Pharma News and Headlines

Third FDA Rejection for Aldeyra’s Dry Eye Disease Drug Sends Shares Plummeting
NewsMar 17, 2026

Third FDA Rejection for Aldeyra’s Dry Eye Disease Drug Sends Shares Plummeting

The FDA issued a third complete response letter rejecting Aldeyra Therapeutics' lead dry‑eye candidate, reproxalap, citing a lack of substantial evidence and inconsistent efficacy data. The agency noted the drug failed to demonstrate clear benefit in well‑controlled studies, though no...

By BioSpace
Gifthealth Launches Off-the-Shelf Solution for Most Favored Nation Pricing
NewsMar 17, 2026

Gifthealth Launches Off-the-Shelf Solution for Most Favored Nation Pricing

Gifthealth unveiled an off‑the‑shelf platform that enables manufacturers to offer Most Favored Nation (MFN) pricing through direct‑to‑patient (DTP) programs. The solution leverages Gifthealth’s position as the nation’s largest DTP partner, handling over 90% of U.S. DTP volume and supporting more...

By PharmaLive
Can Bristol Myers Squibb’s Pipeline Strategy Offset a Major Patent Cliff?
NewsMar 17, 2026

Can Bristol Myers Squibb’s Pipeline Strategy Offset a Major Patent Cliff?

Bristol Myers Squibb faces a major patent cliff as flagship drugs like Revlimid, Pomalyst, Opdivo and Eliquis lose exclusivity, threatening its revenue base. To counteract the decline, the company is reshaping its pipeline through internal R&D and high‑profile acquisitions, emphasizing...

By Labiotech.eu
NVIDIA and Persistent Systems Partner to Bring ‘Agentic AI’ to Drug Discovery
NewsMar 17, 2026

NVIDIA and Persistent Systems Partner to Bring ‘Agentic AI’ to Drug Discovery

Persistent Systems has partnered with NVIDIA to bring Agentic AI to the healthcare and life‑sciences sector, focusing on computational drug discovery. Leveraging NVIDIA’s full AI stack—including AI Enterprise, BioNeMo, the NeMo Agent Toolkit, and NIM microservices—Persistent built GenMolVS, a generative...

By HIT Consultant
EMA Marketing Authorization of New Drugs in February 2026
NewsMar 17, 2026

EMA Marketing Authorization of New Drugs in February 2026

In February 2026 the European Commission and the CHMP granted marketing authorisations and positive opinions for a slate of innovative therapies spanning COVID‑19, oncology, cardiology, immunology and rare diseases. Notable approvals include Moderna’s mNEXSPIKE COVID‑19 vaccine, Hansoh’s Aumseqa for EGFR‑mutated...

By PharmaShots
Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer
NewsMar 17, 2026

Pfizer Reports P-II (FOURLIGHT-1) Trial Data on Atirmociclib Combination for 2L Metastatic Breast Cancer

Pfizer disclosed topline Phase II (FOURLIGHT‑1) data showing that atirmociclib combined with fulvestrant outperformed fulvestrant alone or everolimus + exemestane in 264 HR+, HER2‑negative metastatic breast cancer patients previously treated with CDK 4/6 inhibitors. The trial met its primary endpoint, delivering a statistically significant...

By PharmaShots
Cancer Vaccines Could Transform Treatment and Prevention – but Misinformation About mRNA Vaccines Threatens Their Potential
NewsMar 17, 2026

Cancer Vaccines Could Transform Treatment and Prevention – but Misinformation About mRNA Vaccines Threatens Their Potential

Scientists are accelerating development of mRNA cancer vaccines, with more than 120 clinical trials targeting melanoma, brain, breast, lung and prostate tumors. Early studies, such as personalized vaccines for glioblastoma, demonstrate rapid immune activation and improved survival. Simultaneously, a false...

By The Conversation (US) – Health & Medicine
China’s Control Over US Drug Supply Alarms Lawmakers
NewsMar 17, 2026

China’s Control Over US Drug Supply Alarms Lawmakers

U.S. lawmakers warned that China dominates the supply chain for essential hospital and outpatient medicines, especially generic drugs that fill 90% of prescriptions. Witnesses at a Senate Aging Committee hearing highlighted that China controls roughly 90% of key starting materials...

