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Hutchmed
NEWS

HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

Shots: The P-III (SANOVO) trial assessed Orpathys (300 or 200mg, BID) + Tagrisso (80mg, QD) vs Tagrisso in 326 treatment-naïvepts with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) & MET overexpression The combination significantly improved PFS in both high-MET and ITT populations, while also showing encouraging OS benefit; follow-up…
September 1, 2026

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NEWS

Novartis Reports P-III (REMODEL-1/-2) Trial Data on Remibrutinib for Relapsing Multiple Sclerosis

Shots: Novartis has reported topline data from P-III (REMODEL-1/-2) trials assessing remibrutinib (100mg) vs teriflunomide in ~2,000 adults with relapsing multiple sclerosis (RMS)  Remibrutinib met the 1EP, significantly reducing annualized relapse rate (ARR), plus trial showed clinically meaningful reductions in key 2EPs related to disability progression, with a positive trend in 3mCDP & nominally significant…
September 1, 2026

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NEWS

Ascendis Pharma and BioMarin Reach Global Settlement for Yuviwel

Shots: Ascendis Pharma has entered into a binding term sheet with BioMarin for a global settlement & license agreement covering Yuviwel (navepegritide) & related products, resolving ongoing litigation & disputes between the companies As per the deal, BioMarin will grant Ascendis a non-exclusive, worldwide, royalty-bearing license to research, develop, manufacture & commercialize navepegritide-related products without…
September 1, 2026

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NEWS

PharmaEssentia Reports the US FDA Approval of BESREMi (Ropeginterferon Alfa-2b-njft) for Essential Thrombocythemia

Shots: The US FDA has approved BESREMi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), expanding BESREMi product label beyond polycythemia vera Approval was supported by durable ELN responses and hematologic control in adults with ET. In P-III (SURPASS-ET) trial, it outperformed anagrelide in durable response rates & reduced thromboembolic events over…
September 1, 2026

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NEWS

Eli Lilly to Acquire Merida Biosciences for ~$2.875B

Shots: Eli Lilly has entered into a definitive agreement to acquire Merida Biosciences incl. its antibody-engineering platform & programs, strengthening Lilly's immunology capabilities As per the deal, Eli Lilly will acquire Merida Biosciences for $2.875B in cash, incl. an upfront payment, & contingent milestone payments; closing is expected in the Q4’26 Merida’s lead program, MER511,…
August 31, 2026

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NEWS

Zambon Secures the EC Approval for Hopledo to Treat Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Shots: The EC has approved Hopledo for the treatment of adults with Parkinson’s disease & mod. to sev. motor fluctuations who have not been sufficiently stabilized with oral levodopa/DDC inhibitor-based treatments Approval was based on the P-III (RISE-PD) trial assessing Hopledo in pts with Parkinson’s disease & mod. to sev. motor fluctuations, which showed a…
August 31, 2026

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Gilead
NEWS

Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Shots: The US FDA has approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg) for the treatment of HIV in adults who are virologically suppressed Approval was based on the P-III (ARTISTRY-1 & ARTISTRY-2) trials, assessing Bixlenvo (QD, PO) in adults with HIV who are virologically suppressed, incl. those who switched from complex multi-tablet regimens or from Biktarvy In…
August 31, 2026

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