Denali sells FDA voucher for $195M to support neurodegenerative pipeline
Denali Therapeutics is the latest company to sell a priority review fast pass for an elevated price after the program was renewed earlier this year.
SPECIALIZED HUB
Bio + AI Intelligence
Aggregating recent news and profiling companies at the frontier of computational biology, generative molecular design, and AI-native clinical development.
Recent AI + Bio News
FDA's new voucher program hints at broader policy agenda, making many 'uncomfortable'
Experts say the FDA Commissioner's National Priority Voucher program is still bereft of important details, with candidate selection and interference from the agency's senior leaders topping the list.
The real work for making dramatic gains against pancreatic cancer is just beginning
STAT Plus opinion piece on the next phase of pancreatic cancer drug development, including daraxonrasib.
Amgen CFO to follow David Reese into retirement; Josh Smiley is out at Zai Lab
Amgen's CFO plans to follow David Reese into retirement; Josh Smiley is out at Zai Lab.
At FDA, 'caretaker mode' is better than power trip mode
FDA acting commissioner Kyle Diamantas approves uniQure's Huntington's gene therapy path while keeping the agency in a 'caretaker' posture, raising questions about long-term durability of flexible decisions once a permanent commissioner is seated.
Eli Lilly cuts hospitals' 340B pricing over data policy dispute
Eli Lilly is cutting 340B drug pricing to hospitals that fail to comply with its claims data policy.
Exclusive: Lilly's TuneLab crosses 100-member mark, adds AI models from buzzy startup Chai
Lilly's TuneLab AI platform has crossed the 100-member mark and added AI models from Chai.
'Familiarity' with oral Wegovy has triggered its quick uptake
Spherix data shows Novo Nordisk's oral Wegovy pill is being adopted rapidly because of prescriber and patient 'familiarity' with the semaglutide class, accelerating uptake against Lilly's Foundayo.
IRA's $2,000 out-of-pocket cap helped Medicare patients access expensive drugs, study finds
A new study finds the Inflation Reduction Act's $2,000 Medicare Part D out-of-pocket cap meaningfully increased patient access to expensive drugs, validating a key provision of the law as the 2026 enrollment year begins.
Ones to watch: 4 biotechs with recent Series B raises (that are also hiring)
Four biotechs that closed recent Series B financings are actively hiring across R&D, clinical, and operations roles as they scale toward lead asset milestones.
Prepping for peptides
The pharmaceutical industry is racing to prepare peptide manufacturing capacity as GLP-1 demand and a wave of next-gen peptide therapies strain existing production infrastructure.
RA, Forbion and Sanofi Ventures appear to back new eye drug from Korea
RA Capital, Forbion and Sanofi Ventures are backing a new Korean ophthalmology biotech developing a novel eye drug, with financing details expected to be announced in the coming weeks.
STAT Plus: In pancreatic cancer, Patrick Soon-Shiong makes promises he has not kept
Adam Feuerstein's Biotech Scorecard: Patrick Soon-Shiong's pancreatic cancer program has consistently promised breakthrough results that haven't materialized, raising questions about his broader cancer strategy and the recent Abivax pivot.
Be Bio bins hemophilia B cell therapy trial-the biotech's lead program
Be Bio discontinues its lead hemophilia B cell therapy program after a clinical review, raising questions about the company's engineered B cell platform strategy and pipeline direction.
$25M ransom, no deal: Hackers claim Novo's drug recipes and AI models are for sale
Two hacking groups claim to have stolen Novo Nordisk drug manufacturing data and AI models, seeking a $25M ransom; the company confirms a security breach but denies any data is for sale.
Health groups say HHS is trying to 'rush reinstatement' of ACIP
Public health groups accused HHS of rushing the reinstatement of ACIP vaccine advisory panels without adequate conflict-of-interest vetting, raising alarms about the integrity of federal vaccine policy.
In another reversal, FDA gives uniQure accelerated approval path for Huntington's gene therapy
FDA reverses course again and grants uniQure an accelerated approval pathway for its Huntington's disease gene therapy, with the company planning a Q3 submission.
Jazz turns to AbCellera for T cell engagers against GI cancers in up to $4.1B deal
Jazz Pharmaceuticals signs a deal worth up to $4.1B with AbCellera to develop T cell engagers against gastrointestinal cancers, expanding Jazz's oncology pipeline beyond its existing CNS focus.
STAT Plus: Advocacy groups petition FDA to withdraw approval of 'unsafe' use of antibiotics given to livestock
Advocacy groups petitioned the FDA to withdraw approval for certain livestock antibiotic uses, citing rising antimicrobial resistance risks to human therapeutics.
STAT Plus: Is Abridge's 'patient centered' claim a bridge too far?
STAT examines whether Abridge's marketing as 'patient-centered' AI lives up to the claim, given its clinician-focused ambient documentation product and recent deals with Nvidia and Eli Lilly.
STAT Plus: A prominent VC explains why she's against U.S. restrictions on investment in China's drug industry
A leading biotech VC argues against proposed U.S. restrictions on American investment in China's drug industry, warning it would cut U.S. investors and patients off from key innovations.
Triveni Bio raises $65M ahead of upcoming readouts on eczema drugs
Triveni Bio raises $65M ahead of upcoming readouts on its eczema drug programs, advancing its antibody-based pipeline for immune and inflammatory diseases.
UK waitlist for Novo's Wegovy pill triples in week after approval, major online pharmacy says
Waitlist for Novo Nordisk's oral Wegovy in the UK has tripled in the week following MHRA approval, per a major online pharmacy, signaling strong consumer demand for the pill form.
