Shots:Eisai & Biogen have reported EU launch of Leqembi, starting with Austria on Aug 25, 2025 & Germany on Sep 1, 2025, following EC approval in Apr 2025Approval was based on the P-III (Clarity AD) trial assessing Leqembi (n=757) vs PBO (n=764) in pts with MCI or mild dementia due to AD &…
Shots: In the Biopharma industry, navigating M&A and licensing deals is challenging due to strict antitrust laws and shifting regulations. When these pressures create significant risks, nullifying or restructuring existing agreements can be the most rational and strategic response In 2024, the termination of the $4.45B deal between Adaptimmune and Genentech became a major talking…
Shots:The EC has approved Leqembi for the treatment of early Alzheimer’s disease in all 30 EEA statesEisai handles global development & regulatory filings for Leqembi, co-commercializing & co-promoting it with Biogen while retaining final decision-making authority. Eisai co-promotes Leqembi with Biogen in the EU (excl. Nordics) & with BioArctic in the Nordic countries, distributing it…
Shots:P-III (LEAP-015) trial assessed Keytruda + Lenvima + CT (CAPOX or mFOLFOX6 regimen) as a 1L therapy for LA/M inoperable HER2- GE adenocarcinoma pts in 2 parts (P1: safety run-in & P2: main trial). LEAP program is also assessing it in hepatocellular carcinoma & esophageal cancer
P2 pts (n=880) received Keytruda (400mg, IV…
Shots:Michael spoke about the P-III Clarity AD study evaluating Leqembi (lecanemab) for the treatment of mild cognitive impairment due to Alzheimer’s disease presented at CTAD 2022He also talked about Eisai’s collaboration with Biogen for the co-commercialization and co-promotion of LecanemabThe interview gives an understanding of how Biogen develops and delivers innovative therapies…
Shots:Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versionsLike every other utility patent, pharmaceuticals also get market exclusivity of 20 years. Some companies accept the offered period and open doors to biological drugs or biosimilars. In…
Shots:The US FDA approved 8 NDAs and 1 BLA in January 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 9 novel products in 2023In January 2023, the major highlights drugs were Rykindo (risperidone) approval for schizophrenia and bipolar 1 disorder, Brenzavvy (bexagliflozin) for type…
Shots:Michael talked about the new data from its Alzheimer’s pipeline at the Alzheimer’s Association International (AAIC)Michael also highlighted the study design of the P-II & P-III trial evaluating lecanemabThe interview gives an understanding of Eisai’s human health care (hhc) concept which provides innovative products with high unmet medical needs to target diseases…
The third quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include CVS Health acquired Signify Health for ~$8B, Amgen acquired Chemocentryx for ~$4BThe third quarter of the year also showcases multiple approvals of the therapies which include Incyte's Opzelura US FDA's approval for Vitiligo,…
Shots:The interview provided an understanding of the data from its Alzheimer’s disease pipeline at the AD/PD ConferenceThe spokespeople also talked about the clinical trial data and key mechanisms of Eisai’s anti-amyloid compound in AD The discussion showed gave a gist of four key symposium presentations that showed how its lead candidate has the…

