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Samsung Bioepis and Organon
Organon and Samsung Bioepis Expand Commercialisation Agreement to Broaden Biosimilar Access in Australia
Shots: Organon & Samsung Bioepis have expanded their development and commercialisation agreement to commercialise a new biosimilar in Australia As per the deal, Organon will receive exclusive commercial rights to the biosimilar in Australia while Samsung Bioepis will be responsible for full development, manufacturing & regulatory responsibilities The amended agreement expands their collaboration to 4…
7 hours ago
Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older
Shots: The EMA has accepted a submission to extend marketing authorization of Ebglyss (lebrikizumab) to pts (6mos. to <18yrs., weighing <40kg) with mod. to sev. atopic dermatitis Application was supported by interim data from the pediatric clinical program, incl. the ADorable-1 evaluating Ebglyss in pts (6mos. to <18yrs.), & the ADorable-2 LTE study assessing safety…
8 hours ago
GSK Reports EMA Submission Acceptance to Update Bexsero Label
Shots: The EMA has accepted a submission to update Bexsero’s label to incl. a single-dose booster for individuals (≥10yrs.) who were previously vaccinated with Bexsero Submission was backed by a P-IIIb study showing that a single Bexsero booster dose effectively enhanced immune responses in individuals (10–20yrs.) who completed primary vaccination series during infancy; full data…
11 hours ago
Samsung Biologics to Acquire PolyPeptide for ~$1.8B
Shots: Samsung Biologics has launched an all-cash public tender offer to acquire 100% of the fully diluted share capital of PolyPeptide, expanding its capabilities beyond antibodies & ADCs to include peptide therapeutics As per the deal, PolyPeptide will receive CHF 44.31 (~$54.8) in cash per share, representing an implied equity value of ~CHF 1.46B (~$1.8B);…
13 hours ago
Aqemia Expands Sanofi Collaboration With New Target Nomination
Shots: Aqemia has expanded its multi-year research collaboration with Sanofi, marked by the nomination of a new therapeutic target & an additional payment The collaboration, initially announced in Dec 2023, makes Aqemia eligible to receive up to a total of $140M in upfront & milestone payments across programs Aqemia uses its physics-based generative AI platform,…
3 days ago
Mission Therapeutics Inks a ~$292M Deal with Dimerix for MTX652
Shots: Mission Therapeutics has reported the divestment of its P-II-ready asset MTX652, to Dimerix for initial development in Acute Kidney Injury (AKI) As per the deal, Mission will receive ~$292M in upfront, development & commercial milestones, plus up to double-digit tiered royalties on global net sales The divestment aligns with Mission’s strategy to maximize its…
3 days ago
Boehringer Ingelheim
The EC Approves Boehringer Ingelheim’s Jascayd for Treating IPF and PPF
Shots: The EC has approved Jascayd (nerandomilast) for the treatment of adults with idiopathic pulmonary fibrosis (IPF) & adults with progressive pulmonary fibrosis (PPF) Approval was based on the P-III (FIBRONEER) program, comprising the FIBRONEER-IPF & FIBRONEER-ILD trials. Both met their 1EP, demonstrating that Jascayd slowed lung function decline, measured by the change in FVC…
3 days ago
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