Migraine biotech makes its debut with $46M to advance preclinical pipeline
Vedana Therapeutics launches with $46M in Series A funding to advance its preclinical pipeline of migraine therapies, entering a competitive field with several approved CGRP drugs.
Big Pharma's 10 highest-paid CEOs of 2025
Fierce Pharma's annual ranking of the top 10 highest-paid CEOs among big pharmaceutical companies for 2025, including total compensation packages and stock awards.
Exclusive: UCSF spinout Kopra Bio nets $9.1M to test virus therapy for brain cancer in China
Kopra Bio, a UCSF spinout developing viral immunotherapy for glioblastoma, has raised $9.1M to begin a China clinical trial of its InViTE platform that uses genetically engineered viruses to selectively destroy tumor cells.
FDA, MHRA strengthen transatlantic alliance with liaison program
The FDA and the UK's MHRA announced a new liaison program to deepen transatlantic regulatory cooperation, including shared reviews and joint inspections.
FDA raises efficacy questions for Moderna's flu vaccine but no dire flags
FDA reviewers raise efficacy questions for Moderna's mRNA flu vaccine in briefing documents ahead of an advisory committee meeting, but stop short of major red flags that would derail approval prospects.
Lilly buys another pain biotech; FDA sets decision for once-weekly PrEP pill
Eli Lilly has made another acquisition in the pain therapeutics space, while the FDA set a decision date for the first once-weekly oral PrEP pill for HIV prevention.
STAT Plus: Human Cell Atlas leader's tie to 10x Genomics raises conflict-of-interest questions
A conflict-of-interest disclosure by a Human Cell Atlas consortium leader reveals a relationship with spatial-biology company 10x Genomics, raising governance questions for the global research project.
Verge Labs' new AI model solves patient stratification problems for neurology clinical trials
Verge Labs (formerly Verge Genomics) has launched a new AI model designed to solve patient stratification problems for neurology clinical trials, leveraging its multi-modal human tissue database.
CMS seeks to close Medicare negotiation 'loophole'
The Centers for Medicare & Medicaid Services has proposed a rule to close a loophole in the Medicare drug price negotiation program that some manufacturers have used to delay negotiations.
Eisai Gets UK Backing as It Expands Plant for Leqembi Production
Eisai is expanding its UK packaging and manufacturing footprint for Leqembi with a £65M government-backed investment, securing capacity for the Alzheimer's antibody as global demand ramps post-FDA approval.
Elicio's KRAS Cancer Vaccine Fails in Phase 2, Shares Plummet
Elicio Therapeutics' KRAS-targeted cancer vaccine failed to meet its primary Phase 2 endpoint in metastatic pancreatic cancer, sending shares down more than 60% and forcing a strategic review of the platform.
Elicio Crashes on Midstage Pancreatic Cancer Miss But Will Advance to Phase 3
Elicio Therapeutics' KRAS-targeted cancer vaccine missed its Phase 2 primary endpoint in pancreatic cancer, cratering the stock, but the company said it will still advance the program to a Phase 3 trial based on a subpopulation signal.
Germany scraps variable discount plan meant to cut costs: report
Germany has scrapped a planned variable discount pricing scheme aimed at cutting drug costs, marking a reversal after industry pushback and parallel concerns from companies like Lilly and Boehringer Ingelheim.
German Biotech Nets $50M to Advance Two Depression Drugs, Including Spravato Challenger
Munich-based HMNC Brain Health closed a $50M Series B to advance two depression programs, including an oral esketamine challenger designed to compete with J&J's Spravato on convenience and access.
German biotech nets $50M to advance two depression drugs, including Spravato challenger
Munich-based HMNC Brain Health raises $50M in Series B funding to advance two depression drug candidates, including one positioned as a challenger to Johnson & Johnson's Spravato.
How Does Ibogaine Work? Understanding Matrix Logic to Make a Safer Drug
Researchers are using matrix logic and modern receptor pharmacology to design safer ibogaine analogs that retain the psychedelic's anti-addiction potential while avoiding the cardiac and neurotoxicity risks of the parent compound.
Despite FDA Trial Clearance, Ibogaine Metabolite Won't Receive Red Carpet Treatment
DemeRx is launching the first U.S. clinical trial of an ibogaine-derived drug candidate, marking a pivotal moment for the controversial psychedelic despite a long history of safety concerns and a still-cautious FDA posture.
IQVIA Taps AI to Put Overlooked Prescribers on Marketers' Maps
IQVIA is rolling out an AI-driven prescriber identification tool designed to surface community physicians and nurse practitioners whose prescribing patterns are routinely missed by traditional pharma targeting models.
Neumora Discards Depression Asset, Lays Off Staffers After Pair of Late-Stage Flops
Neumora Therapeutics is laying off 35% of its workforce and discontinuing its lead depression drug after the asset failed two Phase 3 trials, sending shares down sharply and forcing a major pipeline reset.
Neumora Drug Fails Two More Phase 3 Trials, Biotech to Lay Off 35% of Staff
Endpoints News exclusive: Neumora Therapeutics is cutting 35% of staff and shelving its lead depression drug after two more Phase 3 trials missed, the latest in a wave of high-profile central nervous system setbacks.
STAT Plus: Amid Confusion Over Pfizer's Emergency Penicillin Program, Newborn Is Diagnosed With Preventable Syphilis
A STAT investigation details how confusion over Pfizer's emergency penicillin access program has contributed to at least one newborn contracting preventable syphilis, as congenital cases surge nationwide amid ongoing Bicillin shortages.
