Pharma News and Headlines
Pharma News and Headlines
A retrospective TriNetX analysis of 1,691 psoriasis patients compared bimekizumab with IL‑23 inhibitors and found no greater incidence of new‑onset depression, suicidal ideation, or related medication use. Over a two‑year follow‑up, the combined psychiatric event rate was 4.9% for bimekizumab versus 12% for IL‑23 inhibitors, yielding a risk ratio of 2.43 favoring the latter. Six‑month cumulative incidence was 2.7% for bimekizumab and 4% for IL‑23 inhibitors, a non‑significant difference. Researchers recommend continued mental‑health screening for all biologic users despite the reassuring safety signal.
A randomized, double‑blind study published in Mayo Clinic Proceedings found that a single 25 mg dose of off‑prescription Adderall caused significant acute increases in blood pressure and heart rate among healthy young adults. Systolic pressure rose by roughly 10 mm Hg, diastolic by...
Six biotech firms are pushing next‑generation prostate‑cancer therapies through late‑stage trials and financing milestones. Candel Therapeutics secured a $100 million royalty deal to fund aglatimagene’s launch, while Coherus Oncology closed a $50.1 million offering and partnered with J&J for a CCR8 antibody...
Elevara Medicines has dosed the first patient in its phase 2b START‑SYNERGY trial, testing the oral CDK4/6 inhibitor ELV001 in rheumatoid arthritis patients who have failed methotrexate and TNF inhibitors. The randomized, placebo‑controlled study will enroll about 180 participants across nine...
Cir‑Code Bio‑med, a Chinese biotech focused on circular RNA medicines, has secured an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration to commence its first human trial. The therapy targets a rare genetic disorder using a...
Structure Therapeutics announced that its daily oral GLP‑1 obesity pill produced an average 16% body‑weight reduction versus placebo after 44 weeks in a Phase 2 trial. The result outperforms Eli Lilly’s orforglipron, which showed about 11% loss over 72 weeks, and rivals...
Structure Therapeutics released Phase 2 data for its oral GLP‑1 agonist, positioning the candidate as a next‑generation alternative to injectable therapies from Eli Lilly and Novo Nordisk. The trial demonstrated a mean 30% reduction in HbA1c and 70% of participants achieving target...
The Atlantic outlines a surge in off‑label and experimental peptide use, noting that Vyleesi—approved for women’s hypoactive sexual desire disorder—is being bought by men through “research use only” listings and online pharmacies. Compounding pharmacies and telehealth firms now market customized...
The FDA is accelerating the shift of prescription medicines to over‑the‑counter status, highlighted by Commissioner Marty Makary’s call for broader OTC availability and the introduction of the Additional Condition for Non‑Prescription Use (ACNU) framework. Former FDA counsel Heidi Gertner stresses...
Pete Pharma has entered a strategic partnership with Atrium24 Technologies, designating Pete Pharma as the primary 3D‑printing provider within Atrium24’s group‑ purchasing organization. The deal gives Atrium24‑member independent pharmacies preferred pricing on Pete Pharma’s FABRx 3D‑printing platform, enabling on‑site production...
Biophytis has broadened its alliance with AI specialist LynxKite to fast‑track longevity drug discovery, launching the MASSIVE project that seeks Mas receptor activators for sarcopenia. Backed by Enterprise Singapore, the partnership will augment Biophytis’ computational platform with LynxKite’s chemoinformatics, advanced...
Bayer disclosed results from the pivotal Phase III FIND‑CKD trial evaluating Kerendia (finerenone) in more than 1,500 adults with non‑diabetic chronic kidney disease. Patients received 10 mg or 20 mg of Kerendia alongside standard of care and were compared with placebo. The study...
Johnson & Johnson announced encouraging Phase I data for its intravesical drug‑releasing system Erda‑iDRS in non‑muscle‑invasive bladder cancer (NMIBC) with FGFR alterations. The trial met its primary safety endpoint and delivered an 89% complete response rate in intermediate‑risk patients, with responses...
Roche has secured CE Mark approval for its Elecsys ApoE4 in‑vitro diagnostic immunoassay, a blood‑based test that detects the ApoE4 gene variant linked to Alzheimer’s disease. In a validation study of 607 patients with cognitive complaints, the assay achieved 100%...
Viatris agreed to dismiss the Henrietta Lacks estate lawsuit with prejudice, ending claims that the company used HeLa cells without permission in its herpes drug Denavir and depression treatment Mylan‑Mirtazapine. The settlement details were kept confidential. This resolution follows similar...
REGENXBIO's gene therapy RGX‑121 for Hunter syndrome received an FDA Complete Response Letter, with the agency flagging patient‑eligibility definitions, natural‑history control comparability, and the surrogate endpoint as problematic. The rejection redirects focus to Denali Therapeutics, whose enzyme‑replacement candidate tividenofusp alfa...
