Litigation

Delaware district court refuses to shorten 30-month stay, leaving Hopewell unable to launch its generic Mavenclad product.

Enforcements at facilities in Missouri operated by Shaman Botanicals and Relax Relief Rejuvenate Trading were preceded by administrative detention orders, FDA’s first use of the authority since its reorganization in October 2024.

EPO Appeal Board overturns earlier ruling and invalidates Biogen’s 480mg Tecfidera patent, clearing the way for broader dimethyl fumarate competition in Europe.

CRN’s attorneys ask Second Circuit for en banc review of a three-judge panel’s denial of its appeal of 2024 decision in district court rejecting motion for preliminary injunction against enforcement of New York state law age-restricting sales of weight loss and muscle building supplements.

Three-judge Second Circuit panel rejects CRN’s argument that New York General Business Law Section 391-oo, effective since April 2024 as first in US to prohibit sales of certain supplements to consumers under 18, violates First Amendment rights of supplement marketers.

UK ruling clears the way for Alvotech to stockpile its aflibercept biosimilar ahead of Eylea’s SPC expiry later this month, positioning the firm for a day-one launch across Europe and the UK.

A federal judge in Hawaii ruled the FDA failed to consider statutory factors relevant to the REMS and provide a “reasoned explanation” for its restrictive treatment of the drug, but remand could result in an agency determination that more extensive restrictions are needed.

In addition to Kenvue, complaint names as defendant J&J, which for decades marketed Tylenol oral analgesics before spinning Kenvue out in 2023. State asks court to order firms to pay $10,000 for each violation of state Deceptive Trade Practices-Consumer Protection Act.

Sawai’s settlement brings an end to a years-long legal battle over the manufacturing method for the firm’s generic teriparatide injection, following a court ruling that upheld Asahi Kasei’s process patent for its osteoporosis brand Teribone.

The EU’s top court has rejected Teva and Cephalon’s final appeal, ruling that their 2005 settlement to delay a generic version of modafinil was inherently anticompetitive and upheld a €60.5m fine.

The Supreme Court of India has allowed Natco Pharma to continue selling its generic version of Roche’s spinal muscular atrophy drug Evrysdi (risdiplam), declining to interfere with a Delhi High Court order that denied Roche an injunction while the patent infringement case proceeds.

Just days after receiving FDA approval for its Eydenzelt biosimilar rival to Eylea, Celltrion has secured a US aflibercept launch date through a settlement with originator Regeneron. Meanwhile, new launches have helped to boost the Korean firm’s financials in Q3.