Eli Lilly Invests in Startup Abridge for Clinical Trial Recruitment
Eli Lilly has taken a strategic stake in Abridge, the ambient-AI clinical documentation startup, with a focus on accelerating patient identification and consent workflows in Lilly-sponsored clinical trials.
ADA: AstraZeneca Hands Structure a Win With 'Relatively Underwhelming' GLP-1 Pill Data
Structure Therapeutics' oral GLP-1 pill produced a 'relatively underwhelming' but still positive Phase 2 readout in diabetes, with analysts questioning commercial viability against Lilly's Foundayo and Novo's Wegovy pill.
ADA: Lilly Bests Novo Again, Takes GLP-1 Pill Foundayo to FDA for Diabetes Approval
Eli Lilly has submitted Foundayo, its oral GLP-1 receptor agonist, to the FDA for diabetes approval on the strength of head-to-head Phase 3 data presented at ADA showing superior A1C reduction versus Novo Nordisk's Wegovy pill.
Amgen and the FDA Want Two Different Outcomes for Tavneos. What Will Patients Do?
Amgen and FDA reviewers are split on whether Tavneos (avacopan) should remain on the market after reports of patient deaths in Japan, setting the stage for a rare-disease drug safety showdown at an upcoming advisory committee meeting.
Astellas, Takeda, RA Capital: This Week in Asia-Pacific Pharma
Astellas laid out a five-year strategic plan, Takeda's TYK2 inhibitor beat BMS's Sotyktu in a head-to-head psoriasis trial, and RA Capital launched a new China bridge program. Fierce Pharma Asia's weekly roundup of the region's most consequential biopharma moves.
Biopharma Sentiment Index | Q2 2026
The Q2 2026 Endpoints Biopharma Sentiment Index shows industry confidence continuing its 2026 rebound, with sentiment rising across small-molecule, biologics, and AI-driven drug discovery subsectors.
Biotech Stocks Are on a Tear Again: Signal Insights
Endpoints Signal Insights recaps the latest biotech stock surge, with the XBI hitting multi-year highs on the back of strong IPOs, M&A activity, and policy stability after a brutal 2023-2024 bear market.
Eli Lilly Invests in Startup Abridge for Clinical Trial Recruitment
Eli Lilly has made a strategic investment in Abridge, the AI medical scribe company, to accelerate clinical trial recruitment and reduce site burden, deepening the pharma's footprint in generative AI healthcare tools.
Where Does Biopharma Go From Here?
Endpoints' Q2 2026 sentiment survey captures industry executives' views on capital availability, R&D productivity, M&A activity, and policy outlook heading into the second half of the year.
Enliven Prices $400M Offering; Jazz Drug Zepzelca Fails Confirmatory Study
Enliven Therapeutics priced a $400 million public offering, while Jazz Pharmaceuticals and PharmaMar announced that Zepzelca failed its confirmatory Phase 3 study in small cell lung cancer, dealing a fresh blow to the partners' strategy of positioning the drug in earlier lines of therapy.
FDA Imposes Import Alert on Dabur India's Plant After Inspectors Flag GMP Failings
The FDA has imposed an import alert against Dabur India after inspectors found bird droppings, an unidentified black substance on warehouse ceilings, and data integrity deficiencies at one of the company's facilities, potentially allowing authorities to detain shipments of antibiotics, dietary supplements, and other drugs.
Beyond Sunshine: Iberia's Biotech Moment Has Arrived With Developing Capital Networks
Spain and Portugal are emerging as a credible European biotech hub beyond the traditional Catalonia/Madrid axis, with growing capital networks and a new wave of funding vehicles starting to compete with Paris and London for biotech creation.
Merck, Gilead Serve 'Sweet and Sour' Spread After HIV Win, Cancer Stumble
Merck and Gilead posted mixed data at a major oncology-HIV conference, with Merck's HIV program delivering a positive pivotal readout while Gilead's Trodelvy missed again in lung cancer, dragging on the company's oncology narrative.
Novartis Dystrophy Data Tee Up Regulatory Talks on Avidity Drug
Novartis executives said the company's muscular dystrophy data—built around the $12B Avidity Biosciences acquisition—pave the way for near-term regulatory submissions in DM1 and DMD.
Novo Nordisk Hit With Cybersecurity Breach, Urges Vigilance Among Trial Participants
Novo Nordisk disclosed a cybersecurity breach affecting clinical trial participant data, urging patients to remain vigilant. The incident follows a broader pattern of cyberattacks targeting pharma and adds to Novo's 2026 challenges.
The Oral GLP-1 Tracker: Novo's Wegovy Pill Keeps Gaining Ground
Fierce Pharma's quarterly oral GLP-1 launch tracker shows Novo Nordisk's Wegovy pill continuing to capture scripts at a faster rate than Eli Lilly's Foundayo in early launch markets, with both drugs now expanding into new indications.
WuXi AppTec Sues Pentagon in Challenge Over Inclusion on Chinese Military List
WuXi AppTec has filed suit against the U.S. Department of Defense, challenging its inclusion on the Chinese military companies list. The lawsuit escalates a multi-year dispute that has shaped the biotech supply chain and raised concerns from pharma clients about outsourcing to Chinese CDMOs.
Zepzelca Saga Takes Another Turn With Ph. 3 Lung Cancer Flop
Jazz Pharmaceuticals and partner PharmaMar's Zepzelca (lurbinectedin) has failed a confirmatory Phase 3 study in small cell lung cancer, raising fresh questions about the drug's accelerated approval and Jazz's oncology strategy.
