FDA Approves Travere's Filspari as First Drug for the Kidney Disease FSGS
The U.S. Food and Drug Administration has broadened the label for Travere Therapeutics' drug Filspari, adding a second kidney indication to its approval. Filspari, a dual endothelin‑angiotensin receptor antagonist, was already the first therapy cleared for primary focal segmental glomerulosclerosis (FSGS). The expanded indication now includes secondary forms of FSGS, increasing the eligible patient base. Travere projects the new label to accelerate revenue growth and solidify its foothold in the rare‑kidney‑disease market.
Click Therapeutics Cuts 27% of Workforce After $50M Raise
Click Therapeutics, a digital therapeutics company, announced a $50 million Series D round led by Boehringer Ingelheim. Within days of the funding, the startup slashed more than a quarter of its workforce, eliminating roughly 27% of employees. The cuts affect both engineering...
FDA Narrows in on Search for New Biologics and Vaccines Leader
The U.S. Food and Drug Administration is close to naming a new director for its Center for Biologics Evaluation and Research (CBER), ending the turbulent tenure of Vinay Prasad. Sources say the leading candidate is Dr. Susan K. Lee, a...
Allogene’s First Cut of Data on ‘Off-the-Shelf’ CAR-T Shows Promise
Allogene Therapeutics reported that its off‑the‑shelf CAR‑T candidate cleared all detectable lymphoma cells in just over half of trial participants. The interim analysis stems from the pivotal ALLO‑501/ALLO‑501A study in relapsed or refractory B‑cell lymphoma. Researchers highlighted a complete molecular...
Neomorph Raises $100M for Molecular Glues; Spyre's Ulcerative Colitis Data
San Diego‑based NeoMorph announced a $100 million financing round to scale its molecular‑glue drug discovery platform. The capital, led by XYZ Ventures and existing biotech backers, will fund preclinical programs aimed at traditionally undruggable targets. In parallel, Spyre Therapeutics disclosed Phase 2...
BioNTech's HER2 ADC Succeeds in Phase 2 Study, FDA Filing Planned
BioNTech announced that its HER2‑targeted antibody‑drug conjugate, trastuzumab pamirtecan (formerly BNT323), achieved robust efficacy in a Phase 2 trial of HER2‑positive metastatic breast cancer. The study reported a 45% overall response rate and a median progression‑free survival of 8.2 months, with...
Ideaya’s Uveal Melanoma Drug Exceeds Success Benchmark in Late-Stage Trial
Ideaya BioSciences reported that its late‑stage drug for uveal melanoma met its pre‑specified success benchmark, achieving a 27% overall response rate versus the 20% target. The trial also demonstrated a manageable safety profile, reinforcing confidence in the therapy’s risk‑benefit balance....
GSK Plans Five Phase 3 Studies for Gynecological Cancer ADC From Hansoh
GlaxoSmithKline (GSK) announced it will initiate five Phase 3 clinical trials to evaluate an antibody‑drug conjugate (ADC) for gynecological cancers, a candidate licensed from Chinese partner Hansoh Pharma. Early-stage data presented on Sunday showed encouraging tumor responses in ovarian and endometrial...
More Pharma Dealmaking; FDA’s Proposed Budget; Takeda Ends Partnership; and More
The pharma sector is seeing a wave of dealmaking, with Q1 2026 M&A volume up roughly 15% as companies chase high‑value oncology assets. The FDA released a proposed $5.6 billion budget that would raise review fees by about 8% and modestly...
Plan for Remade ACIP Panel Adds Focus on Vaccine Safety, Matching Kennedy’s Push
A federal judge recently halted most Trump-era appointments to the CDC’s Advisory Committee on Immunization Practices (ACIP), prompting the agency to draft a new charter that reshapes the panel’s composition and priorities. The revised charter emphasizes vaccine safety, mandating transparent...
Bayer Pharma Executive Predicts US-Europe Price Spreads Will Narrow
Bayer's chief operating officer for pharmaceuticals warned that the long‑standing price gap between the United States and European markets will shrink sharply. He attributes the change to the Trump administration's push for “most‑favored‑nation” (MFN) pricing agreements, which compel manufacturers to...
China Biotech’s CRISPR Therapy Suggests US Drugmakers Will Face Competition
A Chinese biotech firm used CRISPR‑Cas9 to edit blood stem cells in five beta thalassemia patients, eliminating their need for regular transfusions. The ex‑vivo therapy reactivates fetal hemoglobin and showed durable engraftment with no serious adverse events over a year...
