- Endo comes out on top in its fight with FDA and bulk compounder (fiercepharma.com)
...Endo International...has prevailed in its two-front fight with the FDA and bulk compounders. The resolution has ended competition for its vessel constrictor Vasostrict...The drugmaker...has dropped its litigation against the FDA...the FDA amended its draft guidelines to stop compounders from making vasopressin...While the ruling is specific to vasopressin, it is believed to have precedent for other drugmakers whose drugs are targeted by large-scale compounders for generic competition...READ MORE
- Who joins Purdue on pharma’s top 10 settlements list? Merck, GSK and Pfizer, for starters (fiercepharma.com)
Purdue’s pending opioid settlement with thousands of cities and counties, worth between $10 billion and $12 billion, could rank as the largest deal ever inked by a pharma if it passes a Cleveland federal judge’s muster. But where do pharma’s other major settlements fall on that list?...READ MORE
Here’s the list of pharma’s top 10 largest U.S. settlements.
- Purdue Pharma—$10 billion to 12 billion*
- Merck & Co.—$4.85 billion
- American Home Products Corp. (now Wyeth)—$3.75 billion
- GlaxoSmithKline—$3 billion
- Pfizer—$2.3 billion
- Takeda—$2.3 billion
- Johnson & Johnson—$2.2 billion
- Abbott Laboratories—$1.6 billion
- Eli Lilly—$1.42 billion
- Reckitt Benckiser—$1.4 billion
- Kentucky hospitals sue drugmakers, distributors and retailers for opioid epidemic costs (fiercehealthcare.com)
A group of 23 Kentucky hospitals is suing major drugmakers, distributors and retailers for their role in the opioid epidemic just days after a group of Texas hospitals unveiled a similar suit...The civil lawsuit filed...in Warren County, Kentucky, alleges more than 40 major companies such as CVS Health, Johnson & Johnson and Purdue Pharma along with individuals made actions that directly led to hospitals bearing the financial burden of caring for opioid victims. Kentucky is one of several states hit especially hard by the epidemic...The lawsuit said hospitals have had to add or modify services such as hiring additional security and providing more “specialized training for staff to accommodate the rapid rise in opioid-related illnesses,”...READ MORE
- Amgen patents on Repatha invalid, judge rules in reversal (biopharmadive.com)
A federal judge...ruled two patents held by Amgen on its cholesterol drug Repatha are invalid, reversing a February jury verdict that had upheld the California biotech's claims in its legal battle with rivals Sanofi and Regeneron...Amgen said it plans to appeal. Still, it's a setback that strengthens the position of Sanofi and Regeneron, which sell the competing drug Praluent...Litigation between the companies has dragged on since 2014…Both Amgen and Sanofi and Regeneron have since cut their prices to a about $6,000 a year in bids to grow market share. Repatha sales have so far paced ahead of Praluent's…READ MORE
- Opioid latest: Judge under attack; Ohio counties demand $8B; ‘negotiating class’ wins OK (fiercepharma.com)
With Purdue Pharma agreeing to settle with dozens of cities and states for a record-setting $12 billion, more opioid settlements could be on the way. But Purdue's agreement doesn't mean all the defendants are willing to go to the negotiating table quietly…Defendants in a Cleveland multidistrict litigation have gone so far as to attack the judge in charge of the case. In a...motion, retailers and distributors—but no drugmakers—demanded the removal of Judge Dan Polster for pushing a settlement. The absence of a pharma company there could show opioid makers are looking for deals rather than continuing to spar it out...READ MORE
- Purdue Pharma reaches tentative deal in federal, state opioid lawsuits (beta.washingtonpost.com)
Purdue Pharma, manufacturer of the blockbuster painkiller OxyContin, reached a tentative settlement...with 23 states and more than 2,000 cities and counties that sued the company over its role in the opioid crisis…Under terms of a plan negotiated for months, the Sacklers would relinquish control of Stamford, Conn.-based Purdue Pharma and admit no wrongdoing. The company would declare bankruptcy and be resurrected as a trust whose main purpose would be producing medications to combat the opioid epidemic...If the deal becomes final, it would be the first comprehensive settlement in the broad effort to hold drug companies accountable for their role in the opioid epidemic...READ MORE
- Drugmakers file second court challenge to Canada’s new drug price rules (reuters.com)
Canada’s main pharmaceutical industry lobby group, along with 16 of its member companies, filed a lawsuit...to block new regulations meant to lower patented drug prices, the second legal challenge to a new regime that could eventually reduce prices in the United States as well...Canada published the final regulations in August, despite heavy lobbying from drug companies, which stand to lose revenue as prices drop. The federal government estimates the new rules will save Canadian patients, employers and insurers, including governments, C$13.2 billion ($10 billion) over a decade...lawsuit was filed in federal court and led by Innovative Medicines Canada, which represents major drugmakers in Canada. It is separate from a lawsuit filed last month and focuses on federal patent law, arguing that Canada cannot use regulations to “fundamentally alter” the role of its federal drug price regulator...READ MORE
- Purdue Pharma files for bankruptcy as part of settlement (news.yahoo.com)Purdue Pharma filed for bankruptcy. What does it mean for lawsuits against the opioid manufacturer? (statnews.com)
Purdue Pharma...filed for bankruptcy...days after reaching a tentative settlement with many of the state and local governments suing it…The filing was anticipated before and after the tentative deal, which could be worth up to $12 billion over time, was struck..."This settlement framework avoids wasting hundreds of millions of dollars and years on protracted litigation," Steve Miller, chairman of Purdue's board of directors, said in a statement, "and instead will provide billions of dollars and critical resources to communities across the country trying to cope with the opioid crisis. We will continue to work with state attorneys general and other plaintiff representatives to finalize and implement this agreement as quickly as possible."...READ MORE
- Genentech settles fight over cancer drug trade secrets with Taiwan’s JHL (fiercepharma.com)
Genentech has called a truce with Taiwanese biosimilar firm JHL Biotech, which allegedly stole trade secrets to help it develop copycats to top-selling cancer drugs...The Roche unit said the settlement requires JHL “to abandon development of and destroy” all cell materials related to the cancer drug brands involved—namely Rituxan, Herceptin, Avastin and Pulmozyme—and stop using or sharing them in any way. To make sure JHL complies, Genentech has the right to unannounced checkups...JHL...posted, the Taiwanese firm “will reimburse Genentech for its legal fees and the cost of its investigation, but will not otherwise pay any damages.”...READ MORE
- Purdue Pharma says settlement talks in opioid cases not over (apnews.com)OxyContin maker Purdue Pharma expected to file for bankruptcy after stalled settlement talks (foxnews.com)
OxyContin maker Purdue Pharma and lawyers representing local governments both said...that they’re interested in continuing negotiations to settle lawsuits...a day after two state attorneys general told colleagues that their talks with the company were at an impasse and that they expected the company to file imminently for bankruptcy...The statements add another layer of uncertainty to attempts to strike a deal with a company that’s portrayed as a prime villain in the national opioid crisis...READ MORE