By Chad Shear and Geoff Biegler | August 21, 2020
One key to a successful outcome against generic challengers in a Hatch-Waxman case is a compelling and factual invention story based on evidence that was created in real time—during the drug development and regulatory process, according to Fish & Richardson's Chad Shear and Geoff Biegler.
By Alaina Lancaster | August 20, 2020
Motley Rice's Fidelma Fitzpatrick, who is lead counsel of the plaintiffs' executive committee for the California Joint Council Coordinated Proceedings and helped to negotiate the deal, said the proposed settlement would provide expedited relief to thousands of women.
By Tom McParland | August 19, 2020
U.S. District Judge Denise L. Cote of the Southern District of New York said Tuesday there was reason to believe that alleged scheme at Shkreli's Vyera Pharmaceuticals was still occurring, more than five years after the price of the company's branded drug increased overnight to $750 per pill.
By Alaina Lancaster | August 3, 2020
"In general, California gets a bad rap as being hostile to business, but the true fact is we have a tremendous number of innovators here—both individuals and companies—and I am heartened to see the California Supreme Court appears to be taking an approach that is pro-innovation," said Stephen Newman at Stroock & Stroock & Lavan in Los Angeles.
By Scott Graham | June 3, 2020
Genentech is looking to block sales of Amgen's cancer biosimilar Mvasi because Amgen failed to provide 180 days' notice when it shifted manufacturing plans from California to Rhode Island. Judge Kimberly Moore said Genentech is proposing "an extraordinarily broad view" of the Biologics Price Competition and Innovation Act.
By Chad Shear and Teresa A. Lavoie | May 29, 2020
Putting yourself at the threshold of the other door and considering the room from that perspective can provide useful reminders of each side's strategic opportunities and concerns, and ensure that the doors to the deal are kept open.
By Phillip Bantz | May 15, 2020
"Lawyers, in my personal view and to over-generalize, can be a little too risk-averse," said Charles Berkman, longtime general counsel Ligand Pharmaceuticals Inc., a San Diego-based firm that licenses and supplies Captisol, a crucial ingredient in experimental COVID-19 treatment drug remdesivir.
By Amanda Bronstad | May 13, 2020
Omnicare agreed to settle claims brought by the U.S. Drug Enforcement Administration and federal prosecutors that it dispensed opiate pharmaceuticals to long-term care facilities without valid prescriptions.
By Amanda Bronstad | May 11, 2020
Addressing one of the first substantive decisions in the Risperdal litigation in California, the Second District Court of Appeal reversed summary judgment as to one of the federal preemption arguments raised by the plaintiffs, reinstating potentially hundreds of lawsuits. The court upheld the ruling as to two separate federal preemption arguments.
By Mike Scarcella | April 30, 2020
"Notwithstanding this dispute, Gilead will continue to work with federal agencies, including HHS and the CDC," Gilead, represented by a team from Wilmer Cutler Pickering Hale and Dorr, including former U.S. Attorney Ronald Machen Jr., said in announcing the new lawsuit.
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