Abridge Inks Deals With Nvidia and Eli Lilly to Bring AI Scribes Deeper Into Clinical Workflows
Abridge, the AI medical scribe company, signed separate partnerships with Nvidia and Eli Lilly to integrate its ambient clinical documentation technology deeper into hospital and pharma clinical workflows, joining a wave of generative AI deployments in healthcare.
Astellas Outlines CEO's 5-Year Plan to Counter the Xtandi Patent Cliff
Astellas CEO Naoki Okamura detailed a five-year strategic plan centered on the company's post-Xtandi oncology and women's health franchises, projecting a path back to growth as the prostate cancer blockbuster faces generic competition later this decade.
The Wait Continues: Pressure to Operate Lean Among Factors Behind Slow Biopharma Job Market
Just 23% of respondents to a BioSpace LinkedIn poll expect the biopharma job market to rebound in 2026. Three experts discuss when they see a turnaround happening and how increasing emphasis on cost efficiency is impacting hiring practices across the industry.
Here Are Biopharma's 10 Highest-Paid Scientists and Doctors for 2025
Endpoints News' annual pay report identifies the 10 highest-paid chief scientific officers and chief medical officers in biopharma for 2025, with total compensation packages ranging from $25M to over $100M amid escalating talent competition.
Here Are Biopharma's 10 Highest-Paid Scientists and Doctors for 2025
Endpoints' annual ranking of the 10 highest-paid biopharma scientists and doctors in 2025, with a methodology note on how cash, equity, and performance-share structures shifted versus 2024.
Nonprofit Blood Cancer United Buys Experimental Cancer Drug Luvelta to Maintain Patient Access
The nonprofit Blood Cancer United has acquired the experimental cancer drug Luvelta to ensure continued access for patients enrolled in ongoing trials after the developer signaled it would wind down the program, an unusual arrangement that highlights the financial pressure on small-molecule oncology development.
Camurus' Second CRL for Acromegaly Drug; Teva Details Workforce Cuts
Camurus received a second Complete Response Letter from FDA for its acromegaly candidate, while Teva provided fresh details on its multi-year workforce reduction plan covering both its generics and specialty operations.
Camurus Receives Second CRL for Acromegaly Drug; Teva Details Workforce Cuts
Sweden's Camurus received a second Complete Response Letter from the FDA for its acromegaly treatment, while Teva Pharmaceutical detailed workforce reductions tied to the ongoing divestiture of its API manufacturing business.
Charles River CEO Says It Likely Won't Be the Last Manufacturer to Break Away From Cell and Gene Therapy
Charles River Laboratories' CEO said the company's recent decision to wind down its cell and gene therapy CDMO business is likely a leading indicator of broader industry rationalization, as capital costs and clinical failure rates reshape the manufacturing landscape.
Drugmakers Turn to Logistics Providers as Trade Disruptions Linger, DHL Exec Says
Pharmaceutical manufacturers are increasingly relying on third-party logistics providers to manage supply chain complexity as US-China trade tensions and tariff uncertainty persist, according to a senior DHL executive.
Drugmakers Are Turning to Logistics Providers as Trade Disruptions Linger, DHL Exec Says
A senior DHL executive said drugmakers are signing longer-term, higher-touch logistics contracts as ongoing trade disruptions, tariff uncertainty, and serialization rules make the cold-chain supply chain more complex and more strategically important.
Enliven Therapeutics' Leukemia Drug Shows Promise in New Study
Enliven Therapeutics reported updated clinical data for its allosteric menin inhibitor ELVN-001 in acute myeloid leukemia (AML), showing promising response rates and tolerability in heavily pretreated patients.
Germany's Health-Spending Plan Has Consequences as Lilly, Boehringer Scale Back
Eli Lilly and Boehringer Ingelheim are scaling back German operations in response to the country's proposed health-spending cuts, raising questions about Europe's largest pharma market's ability to attract R&D investment.
Kardigan's $320M IPO Pitch: Three Borrowed Heart Drugs, One Proven Cardio CEO
Kardigan is pitching a $320M IPO built around three in-licensed heart drugs and a CEO track record from prior cardiovascular launches, betting that an aging pipeline of borrowed cardio assets can be assembled into a focused commercial story.
Kardigan Stitches Up $369M IPO Plan for Heart Drugs
Kardigan, the cardiology biotech led by a former MyoKardia executive, has filed to raise up to $369M in a US IPO to fund a pipeline of three in-licensed cardiovascular programs targeting cardiomyopathies and related heart conditions.
Lilly Gives Hospitals Deadline to Comply With 340B Claims Data Policy
Eli Lilly has given hospitals a five-day deadline to comply with the company's new 340B claims data policy or risk losing 340B drug pricing on key products, escalating the fight over federal drug discount program transparency.
Madrigal Takes Giant Inflatable Liver on US Tour for Disease Awareness
Madrigal Pharmaceuticals is touring the United States with a giant inflatable liver to raise awareness of MASH (metabolic dysfunction-associated steatohepatitis) and its approved therapy Rezdiffra, the first FDA-approved drug for the disease.
Mammalian Hair, Roof Leaks: Novo Nordisk's Indiana Site Under FDA Scrutiny Once Again
Novo Nordisk's aseptic manufacturing site in Indiana is under renewed FDA scrutiny after a recent inspection cited mammalian hair contamination and roof leaks, raising concerns about the supply of critical GLP-1 products.
May 2026 Biopharma Layoffs Hit Nearly 7,000, With Most Cuts From Takeda and BioNTech
For the second time in 2026, the number of biopharma professionals affected by made or projected workforce reductions rose year over year. In May, layoffs spiked nearly 50% to 6,956 employees, mainly due to Takeda and BioNTech axing a combined 6,360 employees.
