Substrate
Topic

drug development

37 stories related to this topic, newest first.

FDA Panel Recommends XFG Variant for Fall Covid Shotsmedpagetoday.com
science2 hrs agoDeveloping

FDA Panel Recommends XFG Variant for Fall Covid Shots

Replimune will submit an application to the FDA for the third time. Pfizer and Innovent Biologics reached a collaboration agreement valued at up to $10.5 billion.

Stat
1 source
BigHat Biosciences CEO Describes Limits of AI in Antibody Drug DesignStat
ai3 days agoDeveloping

BigHat Biosciences CEO Describes Limits of AI in Antibody Drug Design

Peyton Greenside, CEO of BigHat Biosciences, said AI can generate antibody designs quickly but that downstream testing still requires substantial time and expense. The company, founded in 2019, has completed projects with several large pharmaceutical partners.

Stat
1 source
Cancer Immunotherapy Pipeline Expands With Multiple New Drug Classesglobenewswire.com
science4 days agoDeveloping

Cancer Immunotherapy Pipeline Expands With Multiple New Drug Classes

More than 2,500 cancer immunotherapy programs are now active. Fifteen years after the first checkpoint inhibitor approval, several additional drug types have reached FDA approval or late-stage testing.

ER
1 source
Podcast Discusses Biotech Summit and China Competitionecns.cn
science6 days agoDeveloping

Podcast Discusses Biotech Summit and China Competition

The weekly biotech podcast covered conversations from a recent health care and science summit. Topics included research publication practices and the role of AI in drug development.

Stat
1 source
Merck drug combination reduces lung cancer progression risk in trialthehindu.com
science7 days agoDeveloping

Merck drug combination reduces lung cancer progression risk in trial

A Merck antibody-drug conjugate combined with Keytruda lowered the risk of tumor progression by 65 percent in a Phase 3 lung cancer study. The results come from an abstract released ahead of the American Society of Clinical Oncology meeting.

Stat
1 source
Biogen and Denali Parkinson’s Drug Fails Randomized TrialStat
science7 days agoDeveloping

Biogen and Denali Parkinson’s Drug Fails Randomized Trial

Biogen and Denali Therapeutics reported that an experimental therapy targeting the LRRK2 protein did not slow Parkinson’s disease progression in a randomized study of 648 adults. The companies announced the results on May 21, 2026.

Stat
1 source
Merck-Kelun Drug Reduced Lung Cancer Progression Risk by 65 Percent in TrialStat
science7 days agoDeveloping

Merck-Kelun Drug Reduced Lung Cancer Progression Risk by 65 Percent in Trial

Phase 3 study results showed that a targeted chemotherapy developed by Kelun-Biotech and licensed to Merck reduced tumor progression risk by 65 percent in patients with advanced non-small cell lung cancer. A preliminary survival benefit was observed but requires longer follow-up…

Stat
1 source
FDA Leadership Changes Prompt Concerns Among Rare Disease Drug DevelopersStat
science9 days agoDeveloping

FDA Leadership Changes Prompt Concerns Among Rare Disease Drug Developers

Drug industry executives and an academic expert discussed the effects of recent FDA personnel changes on rare disease drug development at a conference in San Francisco on May 20, 2026. They expressed uncertainty about clinical trial requirements and investor reactions.

Stat
1 source
FDA Encourages Shift From Animal Testing Modelsfda.gov
science9 days agoDeveloping

FDA Encourages Shift From Animal Testing Models

The FDA is urging pharmaceutical companies to reduce reliance on animal testing. Betts Lacroix stated that current technology does not yet support complete replacement of animal models.

Stat
1 source
AI Technology Helps Identify Treatment for Child's Rare Diseasethehindu.com
ai9 days agoDeveloping

AI Technology Helps Identify Treatment for Child's Rare Disease

Joanie Kraus described how artificial intelligence contributed to finding a drug for her daughter's ultra-rare condition during a presentation at the STAT Breakthrough West event. The account highlighted an emotional response from attendees.

Stat
1 source
Amplia Therapeutics Starts Phase 2b Trial of Narmafotinib for Pancreatic CancerThe Sydney Morning Herald
business10 days ago

Amplia Therapeutics Starts Phase 2b Trial of Narmafotinib for Pancreatic Cancer

Amplia Therapeutics has begun a Phase 2b study testing daily dosing of narmafotinib in newly diagnosed pancreatic cancer patients. The trial combines the drug with standard chemotherapy and will initially enroll 12 patients across Australian sites.