By Forbes – Healthcare
Scientists Finally Reveal How This Alzheimer’s Drug Really Works
NewsMar 17, 2026

Scientists Finally Reveal How This Alzheimer’s Drug Really Works

Scientists from VIB and KU Leuven have identified the mechanism by which lecanemab (Leqembi) clears amyloid plaques in Alzheimer’s disease. Their study shows that the antibody’s Fc fragment engages microglia, reprogramming them to phagocytose and degrade plaques. Removing the Fc...

By ScienceDaily – Neuroscience
R1: China-to-U.S. NewCo Planning Global Testing of New CKD Mechanism
NewsMar 17, 2026

R1: China-to-U.S. NewCo Planning Global Testing of New CKD Mechanism

The article outlines BioCentury’s cookie policy, detailing categories of cookies used on its website. Strictly necessary cookies are always active and enable authentication, registration, and core navigation. Functional, marketing, advertising, and analytics cookies provide personalization, targeted promotions, ad tracking, and...

By BioCentury
Balancing the Risks and Rewards of Drug Development in China: A Small Biotech CEO Perspective
NewsMar 17, 2026

Balancing the Risks and Rewards of Drug Development in China: A Small Biotech CEO Perspective

The blog by HotSpot Therapeutics CEO Jonathan Montagu argues that China is no longer just a manufacturing hub but a burgeoning source of innovative drug candidates, evidenced by its 17% lead over the U.S. in Nature’s Index and nearly half...

By LifeSciVC
AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers
NewsMar 17, 2026

AstraZeneca Secures the EC Approval of Imfinzi as a Perioperative Therapy for G/GEJ Cancers

The European Commission has granted approval for AstraZeneca’s Imfinzi (durvalumab) combined with FLOT chemotherapy as a perioperative treatment for resectable, early‑stage and locally advanced gastric and gastro‑esophageal junction (G/GEJ) cancers. The decision is based on the Phase III MATTERHORN trial, which...

By PharmaShots
GEN Secures BEBO Foundation Approval for Phase II PD Trial
NewsMar 17, 2026

GEN Secures BEBO Foundation Approval for Phase II PD Trial

GEN Pharmaceuticals received BEBO Foundation ethical approval to launch a Phase II proof‑of‑concept trial of its mitochondrial‑targeting drug SUL‑238 in Parkinson’s disease. The single‑centre, randomised, double‑blind, placebo‑controlled study, named SHEPHERD, will begin patient enrolment in Groningen in April 2026. Over a 28‑day...

By Hospital Management
Opinion: Semaglutide Is Going Off-Patent in India. But Will People Who Need It Be Able to Get It?
NewsMar 17, 2026

Opinion: Semaglutide Is Going Off-Patent in India. But Will People Who Need It Be Able to Get It?

Semaglutide’s patent will lapse in India on March 24, 2026, unlocking generic competition that could slash prices by up to 90%. The GLP‑1 drug, sold as Ozempic and Wegovy, has been shown to cut major cardiovascular events by 20%. Indian regulators, however,...

By STAT News — Pharma
STAT+: White House Digs in on ‘Most-Favored Nation’ Drug Pricing Despite Congress’ Cool Reception
NewsMar 17, 2026

STAT+: White House Digs in on ‘Most-Favored Nation’ Drug Pricing Despite Congress’ Cool Reception

The White House is intensifying pressure on Congress to pass a “most‑favored nation” drug‑pricing bill that would cap U.S. medication prices at levels paid by peer nations. Administration officials say the proposal would overhaul pricing for providers, insurers, federal programs...

By STAT (Biotech)
NeuroScientific Readies Stem Cell Supply Boost for Bowel Disease Trials
NewsMar 17, 2026

NeuroScientific Readies Stem Cell Supply Boost for Bowel Disease Trials

NeuroScientific Biopharmaceuticals has begun its first manufacturing run of the StemSmart mesenchymal stem cell therapy at Q‑Gen Cell Therapeutics in Brisbane, initiating a critical technology transfer. The engineering run will validate quality, potency and regulatory compliance ahead of a Phase 2...

