FDA Greenlights Life Biosciences' Gene Therapy Study to Rewind the Age of Cells
The U.S. Food and Drug Administration has granted Life Biosciences IND clearance to begin a first‑in‑human gene‑therapy trial aimed at reversing cellular aging. The study will test an epigenetic reprogramming platform that delivers modified mRNA encoding Yamanaka factors to rejuvenate senescent cells. Up to 30 healthy participants will receive the therapy in a Phase 1 safety and dose‑escalation design. If successful, the approach could validate a new class of anti‑aging interventions.
Roche’s Obesity Shot Posts Decent Weight Loss in Mid-Stage Test, Heads to Phase 3
Roche’s most advanced obesity candidate achieved an average 18.3% weight reduction in a Phase 2 study after nearly a year of treatment. The trial enrolled patients with moderate to severe obesity and demonstrated sustained efficacy without major safety signals. Based on...
TRexBio Gets Another $50M to Bring More Treg Candidates Into the Clinic
Bay Area biotech TRexBio announced an additional $50 million extension to its 2024 Series B round. The new capital will be used to advance multiple regulatory T‑cell (Treg) candidates through IND‑enabling studies and early clinical trials. The raise brings the company’s total...
IRA Drug Pricing Petitions Pile up at the Supreme Court
Novartis has become the sixth pharmaceutical company to file an Inflation Reduction Act (IRA) challenge with the U.S. Supreme Court, adding to a growing docket of drug‑pricing disputes. The petitions argue that the IRA’s Medicare price‑negotiation provisions overstep congressional authority...
Ex-CytoDyn CEO Sentenced to 30 Months for Pump-and-Dump Scheme
Former CytoDyn CEO Nader Pourhasan received a 30‑month prison sentence after a federal jury found he orchestrated a pump‑and‑dump scheme by falsely promoting a prospective drug candidate. Prosecutors said he inflated the company’s stock by disseminating misleading statements, leading to...
Catalent Plans to Close Belgium Cell Therapy Site
Catalent announced it will shut its cell‑therapy manufacturing site in Gosselies, Belgium, citing changing market dynamics and evolving customer needs. The facility, a key European hub for autologous and allogeneic cell‑based products, will cease operations later this year. The decision...
Sarepta Touts Three-Year Duchenne Gene Therapy Data After Patient Deaths
Sarepta Therapeutics presented three‑year follow‑up data for its Duchenne muscular dystrophy (DMD) gene therapy, showing that functional gains and dystrophin expression remain durable through 36 months. The long‑term results were released shortly after several trial participants died, prompting renewed safety...
Genyro Licences DNA Builder From Caltech; Dizal Targets Hong Kong Listing
Genyro, a San Diego biotech startup, has secured exclusive rights to Caltech’s DNA builder technology, a platform that automates the assembly of long DNA sequences. The system combines high‑throughput enzymatic reactions with error‑correction software, enabling gene circuits and even whole...
UK Medicines Agency Seized 20M Illegal Drugs Last Year, Including GLP-1s
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) reported seizing nearly 20 million doses of illegally traded medicines in 2025, valued at roughly £200 million. The haul included a large share of GLP‑1 agonists, which have surged in demand for obesity and...
Genmab Halts Enrollment for Cancer Drug From ProfoundBio Buyout
Genmab announced it has stopped enrolling patients in an early‑stage trial of a cancer candidate acquired from ProfoundBio. The drug was part of Genmab’s $1.8 billion purchase of the US‑China biotech firm. The pause comes shortly after the acquisition closed, raising...
First-Movers Respond to Herding; BioMarin Vets Start New Biotech; GSK Buys RAPT Therapeutics; and More
Industry leaders are reacting to a recent wave of investor herding by fast‑tracking biotech launches and strategic deals. BioMarin announced a new venture to spin out a next‑generation gene‑therapy platform, while GSK completed its acquisition of RAPT Therapeutics to bolster...
Novo's Wegovy Pill Off to a Solid Start After Just Two Weeks on Market
Novo Nordisk’s oral semaglutide, sold as the Wegovy pill, has demonstrated a strong start within its first three weeks on the U.S. market. Prescription volume has risen sharply, outpacing early forecasts and indicating robust demand for an oral alternative to...