The Sydney Morning Herald
1 source
U.S. Biotech Firms Spent $60 Billion on Chinese Drugs in First Quarterforbes.com
science11 days agoDeveloping

U.S. Biotech Firms Spent $60 Billion on Chinese Drugs in First Quarter

American drug companies purchased Chinese-developed molecules at a pace that would double last year's total. The purchases have created divisions within the industry over whether to treat Chinese firms as partners or competitors.

Stat
1 source
Quince Therapeutics Acquires Orphai Therapeutics and Raises Up to $187 Millionbenzinga.com
finance11 days ago

Quince Therapeutics Acquires Orphai Therapeutics and Raises Up to $187 Million

Quince Therapeutics announced the acquisition of Orphai Therapeutics and a concurrent private placement to fund development of an inhaled rapamycin formulation for pulmonary diseases. The deal brings LAM-001 into Quince's pipeline and extends the company's cash runway through 202…

Benzinga
1 source
Researchers Develop Method to Insert Nitrogen into Carbon-Hydrogen Bondsenglish.radio.cz
science11 days agoDeveloping

Researchers Develop Method to Insert Nitrogen into Carbon-Hydrogen Bonds

A study published in Science describes a chemical method that selectively adds nitrogen to specific carbon-hydrogen bonds. The technique uses common chemical feedstocks and targets late-stage construction of carbon-nitrogen bonds.

SC
1 source
Researchers Develop Molecular Glue to Reduce Activity of Hard-to-Target ProteinsForbes
finance12 days ago

Researchers Develop Molecular Glue to Reduce Activity of Hard-to-Target Proteins

University of Toronto and University of British Columbia scientists created a molecular glue that binds to one protein and alters its shape to reduce activity of a second protein. The approach was tested on ACAA1, a protein involved in fat processing, using X-ray imaging at the C…

Forbes
1 source
Bristol Myers Squibb Partners With China's Hengrui Pharma on Early-Stage Drug Development and Discoverykr-asia.com
science14 days agoDeveloping

Bristol Myers Squibb Partners With China's Hengrui Pharma on Early-Stage Drug Development and Discovery

Bristol Myers Squibb will send four of its experimental drugs to China for early-stage clinical trials under the deal announced Tuesday. The companies will also collaborate to discover new medicines, with each contributing assets to the potentially multi-billion dollar partnershi…

FI
Cnbc
2 sources
Biogen Advances Tau-Targeting Alzheimer’s Drug to Phase 3 Despite Mixed Phase 2 DataStat
science15 days agoDeveloping

Biogen Advances Tau-Targeting Alzheimer’s Drug to Phase 3 Despite Mixed Phase 2 Data

Biogen reported that its drug diranersen reduced tau levels in spinal fluid and brains of patients with early-stage Alzheimer’s in a Phase 2 trial. The reductions correlated with slower cognitive decline, though the study did not meet its primary efficacy goal of showing a dose r…

Stat
1 source
CREATE Medicines Raises $122 Million to Advance CAR-T Candidates Into Human Trialsrte.ie
health15 days agoDeveloping

CREATE Medicines Raises $122 Million to Advance CAR-T Candidates Into Human Trials

The biotechnology company, formerly known as Myeloid Therapeutics, secured the funding from Newpath Partners, ARCH Venture Partners and Hatteras Venture Partners. CREATE Medicines, cofounded by Siddhartha Mukherjee, is developing CAR-T therapies using myeloid cells to target soli…

Stat
1 source
US Cancer Centers Report Surge in Requests for Experimental Pancreatic Cancer DrugThe Independent
world15 days agoDeveloping

US Cancer Centers Report Surge in Requests for Experimental Pancreatic Cancer Drug

US cancer centers are seeing increased patient requests for daraxonrasib following positive clinical trial results that showed doubled survival rates for advanced pancreatic cancer. The FDA approved an expanded access program for the drug on 1 May, three weeks after the developer…

The Independent
1 source
Bristol Myers Squibb Partners With Hengrui Pharma on Early-Stage Programsmanilatimes.net
science16 days agoDeveloping

Bristol Myers Squibb Partners With Hengrui Pharma on Early-Stage Programs

Bristol Myers Squibb announced a partnership with Hengrui Pharma covering more than a dozen early-stage programs. The agreement is the latest instance of a global pharmaceutical company seeking medicines from China. Separately, Viiv lost an HIV treatment patent case while other c…