By The Age – Business
Abeona Therapeutics Inc (ABEO) Q4 2025 Earnings Call Transcript
NewsMar 17, 2026

Abeona Therapeutics Inc (ABEO) Q4 2025 Earnings Call Transcript

Abeona Therapeutics reported its Q4 2018 results, highlighting progress on its lead cell therapy EB-101 for recessive dystrophic epidermolysis bullosa (RDEB). The Phase 1/2 trial demonstrated continuous type VII collagen expression for over two years, a favorable safety profile, and durable wound...

By Motley Fool – Earnings Transcripts
No Evidence to Suggest Medicinal Cannabis Is Effective for Depression, Anxiety or PTSD, Says Systematic Review
NewsMar 16, 2026

No Evidence to Suggest Medicinal Cannabis Is Effective for Depression, Anxiety or PTSD, Says Systematic Review

A systematic review published in Lancet Psychiatry, analysing 54 randomized controlled trials from 1980‑2025, found no evidence that medicinal cannabis treats depression, anxiety or PTSD. The paper highlights modest benefits for conditions such as epilepsy, multiple sclerosis spasticity, pain and...

By Medical Xpress
Roche Bought Thousands Of Nvidia AI Chips To Speed Up Drug Development
NewsMar 16, 2026

Roche Bought Thousands Of Nvidia AI Chips To Speed Up Drug Development

Roche announced a new AI factory, adding 2,176 Nvidia Blackwell GPUs to its existing pool and bringing total GPU count above 3,500 – the highest in the pharmaceutical sector. The purchase, likely costing $65 million or more, aims to accelerate drug...

By Forbes – Healthcare
TrumpRx List Grows To 54 Drugs, Many Nearing End Of Exclusivity
NewsMar 16, 2026

TrumpRx List Grows To 54 Drugs, Many Nearing End Of Exclusivity

The TrumpRx website now lists 54 prescription drugs after adding seven products from GlaxoSmithKline and Amgen. The expansion pushes the total from 47 to 54, but health‑policy analysts note that the majority are older medicines nearing the end of their...

By Inside Health Policy
New Recommendations for Naloxone
NewsMar 16, 2026

New Recommendations for Naloxone

On July 23, 2020 the FDA issued new recommendations urging health‑care professionals to discuss and consider prescribing naloxone for any patient at heightened risk of opioid overdose. The guidance covers three groups: patients on opioid pain relievers, patients receiving medications...

By FDA
Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use
NewsMar 16, 2026

Benzodiazepine Drug Class: Drug Safety Communication - Boxed Warning Updated to Improve Safe Use

The FDA is revising the boxed warning for every benzodiazepine product to explicitly list risks of abuse, misuse, addiction, physical dependence, and withdrawal. Updated patient Medication Guides will mirror these warnings, and prescribing information sections such as Warnings, Precautions, and...

By FDA
Sleep Disorder (Sedative-Hypnotic) Drug Information
NewsMar 16, 2026

Sleep Disorder (Sedative-Hypnotic) Drug Information

The FDA has issued a series of safety communications and label updates for sedative‑hypnotic drugs, including a 2019 boxed warning for sleepwalking injuries and stricter dosing guidance for zolpidem products. Recent alerts also highlight the lethal risk of combining benzodiazepines...

By FDA
FDA Drug Safety Communication: Updated Drug Labels for Pioglitazone-Containing Medicines
NewsMar 16, 2026

FDA Drug Safety Communication: Updated Drug Labels for Pioglitazone-Containing Medicines

The FDA has approved updated labeling for all pioglitazone‑containing medicines, adding a warning that use longer than one year may increase bladder cancer risk. Healthcare professionals are instructed not to prescribe pioglitazone to patients with active bladder cancer and to...

By FDA
FDA Drug Safety Communication: FDA Approves Label Changes for Use of General Anesthetic and Sedation Drugs in Young Children
NewsMar 16, 2026

FDA Drug Safety Communication: FDA Approves Label Changes for Use of General Anesthetic and Sedation Drugs in Young Children

The FDA has approved label changes for general anesthetic and sedation drugs used in children under three, adding a warning that prolonged exposure—more than three hours or multiple procedures—may harm brain development. The revisions incorporate animal study data showing neuronal...

