Business

Regulatory Departments Must Prepare For The Digital-First Era In Europe

Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.

Merck To Buy Terns For $6.7bn, Boosting Blood Cancer Portfolio Further

Its latest acquisition adds to Merck’s arsenal of hemato-oncology candidates, with TERN-701 aiming to challenge Novartis's Scemblix.

Novartis Makes $3bn Bet On Synnovation’s PI3Kα Inhibitor SNV4818

The deal, which is expected to close in the first half of 2026, includes $2bn upfront plus $1bn in milestone related payments.

Samsung Bioepis Partners With G2GBIO For Long-Acting Semaglutide

Samsung Bioepis’ explorations for an alternate semaglutide formulation will be powered by G2GBIO’s microsphere technology.

Regulatory Departments Must Prepare For The Digital-First Era In Europe

Digitalization is expected to reform the European pharmaceutical industry. But it will also change perceptions towards technology and current regulatory skillsets.

The Game Of Balancing Green Regulations While Keeping Off-Patent Drug Investment In Europe

In the second part of our exclusive interview with Medicines for Europe leaders, Generics Bulletin delves into medicinal product regulation by environmental and chemical agencies, and the need to maintain the historical off-patent drug heritage in Europe.

Formycon Flags Missed Guidance Ahead Of The FY2025 Results Report

Deal after deal, Formycon was inching toward closing the gap in its annual guidance. Still, it was not enough to meet the goal, as the German biosimilars developer’s preliminary financial report reveals.

Affordable Medicines To Be Key Driver For Amneal In 2026 As Specialty Takes Back Seat

Even Amneal, a prominent off-patent player, is not immune to generic competition, as its Parkinson’s disease drug Rytary is expected to take a hit.

Lupin Confident In Soon-To-Be-Launched Pegfilgrastim Biosimilar Despite Crowded Market

Lupin is riding a wave of growth across most of its global markets, with biosimilars and other complex products filling its portfolio.

Biocon To Explore Further Possibilities For Fully Acquired Humira Biosimilar

Biocon Biologics hinted about exploring the development of a higher concentration adalimumab biosimilar, now that it has full rights to the Hulio franchise.

Samsung Bioepis Secures US Launch Date For Eylea Biosimilar – Though Later Than Others

Samsung Bioepis has signed off on another settlement for its Eylea biosimilar rival, opening up the US market from the start of 2027. While later than other competitors, for Bioepis this marks the resolution of all patent-related matters.

Samsung Bioepis Settles Global Launches For Its Eylea Biosimilar

Just a few days after Alvotech announced global settlements for its Eylea rival, Samsung Bioepis has followed up with its own agreements with the originators.