Stat
1 source
Hims Sales Miss Estimates as Telehealth Competition Increaseswallstreetpit.com
health17 days agoDeveloping

Hims Sales Miss Estimates as Telehealth Competition Increases

Hims & Hers Health reported sales that fell short of analyst expectations amid rising competition in the telehealth sector. The company is one of several firms offering online health services including weight loss and other treatments. Separately, Bristol Myers Squibb announced a…

Stat
1 source
Bristol Myers Squibb Agrees to Up to $15.2B Deal With Hengrui Pharma for 13 Early-Stage ProgramsBenzinga
science17 days agoDeveloping

Bristol Myers Squibb Agrees to Up to $15.2B Deal With Hengrui Pharma for 13 Early-Stage Programs

The deal covers 13 early-stage programs in oncology, hematology and immunology. Bristol Myers Squibb will pay up to $950 million in near-term payments while gaining rights to several drug candidates outside China.

Stat
Benzinga
2 sources
Drug Daraxonrasib Extends Survival in Pancreatic Cancer Trialapp.buzzsumo.com
science18 days agoDeveloping

Drug Daraxonrasib Extends Survival in Pancreatic Cancer Trial

A small clinical trial found that daraxonrasib, which blocks a family of mutant proteins, helped patients with a deadly form of pancreatic cancer live longer. The drug shrank or halted tumor growth in many participants. Nature reported the findings from the trial published in 202…

NA
1 source
Entrada Duchenne Therapy Falls Short in Early Trialprnewswire.com
science22 days agoDeveloping

Entrada Duchenne Therapy Falls Short in Early Trial

Entrada Therapeutics reported that its next-generation exon-skipping drug for Duchenne muscular dystrophy did not meet expectations in an early-stage study. The company is among several developing improved treatments aimed at increasing functional dystrophin production in patient…

Stat
1 source
FDA Announces Initiative to Improve Clinical Trial Efficiency with Real-Time Data Reviewstockhead.com.au
ai30 days agoDeveloping

FDA Announces Initiative to Improve Clinical Trial Efficiency with Real-Time Data Review

The Food and Drug Administration announced efforts to enhance the efficiency of clinical trials by reviewing data in real time from studies by AstraZeneca and Amgen. The agency also sought public input on a potential pilot program incorporating artificial intelligence for tasks s…

Stat
1 source
FDA Greenlights First U.S. Trial of Ibogaine Derivative for Treating Alcohol Use DisorderSubstrate placeholder — needs review
finance34 days agoDeveloping

FDA Greenlights First U.S. Trial of Ibogaine Derivative for Treating Alcohol Use Disorder

The Food and Drug Administration has greenlit the first human clinical trial of an ibogaine derivative in the United States to test its potential as a treatment for alcohol use disorder. This follows President Trump's executive order to fast-track psychedelic research. The agency…

New York Post
fortune.com
2 sources
Revolution Medicines Presents Strong KRAS Drug Data and Preclinical Compound InsightsSubstrate placeholder — needs review
science37 days agoDeveloping

Revolution Medicines Presents Strong KRAS Drug Data and Preclinical Compound Insights

Revolution Medicines shared clinical trial success for its pancreatic cancer therapy last week and preclinical data on a new compound yesterday. The company also presented strong results for its KRAS drug at the AACR meeting on April 21, 2026. Additional biotech developments incl…

ST
1 source
Trial Data: Nipocalimab Reduces IgG by 64% in Myasthenia Gravis Patients Over 120 WeeksSubstrate placeholder — needs review
science37 days agoDeveloping

Trial Data: Nipocalimab Reduces IgG by 64% in Myasthenia Gravis Patients Over 120 Weeks

Johnson & Johnson's Imaavy (nipocalimab) showed sustained improvements in generalized myasthenia gravis through 120 weeks, according to seekingalpha.com. The treatment cut IgG levels by 64% and boosted symptom control. Imaavy is a product developed by J&J.

seekingalpha.com
1 source
Startup 10x Science Raises $4.8 Million to Analyze AI-Generated Drug CandidatesSubstrate placeholder — needs review
technology37 days agoDeveloping