A CRISPR‑Cas9 screen revealed that riboflavin (vitamin B2) sustains the ferroptosis suppressor protein FSP1, shielding cancer cells from iron‑driven lipid peroxidation. Depleting vitamin B2 destabilizes FSP1 and renders tumor cells highly susceptible to ferroptosis. The researchers demonstrated that roseoflavin, a bacterial analog...
At SXSW, Mark Cuban and eMed CEO Linda Yaccarino announced a partnership that will route employer‑sponsored GLP‑1 weight‑loss prescriptions through Cuban’s Cost Plus Drugs. Yaccarino highlighted eMed’s 90 % one‑year retention rate, contrasting it with the 50‑60 % churn seen at direct‑to‑consumer players...
Summit Therapeutics reported a cash balance of $713 million and zero debt at year‑end, while GAAP operating expenses fell to $225 million. The FDA accepted its Biologics License Application for ivonesumab in EGFR‑mutant non‑small cell lung cancer, setting a PDUFA action date...
Researchers published a longitudinal study showing that people living with HIV who switch from daily oral antiretrovirals to the long‑acting injectable combo cabotegravir‑rilpivirine experience an early, transient rise in monocyte activation followed by a sustained decline below baseline levels. Flow...
The documentary "The Pink Pill" chronicles the decade‑long fight to bring Addyi, the first FDA‑approved drug for women’s low libido, to market. Founder Cindy Eckert bought the rights after a major pharma abandoned the project, launched a 13,000‑patient trial, and...
During a congressional hearing, neurologists warned that rare disease patients are dying while therapies linger in FDA review. The FDA recently rejected the SCA drug troriluzole, demanding more statistical certainty despite trial data showing over 50% fall‑risk reduction. Congress has...
Clinical trials have long relied on site‑based recruitment, leaving under‑ and misdiagnosed patients underrepresented. Recent studies show digital outreach can identify symptomatic individuals who never enter traditional healthcare pathways, dramatically expanding the eligible pool. Digital campaigns have cut cost per...
Lupin is pivoting toward proprietary new chemical entities (NCEs) in India, aiming to launch multiple innovative products by next year. The company plans to focus on cardiac, diabetes, respiratory and oncology molecules, leveraging lower development costs and faster time‑to‑market. AI...
Eli Lilly has launched Employer Connect, a platform that lets large employers purchase its weight‑loss injection Zepbound at a discounted $449 price, aiming to close the coverage gap that leaves over half of workers without obesity drug benefits. The program bypasses...
Japan has become the first country to grant conditional approval for two regenerative medicines that use induced pluripotent stem cells—AMCHEPRY for Parkinson’s disease and RiHEART for severe heart failure. The Parkinson’s therapy implants dopamine‑producing neurons into the brain, while the...
Researchers analyzing over 30 million adverse‑event reports found that patients using Wegovy, the high‑dose semaglutide injection for obesity, have about five times the odds of developing ischemic optic neuropathy (ION) compared with those on Ozempic, the lower‑dose diabetes formulation. The association...
A systematic review and network meta‑analysis of 32 randomized trials examined twelve hypnotic agents in adults with obstructive sleep apnea (OSA). The analysis found that most sleep‑inducing drugs do not worsen the apnea‑hypopnea index or oxygen saturation, challenging the long‑standing...
A phase‑3 BMJ trial reported that adding camrelizumab to standard chemoradiotherapy improved 36‑month progression‑free, distant‑metastasis‑free and locoregional‑recurrence‑free survival in high‑risk nasopharyngeal carcinoma. The protocol combined two concurrent cycles with 17 adjuvant cycles, yet only 61.9% of patients completed the full...
Zydus Lifesciences has received NMPA approval for its oral anaemia drug Desidustat, targeting renal anaemia in adult chronic kidney disease patients who are not on dialysis. The therapy, a hypoxia‑inducible factor‑prolyl hydroxylase inhibitor, demonstrated efficacy and safety in Chinese Phase III...
Cambridge chemists have unveiled a light‑driven “anti‑Friedel‑Crafts” reaction that forms carbon‑carbon bonds using only LED illumination at ambient temperature. The metal‑free method allows precise, late‑stage modifications of complex drug molecules, cutting months of multistep synthesis. Tested on a broad set...
Pretzel Therapeutics presented preclinical data for its investigational small‑molecule PX578 at the 2026 MDA Clinical and Scientific Conference. The drug is designed to activate the mitochondrial DNA polymerase gamma (POLG) and restore mitochondrial DNA levels in patients with mitochondrial DNA...
The FDA released draft Q&A guidance that clarifies how drug sponsors can qualify for three‑year non‑patent exclusivity by conducting a “new clinical investigation.” It defines a new study as a human, non‑bioavailability trial whose results have not been previously relied...