Vivatides Gets $54M; Wegovy Drops Cold Chain in EU; Gilead Takes Kymera Option
Vivatides Therapeutics announced a $54 million Series A round to accelerate its pre‑clinical siRNA and antisense oligonucleotide programs, with Sequoia Capital leading the investment. In Europe, Novo Nordisk confirmed that its obesity drug Wegovy will drop the costly cold‑chain requirement, simplifying distribution. Meanwhile,...
Biotech VCs Ramp up Checks on New Bets After Years of Focusing on Existing Portfolios
Biotech venture capitalists are shifting back to high‑risk, high‑reward investing, with 65% of Q1 2026 capital directed at new startups. Total venture funding in the sector rose to roughly $2.1 billion, up from $1.5 billion a quarter earlier, and average deal size climbed...
Novo's Double Departures: As GLP-1 Luminary Retires, an Obesity Leader Goes to Boehringer Ingelheim
Novo Nordisk announced two high‑profile departures this week. Lotte Bjerre Knudsen, a veteran who helped launch the company’s breakthrough GLP‑1 therapies, is retiring after more than two decades. At the same time, the head of Novo’s obesity unit has accepted a...
China-Based CAR-T Company Oricell Raises $40M More as It Looks to Go Public
Oricell Therapeutics, a China‑based CAR‑T developer, announced a pre‑IPO financing round that brings its total capital raised to over $110 million, including an additional $40 million injection. The funding will support the advancement of its autologous CAR‑T program targeting GPC3 in liver...
Post-Hoc Live: Biopharma M&A Is Back, with Barclays' Emily Field
Biopharma mergers and acquisitions are experiencing one of their strongest periods in years, as major pharmaceutical firms rush to absorb smaller biotech innovators. In a Post‑Hoc Live interview, Emily Field, head of U.S. biopharma‑catalytics equity research at Barclays, and deals...
Pulmonary Fibrosis Biotech Avalyn Pharma Files for IPO
Pulmonary‑fibrosis biotech Avalyn Pharma has filed a Form S‑1 to launch an initial public offering. The company is developing inhaled formulations of FDA‑approved PF drugs, aiming to deliver medication directly to the lungs and improve efficacy. Proceeds from the IPO...
PhRMA Head Steve Ubl to Step Down at End of Year
Steve Ubl, who has led the pharmaceutical lobbying coalition PhRMA for more than a decade, announced he will step down at the end of the year. Under his stewardship, the group amplified its influence on Capitol Hill, championing policies that...
Merck Adjusts Its Vaccine Supply Deal in China; Soleno Withdraws EU Application
Merck and its Chinese partner Zhifei have revised their COVID‑19 vaccine supply agreement, lowering the committed volume and adding a flexible delivery schedule to reflect waning demand. The updated contract preserves Zhifei’s exclusive distribution rights but shifts risk back to...
Gilead Takes Another Big Swing at Expanding Beyond HIV
Gilead Sciences has earmarked roughly $11 billion this year for three strategic acquisitions aimed at strengthening its cancer and immunology pipelines. The moves signal a decisive pivot away from its historic reliance on HIV therapeutics toward broader biotech markets. The targeted...
Inside the Talkspace-Universal Health Services Deal
Talkspace, the pandemic‑era teletherapy platform, agreed to be acquired by Universal Health Services (UHS) in a deal valued at roughly $600 million in cash and stock. The transaction gives UHS a digital mental‑health capability across its 400‑plus hospitals and outpatient centers....
David Sinclair Startup Life Biosciences Raises $80M for Clinical Test of Anti-Aging Gene Therapy
Life Biosciences, the anti‑aging startup co‑founded by Harvard biologist David Sinclair, announced an $80 million financing round to launch its first human clinical trial. The capital, led by Andreessen Horowitz and joined by several biotech investors, will fund a one‑time gene‑therapy...
ADC Biotech Sidewinder Collects $137M for Bispecific Approach
Sidewinder Therapeutics, a San Diego‑based biotech, closed a $137 million Series B round to fund its bispecific antibody‑drug conjugate (ADC) platform. The financing, led by OrbiMed with participation from several venture firms, will accelerate preclinical programs targeting solid tumors and hematologic cancers....
Insmed Shelves Brinsupri in Skin Disease After Mid-Stage Flop
Insmed announced it is discontinuing development of Brinsupri for hidradenitis suppurativa (HS) after a Phase 2b trial failed to meet its primary endpoint. The drug, originally pursued for sinus inflammation, had already been shelved in that indication last year. The...
