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Every morning
Weekly
Tuesday recap
Shionogi completes $2.5B acquisition of ALS drug Radicava
Shionogi has finalized a $2.5 billion purchase of global rights to the ALS therapy Radicava from Tanabe Pharma, adding a rare‑disease asset and a U.S. commercial platform that is expected to generate roughly $700 million in revenue starting fiscal 2026.
Also developing:
By the numbers: Lupin Limited acquires VISUfarma in undisclosed deal
A Harvard‑led sub‑study of the COSMOS trial, published in Nature Medicine, reports that two years of daily Centrum Silver multivitamin‑mineral supplementation slowed biological aging by roughly 4‑5 months. The finding provides the first randomized, large‑scale evidence that an over‑the‑counter supplement can measurably decelerate molecular aging markers.
The United States announced a 100% tariff on imported patented pharmaceuticals and ingredients effective July 31, while exempting generic drugs. The move targets a market that accounts for roughly 40% of India’s pharma exports and has triggered swift responses from Indian...
Cipla USA Inc. received final FDA approval for its generic Nintedanib capsules (100 mg and 150 mg) to treat idiopathic pulmonary fibrosis, positioning the company against Boehringer Ingelheim's Ofev. The launch comes as the U.S. imposes 100% tariffs on patented drugs, leaving...
The FDA’s 2026 approval of Eli Lilly’s oral GLP‑1 agonist orforglipron marks a turning point for drug‑based biohacking, adding a needle‑free option to a class already shown to cut cardiovascular events by 20% and hint at longevity gains. Researchers cite robust...
A team led by Professor Takeo Miyake at Waseda University demonstrated a gold‑membrane nanotube injector that can extract and deliver cytoplasmic contents—including functional mitochondria—between living cells with over 90% transfer efficiency and 95% cell viability. The breakthrough promises more precise...
Lipocine Inc.’s Phase 3 trial of LPCN‑1154, an oral brexanolone for postpartum depression, failed to meet its primary endpoint, triggering a 78% plunge in the company’s share price. The setback raises questions about the viability of oral neurosteroid therapies and...
Hong Kong is positioning itself as a regional hub for biopharmaceutical innovation, focusing on advanced therapeutic products (ATPs) such as cell therapy. Invest Hong Kong is attracting mainland and international firms to set up R&D in the city, backed by...
BioCentury’s website now outlines a comprehensive cookie framework that classifies cookies into five distinct groups: strictly necessary, functional, marketing, advertising, and analytics. Each category serves a specific purpose, from enabling authentication and core site functions to gathering anonymous usage metrics...
The Federal Trade Commission has submitted a FY2027 budget request of $426.7 million and 1,183 full‑time positions. The request emphasizes continuing its consumer‑protection agenda, notably the 2024 administrative complaint accusing pharmacy‑benefit managers (PBMs) of inflating insulin prices. It also funds an...
The FDA has approved an extension of dosing intervals for Regeneron's Eylea HD, allowing injections as infrequently as every 20 weeks for patients with wet age‑related macular degeneration (AMD) and diabetic macular edema (DME). The label update incorporates two‑year efficacy and...
Scientists have cured type 1 diabetes in mice by engineering a hybrid immune system that accepts donor insulin‑producing cells without long‑term immunosuppression. The breakthrough could reshape how autoimmune diseases are treated, moving beyond blanket immune suppression toward targeted tolerance.
Pfizer and its partner BioNTech have ended a U.S. phase III trial of an updated COVID-19 vaccine for healthy adults aged 50‑64, citing insufficient enrollment. The decision, announced in a March 30 letter, comes amid waning demand for boosters and...
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...
Biotech markets are poised to sustain their outperformance as they navigate heightened geopolitical uncertainty. BioCentury’s Q2 2026 preview highlights strong follow‑on equity offerings and a robust M&A pipeline as primary catalysts. The sector’s resilience is underscored by more than $1 billion in...