Friedreich ataxia (FA) received its first FDA‑approved therapy in 2023 when omaveloxolone, marketed as Skyclarys, earned accelerated approval. Biogen’s $7.3 billion acquisition of Reata Pharmaceuticals secured the drug and highlighted the market’s appetite for rare‑disease assets. Skyclarys works by activating the...
The study introduces a quantum‑annealing algorithm that predicts effective drug combinations by casting the problem as a quadratic unconstrained binary optimisation (QUBO). It leverages the network‑medicine concept of disease modules and the “Complementary Exposure” principle, which seeks drugs that hit...
The FDA has issued a safety alert warning consumers not to purchase or use Kian Pee Wan, a product marketed as an appetite stimulant and weight‑gain aid. Laboratory testing revealed the supplement contains the prescription steroid dexamethasone and the antihistamine...
CMS announced that the third round of the Medicare Drug Price Negotiation Program will proceed with full manufacturer participation, covering 15 high‑cost, single‑source drugs and one drug slated for renegotiation. The agency will issue initial price offers by June 1, 2026,...
An international research team has engineered a bacterial strain that boosts doxorubicin output by 180% compared with current industrial methods, overcoming three long‑standing bottlenecks—insufficient redox partners, drug‑binding “sponge” proteins, and suboptimal enzyme positioning. The findings, published in Nature Communications, detail...
SpyGlass Pharma’s Bimatoprost Drug Pad‑IOL System demonstrated significant intra‑ocular pressure (IOP) reductions and vision gains in a phase 1/2 trial of 104 patients with open‑angle glaucoma or ocular hypertension undergoing cataract surgery. At 12 months, the 78 µg dose lowered mean IOP 34%...
The U.S. Food and Drug Administration has approved Novartis' secukinumab, marketed as Cosentyx, for adolescents aged 12 and older with moderate‑to‑severe hidradenitis suppurativa (HS). This marks the first IL‑17A inhibitor cleared for a pediatric indication, extending the drug’s adult HS...
Kenai, a new allogeneic cell‑therapy company, is developing off‑the‑shelf iPSC‑derived progenitor cells for Parkinson’s disease, paired with a precision brain‑delivery platform that uses real‑time functional imaging. The approach builds on Japan’s recent approvals of iPSC‑based Parkinson’s treatments and aims to...
Researchers at Jeonbuk National University have unveiled DDINet, a lightweight neural network designed to predict drug‑drug interactions (DDIs) for previously unseen compounds. The model employs five fully‑connected layers and molecular fingerprints, with Morgan fingerprints delivering the best results. Using a...
The FDA has released a searchable table of extended use dates for specific drug lot numbers, based on manufacturer‑provided stability data. These extensions allow providers and patients to continue using existing stock beyond original expiration dates, helping to mitigate ongoing...
Researchers at INSERM uncovered hypothalamic tanycytes as a previously unknown tau‑clearing pathway, opening fresh therapeutic avenues for Alzheimer’s and related tauopathies. Merck Sharp & Dohme (MSD) announced the synthesis and pre‑clinical testing of novel PET tracers that bind α‑synuclein, aiming...
Shilpa Biologicals and mAbTree Biologics received FDA orphan drug designation for an investigational monoclonal antibody that targets an immune‑evasion pathway in essential thrombocythemia and polycythemia vera. The designation validates the novel mechanism and accelerates plans for IND‑enabling studies and first‑in‑human...
The FDA’s Center for Drug Evaluation and Research has expanded its Drug Safety Podcast series, delivering concise audio briefings that coincide with official Drug Safety Communications. Recent episodes address serious liver injury linked to Ocaliva, rare hypocalcemia risks with Prolia,...
The FDA released draft guidance that lets biosimilar developers use foreign comparator data and, in some cases, replace clinical studies with chemical analysis, potentially cutting development costs by $20 million. Simultaneously, the agency launched the Adverse Event Monitoring System (AEMS), a...
The J. Craig Venter Institute unveiled a 4D, nanoscale simulation that tracks the entire life cycle of a minimal bacterial cell, marking a milestone for synthetic biology. A new gene‑editing platform designs DNA donors that dodge immune detection, enabling safer,...
San Francisco biotech Tahoe Therapeutics is building the world’s largest single‑cell atlas of cell‑chemical interactions, leveraging Integra Biosciences’ Assist Plus pipetting robot, Parse Biosciences’ Evercode scRNA‑seq kits, and its own AI analytics. Automation has increased single‑cell preparation throughput more than fivefold...
A new JAMA Internal Medicine study finds that the Inflation Reduction Act’s 2024 drug‑pricing provisions have reduced cost‑related medication nonadherence among Medicare beneficiaries. Compared with privately insured peers, seniors saw a 4.9‑percentage‑point drop overall and a 7.8‑point decline among those...