European VC Jeito Gets $1.2B to Help Private Biotechs Control Their 'Destiny'
Jeito Capital, a Paris‑based venture firm, closed its second fund at $1.2 billion (over €1 billion, roughly $1.08 billion). The capital will be deployed to a dozen or so European drug‑development startups seeking to advance pre‑clinical and early‑stage clinical programs. By providing sizable,...
Did Eli Lilly Just Strike Another Gold Mine?
Eli Lilly announced a $1.5 billion acquisition of a biotech portfolio centered on orexin‑targeting therapeutics. The deal adds late‑stage candidates for insomnia, narcolepsy and metabolic disorders to Lilly’s central‑nervous‑system pipeline. Analysts estimate the combined market for orexin drugs could surpass $10 billion by...
What’s Familiar in Health Tech’s Q1 Funding Totals
Health‑tech funding surged in Q1, highlighted by Whoop’s $575 million Series G round that lifted its valuation into the multibillion‑dollar range. Smaller but notable deals included OpenEvidence, eMed, Talkiatry and Alphabet’s Verily, each securing tens of millions to expand data, telehealth, AI‑driven...
Study Suggests $35 Monthly Insulin Cap Has Increased Patient Access
A 2023 Medicare policy capped insulin co‑payments at $35 per month, and a new study shows the limit sharply reduced patients' out‑of‑pocket spending in its first year. Average insulin expenditures fell by roughly 30%, while prescription fill rates climbed, indicating...
White House Adds AbbVie's Humira to TrumpRx Alongside Cheaper Biosimilars
The White House’s drug‑discount portal TrumpRx now lists AbbVie’s Humira at $950 per month, a steep cut from its typical $5,000‑plus price. The listing appears alongside two lower‑cost biosimilars that target the same inflammatory conditions. TrumpRx aims to provide seniors...
ARPA-H Selects Three Teams in $100M Effort to Repair and Regrow Ailing Joints
ARPA-H announced a $100 million program to fund clinical trials for joint regeneration. Three leading academic centers were selected to test innovative therapies aimed at repairing and regrowing damaged cartilage and bone. The projects will explore senolytic drugs, engineered tissue scaffolds,...
Terns Sold to Merck for 13% Lower than Pharma's Initial Offer because of Clinical Data
Merck agreed to acquire Terns Pharmaceuticals for $6.7 billion, a price roughly 13% lower than its initial offer after new clinical data raised concerns. The renegotiated deal reflects the impact of late‑stage trial results on valuation in the biotech M&A wave....
Novo Launches High-Dose Wegovy in the US; Evotec Pressured to List Its US Unit
Novo Nordisk has introduced a high‑dose 7.2 mg version of its obesity drug Wegovy in the United States, expanding the GLP‑1 portfolio beyond the standard 2.4 mg dose. The new formulation targets patients with severe obesity who need greater weight‑loss efficacy. Pricing...
Gilead Continues Dealmaking Streak with $3.15B Tubulis Buy for ADCs
Gilead announced its third acquisition of 2026, agreeing to pay $3.15 billion upfront for Tubulis, a German startup that has built a next‑generation antibody‑drug conjugate (ADC) platform. The deal includes a contingent earn‑out of up to $1.85 billion tied to future milestones....
BioNTech to Shutter Singapore HQ After 'Comprehensive Review'
BioNTech announced it will close its Singapore headquarters, a manufacturing site it purchased from Novartis in 2020. The Tuas Biomedical Park facility, which employs roughly 200 staff, will be shuttered as part of a comprehensive operational review. The decision reflects...
Sanofi Bispecific Sails Through Asthma, Sinusitis Trials, but Disappoints in Eczema
Sanofi announced mixed mid‑stage results for its bispecific nanobody aimed at treating multiple immune‑mediated diseases. The drug achieved its primary endpoints in Phase 2 trials for asthma and chronic rhinosinusitis with nasal polyps, demonstrating clinically meaningful improvements. Conversely, the same molecule...
Proposed FDA Budget Sets Makary up to Boost US Biotech
The White House’s FY budget proposes a sizable increase for the FDA, positioning Dr. Robert Makary to spearhead regulatory reforms aimed at accelerating U.S. biotech development. The plan includes policy changes that would shorten clinical‑trial timelines, lower fees for early‑stage...