EU Kicks Off One-Year Pilot to Expedite Multinational Trials
The European Union has launched a one‑year voluntary pilot to accelerate the start of multinational clinical trials. The initiative introduces a single EU‑wide application that will be reviewed jointly by the European Medicines Agency and national regulators. By streamlining approval...
F2G CEO Outlines Biotech's FDA Resubmission Plans, Funding and Expansion
F2G Biotherapeutics will re‑submit its lead antifungal candidate to the FDA after completing Phase 3 enrollment in June. The company has secured a new financing round to fund the filing and scale production. Expansion plans include a U.S. manufacturing site and...
Lilly Was the only Pharma Bidder for Ventyx
Eli Lilly emerged as the only pharmaceutical bidder for Ventyx Biosciences, a biotech renowned for its NLRP3 inflammasome programs. The lack of competing offers underscores Ventyx’s niche position in a rapidly expanding therapeutic arena. Lilly’s move signals a strategic push to deepen...
Former FDA Deputies Land at Lilly, AbbVie; Italy's Angelini Has a New CEO
Eli Lilly and AbbVie have each hired former FDA deputy officials, with Karin Bok joining Lilly’s regulatory affairs team and an unnamed former FDA deputy moving to AbbVie’s drug‑development unit. The moves follow a broader trend of big pharma recruiting regulators to...
High Court Picked Hikma’s ‘Skinny Label’ Fight After Letting the Issue ‘Percolate’
The U.S. Supreme Court has agreed to hear Hikma Pharmaceuticals’ challenge over the use of “skinny labels,” a practice that allows generic manufacturers to market lower‑cost versions of drugs without copying the original brand’s full label. The case follows years...
Drugmakers Spent Less on Washington Lobbying in 2025's Final Quarter
The five largest biotech firms reduced their congressional lobbying expenditures in the fourth quarter of 2025, marking a modest decline from the previous quarter. Collectively, they spent roughly $45 million, down about 4 percent year‑over‑year. The dip reflects tighter corporate budgets and...
Corcept's Drug Extends Patients' Lives in Key Ovarian Cancer Study
Corcept Therapeutics announced that its experimental drug, when combined with standard chemotherapy, cut the risk of death by 35% for patients with a difficult-to‑treat form of ovarian cancer. The reduction was observed in a Phase 2 trial that met its primary...
Roche Boosts NC Factory Investment to $2B; Rentschler CEO Steps Down
Roche’s Genentech is increasing its capital outlay for the Holly Springs, North Carolina manufacturing complex to nearly $2 billion, marking a substantial boost to its U.S. production capacity. The additional funds will expand biologics and vaccine output, positioning the site as a...
Bristol Myers Signs Deal with Janux on T Cell Engager for $50M Upfront
Bristol Myers Squibb has entered a collaboration with San‑diego biotech Janux Therapeutics to develop a novel tumor‑activated T‑cell engager for solid cancers. The agreement provides Janux with a $50 million upfront cash payment, along with potential milestone and royalty payments. Janux...
Erasca, Corvus, BioAge Target $500M+ Offerings
Erasca announced the pricing of an upsized public offering of common stock that pushes its capital raise beyond $500 million. Around the same time, Corvus Therapeutics and BioAge Labs filed registration statements for similarly sized equity offerings, signaling a coordinated surge...
#JPM26: Hua Medicine Plots Diabetes Drug Expansion in China and Beyond
Shanghai‑based Hua Medicine announced a strategic push to broaden its diabetes drug portfolio, aiming to capture a larger slice of the global market. The company is developing an oral GLP‑1 alternative that promises lower dosing and cost advantages over existing...
BioMarin Vets Spearhead New Biotech with $82M for Rare Disease Drugs
Former BioMarin executives have launched a new biotech focused on rare‑disease therapeutics, securing $82 million in seed financing. The capital will be used to acquire orphan‑drug candidates that lack commercial partners and to advance them through pre‑clinical and early‑clinical stages. The...
The Status of EU Drug Price Talks Depends on Who You Ask
European drug price negotiations for 2026 are at a crossroads, with member states and the EU Commission offering conflicting perspectives. U.S. policymakers are lobbying for tighter price alignment to curb American market spillover, while European regulators stress sovereign health budgets....