By FDA
Ultrasound-Activated Nanoparticles Breach Bacterial Biofilms
NewsMar 16, 2026

Ultrasound-Activated Nanoparticles Breach Bacterial Biofilms

Scientists have engineered silica‑based nanoparticles that encapsulate rifampicin and release it only when exposed to low‑frequency ultrasound. The ultrasound both propels the particles through the protective matrix of bacterial biofilms and triggers cavitation that opens the particles, delivering the antibiotic...

By Chemical & Engineering News (ACS)
STAT+: Asthma Patients Suffered as GSK Pursued ‘Egregious’ Price Hikes, Senator Says
NewsMar 16, 2026

STAT+: Asthma Patients Suffered as GSK Pursued ‘Egregious’ Price Hikes, Senator Says

GlaxoSmithKline replaced its Flovent HFA and Flovent Diskus inhalers with an identical authorized‑generic version priced substantially higher. The move was designed to sidestep Medicaid rebate requirements, prompting health plans and pharmacy benefit managers to erect new access hurdles. Senator Maggie...

By STAT News — Pharma
VIS-101 Shows Safety, Rapid Efficacy in Wet AMD
NewsMar 16, 2026

VIS-101 Shows Safety, Rapid Efficacy in Wet AMD

NovaBridge’s VIS‑101, a dual VEGF‑A and angiopoietin‑2 inhibitor, delivered rapid and durable efficacy in a phase 2a trial of 38 wet AMD patients in China. Participants receiving 3 mg or 6 mg doses achieved mean visual gains exceeding 10 ETDRS letters and central...

By Healio
Structure Therapeutics Inc. (GPCR) Discusses Positive Topline Results From ACCESS II and Related Studies of Aleniglipron Oral GLP-1 Transcript
NewsMar 16, 2026

Structure Therapeutics Inc. (GPCR) Discusses Positive Topline Results From ACCESS II and Related Studies of Aleniglipron Oral GLP-1 Transcript

Structure Therapeutics announced positive topline data from its ACCESS II trial of aleniglipron, an oral small‑molecule GLP‑1 receptor agonist. The study demonstrated statistically significant reductions in HbA1c and weight loss comparable to injectable GLP‑1 therapies. Safety signals were mild, with few...

By Seeking Alpha — Site feed
CytomX Surges on Positive Data for ‘Masked’ ADC in Colorectal Cancer
NewsMar 16, 2026

CytomX Surges on Positive Data for ‘Masked’ ADC in Colorectal Cancer

CytomX Therapeutics’ shares surged 66% after the company released expansion data from its Phase 1 study of Varseta‑M, a masked antibody‑drug conjugate targeting EpCAM in late‑stage colorectal cancer. The trial evaluated three dose levels, with the two highest doses achieving response...

By BioPharma Dive
Sun Pharma's Tildrakizumab Advances Into Psoriatic Arthritis as FDA Accepts sBLA
NewsMar 16, 2026

Sun Pharma's Tildrakizumab Advances Into Psoriatic Arthritis as FDA Accepts sBLA

Sun Pharmaceutical's tildrakizumab (Ilumya) received FDA acceptance for a supplemental biologics license application to treat active psoriatic arthritis. The sBLA is backed by two Phase III INSPIRE studies involving more than 800 patients, which met primary endpoints with significant ACR20 improvements...

By BioPharm International
This Hidden Immune Signal Could Change Cancer Therapy
NewsMar 16, 2026

This Hidden Immune Signal Could Change Cancer Therapy

Researchers have identified that a surface‑defensive molecule on cancer cells not only sends a “don’t‑eat‑me” signal but also conceals an “eat‑me” cue that would normally trigger immune clearance. A newly engineered antibody can disrupt this masking interaction, making tumors visible...

By Forbes – Healthcare
Bimekizumab Does Not Increase Depression, Suicide Risk Vs. Other Psoriasis Biologics
NewsMar 16, 2026

Bimekizumab Does Not Increase Depression, Suicide Risk Vs. Other Psoriasis Biologics

A retrospective TriNetX analysis of 1,691 psoriasis patients compared bimekizumab with IL‑23 inhibitors and found no greater incidence of new‑onset depression, suicidal ideation, or related medication use. Over a two‑year follow‑up, the combined psychiatric event rate was 4.9% for bimekizumab...

