Legal Issues

A Delhi High Court has declined Novo Nordisk’s bid to halt Reddy’s ongoing production, allowing exports while patent validity proceeds to trial.

Treasurer Jim Chalmers has blocked the AU$677m bid following FIRB advice that the acquisition posed unacceptable risks to Australia’s critical medicine supply chains.

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.

Teva has agreed to pay $35m and delist six patents tied to its QVAR asthma inhalers to resolve claims it illegally blocked cheaper generics.

Dr Reddy's had not ruled out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

Dr. Reddy's doesn’t fully rule out "queries" from the Canadian regulator for generic semaglutide, though it is confident of selling “all its capacity” for the GLP-1 across target markets. A backup CMO site in the US for abatacept is expected to mitigate risks amid tariff and other uncertainties.

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.

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.

Speakers at recent Council for Responsible Nutrition conference noted Trump using executive office authorities to extent no other president has while discussing impact of his tariff-driven trade policies on US industries and complaints challenging his tariff orders the Supreme Court will consider.

As the European Commission prepares to publish its latest study on the Urban Waste Water Treatment Directive, industry leaders have bemoaned a lack of consultation and have suggested that a simple update of existing cost estimates should be replaced by a more thorough impact assessment.