An intranasal vaccine using extracellular vesicles displaying inverted influenza hemagglutinins induced broad, cross-protective immunity in mice, offering a promising strategy for universal flu prevention at the mucosal level. vaccines
Researchers at The Jackson Laboratory have demonstrated that inhibiting KDM4 enzymes can reactivate the silenced tumor‑suppressor gene ZBTB7A in acute myeloid leukemia (AML) models. Using a novel FISHnCRISP platform that combines fluorescence in‑situ hybridization, flow cytometry and CRISPR editing, they...
A systematic review and meta‑analysis of four trials involving 508 relapsed or refractory CLL/SLL patients found that zanubrutinib (Brukinsa) has low treatment‑discontinuation (7.2%) and atrial fibrillation rates (2.9%). While 98.5% of patients experienced at least one adverse event, only 67%...
Dr. Turab Mohammed, a hematologist‑oncologist at Novant Health, outlined how community systems can operationalize seamless collaboration with academic centers through dedicated care‑navigation teams and real‑time communication protocols. He emphasized early referral of high‑risk leukemia and lymphoma patients to preserve T‑cell...
A computational study proposes a multi‑target gene therapy for osteoarthritis that combines anti‑inflammatory, anabolic, and catabolic‑blocking transgenes delivered via a dual‑vector AAV system. Network perturbation modeling shows the multi‑axis approach achieves an ECM Recovery Score of 76.2, markedly higher than...
The FDA’s November 1, 2024 drug safety communication reports a preliminary review of suicidal thoughts and actions among patients using glucagon‑like peptide‑1 receptor agonists (GLP‑1 RAs). After analyzing adverse event reports, clinical trials and observational studies, regulators found no clear causal link,...
Scientists at James Cook University used spatial transcriptomics to map where latent Mycobacterium tuberculosis resides within lymph nodes and bone marrow, revealing how the immune system contains the dormant bacteria. The study, published in Nature Communications, identified CD8⁺ T cells...
On December 16, 2024, the FDA issued a Boxed Warning for Veozah (fezolinetant), the first non‑hormonal drug approved for menopausal hot flashes, highlighting a rare but serious risk of liver injury. The agency now mandates baseline liver testing and monthly...
The FDA’s latest safety communication reveals that Ocaliva (obeticholic acid) is causing serious liver injury in primary biliary cholangitis (PBC) patients without cirrhosis, including cases that required liver transplants or resulted in death. In a post‑market trial, 7 of 81...
The FDA issued a new boxed warning for glatiramer acetate (Copaxone, Glatopa), highlighting a rare but potentially fatal anaphylactic reaction. Data from 1996‑2024 show 82 reported cases worldwide, including six deaths, with most events occurring within an hour of injection...
The FDA issued a drug safety communication warning that stopping long‑term use of oral antihistamines cetirizine (Zyrtec) or levocetirine (Xyzal) can trigger rare but severe itching (pruritus). Between April 2017 and July 2023, 209 cases—including 197 in the United States—were...
The FDA has issued a Drug Safety Communication adding a new warning to the Transderm Scōp scopolamine patch about serious heat‑related complications, including hyper‑temperature, hospitalization and death. The warning follows 13 reported cases worldwide—seven in the U.S.—with four hospitalizations and two...
The FDA is requiring a uniform "Limitation of Use" label for all extended‑release stimulants used in ADHD treatment, warning that children under six years face higher drug exposure and a significant risk of weight loss. The agency’s analysis of clinical...
The FDA has mandated that manufacturers of extended‑release/long‑acting opioid analgesics update their prescribing information to reflect new post‑marketing study results. Two large PMR studies (3033‑1 prospective cohort and 3033‑2 retrospective cohort) found that roughly 22% of long‑term users develop opioid...
The FDA announced that, effective June 13 2025, the risk evaluation and mitigation strategy (REMS) for clozapine is being eliminated. While the drug’s potential to cause severe neutropenia remains, the agency concluded that updated labeling and a new Medication Guide provide sufficient...
On August 28, 2025 the FDA issued a drug‑safety communication recommending an additional magnetic resonance imaging (MRI) scan before the third infusion of Leqembi (lecanemab) for Alzheimer’s patients. The agency’s analysis identified 101 serious cases of amyloid‑related imaging abnormalities with...
