Legal & IP
Natco has announced a 90% difference in the price of its semaglutide generic in multi-dose vials versus originator Novo Nordisk’s Ozempic pen ahead of launch tomorrow as Novo’s patents on the product expire today. Its pen will be 70% cheaper.
Moderna will pay $950m upfront under the settlement, which lifts a significant weight off its shoulders, as investors had feared it could be on the hook for $5bn.
The payout could increase to $2.25bn if Moderna loses an ongoing appeal that would shift $1.3bn in liability to US taxpayers, making it the largest patent settlement in pharma history.
Albert Bourla has once again been outspoken in his criticism of Vinay Prasad’s attempts to overrule FDA staff approval recommendations for vaccines, but he was more positive about other US policy reforms.
The German drugmaker alleges false advertising by J&J and methodological flaws in its real-world evidence analysis, which it presented at a conference earlier this month.
The company said the FDA has now accepted its application for mRNA-1010, but it will have to do a postmarketing study in individuals aged 65 and older.
Do Zydus and Lupin’s settlements of Myrbetriq (mirabegron) US patent litigation with Astellas constitute a win or a loss?
Following a $90m settlement with Astellas over Myrbetriq (mirabegron) in the US, Lupin can continue selling its generic product even as Zydus says the Delaware district court has directed mediation but the trial is proceeding. How have the generics fared and what does this mean now?
The drugmaker filed a patent suit against the telehealth company over its announcement four days before that it would sell a cheaper compounded version of oral Wegovy.
Novo Nordisk said it will take legal action against mass compounding of the new oral semaglutide formulation by Hims & Hers.
Conclusion of India-EU talks sets ground for a free trade agreement to cut pharma tariffs, in turn lowering the cost for novel drugs like Novo’s obesity treatment Wegovy, though an investment protection agreement – likely influencing data exclusivity – will be concluded later.
The CytoDyn board of directors fired Nader Pourhassan in early 2022 as the company faced US FDA scrutiny over his comments about HIV and COVID-19 candidate leronlimab and as investors sued the firm.
BMS tells Scrip it will continue to seek legal recourse even as Zydus Lifesciences launches the world’s first cut-price nivolumab biosimilar in India following a Delhi High Court division bench ruling in favor of the Indian company
Novo backs out, leaving Pfizer to complete its acquisition of the obesity specialist for nearly $3bn more than its initial offer.
Pfizer filed another lawsuit to halt Novo Nordisk’s attempt to acquire obesity drug developer Metsera instead of the US big pharma. Novo said Pfizer’s legal actions are “without merit” and “desperate.”
The US pharma company has come out all guns blazing, claiming that Novo Nordisk is looking to block new competitors entering the anti-obesity market.
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.
Roche, which faced a high stakes patent setback for Evrysdi in India, appears to have appealed against a lower court’s ruling, which went decisively Natco’s way but also included distinct 'reservations' by the judges.
The company is looking to boost US investor exposure while retaining UK headquarters and tax residence.
India revokes Novartis's patent pertaining to Entresto, upholding the objections of opponents including the Indian Pharmaceutical Alliance on lack of novelty and prior claiming, among others. Novartis decided against participating in the hearings.