J&J Praises New FDA Guidance to Speed Development of Multiple Myeloma Drugs
The FDA released a draft guidance aimed at accelerating the development of multiple myeloma therapies by clarifying the use of surrogate endpoints and adaptive trial designs. Johnson & Johnson, which already markets several approved MM drugs, welcomed the guidance as...
Johnson & Johnson Brushes Off MFN Impact, Sees Strong Growth for 2026
Johnson & Johnson downplayed the impact of the new Most‑Favored‑Nation (MFN) pricing clause on its earnings, asserting that existing contracts and a diversified portfolio cushion any downside. The company projected a robust growth trajectory through 2026, driven by its oncology...
Tanabe Pill Delays Blood Disorder; enGene Adds up to $100M From Loans
Tanabe Pharma announced that its oral melanocortin‑1 receptor (MC1R) agonist achieved its primary endpoint in a Phase 2 trial for a rare blood disorder, delivering a 60% response rate among patients. The pill offers a non‑injectable option that could reduce transfusion...
IntraBio Says Rare Disease Drug Passes Phase 3, Will Seek FDA Approval
IntraBio announced that its experimental therapy for ataxia‑telangiectasia (A‑T) achieved statistically significant improvement in motor function in a pivotal Phase 3 trial. The study met its primary endpoint and demonstrated a favorable safety profile across a genetically defined patient cohort....
#JPM26: Regeneron, Lilly, Summit on Rivals Crowding Into Same Targets
Drug makers Regeneron, Eli Lilly and Summit Therapeutics are converging on identical biological targets, intensifying competition for potential megablockbuster therapies. The firms are pursuing treatments for diseases lacking effective options, hoping to capture large market share. Their pipelines reveal overlapping...
Exclusive: Claim Health Raises $4.4M to Help Home Care Providers Get Paid
Claim Health announced a $4.4 million financing round aimed at expanding its AI‑driven platform that manages the entire revenue‑cycle for home‑care providers. The startup moves beyond earlier AI tools that only handled isolated administrative tasks, now offering end‑to‑end claim submission,...
Think Bioscience Gets $55M to Unearth New Drug Pockets
Think Bioscience, a Boulder‑based biotech, announced a $55 million Series A round that was oversubscribed by investors. The capital will fund its platform that seeks previously hidden binding pockets on proteins and other molecules. By targeting these cryptic sites, the company aims...
Government Funding Bill Features PBM Reforms, Voucher Reauthorization
The U.S. House will vote on a bipartisan continuing resolution to keep the federal government operating beyond Jan. 30, bundling sweeping pharmacy‑benefit‑manager (PBM) reforms and a reauthorization of the children's health voucher program. The PBM provisions aim to increase pricing transparency,...
EU Parliament Adopts Stricter Drug Stockpiling Rules Under Critical Medicines Act
The European Parliament approved amendments to the Critical Medicines Act, introducing stricter drug‑stockpiling requirements and new financial incentives for manufacturers. The legislation mandates a minimum safety‑stock level—roughly 5 % of a product’s annual EU consumption—and tighter reporting on supply‑chain data. Companies...
Valneva Withdraws Chikungunya Vaccine From US
Valneva announced the withdrawal of its chikungunya vaccine from the United States, removing the product from the market and suspending a post‑marketing study. The decision follows internal safety assessments and regulatory feedback. The company has not provided detailed efficacy data,...
Clinician Groups Ask Court to Overturn CDC's Childhood Vaccine Overhaul
Leading physician organizations have filed a federal lawsuit seeking to overturn the CDC’s recent overhaul of the U.S. childhood vaccine schedule. The groups contend the new recommendations are reckless and lack adequate safety evidence. The legal challenge targets the addition...
Teladoc’s Mental Health Arm BetterHelp Has Quietly Expanded the Use of AI
BetterHelp, Teladoc's flagship mental‑health platform, has quietly broadened its use of artificial intelligence across multiple service layers. The AI tools now support client intake, symptom triage, and therapist recommendation workflows, aiming to streamline care delivery. BetterHelp claims the expansion will...
Pfizer to Depart GSK's ViiV as Shionogi Doubles Its Stake
Pfizer announced it will withdraw from ViiV Healthcare, the HIV specialist joint venture it formed with GSK over a decade ago. Shionogi will step into Pfizer's slot, doubling its ownership stake in ViiV. The move reshapes the ownership balance of...
