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,…
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%…
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…
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…
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…
Have you ever wondered why some people skip medications even when it’s vital for their health? Or why certain drugs gain attention while others don’t? These questions highlight the intersection of healthcare and human behavior in pharma. Pharma doesn’t just develop life-saving treatments—it also needs to understand why patients make specific decisions, like skipping doses or…
Shots: The biopharma industry faces several challenges, including digital transformation, regulatory compliance, and managing large volumes of data Intelligent automation plays a vital role in drug discovery, clinical trials, manufacturing, and commercialization, helping optimize operations and better meet customer needs Astrix CEO Dale Curtis Jr. discusses the role of AI and machine learning in global…
Shots: PharmaShots' designation report provides a concise overview of the latest drug designations by major regulatory authorities, including the FDA, EMA, MHLW and NMPA The December 2024 report covers designations granted to 43 drugs and 3 devices, encompassing 13 small molecules, 10 biologics, 7 cell and gene therapies & 3 medical devices among others Significant…
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,…
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…