Neion Bio Lands $23M Series A to Make Proteins From Chicken Eggs
Neion Bio raised a $23M Series A to scale its chicken-egg-based recombinant protein production platform, pitching the approach as a low-cost, scalable alternative to CHO-cell bioreactors for certain biologics.
Neion Bio Lands $23M Series A to Make Proteins from Chicken Eggs
Neion Bio has raised a $23M Series A to develop its platform for producing recombinant proteins in chicken eggs, an alternative to traditional mammalian cell culture manufacturing that promises faster, cheaper biologics production.
An Obesity Drug Deep-Dive, and Peptides Move Mainstream
The Readout LOUD podcast team recaps the biggest obesity data from ADA 2026 and explores how the rise of oral peptides is reshaping the GLP-1 market and the broader peptide therapeutics landscape.
Portugal, Spain, and the New Biotech Frontier
Iberia's biotech sector is emerging as a serious third hub behind the U.K. and Germany, with deep academic science, growing late-stage capital, and a new wave of cross-border partnerships.
Sky-High Parabilis, Kailera IPOs Spur Optimism—But Only for Derisked Biotechs
Two biotechs—Parabilis Medicines and Kailera—have set industry records with back-to-back IPOs, but experts caution that only derisked pipelines with validated mechanisms are reaping rewards while broader biotech sentiment remains cautious.
Takeda's AI-Designed Pill Bests BMS' Sotyktu in Head-to-Head Psoriasis Trial
Takeda's oral allosteric TYK2 inhibitor, designed with the help of generative AI, beat Bristol-Myers Squibb's Sotyktu in a head-to-head Phase 3 trial in moderate-to-severe plaque psoriasis, positioning it as a potential best-in-class oral therapy.
New Biotech Group Rises to Fuel American Rockets in China 'Space Race'
The American Biotech Innovation Alliance (ABIA) launched with the goal of building a national biotech strategy for the United States, modeled on China's coordinated approach to the sector, to maintain American competitiveness in life sciences innovation.
ADC Therapeutics' Confirmatory Data for Zynlonta Muddied by Death Rates
ADC Therapeutics' confirmatory Phase 3 data for Zynlonta (loncastuximab tesirine) in diffuse large B-cell lymphoma was complicated by elevated death rates in the experimental arm, raising new doubts about the drug's risk-benefit profile.
Now at FDA's Doorstep, Beren Therapeutics Tacks On $300M in New Financings
Beren Therapeutics has added $300M in fresh financing as it approaches an FDA filing for its lead rare-disease program, bringing the company's total private capital raise to over half a billion dollars.
Eli Lilly's 340B Claims Data Deadline May Kick Off a New 340B Fight
Eli Lilly is moving forward with a hospital claims data submission deadline tied to its 340B drug pricing program, a step that could trigger a new round of disputes with safety-net hospitals and reshape how the contract pharmacy channel operates.
Ethyreal Lands $101M to Treat Both Graves' and Thyroid Eye Disease
Ethyreal has raised $101 million to advance a pipeline targeting Graves' disease and the related thyroid eye disease, with an antibody-based approach designed to address the underlying autoimmune pathology.
Ethyreal Lands $101M to Treat Both Graves' and Thyroid Eye Disease
Ethyreal Therapeutics closed a $101M financing to advance a dual-acting antibody aimed at both Graves' disease and thyroid eye disease, two autoimmune indications with overlapping biology but few targeted therapies.
FDA Details Flexibilities for New Cell and Gene Therapies to Leverage Past Data
The FDA has released new guidance clarifying how sponsors of cell and gene therapies can leverage prior clinical and CMC data from related programs to accelerate development timelines, in a move likely to speed the next wave of regenerative medicine approvals.
Explaining Unapproved Drugs to Payors: FDA Offers Pharma New Guidance to Avoid Pitfalls
The FDA has issued new draft guidance for pharmaceutical companies on how to communicate with payors about unapproved drugs and investigational uses, aiming to reduce off-label misinformation and clarify permissible pre-approval communication.
Genentech Lays Off Top Scientist Vishva Dixit, Closes Infectious Disease Research Unit in Restructuring
Genentech, a Roche subsidiary, has laid off its top infectious disease scientist Dr. Vishva Dixit and is closing its infectious disease research unit as part of a broader R&D restructuring. The move signals a strategic pullback from anti-infective drug development.
Local Trade Groups Must Support Life Sciences in These Difficult Times
An opinion column arguing that as the industry faces policy changes and significant cuts to federal funding, local life sciences trade groups can bolster companies through innovative resources to sustain growth and keep the US at the center of biomedical innovation.
Parabilis' $670M IPO Sets New Biotech Record, Will Fund Cancer Drug
Parabilis Medicines raised $670 million in an industry-record IPO, the largest biotech public offering to date, with proceeds earmarked to advance its lead cancer program into the clinic.
'Going for Our Own Moonshot': Parabilis CEO on Biotech's Record IPO
Parabilis Medicines CEO Mathai Mammen discusses the company's $670M IPO, the largest biotech public offering on record, and how the proceeds will fund the company's oncology pipeline targeting historically undruggable cancer targets.
Shattuck Raises $75M; Servier Inks Neuro ASO Pact with n-Lorem Foundation
Shattuck Labs closed a $75M financing round, while Servier announced a partnership with the n-Lorem Foundation to develop antisense oligonucleotide (ASO) therapies for ultra-rare neurological diseases.
Big Pharma-Backed SonoThera Sounds Off With $125M Series B for Ultrasound-Based Gene Therapy
SonoThera, a biotech developing ultrasound-based, non-viral gene therapies, raised a $125 million Series B led by multiple Big Pharma partners. The funding will advance its lead programs in genetic medicine toward clinical trials.
