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National Law Journal

'Good Law': DC Judge Denies Hogan Lovells Motion in Big Pharma Dispute

"The Court further finds that FDA did not act arbitrarily by excluding part of Entresto's dosing regimen from MSN's generic drug label," U.S. District Judge Dabney L. Friedrich wrote in her memorandum opinion unsealed with minimal redactions. "For these reasons, the Court will uphold FDA's approval of MSN's generic drug."
3 minute read

The Recorder

Who Got the Work: Saul Ewing Team Appears for Samsung Bioepis in Amgen Patent Case

California-based Amgen has filed a patent infringement suit to stop Samsung Bioepis from developing bone-treatment drugs that would rival two of its top-performing products.
4 minute read

Law.com

Quinn Emanuel Client Sues Biotech Company, Seeking $100M Over Allegedly Breached COVID-19 Test Kit Agreement

Upon obtaining approval from the Food and Drug Administration, the plaintiffs claim the defendants "unilaterally cancelled plaintiffs' manufacturing and distribution rights, and unfairly demanded that plaintiffs agree to new, less favorable terms, or else defendants would choose a new manufacturer and cut plaintiffs out entirely. When plaintiffs refused to capitulate to defendants' deceptive scheme, defendants made good on their threats by deserting the deal and ignoring plaintiffs' demands for just compensation," according to the complaint.
3 minute read

The Legal Intelligencer

SEC Agrees to Dismiss Civil Suit Against Former Pharma CIO Over Alleged Insider Trading

"We are delighted that Ram has been fully vindicated of these meritless allegations," former Mylan executive Ramkumar V. Rayapureddy's lead counsel, Adam Lurie, a partner at Linklaters, said of the outcome. "He has shown remarkable courage and resilience throughout this long injustice and is looking forward to moving on with his life and his career."
3 minute read

National Law Journal

'Irreparable Harm'?: US Judge Denies Big Pharma Motion to Halt FDA-Approved Generic Drug

"Novartis has not established on the current record that it is likely to suffer irreparable harm if injunctive relief is not granted," U.S. District Judge Dabney L. Friedrich wrote in her memorandum opinion denying Novartis's motion for a preliminary injunction without prejudice.
3 minute read

Corporate Counsel

As Organ-Transplant Industry Draws Scrutiny, FDA Alleges Eye Bank Accepted Donors With Sepsis

The Food and Drug Administration said five donors either had a sepsis diagnosis or showed clinical signs of sepsis. But the Indiana Lions Eye Bank countered that blood cultures from all five tested negative. "There is still only one gold standard for the diagnosis of sepsis, and that is a positive blood culture," it said.
6 minute read

Litigation Daily

Litigator of the (Past) Week: SCOTUS Unanimously Preserves Access to Abortion Pill Mifepristone

Jessica Ellsworth of Hogan Lovells represented pharmaceutical company Danco Laboratories throughout a court challenge to the way the FDA regulated the use of mifepristone.
9 minute read

New Jersey Law Journal

How Safe Is Cannabis, Really? Here's What Plaintiffs' Attorneys Should Know

"The cannabis industry is following the playbook of the tobacco and opiate industries by putting profits before people," according to David G. Evans, senior counsel for the Cannabis Industry Victims Educating Litigators.
8 minute read

The Legal Intelligencer

DEA's Psychedelic-Outlawing Effort Attacked by Private Industry

Despite the U.S. Food and Drug Administration's approval of depression treatment drug Esketamine and conferring of "breakthrough therapy" status on other psychedelics, the DEA is amping up its prohibition efforts and private industry is punching back.
8 minute read

Corporate Counsel

$42M Rat-Infestation Fine Underscores Sanitation Risks Facing Warehouses

The Justice Department lowered the boom on Family Dollar after federal inspectors found 1,270 dead rodents at its Arkansas distribution center.
6 minute read

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