NEWS

Accord Healthcare Reports the MHRA’s Approval of Hetronifly as 1L Treatment of ES-SCLC

Shots: The UK’s MHRA has approved Hetronifly (serplulimab) to treat previously untreated adults in the UK with extensive-stage small cell lung cancer (ES-SCLC) Approval were based on the global P-III (ASTRUM-005) study (n=585) across 128 trial sites, which showed a mFU of 42.4 mos. & 4-year OS rate of 21.9% with serplulimab + CT, confirming its long-term…

June 24, 2025

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

Shots: Johnson & Johnson launched ACUVUE OASYS MAX 1‑DAY MULTIFOCAL for astigmatism daily disposable lens in the U.S. and Canada for people with both astigmatism and presbyopia A study showed 95% of people wearing ACUVUE OASYS MAX 1-DAY MULTIFOCAL for ASTIGMATISM contact lenses reported clear vision during daily activities, while 87% saw clearly while driving…

June 24, 2025

PTC Therapeutics Receives the EC’s Approval for Sephience to Treat Phenylketonuria (PKU)

Shots: The EC has approved Sephience (sepiapterin) to treat PKU in pts of all ages and disease severities across all 30 EEA states; launch is anticipated in Germany in H1 of July Approval was based on APHENITY study results and long-term extension data showing durable effects and improved dietary flexibility Sephience is an oral synthetic…

June 24, 2025

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Shots: The CHMP has recommended AVT06, a biosimilar version of Eylea (aflibercept 2 mg), across all 30 EEA states AVT06 is a recombinant fusion protein that inhibits VEGF to reduce neovascularization and vascular permeability. The CHMP recommends MAA for wet AMD, visual impairment from macular oedema due to RVO (branch or central), diabetic macular oedema…

June 24, 2025

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

Shots : The P-III (HYPERION) study evaluating Winrevair vs PBO (both in combination with background therapy) in recently diagnosed adults (N=320, >18) with PAH (WHO Group 1) functional class (FC) II or III at intermediate or high risk of disease progression The study met its 1EP of TTCW measured by the first confirmed morbidity or…

June 24, 2025

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

Shots: The CHMP has recommended Nirogacestat as a monotx. for adults with progressing desmoid tumors needing systemic treatment, the EC’s decision is expected in Q3’25 Opinion was supported by the MAA on P-III (DeFi) global trial (N=142) assessing Nirogacestat (n=700) vs PBO (n=72), which met the 1EP, showing a 71% reduction in PFS vs PBO,…

June 23, 2025

Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention

S Shots: The P-IV (PEARL) study (N=1140) evaluating fremanezumab met its 1EP and 2EPs, demonstrating long-term effectiveness over two years, significantly reducing the frequency, duration, and severity of migraine attacks in both chronic and episodic migraine pts The study met 1EP of ≥50% reduction in MMD within the first 6mos. of treatment. Injection adherence remained high…

June 23, 2025

Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Shots: The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA states The EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed…

June 23, 2025

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)

Shots: The EC has granted approval to the company’s Wyost and Jubbonti, biosimilar of Xgeva and Prolia (denosumab), across the EU for treating same indications as that of Xgeva and Prolia incl. cancer-related bone disease & osteoporosis, respectively. Their launch is anticipated from Nov 2025 onwards The EC’s approval was supported by the clinical evaluations…

June 23, 2025

Harbour BioMed Enters a ~$670M Partnership with Otsuka Pharmaceutical to Advance HBM7020 for Autoimmune Diseases

Shots: Harbour BioMed & Otsuka Pharmaceutical have entered into a global strategic collaboration to advance HBM7020 for the treatment of autoimmune diseases As per the deal, Otsuka will receive an exclusive global license to develop, manufacture, & commercialize HBM7020 excl. Mainland China, Hong Kong, Macau & Taiwan in exchange for $47M in upfront & near-term…

June 23, 2025

NEWS

Accord Healthcare Reports the MHRA’s Approval of Hetronifly as 1L Treatment of ES-SCLC

Johnson & Johnson launches ACUVUE OASYS MAX 1-Day MULTIFOCAL for ASTIGMATISM Contact Lens in the US and Canada

PTC Therapeutics Receives the EC’s Approval for Sephience to Treat Phenylketonuria (PKU)

Alvotech & Advanz Pharma Secure the CHMP’s Positive Opinion for AVT06 (Biosimilar, Eylea)

Merck Reports the Data from P-III (HYPERION) Study of WINREVAIR (sotatercept-csrk) in Adults with Recently Diagnosed PAH

SpringWorks Therapeutics’ Nirogacestat Receives the CHMP’s Positive Opinion for Desmoid Tumors

Teva Reports the Data from the P-IV (PEARL) Study of Ajovy (fremanezumab) for Chronic and Episodic Migraine Prevention

Argenx Receives the EC’s Approval for Vyvgart SC to Treat Chronic Inflammatory Demyelinating Polyneuropathy

Sandoz Reports EC’s Approval of Wyost and Jubbonti (Biosimilars, Xgeva and Prolia)

Harbour BioMed Enters a ~$670M Partnership with Otsuka Pharmaceutical to Advance HBM7020 for Autoimmune Diseases

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