ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Shots:ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024 MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…

ByDipanshu DixitJanuary 31, 2025

NEWS

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Shots:The US FDA has approved Symbravo for acute treatment of migraine with/without aura in adults based on P-III (MOMENTUM), P-III (INTERCEPT) & P-III (MOVEMENT) trial; commercially available in ~4mons. MOMENTUM trial assessed Symbravo (single dose) vs PBO/meloxicam/rizatriptan, showing greater pain & symptoms freedom (photophobia, phonophobia & nausea) at 2hrs., sustained through 24-48hrs., 77%…

ByDipanshu DixitJanuary 31, 2025

NEWS

Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support

Shots:Bayer launched CanesMeno in the UK to provide menopause support that incl. digital informative resources (CanesMeno Hub) & scientifically-backed products (Hydration & Comfort Gel, Multi-Support, & Night Support). Wider availability in major supermarkets & grocery stores will start from early spring 2025 The hub offers a 3-min. guide, a tracker for personalized insights…

ByDipanshu DixitJanuary 31, 2025

NEWS

Celltrion Secures the US FDA’s Approval for Avtozma (Biosimilar, Actemra)

Shots:The US FDA has approved Avtozma (biosimilar, Actemra) for treating diseases such as RA, GCA, pJIA, sJIA, and COVID-19 Approval was based on P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.24 & with…

ByDipanshu DixitJanuary 31, 2025

NEWS

Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC

Shots:Daiichi & AstraZeneca have dosed first patient with adj. Datroway (6 mg/kg) + rilvegostomig/ rilvegostomig monotx. (750mg) in P-III (TROPION-Lung12) trial to treat stage 1a/1b adenocarcinoma NSCLC (tumors <4 cm) after complete tumor resection who are ctDNA+ or exhibit high-risk of relapse Study will evaluate DFS as the 1EP, while OS, safety, patient-reported…

ByDipanshu DixitJanuary 31, 2025

NEWS

Ethris Reports Topline Data from P-I trial of ETH47 for Uncontrollable Asthma

Shots:Ethris presented full topline data from P-I trial of ETH47 (nasal) in 40 healthy subjects as a potential treatment for uncontrollable asthma Study showed dose-dependent IFNλ production in nasal lining fluid above therapeutic levels & activated antiviral ISG mRNA expression in nasal brush samples, confirming ETH47’s pharmacodynamic activity & MoA. Based on this,…

ByDipanshu DixitJanuary 30, 2025

NEWS

Siolta Therapeutics Enters into a Joint Research Agreement with Cowellnex

Shots:Siolta Therapeutics has entered into a preclinical research partnership with Cowellnex, a joint investment of Kirin and Kyowa Kirin, to develop an LBP focused on preventing necrotizing enterocolitis (NEC) The collaboration will utilize Siolta’s Precision Symbiotics Platform, enabling Cowellnex to expedite the discovery and development of innovative product aimed at preventing the occurrence…

ByDipanshu DixitJanuary 30, 2025

NEWS

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Shots:The US FDA received BLA, plus a request for a priority review of apitegromab to improve motor function in pts with SMA who are on SMN-targeted therapy. The EMA’s MAA to be filed in Q1’25 The BLA was supported by the P-III (SAPPHIRE) & P-II (TOPAZ) trial, where SAPPHIRE met its 1EP of…

ByDipanshu DixitJanuary 30, 2025

NEWS

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Shots:The FDA has approved Journavx (50mg; BID) to treat moderate-to-severe acute pain in adults JOURNAVX is an oral, non-opioid pain signal inhibitor that selectively targets NaV1.8 relative to other NaV channels The company is also testing suzetrigine for peripheral neuropathic pain (PNP), with ongoing P-III trial for diabetic neuropathy and plans for…

ByDipanshu DixitJanuary 30, 2025

NEWS

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

Shots:The EC has approved Blincyto monotherapy as a part of consolidation therapy to treat 1L philadelphia chromosome-negative CD19+ B-ALL adults based on P-III (E1910) trial Blincyto + CT showed improved OS with 4.5yrs. median follow up vs CT alone, whereas 5-yrs. mFU demonstrated 82.4% vs 62.5% OS in 112 pts The trial was led by…

ByDipanshu DixitJanuary 30, 2025

Dipanshu Dixit

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Axsome Therapeutics Receives the US FDA Approval for Symbravo (meloxicam and rizatriptan) to Treat Migraine

Bayer Introduces CanesMeno Digital Educational Hub and Products in the UK to Provide Menstrual Support

Celltrion Secures the US FDA’s Approval for Avtozma (Biosimilar, Actemra)

Daiichi Sankyo and AstraZeneca Dose the First Patient with Adjuvant Datroway in P-III (TROPION-Lung12) Trial for Adenocarcinoma NSCLC

Ethris Reports Topline Data from P-I trial of ETH47 for Uncontrollable Asthma

Siolta Therapeutics Enters into a Joint Research Agreement with Cowellnex

Scholar Rock Reports the US FDA’s BLA Submission for Apitegromab to Treat Spinal Muscular Atrophy (SMA)

Vertex Receives the US FDA Approval for Journavx (Suzetrigine) to Treat Acute Pain

Amgen Receives EC’s Approval for Blincyto to Treat Philadelphia Chromosome-Negative CD19-Positive B-Cell Precursor Acute Lymphoblastic Leukemia (B-ALL)

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