By Healio
Off-Prescription Adderall Increases Blood Pressure, Heart Rate
NewsMar 16, 2026

Off-Prescription Adderall Increases Blood Pressure, Heart Rate

A randomized, double‑blind study published in Mayo Clinic Proceedings found that a single 25 mg dose of off‑prescription Adderall caused significant acute increases in blood pressure and heart rate among healthy young adults. Systolic pressure rose by roughly 10 mm Hg, diastolic by...

By Healio
Six Biotech Companies Advancing the Next Generation of Prostate Cancer Therapies
NewsMar 16, 2026

Six Biotech Companies Advancing the Next Generation of Prostate Cancer Therapies

Six biotech firms are pushing next‑generation prostate‑cancer therapies through late‑stage trials and financing milestones. Candel Therapeutics secured a $100 million royalty deal to fund aglatimagene’s launch, while Coherus Oncology closed a $50.1 million offering and partnered with J&J for a CCR8 antibody...

By Labiotech.eu
Elevara Begins Phase 2b Trial of ELV001 in Rheumatoid Arthritis
NewsMar 16, 2026

Elevara Begins Phase 2b Trial of ELV001 in Rheumatoid Arthritis

Elevara Medicines has dosed the first patient in its phase 2b START‑SYNERGY trial, testing the oral CDK4/6 inhibitor ELV001 in rheumatoid arthritis patients who have failed methotrexate and TNF inhibitors. The randomized, placebo‑controlled study will enroll about 180 participants across nine...

By PharmaTimes
China Startup CirCode Gets Clearance for Trial of Circular RNA Therapy
NewsMar 16, 2026

China Startup CirCode Gets Clearance for Trial of Circular RNA Therapy

Cir‑Code Bio‑med, a Chinese biotech focused on circular RNA medicines, has secured an Investigational New Drug (IND) approval from the U.S. Food and Drug Administration to commence its first human trial. The therapy targets a rare genetic disorder using a...

By Endpoints News
STAT+: Structure Therapeutics Reports Significant Weight Loss From Mid-Stage GLP-1 Pill
NewsMar 16, 2026

STAT+: Structure Therapeutics Reports Significant Weight Loss From Mid-Stage GLP-1 Pill

Structure Therapeutics announced that its daily oral GLP‑1 obesity pill produced an average 16% body‑weight reduction versus placebo after 44 weeks in a Phase 2 trial. The result outperforms Eli Lilly’s orforglipron, which showed about 11% loss over 72 weeks, and rivals...

By STAT (Biotech)
Structure Therapeutics Reports More Phase 2 Data for Oral GLP-1
NewsMar 16, 2026

Structure Therapeutics Reports More Phase 2 Data for Oral GLP-1

Structure Therapeutics released Phase 2 data for its oral GLP‑1 agonist, positioning the candidate as a next‑generation alternative to injectable therapies from Eli Lilly and Novo Nordisk. The trial demonstrated a mean 30% reduction in HbA1c and 70% of participants achieving target...

By Endpoints News
The Peptide Boom Is Getting Out of Hand
NewsMar 16, 2026

The Peptide Boom Is Getting Out of Hand

The Atlantic outlines a surge in off‑label and experimental peptide use, noting that Vyleesi—approved for women’s hypoactive sexual desire disorder—is being bought by men through “research use only” listings and online pharmacies. Compounding pharmacies and telehealth firms now market customized...

By The Atlantic (Health)
Widespread US Shift From Prescription to OTC Lies in Pharma’s Hands
NewsMar 16, 2026

Widespread US Shift From Prescription to OTC Lies in Pharma’s Hands

The FDA is accelerating the shift of prescription medicines to over‑the‑counter status, highlighted by Commissioner Marty Makary’s call for broader OTC availability and the introduction of the Additional Condition for Non‑Prescription Use (ACNU) framework. Former FDA counsel Heidi Gertner stresses...

