has been responsible for a number of drug safety scandals...Our dependence on Chinese pharmaceutical products, the commission concluded, means “the American public, including its armed forces, are at risk of exposure to contaminated and dangerous medicines.”...READ MORE
- Bristol-Myers wins $752 million in U.S. patent case against Gilead (reuters.com)
Bristol-Myers Squibb Co...said it won a $752 million jury verdict against Gilead Sciences Inc in a U.S. patent dispute relating to technology for treating cancer...A jury...awarded the damages after finding that Yescarta, a treatment sold by Gilead’s Kite Pharma unit, infringed on a patent exclusively licensed by Bristol-Myers’ Juno Therapeutics division...The patent at issue in the lawsuit...relates to CAR T-cell immunotherapy for cancer...READ MORE
- December 13 Pharmacy Week in Review (pharmacytimes.com)
Nicole Grassano, PTNN, Pharmacy Week in Review, this weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings and more.
- PhRMA Statement on the United States-Mexico-Canada Agreement (phrma.org)United States-Mexico-Canada Agreement (usmca.com)
“The announcement made today puts politics over patients. Eliminating the biologics provision in the USMCA removes vital protections for innovators while doing nothing to help U.S. patients afford their medicines or access future treatments and cures. The only winners today are foreign governments who want to steal American intellectual property (IP) and free ride on America’s global leadership in biopharmaceutical research and development...“We cannot support abandoning provisions that protect American companies and raise standards abroad. We hope that Congress and the Administration will pursue international trade agreements that hold foreign governments accountable by ensuring that they protect and value the ongoing discovery of much-needed medicines to treat and potentially cure the world’s most devastating diseases.”...READ MORE