K.C. Pharmaceuticals announced a voluntary recall of over 3.1 million bottles of over‑the‑counter eye drops sold across the United States. The FDA classified the action as a Class II recall on March 31, 2026, citing a lack of assurance of sterility. The recall...
Researchers published in the Journal of Pharmaceutical Investigation that multifunctional nanoparticles can reprogram pathological skin microenvironments, delivering anti‑inflammatory and antifibrotic agents directly to scar tissue and atopic dermatitis lesions. The approach modulates immune cells and fibroblast activity, promising more effective,...
Trump once again going for draconian cuts to NIH, though not as catastrophic as he sought for the last round (and didn't get). Meanwhile, he wants $1.5T for war. I doubt he'll be any more successful with NIH cuts than...
Prilenia Therapeutics and Ferrer have opened enrollment for the PREVAiLS phase‑3 trial of pridopidine, a sigma‑1 receptor agonist, in 500 early‑stage ALS patients. The study spans up to 60 sites in 13 countries and builds on mixed results from a...
The FDA approved Eli Lilly’s oral GLP‑1 tablet Foundayo (orforglipron) in April 2024, pricing it at $25 per month with insurance or $149 self‑pay. New pipeline candidates—including Eli Lilly’s triple‑agonist retatrutide, Novo Nordisk’s high‑dose Wegovy and CagriSema, and Amgen’s monthly‑dose MariTide—promise greater efficacy,...
The FDA released draft guidance proposing minimal residual disease (MRD) negativity and complete response as primary endpoints for accelerated approval of multiple myeloma therapies. MRD is defined as fewer than one myeloma cell per million bone‑marrow cells, measured by flow...
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...
Kodiak Sciences reported that its intravitreal biologic Zenkuda (tarocimab tedromer) outperformed sham in the phase 3 GLOW2 trial for diabetic retinopathy. At week 48, 62.5% of patients receiving Zenkuda achieved a two‑step or greater improvement on the Diabetic Retinopathy Severity Scale versus...
ARS Pharmaceuticals (ticker SPRY) received FDA approval to broaden the label of its Neffy 1 mg needle‑free epinephrine nasal spray, eliminating the previous age restriction and allowing use by anyone weighing at least 33 lb. The change expands market access for the...
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...
Revolution Medicines has launched the global Phase III RASolute 303 trial to evaluate daraxonrasib, a direct RAS(ON) multi‑selective inhibitor, in previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). The study tests the drug as monotherapy and alongside chemotherapy, with progression‑free survival and overall...
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...
BioNTech announced it will shut its Singapore mRNA manufacturing plant by the end of February 2027, ending a venture that began with a $355 million investment in 2022. The site, originally slated to create over 100 jobs and produce several hundred...
Researchers at the University of Colorado Boulder have identified a python‑derived metabolite, para‑tyramine‑O‑sulfate (pTOS), that spikes dramatically after the snakes eat and appears to suppress appetite. In mouse studies, high doses of pTOS triggered weight loss without the gastrointestinal side...
Are you pro-bodyoid or anti-bodyoid? For the purpose of this poll, a bodyoid is: a newborn clone of you lacking a cortex, a.k.a. a brainless clone, gestated by a paid surrogate. It's organs are a perfect match (isogenic) to you...
I mis-spoke here. This study showed 5-meo-DMT much more effective than psilocybin. This was specifically on treatment resistant depression. A 15 point MADRS reduction there is ~2x psilocybin and ~3x ketamine. 5-meo-DMT really is the most potent antidepressant known to...
Great conversation with Jamie Bacher about the one challenge synbio must solve: time to market. Jamie argues that scaling biotech requires more than great strains—process dev, downstream, analytics, and new financing models all matter. Excited to have him at #SynBioBeta2026. Read the...
NIH would get $5 billion cut under Trump’s 2027 budget, but Congress unlikely to go along https://t.co/PPQbrSBwi0 via @statnews
3April: Which are GEN's first-ever Top 10 Organoid Companies (5 publicly traded, 5 privately held)? And what's driving growth for these and other organoid companies? Check out my latest A-List for @GENbio: https://t.co/6D589lVk9s
