European Academy of Neurology (EAN 2022) – Braintale to Present Promising Results on Amyotrophic Lateral Sclerosis Biomarker Potential of Its Digital Platform

STRASBOURG, France–(BUSINESS WIRE)–Braintale, a medtech deciphering white matter, spin off from the Paris Greater Hospitals has presented the results of SOM-ALS sub-study in amyotrophic lateral sclerosis (ALS) during the European Academy of Neurology (EAN 2022) congress both in Vienna (Austria) and digitally from June 25th to 28th, 2022. Long underestimated in neurosciences, white matter, which … [Read more…]

Global Ultra large Volume Wearable Injectors Market (2022 to 2027) – Presence of Products in the Development Phase Presents Opportunities – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Global Ultra large Volume Wearable Injectors Market (2022-2027) by Product, Application, Geography, Competitive Analysis, and the Impact of Covid-19 with Ansoff Analysis” report has been added to ResearchAndMarkets.com’s offering. The Global Ultra large Volume Wearable Injectors Market is estimated to be USD 2.34 Bn in 2022 and is projected to reach USD 4.54 … [Read more…]

 US FDA Approves Prestige Biopharma’s IND for Phase 1/2a Trial of First-in-Class Pancreatic Cancer Treatment, PBP1510

SINGAPORE–(BUSINESS WIRE)–#CancerTreatment–Prestige Biopharma Limited, a Singapore-based biopharmaceutical company with operations in USA and South Korea, announced that the U.S. Food and Drug Administration (FDA) has approved the Phase 1/2a clinical trial of its first-in-class anti-PAUF monoclonal antibody, PBP1510 (INN: Ulenistamab), for the treatment of pancreatic cancer. The clinical trial will be conducted on patients with … [Read more…]

Trastuzumab Deruxtecan Recommended for Approval in the EU by CHMP for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Recommendation based on DESTINY-Breast03 trial results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced the risk of disease progression or death by 72% vs. trastuzumab emtansine (T-DM1) TOKYO & MUNICH–(BUSINESS WIRE)–Daiichi Sankyo (TSE: 4568) and AstraZeneca’s (LSE/STO/Nasdaq: AZN) trastuzumab deruxtecan has been recommended for approval in the European Union (EU) as a monotherapy for the … [Read more…]

Transgene and BioInvent Announce Positive Progress for BT-001

The oncolytic virus BT-001 replicates in the tumor for several days and expresses the anti-CTLA-4 monoclonal antibody                                                     STRASBOURG, France & LUND, Sweden–(BUSINESS WIRE)–Regulatory News: Transgene (Euronext Paris: TNG) (Paris:TNG), a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB (“BioInvent”) (Nasdaq Stockholm: BINV), a biotech company focused on the … [Read more…]

Slingshot Biosciences, Inc. Partners With Almog Diagnostic to Distribute Synthetic Cells Throughout Israel

EMERYVILLE, CA–(BUSINESS WIRE)–SLINGSHOT BIOSCIENCES, INC., the makers of synthetic cells that bring consistent precision and accurate control to replace inconsistent blood and tissue controls for use in flow cytometry and other biotech markets, today announced they have extended their distribution channel through a new agreement with Almog Diagnostic, a private company established in 1987 and … [Read more…]

Ipsen to Acquire Epizyme, Expanding Its Portfolio in Oncology

Transaction focused on lead asset Tazverik® (tazemetostat), a first-in-class EZH2a inhibitor approved in the U.S. Acquisition to bolster Ipsen’s growing oncology presence and leverage its infrastructure Ipsen to commence all-cash tender offer to acquire all outstanding shares of Epizyme for $1.45 per share plus a contingent value right (CVR) of $1.00 per share PARIS & … [Read more…]

Italfarmaco Group Announces Positive Topline Data from Phase 3 Trial Showing Beneficial Effect of Givinostat in Patients with Duchenne Muscular Dystrophy

— Study meets primary endpoint with secondary and exploratory endpoints showing consistency with primary endpoint — — Data reinforces previously observed safety profile for Givinostat; treatment in boys with DMD continues to show a good tolerability profile — — The company is planning to discuss the potential for marketing application submission with regulatory authorities for … [Read more…]

Pfizer and BioNTech Announce Omicron-Adapted COVID-19 Vaccine Candidates Demonstrate High Immune Response Against Omicron

Omicron-adapted monovalent candidate given as a fourth booster dose elicited a 13.5 and 19.6-fold increase in neutralizing geometric titers against Omicron BA.1 at 30 µg and 60 µg dose levels; bivalent vaccine candidate exhibited a 9.1 and 10.9-fold increase against Omicron Geometric mean ratios for Omicron neutralizing antibody response consistent with regulatory requirement of superiority … [Read more…]