Amgen Seeks to Buoy Tepezza with Injectable Data in Face of Incoming Competition
Amgen announced that its injectable formulation of Tepezza achieved its primary endpoint in a Phase 3 trial for thyroid eye disease (TED). The data suggest the drug can be administered subcutaneously, offering a more convenient alternative to the current intravenous...
Anthropic Pays $400M for Biotech; Praxis Epilepsy Drug Hits in Phase 1/2 Trial
San Francisco AI firm Anthropic announced a $400 million acquisition of stealth biotech Coefficient Bio, signaling its push into drug discovery. The purchase aims to integrate Anthropic’s large‑language‑model capabilities with biotech research pipelines. In parallel, Praxis Therapeutics disclosed encouraging Phase 1/2 data...
Takeda Ends Partnership with Denali Amid Restructuring
Takeda announced the termination of its eight‑year partnership with Denali Therapeutics, returning full rights to the experimental drug DNL593 ahead of its upcoming Phase I trial. The move is part of Takeda's broader restructuring aimed at streamlining its portfolio and...
Neurocrine Will Pay $2.9B for Soleno and Its Prader-Willi Medicine
Neurocrine BioSciences announced a $2.9 billion acquisition of Soleno Therapeutics, paying $53 per share for the rare‑disease specialist. The deal brings Soleno’s late‑stage Prader‑Willi syndrome therapy into Neurocrine’s growing portfolio. Soleno, a profitable company, adds a commercial platform and additional rare‑disease...
Stipple Bio Launches with $100M to Find More Precise Targets on Cancer Proteins
Stipple Bio, founded by cancer biologists Aaron Ring and colleagues, announced its launch with a $100 million Series A round. The company’s mission is to pinpoint highly precise binding sites on cancer‑related proteins, steering clear of oversaturated targets like PD‑1×VEGF or HER2....
China's Syneron Raises $150M for Peptides, Adding to Last Year's $100M
Chinese biotech Syneron Bio announced a $150 million Series B financing round, bringing its total capital raised to $250 million after a $100 million round last year. The funds will be allocated to advance its peptide therapeutic platform, a drug...
OpenLoop Health Has Acquired Nutrition Startup Season Health
OpenLoop Health, a tele‑health infrastructure startup, announced the acquisition of food‑as‑medicine company Season Health. The deal, whose financial terms were not disclosed, adds a nutrition‑focused platform to OpenLoop's suite of services. Season Health brings personalized dietary programs that align with...
Aspect Biosystems Gets $79M From Canadian Government for Diabetes Cell Therapy
Vancouver‑based biotech Aspect Biosystems has secured a $79 million CAD grant from the Canadian government, roughly $58 million USD, to advance its 3D‑printed pancreatic cell therapy for diabetes. The funding will accelerate pre‑clinical trials and scale‑up of a manufacturing platform that could...
DOJ Weighs in Favor of Pharma on 340B Dispute
The U.S. Department of Justice filed a brief backing pharmaceutical manufacturers in the ongoing 340B drug‑discount litigation. The brief argues that discounts should be calculated using the average manufacturer price rather than the lowest price, a stance that could curb...
The Peptide Fad Lures Health Tech
Health‑tech firms are pivoting toward peptide therapeutics as the next growth engine after the blockbuster GLP‑1 weight‑loss drugs. Peptides, which include insulin and GLP‑1, are being explored for obesity, metabolic and chronic disease treatments. Industry analysts project the global peptide...
Drug Substance Maker Raises Prices Due to Energy Crisis; SpectronRX Gets $85M
BASF Pharma Solutions announced a 12% price increase on its active pharmaceutical ingredients (APIs) as soaring energy costs, driven by the ongoing Middle East conflict, strain its supply chain. The hike affects generic manufacturers and could push drug prices higher...
Lipocine's Postpartum Depression Drug Fails; AstraZeneca Claims Liver Cancer Win
Lipocine reported top‑line Phase 3 data for its postpartum depression candidate LPCN‑1154, revealing no statistically significant improvement over placebo and prompting a 77% plunge in its shares. The Utah‑based biotech’s safety profile was acceptable, but efficacy shortfalls undermine its commercial prospects....
Trump Is Preparing 100% Tariffs on some Drugmakers, Documents Show
President Donald Trump is preparing to announce 100% tariffs on select pharmaceutical products, according to a draft memo obtained by Endpoints News. The tariffs would apply to a limited group of drugmakers, targeting high‑priced brand‑name drugs rather than the entire...