By Pharmaceutical Technology (GlobalData)
Pete Pharma Partners with Atrium24 on Pharmacy 3D Printing
NewsMar 16, 2026

Pete Pharma Partners with Atrium24 on Pharmacy 3D Printing

Pete Pharma has entered a strategic partnership with Atrium24 Technologies, designating Pete Pharma as the primary 3D‑printing provider within Atrium24’s group‑ purchasing organization. The deal gives Atrium24‑member independent pharmacies preferred pricing on Pete Pharma’s FABRx 3D‑printing platform, enabling on‑site production...

By Engineering.com
Biophytis and LynxKite Expand Alliance to Boost AI-Driven Drug Discovery
NewsMar 16, 2026

Biophytis and LynxKite Expand Alliance to Boost AI-Driven Drug Discovery

Biophytis has broadened its alliance with AI specialist LynxKite to fast‑track longevity drug discovery, launching the MASSIVE project that seeks Mas receptor activators for sarcopenia. Backed by Enterprise Singapore, the partnership will augment Biophytis’ computational platform with LynxKite’s chemoinformatics, advanced...

By Pharmaceutical Technology (GlobalData)
Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease
NewsMar 16, 2026

Bayer Reports the P-III (FIND-CKD) Trial Data on Kerendia in Non-Diabetic Chronic Kidney Disease

Bayer disclosed results from the pivotal Phase III FIND‑CKD trial evaluating Kerendia (finerenone) in more than 1,500 adults with non‑diabetic chronic kidney disease. Patients received 10 mg or 20 mg of Kerendia alongside standard of care and were compared with placebo. The study...

By PharmaShots
J&J Reports Positive Data for Erda-iDRS in Bladder Cancer
NewsMar 16, 2026

J&J Reports Positive Data for Erda-iDRS in Bladder Cancer

Johnson & Johnson announced encouraging Phase I data for its intravesical drug‑releasing system Erda‑iDRS in non‑muscle‑invasive bladder cancer (NMIBC) with FGFR alterations. The trial met its primary safety endpoint and delivered an 89% complete response rate in intermediate‑risk patients, with responses...

By Hospital Management
Roche Receives CE Mark for Its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing
NewsMar 16, 2026

Roche Receives CE Mark for Its Elecsys ApoE4 Test to Support Blood-Based Alzheimer’s Biomarker Testing

Roche has secured CE Mark approval for its Elecsys ApoE4 in‑vitro diagnostic immunoassay, a blood‑based test that detects the ApoE4 gene variant linked to Alzheimer’s disease. In a validation study of 607 patients with cognitive complaints, the assay achieved 100%...

By PharmaShots
Viatris Settles Lawsuit Over Use of Woman’s ‘Immortal’ Cells to Power Drug Research
NewsMar 16, 2026

Viatris Settles Lawsuit Over Use of Woman’s ‘Immortal’ Cells to Power Drug Research

Viatris agreed to dismiss the Henrietta Lacks estate lawsuit with prejudice, ending claims that the company used HeLa cells without permission in its herpes drug Denavir and depression treatment Mylan‑Mirtazapine. The settlement details were kept confidential. This resolution follows similar...

By Claims Journal
Denali’s Hunter Syndrome Candidate in the Spotlight After REGENXBIO Rejection
NewsMar 16, 2026

Denali’s Hunter Syndrome Candidate in the Spotlight After REGENXBIO Rejection

REGENXBIO's gene therapy RGX‑121 for Hunter syndrome received an FDA Complete Response Letter, with the agency flagging patient‑eligibility definitions, natural‑history control comparability, and the surrogate endpoint as problematic. The rejection redirects focus to Denali Therapeutics, whose enzyme‑replacement candidate tividenofusp alfa...

By BioSpace
Vitamin B2 Pathway Identified as Potential Target for Cancer Therapy
NewsMar 16, 2026

Vitamin B2 Pathway Identified as Potential Target for Cancer Therapy

A CRISPR‑Cas9 screen revealed that riboflavin (vitamin B2) sustains the ferroptosis suppressor protein FSP1, shielding cancer cells from iron‑driven lipid peroxidation. Depleting vitamin B2 destabilizes FSP1 and renders tumor cells highly susceptible to ferroptosis. The researchers demonstrated that roseoflavin, a bacterial analog...

By GEN (Genetic Engineering & Biotechnology News)