City Therapeutics Gets $99M to Gather Data on Three RNAi Medicines
City Therapeutics has closed a $99M financing round to advance its pipeline of three RNAi medicines, betting on a next-generation small interfering RNA platform that aims to improve potency and durability over current standards.
Drug Shortages Remain a 'Systemic' Problem in U.S., New Analysis Finds
A new analysis published by STAT reveals that shortages of essential medicines across multiple therapeutic classes remain a systemic, persistent problem in the United States, with no clear federal policy path to resolution in 2026.
Trodelvy Misses Again in Lung Cancer, but Gilead and Merck Have an HIV Success to Soften the Blow
Gilead's Trodelvy failed a second late-stage lung cancer trial, further narrowing the ADC's commercial prospects outside of triple-negative breast cancer. Gilead and Merck separately reported positive HIV data, providing partial offset to the disappointing oncology readout.
WuXi AppTec Added to Pentagon's List of Companies Linked to Chinese Military
WuXi AppTec has been added to the Pentagon's list of companies with alleged ties to the Chinese military, escalating U.S.–China biotech tensions and raising fresh concerns about the company's U.S. customer base and supply chain.
ADA: Kailera 'Back at Work' After Record-Breaking IPO With China Data in Hand
Kailera Therapeutics executives said the obesity biotech is back to building pipeline after a record-breaking IPO, presenting Phase 2 data from China on its lead GLP-1/GIP candidate at the American Diabetes Association conference.
Amgen Stands By Tavneos Despite Reports of 20 Deaths in Japan
Amgen is defending the safety profile of its rare disease drug Tavneos after reports of roughly 20 patient deaths in Japan, arguing that the data still supports the drug's continued availability in major markets including the U.S. and EU.
Cavalry Biosciences Pursues $75M Series B to Test Eye and Muscle Disorder Drugs
Cavalry Biosciences is raising a $75 million Series B to advance its pipeline of oligonucleotide therapies for inherited eye and muscle disorders, joining a small group of well-capitalized genetic medicine startups building on the success of the modality in neuromuscular disease.
Sanofi, OpenAI, and Formation Bio Partner to Accelerate Drug Development
A first-of-its-kind collaboration to build AI-powered software and custom applications, aiming to bring new medicines to patients more efficiently by leveraging OpenAI's technology and Formation Bio's clinical platform.
J&J Makes $1B Move for Firefly Bio, Carolyn Bertozzi's Twist on ADCs in the KRAS Field
Johnson & Johnson agreed to acquire Firefly Bio for up to $1 billion, gaining an antibody-drug conjugate platform that applies chemistry pioneered by Nobel laureate Carolyn Bertozzi to the KRAS-mutant cancer field, one of the most competitive targets in oncology.
AI-Designed Candidate for Idiopathic Pulmonary Fibrosis Enters Phase 2 Trials
A major milestone for computational drug discovery as the first fully AI-generated drug candidate enters Phase 2 clinical trials, testing efficacy in human patients.
Surviving (and Thriving With) DEI in Biotech
As DEI programs face political and legal headwinds, biotech companies and professionals are finding new ways to maintain diverse, inclusive workplaces.
Rethinking Hair Loss Treatment: New Mechanisms Move Into the Clinic
A new generation of hair-loss therapies is moving into clinical trials, targeting pathways beyond the JAK-IGF-1 axis that have dominated the field since the approval of JAK inhibitors for alopecia areata.
The Shift in Biotech Careers: Computational Skills Dominate 2026 Hiring Market
An analysis of current recruitment trends across major biotech hubs shows a sharp increase in demand for wet-lab scientists with computer science proficiency.
The cost of a PRV is twice as high as it was three years ago — and it's likely to stay that way
Priority Review Voucher prices have roughly doubled over the past three years as supply remains constrained by capped issuances and demand from rare disease developers continues to grow.
Can AI do scientific research? Billions are pouring in to find out
Billions of dollars are flowing into AI-driven scientific research platforms, with pharma and tech investors betting that machine learning can compress the lab-to-clinic timeline for new therapeutics.
AI-Native Biopharma
Therapeutics developers leveraging computational biology and AI foundation models as core pipelines.
Abridge
PrivateAbridge is a privately held healthcare AI company that builds ambient-AI clinical documentation and conversation-summarization tools used by physicians, nurses, and health systems. The platform listens to patient-clinician encounters and automatically generates structured clinical notes, billing codes, and patient summaries. In June 2026, Abridge announced parallel strategic partnerships with Nvidia (for compute infrastructure) and Eli Lilly (to deploy its platform in Lilly-sponsored clinical trial recruitment and consent workflows).
HQ: San Francisco
Funding: >$700M cumulative venture-backed funding through 2026
Key Pipeline Asset:
Alto Neuroscience
NYSE: ANROAlto Neuroscience is a clinical-stage biopharmaceutical company developing precision psychiatry medicines using biomarker-driven patient stratification to treat depression and other central nervous system disorders.
HQ: Mountain View
Funding: N/A
Key Pipeline Asset:
Formation Bio
PrivateFormation Bio is an AI-native drug development company building a clinical-stage pipeline through in-licensing and asset acquisition, with a focus on using technology and AI to accelerate clinical trial execution. In early 2026, the company launched a new subsidiary, Kenmare Bio, to develop a miR-124 inhibitor licensed from a Chinese partner for inflammatory diseases.
