BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Shots: The CHMP has recommended Opdivo + Pt-based CT as neoadj. followed by Opdivo alone as adj. treatment of adults with resectable NSCLC at high risk of recurrence & PD-L1 expression ≥1%. If approved, EC’s decision would be valid in all 30 EEA states The P-III (CheckMate-77T) study assessed neoadj. Opdivo + CT, followed by surgery…

ByRidhi RastogiMarch 31, 2025

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Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Shots: Following ODD grant, the EMA has accepted MAA of paltusotine for the treatment & long-term maintenance of acromegaly; NDA under the US FDA's review (PDUFA: Sep 25, 2025) Submission was supported by data from 18 trials, incl. 2 P-III trials (PATHFNDR-2 & PATHFNDR-1) assessing paltusotine vs PBO in treatment-naïve & experienced pts, respectively. These…

ByRidhi RastogiMarch 28, 2025

NEWS

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

Shots: Japan’s MHLW has approved Dupixent to treat COPD in adults whose disease is inadequately controlled with existing therapy Approval was based on P-III (BOREAS) trial assessing Dupixent + SoC vs PBO in uncontrolled COPD adults with elevated blood eosinophils, which showed reduced exacerbations & improved lung function; data from BORUS & its replicate P-III (NOTUS)…

ByRidhi RastogiMarch 28, 2025

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BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Shots: Japan’s MHLW has approved Beyonttra to treat ATTR-CM in adult pts based on P-III (ATTRibute-CM) study assessing Beyonttra (BID, oral) vs PBO (n=632) in ATTR-CM pts; commercialization to begin in H1’25 Trial showed 42% decrease in composite ACM & recurrent CVH events, plus 50% reduction in cumulative frequency of CVH events at 30mos., with pts…

ByRidhi RastogiMarch 28, 2025

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Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Shots: The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s review Trial showed that SC is noninferior to IV in AUC…

ByRidhi RastogiMarch 28, 2025

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Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Shots: Ionis has granted Sobi global exclusive rights of olezarsen excl. the US, Canada & China to treat familial chylomicronemia syndrome (FCS) & severely elevated triglycerides; Ionis to independently market Olezarsen in the US, whereas Theratechnologies holds the rights in Canada As per the deal, Ionis will get an upfront, with potential milestone payments &…

ByRidhi RastogiMarch 27, 2025

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Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Shots: The US FDA has approved Cabometyx for treatment-experienced, inoperable, LA/M, well-differentiated pancreatic NET (pNET) & extra-pancreatic NET (epNET) pts (≥12yrs.) Approval was based on P-III (CABINET) study assessing Cabometyx (60mg) vs PBO among 298 US pts (2 arms: pNET: n=99; epNET: n=199) that showed improved PFS; data was presented at ESMO 2024 & published…

ByRidhi RastogiMarch 27, 2025

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Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)

Shots: Axsome Therapeutics has reported P-III (FOCUS) trial data assessing solriamfetol (150 or 300mg, QD) vs PBO for 6wks. to treat of ADHD adults (n=516) in the US Trial met its 1EP, with 150mg showing greater AISRS score reductions vs PBO at Wk. 6 (17.7 vs 14.3 mean point decrease); improvements began at Wk. 1,…

ByRidhi RastogiMarch 26, 2025

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GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

Shots: The US FDA has approved Blujepa to treat uUTIs in female adults (≥40kg) & adolescents (≥12yrs., ≥40kg) caused by E. coli, K. pneumoniae, C. freundii complex, S. saprophyticus & E. faecalis; commercially available in H2’25 Approval was based on P-III (EAGLE-2, n=1531; EAGLE-3, n=1605) studies assessing gepotidacin (1500mg, PO, BID for 5 days) vs nitrofurantoin (100mg, PO, BID for 5 days)…

ByDipanshu DixitMarch 26, 2025

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AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

Shots: AstraZeneca to present Tagrisso’s data from P-III (LAURA & FLAURA2) & P-II (SAVANNAH & ORCHARD) trials at ELCC 2025 for EGFRm NSCLC pts who failed or received 1L therapy; data to support global filings In LAURA, Tagrisso showed favorable OS trend (mOS: 58.8 vs 54.1mos.; maturity: 31%) despite 78% of PBO pts receiving it…

ByRidhi RastogiMarch 25, 2025

BMS’ Opdivo Receives the CHMP’s Positive Opinion as a Neoadjuvant Treatment of Resectable NSCLC

Crinetics Pharmaceuticals Reports the EMA’s Acceptance of Paltusotine for Acromegaly

Sanofi and Regeneron’s Dupixent Receives the MHLW’s Approval to Treat Chronic Obstructive Pulmonary Disease (COPD)

BridgeBio Receives the MHLW’s Approval for Beyonttra (Acoramidis) for Transthyretin-Mediated Amyloidosis Cardiomyopathy (ATTR-CM)

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Ionis Partners with Sobi for Olezarsen to Treat Familial Chylomicronemia Syndrome (FCS) & Severely Elevated Triglycerides

Exelixis Reports the US FDA’s Approval of Cabometyx (Cabozantinib) to Treat Advanced Neuroendocrine Tumors (NETs)

Axsome Therapeutics Reports P-III (FOCUS) Trial Data of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD)

GSK Reports the US FDA’s Approval of Blujepa (Gepotidacin) to Treat Uncomplicated Urinary Tract Infections (uUTIs)

AstraZeneca to Highlight Tagrisso’s Clinical Data for NSCLC at ELCC 2025

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