Pharmaceutical manufacturers have been hoping to fly under Washington, D.C.'s radar, but Allergan's attempt to shield Restasis from the IPR process using a controversial deal with a Native American tribe, has led to calls for an investigation.
Allergan PLC's pact with the Saint Regis Mohawk Tribe, intended to help Allergan secure patent protection for its dry eye blockbuster Restasis (cyclosporine), has done what many companies are hoping not to do – caught the attention of legislators in Washington, D.C.
Four Democratic Senators sent a letter to Senate Judiciary Committee Chairman Charles Grassley, R-IA, Sept. 27 calling on the committee...
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
The US FDA approved Merck’s Enflonsia (clesrovimab) to prevent RSV in newborns and infants on the same day Sanofi assured that it would ship Beyfortus in time for the 2025-2026 RSV season.
Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.
The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.