Corvus' New Phase 1 Atopic Dermatitis Data Meet High Expectations
Corvus Pharmaceuticals announced that its Phase 1 trial for a novel severe atopic dermatitis therapy met predefined safety and efficacy benchmarks. The data demonstrated favorable tolerability and early signs of clinical improvement, prompting the company to advance the program into...
J&J, Isomorphic Sign Research Deal for AI-Made Molecules
Isomorphic Labs, a Google DeepMind spin‑out specializing in AI‑driven drug design, announced its third pharmaceutical collaboration, signing a multi‑target research agreement with Johnson & Johnson. The partnership will leverage Isomorphic’s generative‑AI platform to design novel molecules across several therapeutic areas....
GSK Makes $2.2B Deal for RAPT and Its Food Allergy Candidate
GlaxoSmithKline announced a $2.2 billion acquisition of RAPT, a privately held biotech focused on food allergy therapies. The deal includes RAPT’s lead candidate, a novel oral immunotherapy for peanut and other food allergies, which has shown promising Phase 2 data. The transaction,...
Exciva Raises $59M Series B to Fund Phase 2 Test of Alzheimer’s Agitation Drug
Exciva announced a €51 million ($59 million) Series B round to finance the Phase 2 clinical trial of its lead candidate targeting agitation in Alzheimer’s disease. The funding, led by several biotech‑focused venture firms, will support enrollment, biomarker development, and regulatory preparation. The trial...
JPM Recap; Mirador Raises $250M; Genentech’s PBM Shift; and More
The JPMorgan Healthcare Conference (JPM26) highlighted a surge in biotech financing, with several firms announcing sizable funding rounds. Mirador Therapeutics disclosed a $250 million Series B raise to accelerate its gene‑therapy platform. Genentech revealed plans to bring its pharmacy‑benefit‑manager (PBM) operations in‑house,...
Agomab and SpyGlass File for IPOs as Investor Enthusiasm Builds After JPM
SpyGlass Pharma and Agomab Therapeutics announced filings for initial public offerings on Friday, signaling a new wave of biotech listings. Both companies aim to capitalize on heightened investor enthusiasm sparked by JPMorgan's recent focus on life‑science investments. SpyGlass plans to...
AbbVie, Genmab Say Epkinly Didn't Prolong Overall Survival in Lymphoma Study
AbbVie and Genmab announced that their antibody‑drug conjugate Epkinly failed to extend overall survival in a Phase 3 trial for diffuse large B‑cell lymphoma (DLBCL). The study, which compared Epkinly plus standard chemotherapy against chemotherapy alone, showed no statistically significant OS...
Drugmakers without MFN Pacts Are Bracing to Make One
Last year President Donald Trump urged almost all U.S. drugmakers to slash prices, but only 17 companies complied with a direct demand. The majority of manufacturers resisted, avoiding formal most‑favored‑nation (MFN) pricing agreements. Industry analysts now warn that, facing renewed...
Makary Talks FDA's Plans to Combat China's Biotech Growth
FDA Commissioner Marty Makary announced that the agency is overhauling its Phase 1 clinical‑trial framework to address the rapid influx of Chinese biotech firms into the U.S. market. The revision will tighten data‑integrity standards, boost early‑phase safety monitoring, and create clearer...
ImmunityBio's Cell Therapy Posts Encouraging Early Data in Rare Blood Cancer
ImmunityBio reported encouraging early data from its off‑the‑shelf cell‑therapy platform in a Phase 1 trial (QUILT) targeting a rare form of lymphoma. The small study demonstrated a favorable safety profile and preliminary efficacy signals, including objective responses in several patients. The...
#JPM26: Sandoz CEO on Ozempic Generic Launch Plans for 2026
Sandoz, Novartis' generics arm, announced plans to launch a generic version of Ozempic (semaglutide) in 2026. The move aligns with the anticipated expiration of Novo Nordisk's patents on the GLP‑1 drug, opening the U.S. and European markets to lower‑priced alternatives....
European Regulators Recommended 38 Novel Drugs in 2025, 15 Fewer than the FDA
The European Medicines Agency (EMA) recommended 104 medicines for approval in 2025, marking the second‑highest total in the past 15 years. Of those, 38 are classified as novel drugs, a figure that trails the U.S. Food and Drug Administration (FDA)...