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…

ByRidhi RastogiJuly 20, 2026

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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…

ByRidhi RastogiJuly 20, 2026

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4DMT Reports P-IIb (PRISM) Trial Data on 4D-150 in a Broad Wet AMD Population

Shots: 4DMT reported 2yr. data from the P-IIb (PRISM) trial evaluating intravitreal 4D-150 at 3E10 vg/eye (n=30) & 1E10 vg/eye (n=15) in 45 pts with wet age-related macular degeneration P-IIb subgroup incl. 15 recently diagnosed pts treated with 3E10 vg/eye, which was also selected for the P-III (4FRONT) trials, with the 2-year Phase 2b data…

ByRidhi RastogiJuly 20, 2026

NEWS

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…

ByRidhi RastogiJuly 20, 2026

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SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Shots: The NMPA has approved iza-bren (izalontamab brengitecan) for the treatment of adult pts with recurrent or metastatic ESCC whose disease has progressed following prior Pt-based CT & PD-1/PD-L1 inhibitor therapy Approval was based on the P-III (PANKU-Esophagus01) trial assessing iza-bren vs CT in the above-mentioned pts (n=497) across China, which met its dual 1EP…

ByRidhi RastogiJuly 20, 2026

NEWS

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);…

ByRidhi RastogiJuly 20, 2026

NEWS

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,…

ByRidhi RastogiJuly 17, 2026

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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…

ByRidhi RastogiJuly 17, 2026

NEWS

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…

ByRidhi RastogiJuly 17, 2026

NEWS

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

Ridhi Rastogi

Organon and Samsung Bioepis Expand Commercialisation Agreement to Broaden Biosimilar Access in Australia

Almirall Reports EMA Acceptance of Ebglyss Pediatric Filing for Atopic Dermatitis in Children Aged 6 Months and Older

4DMT Reports P-IIb (PRISM) Trial Data on 4D-150 in a Broad Wet AMD Population

GSK Reports EMA Submission Acceptance to Update Bexsero Label

SystImmune Reports the NMPA Approval of Iza-bren to Treat Recurrent or Metastatic ESCC

Samsung Biologics to Acquire PolyPeptide for ~$1.8B

Aqemia Expands Sanofi Collaboration With New Target Nomination

Mission Therapeutics Inks a ~$292M Deal with Dimerix for MTX652

The EC Approves Boehringer Ingelheim’s Jascayd for Treating IPF and PPF

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

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