HQ: New York
Funding: $600M+
Key Pipeline Asset:
Insilico Medicine
PrivateInsilico Medicine is an end-to-end generative artificial intelligence-driven drug discovery company connecting biology, chemistry, and clinical trials analysis.
HQ: New York
Funding: $415M
Key Pipeline Asset:
Slate Medicines
PrivateSlate Medicines is a clinical-stage biotechnology company developing anti-PACAP therapeutics for migraine and headache disorders. The company launched in 2026 with a $130M Series A to advance its lead program SLTE-1009 and other PACAP-pathway candidates, joining a competitive class of next-generation migraine developers seeking to challenge the CGRP inhibitor standard of care.
HQ: Raleigh
Funding: $130M
Key Pipeline Asset:
Verge Labs
PrivateVerge Labs (formerly Verge Genomics) is a frontier AI lab for human disease biology founded in 2015. The company develops world models of patient biology built on proprietary multi-modal human tissue data and partners with drug developers on target discovery, patient stratification, and biomarker prediction across CNS and beyond.
HQ: San Francisco
Funding: $130M+ to date
Key Pipeline Asset:
AI Infrastructure & Software
Software platforms, digital notebooks, and LIMS offering GxP-compliant AI-powered co-pilots and analytics.
10x Genomics
Hardware10x Genomics is a life sciences technology company building instruments, consumables, and software for single-cell sequencing and spatial transcriptomics. Its platforms include Chromium (single-cell RNA-seq, ATAC-seq, multiome), Visium (spatial gene expression), and Xenium (in-situ RNA imaging). LIMS integrations are available through the Loupe Browser and Connect software.
Key Tool:
Chromium X Series Single-cell partitioning and barcoding platform for gene expression, immune profiling, ATAC-seq, and multiome (RNA + ATAC) assays.
Accruent
SoftwareAccruent is an enterprise asset management and CMMS provider for healthcare and life sciences, with strong adoption in hospital systems and pharma facilities. Now part of Fortive (parent of Fluke, eMaint, Gatan, etc.), Accruent provides the TMS (Trakker Maintenance System) and the Connectiv healthcare technology management platform.
Key Tool:
Accruent TMS (Trakker Maintenance System) Enterprise CMMS / EAM for healthcare and life sciences facilities, with strong regulatory compliance and audit trails.
Arena Solutions (PTC)
SoftwareArena Solutions is a cloud QMS and PLM platform acquired by PTC in 2021. Strong in medical device, life sciences, and high-tech hardware companies needing integrated product lifecycle and quality management. Built on Salesforce.
Key Tool:
Arena Quality Management System (QMS) Cloud QMS for design controls, CAPA, document control, training, and supplier quality.
Aspen Technology
SoftwareAspen Technology (AspenTech) is a leading provider of asset optimization software for industrial process manufacturers, including pharmaceuticals, chemicals, and energy. The 2024 acquisition of Open Systems International (OSI) brought the OSIsoft PI System under AspenTech's umbrella — the de facto industrial time-series historian used in pharma continuous manufacturing, plus power, water, metals, and other process industries.
Key Tool:
Aspen Technology OSIsoft PI System Industrial time-series data historian — captures, stores, and visualizes sensor and process data from manufacturing equipment.
Blue Mountain
SoftwareBlue Mountain Quality Resources provides calibration and maintenance management software (EAM) designed specifically for the life sciences industry, enabling paperless calibration, asset management, and GMP compliance.
Key Tool:
Blue Mountain RAM Regulatory Asset Manager platform integrating asset management, calibration management, and maintenance work orders in a compliant GxP environment.
ComplianceQuest
SoftwareComplianceQuest is a native Salesforce-based QMS for life sciences and medical devices. Provides document control, training, CAPA, audits, and supplier quality on the Salesforce platform, with 21 CFR Part 11 compliance and GxP templates out of the box.
Key Tool:
CQ Quality Management (EQMS) Native Salesforce QMS for document, training, CAPA, audit, change, and supplier quality.
Dotmatics
SoftwareDotmatics is a scientific informatics platform for drug discovery, providing electronic lab notebook (ELN), laboratory information management (LIMS), and scientific data management (SDMS) in a unified cloud platform. Acquired by Siemens AG in 2024, it now anchors Siemens' Life Sciences portfolio for the digital lab.
Key Tool:
Studies Cloud-based electronic lab notebook purpose-built for chemistry, biology, and assay workflows with structured data capture.
eLabNext
SoftwareeLabNext is a modern electronic lab notebook and sample management platform popular in European biotech and academic labs. Renamed from eLabJournal/MonkeyBin in 2020, it now provides a unified ELN, LIMS, and lab automation platform with strong API extensibility and the Add-on Marketplace.
Key Tool:
eLabNext ELN Cloud electronic lab notebook with sample tracking, protocol execution, and a Marketplace of add-ons for qPCR, plate readers, and imaging.
eMaint (Fluke Corporation)
SoftwareeMaint is a CMMS for life sciences facilities and equipment maintenance, with strong adoption in pharma manufacturing. Now part of Fluke Corporation (a Fortive operating company), it offers work order management, preventive maintenance, calibration management, and GxP-compliant maintenance records.
Key Tool:
eMaint CMMS Cloud CMMS for work orders, preventive maintenance, asset tracking, and parts inventory with GxP-compliant audit trails.
Emerson Electric's Automation Solutions segment provides process control, measurement, and analytical instrumentation. In pharma, Emerson is one of the two dominant DCS vendors (alongside Honeywell Experion), with DeltaV and Syncade MES used in batch and continuous manufacturing plants worldwide.