Startup 10x Science Raises $4.8 Million to Analyze AI-Generated Drug Candidates

10x Science, a startup founded in December 2025, announced a $4.8 million seed funding round to develop a platform for characterizing potential drug candidates generated by AI models. The platform uses algorithms and AI to interpret mass spectrometry data for biologic drugs. Foun…

TE
1 source
Eli Lilly Acquires Kelonia Therapeutics for $3 Billion as Biotech Sector Sees New DevelopmentsSubstrate placeholder — needs review
science38 days agoDeveloping

Eli Lilly Acquires Kelonia Therapeutics for $3 Billion as Biotech Sector Sees New Developments

Eli Lilly completed a $3 billion acquisition of Kelonia Therapeutics, according to reports. A venture capital partner shared the original investment memo and slide deck for Kelonia. Other biotech news includes BioAge's inflammation trial results, a Pfizer executive departure, and…

ST
1 source
Revolution Medicines Reports Extended Survival in Pancreatic Cancer Trialnews.google.com
science42 days ago

Revolution Medicines Reports Extended Survival in Pancreatic Cancer Trial

Revolution Medicines announced results from a Phase 3 study of its experimental drug daraxonrasib for advanced pancreatic adenocarcinoma. Patients treated with the drug had a median survival of 13.2 months, compared to 6.7 months for those on standard chemotherapy. The company pl…

ST
1 source
Whitehawk Therapeutics Shares Spike After Citizens Launches Coverage with Outperform Ratinginsidermonkey.com
finance42 days ago

Whitehawk Therapeutics Shares Spike After Citizens Launches Coverage with Outperform Rating

Shares of Whitehawk Therapeutics rose sharply on Thursday following the initiation of coverage by Citizens. The firm assigned a Market Outperform rating to the stock. This development comes ahead of early-stage data readouts for the company's drug candidates licensed from WuXi Bi…

seekingalpha.com
1 source
GSK Presents Early-Stage Data on Experimental Cancer Drug and Plans Five Phase 3 TrialsSubstrate placeholder — needs review
science46 days ago

GSK Presents Early-Stage Data on Experimental Cancer Drug and Plans Five Phase 3 Trials

GSK presented data from an early-stage clinical trial of an experimental cancer drug over the weekend. The company stated that the results support advancing the drug to five Phase 3 trials this year. This development follows initial testing to evaluate the drug's safety and preli…

ST
1 source
Experimental Opioid Derivative DFNZ Shows Pain Relief Without Addiction or Respiratory Risks in Mouse Studyneurosciencenews.com
health50 days ago

Experimental Opioid Derivative DFNZ Shows Pain Relief Without Addiction or Respiratory Risks in Mouse Study

Researchers at the National Institute on Drug Abuse developed DFNZ, a derivative of nitazene compounds, which provided pain relief in mice for at least two hours without signs of addiction, tolerance, or breathing suppression. The study, published in Nature, suggests potential ap…

Fox News
1 source
Biotech Developments Include Duchenne Drug Class, Gilead Acquisitions and Industry UpdatesSubstrate placeholder — needs review
science50 days ago

Biotech Developments Include Duchenne Drug Class, Gilead Acquisitions and Industry Updates

A class of drugs for Duchenne muscular dystrophy has drawn attention in recent discussions. Gilead Sciences continues its series of mergers and acquisitions in the biotech sector. Additional news covers ongoing advancements and regulatory matters in biotechnology.

ST
1 source
Organoids Offer Potential in Research and Medicine with Calls for Usage BoundariesSubstrate placeholder — needs review
science51 days ago

Organoids Offer Potential in Research and Medicine with Calls for Usage Boundaries

Organoids, miniature organ models grown from stem cells, show promise for advancing fundamental research and medical applications. @Nature highlights their substantial potential benefits. The publication also advocates for establishing appropriate boundaries to guide their use.

NA
1 source
Insmed Halts Development of TPX-201 for Hidradenitis Suppurativa After Phase 2 Trial FailureOak Ridge National Laboratory / Wikimedia (CC BY 2.0)
world51 days ago

Insmed Halts Development of TPX-201 for Hidradenitis Suppurativa After Phase 2 Trial Failure

Insmed Incorporated announced the discontinuation of its topical drug TPX-201 for hidradenitis suppurativa following negative results from a Phase 2 clinical trial. The trial did not meet its primary endpoint of achieving Hidradenitis Suppurativa Clinical Response at Week 12. The…

RE
1 source