Pharma Blogs and Articles
Pharma Blogs and Articles
Pharma Pulse
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The late‑March FDA Group news roll highlights mounting political pressure on HHS officials after a POLITICO MAHA poll showed mixed support for President Trump’s health agenda, while the agency grapples with internal turnover that could impede reform. FDA leadership announced an accelerated push toward non‑prescription drug conversions and the use of AI to slash drug filing review times by up to 25%. Significant regulatory shifts include reclassifying melanoma detection devices to the 510(k) pathway, proposing Class II status for tuberculosis tests, and cutting OMUFA facility fees by roughly 50%. The rollout of new guidance on non‑animal testing and patient‑preference data further underscores the FDA’s evolving regulatory landscape.
Corvus Pharmaceuticals announced soquelitinib (CPI‑818), an oral covalent inhibitor that irreversibly engages ITK at Cys442 while sparing the related kinase RLK. The selectivity addresses the broader off‑target activity seen with earlier covalent ITK agents such as ibrutinib. Soquelitinib is currently...
Agenus announced that data from an investigator‑initiated Phase II trial of its multi‑mechanistic immunotherapy combo—botensilimab (BOT), balstilimab (BAL) and the allogeneic iNKT cell therapy agenT‑797—will be presented at the AACR Annual Meeting in April 2026. The study targets patients with PD‑1‑refractory gastroesophageal...
Shionogi has completed a $2.5 billion purchase of global rights to the ALS drug Radicava from Tanabe Pharma. The deal adds a rare‑disease asset and an established U.S. commercial platform, projecting roughly $700 million in revenue beginning fiscal 2026. Simultaneously, the escalating...
The White House announced 100% tariffs on branded drug imports from countries lacking trade agreements, prompting biotech firms to reassess supply‑chain and pricing strategies. Eli Lilly secured a rapid FDA approval for Foundayo, the first oral small‑molecule GLP‑1 for chronic weight...
Johns Hopkins researchers have created an intranasal DNA vaccine that fuses the relMtb and Mip3α genes to target drug‑tolerant tuberculosis persisters. In mouse models the vaccine accelerated bacterial clearance, lowered lung inflammation and prevented relapse when combined with standard therapy....
Vedanta Biosciences announced that the independent Data Monitoring Committee has completed the first prespecified interim analysis of its Phase 3 RESTORATiVE303 trial and recommended the study continue unchanged. The interim data showed efficacy surpassing the futility threshold with no new safety...
SV Health Investors (SVHI) announced the acquisition of EpiVax, a Providence‑based bioanalytical CRO that specializes in immunogenicity risk assessments for pharma and biotech firms. The deal adds a proven scientific platform, including the ISPRI predictive software and cell‑based assays, to...
Boston University, leading the AI for Alzheimer’s Disease (AI4AD) consortium, is coordinating 11 research institutes to apply machine learning to massive genomic, biomarker and cognitive datasets. The team is building the PreSiBO database, which tags predictor, signature, biomarker and outcome...
Pfizer announced it is halting development of its updated COVID‑19 vaccine candidates, ending ongoing Phase 2/3 trials that targeted newer variants. The decision follows mixed efficacy data and waning commercial demand as the pandemic recedes. Pfizer will redirect resources toward...
The pharmaceutical sector is reshaping its workforce as AI, precision medicine, tighter regulations, and global manufacturing scale become central to drug development. Companies are seeking talent that can harness data‑driven discovery, navigate complex clinical trials, and ensure compliance across jurisdictions....
A multi‑institution team led by Michigan State University unveiled GPS, a machine‑learning platform that predicts how a compound will alter gene expression from its chemical structure. Trained on millions of transcriptomic measurements across more than 70 cell lines, GPS screened...
Pfizer and BioNTech have halted a large U.S. clinical trial of an updated COVID‑19 booster after failing to enroll enough healthy adults aged 50‑64. The study required tens of thousands of participants, but recruitment stalled amid a sharp decline in...
Bayer’s oral factor XIa inhibitor asundexian (BAY 2433334) has delivered positive Phase 3 data in the OCEANIC‑STROKE trial, positioning it as a potential first‑in‑class therapy for secondary stroke prevention. The drug aims to block pathological clot formation while minimizing the bleeding complications common...
Shionogi completed a $2.5 billion acquisition of global rights to Radicava from Tanabe Pharma, adding an approved ALS treatment to its portfolio. The deal transfers all intellectual property, sales rights and the existing commercial team, delivering an estimated $700 million in annual...