Key Tool:
DeltaV DCS Distributed control system (DCS) purpose-built for batch and continuous pharma manufacturing, with native S88 batch recipes and electronic signatures.
ETQ (Hexagon)
SoftwareETQ Reliance is an enterprise eQMS with deep pharma and biotech presence, particularly in document control, CAPA, audit management, and supplier quality. Acquired by Hexagon AB in 2023 to anchor its Manufacturing Intelligence division, and now part of Hexagon's Manufacturing Intelligence business unit.
Key Tool:
ETQ Reliance Quality Management System Enterprise eQMS for document control, CAPA, training, audits, and supplier quality, with deep pharma workflows.
Greenlight Guru
SoftwareGreenlight Guru is an eQMS purpose-built for medical device companies with built-in design controls, DHF (Design History File), risk management, and FDA 21 CFR Part 11 / ISO 13485 compliance. Acquired by Collabware in 2024 to scale into adjacent regulated industries.
Key Tool:
Greenlight Guru QMS Medical device QMS with design controls, DHF, CAPA, complaint handling, and FDA 21 CFR Part 11 compliance.
IQVIA
MixedIQVIA is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, offering Orchestrated Customer Engagement (OCE) and clinical data platforms.
Key Tool:
Orchestrated Customer Engagement (OCE) Life sciences commercial platform integrating CRM, marketing, and analytical tools tailored for healthcare sales.
LabArchives
SoftwareLabArchives is a leading electronic lab notebook (ELN) platform widely adopted by academic institutions, pharmaceutical companies, and biotech startups. It offers a Marketplace of integrations with SnapGene, GraphPad Prism, and other lab applications, plus a free tier for individual researchers.
Key Tool:
LabArchives Notebook Cloud-based electronic lab notebook with rich-text editing, version history, e-signatures (21 CFR Part 11), and offline sync.
MaintainX
SoftwareMaintainX is a modern mobile-first CMMS for maintenance, inspections, and work order management. Used in manufacturing and life sciences facilities for uptime tracking, with strong mobile UX for technicians and a freemium model for small teams.
Key Tool:
MaintainX CMMS Mobile-first CMMS with work orders, preventive maintenance, asset hierarchy, and procedures with photos/videos.
MasterControl
SoftwareMasterControl Inc. is a leading provider of cloud-based quality management systems (QMS) and manufacturing execution software (MES) for life sciences and other highly regulated industries.
Key Tool:
MasterControl Quality Excellence Enterprise QMS platform covering document control, training, CAPA, and audits to ensure GxP regulatory compliance.
Mettler-Toledo International
HardwareMettler-Toledo International is a leading global manufacturer of precision instruments and services for use in laboratories and manufacturing. Its portfolio includes laboratory balances, pipettes, pH meters, density meters, refractometers, and process analytics for pharma manufacturing. The LabX software platform centralizes instrument data management.
Key Tool:
Mettler Toledo XPR Analytical Balances High-precision analytical and microbalances with integrated StatusLight, ProFACT advanced internal adjustment, and RFID-enabled SmartGrid weighing pans.
Qualio
SoftwareQualio is a cloud-based Quality Management System (QMS) built specifically for life sciences start-ups and growing companies in medical devices, pharmaceutical, and biotech sectors.
Key Tool:
Qualio QMS An intuitive, cloud-native QMS built to automate document control, training logs, CAPA, and supplier management.
Sapio Sciences
SoftwareSapio Sciences is a modern cloud-based LIMS+ELN platform with a configurable scientific data model. Strong adoption in clinical genomics, cell therapy, antibody discovery, and pharma R&D, where labs need flexibility to model complex molecule-centric workflows.
Key Tool:
Sapio LIMS Cloud LIMS with no-code workflow builder, sample tracking, and chain-of-custody for regulated labs.
SciNote
SoftwareSciNote is a modern electronic lab notebook with a free tier for individual labs and team plans for biotech, with strong integrations for molecular biology (SnapGene), statistics (GraphPad), and electronic signatures. Particularly strong in academic and small-biotech settings.
Key Tool:
SciNote ELN Cloud electronic lab notebook with 21 CFR Part 11-ready electronic signatures, integrations, and offline mode.
Scispot
SoftwareScispot is a modern LIMS and ELN platform purpose-built for biotech and synthetic biology labs. Includes inventory, sample tracking, and AI-driven notebook features, with strong out-of-the-box support for plasmid design, cell line tracking, and bioprocess workflows.
Key Tool:
Scispot LIMS+ Cloud LIMS with built-in plasmid/sequence registries, inventory, and bioprocess tracking — no code required.
Seal
SoftwareSeal (formerly Opvia) provides a modern, all-in-one GxP workspace for biotechnology and manufacturing teams, integrating quality management (QMS), electronic lab notebooks (ELN), and lab information systems (LIMS) with AI-powered co-pilots.
Key Tool:
Seal GxP Platform A consolidated cloud platform designed to replace fragmented MES, LIMS, QMS, and ELN systems, featuring version-controlled blueprints and AI co-pilots.
Veeva Systems
SoftwareVeeva Systems Inc. is a leading provider of cloud-based software solutions for the global life sciences industry, specializing in clinical trial management, regulatory compliance, and customer relationship management.
Key Tool:
Veeva Vault Clinical Unified suite of cloud applications designed to streamline clinical trial operations, data management, and documentation.
ZenQMS
SoftwareZenQMS is a modern cloud eQMS for life sciences with strong focus on GMP document control, training, and change management. Popular in mid-market pharma/biotech for its clean UX and quick implementation.
Key Tool:
ZenQMS eQMS Cloud eQMS for document control, training, change control, deviations, and CAPA with GxP templates.