Legal & IP
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.
Dr Reddy’s CEO discusses the growth opportunity for semaglutide, including production capacity and ‘crazy’ demand indications, and a potential 20-plus product GLP-1 portfolio. All eyes are also on an upcoming hearing in India pertaining to Novo Nordisk’s semaglutide patent in the country.
Swiss major confident that new oncology drugs will fill revenue gap.
An employee of Astellas faces three and a half years in prison after sentencing by a court in China on espionage charges.
A federal court jury found Amgen liable for violating antitrust laws in allegedly preventing Praluent from competing against Repatha.
Vaccine and accelerated approvals are expected to face greater scrutiny under new CBER leader Vinay Prasad, but he has promised “no light switch change” to policy, giving some reassurance to companies whose share prices have been battered.
Anil Matai, director general, Organization of Pharmaceutical Producers of India, talks in this audio interview about the evolving intellectual property landscape in India post the 2024 amendments, including long-standing sticking points such as Section 3(d) of India’s patent regulations and innovator firms' experience of the Bolar provision. There’s also a "compelling reason" to consider regulatory data protection, he claims.
Funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, GCC partnerships and talks with the Indian government to solve intellectual property challenges are discussed in an interview with Aragen’s CEO, who is also keenly watching the Trump administration’s moves on pharma tariffs
Plus deals involving Incyte/Genesis, Merck & Co./Epitopea, Merck Serono/Asceneuron, Tivic Health/Statera and more.
Legal heavyweights from Nishith Desai Associates, Anand and Anand, Corporate Law Group and EY partner and national cyber leader outline key compliance aspects that pharma and their global capability centers may need to factor as India moves to strengthen the framework for the protection of digital personal data.
Novo took the biggest stock price hit of all the drug makers with products subject to Medicare price negotiations in 2027 under the IRA, but at least 11 of its peers on the list will be subject to generic competition between 2025 and 2027.
India cracks down on unethical marketing practices, with AbbVie in the eye of a storm for allegedly violating norms. While the action sends the right signal, a wider clean up including in the devices segment, where things may be “more harmful” may not be easy, say some experts.
With Chair Lina Khan expected to exit the commission, the incoming administration may consider elevating one of the Republican commissioners on the panel to succeed her, at least on an acting basis.
The exact causes leading to Chinese authorities’ investigation of the UK major remain unclear at this point, but its key oncology drugs are facing fierce local competition from homegrown rivals.