Apnimed Set to Exit Sleep Disorder Joint Venture with Shionogi for $100M Upfront
Japanese pharmaceutical company Shionogi is buying out Apnimed’s 50% stake in their sleep‑disorder joint venture for an upfront payment of $100 million. The acquisition gives Shionogi full control over the partnership’s pipeline, which focuses on treatments for conditions such as obstructive sleep apnea and insomnia. With the buyout, Apnimed will exit the collaboration and redirect resources to its own development programs. The transaction highlights Shionogi’s commitment to expanding its presence in the niche sleep‑disorder market.
Clemastine Fumarate Activates Lipophagy to Promote Oligodendrocyte Progenitor Cells Differentiation and Remyelination in a Cuprizone-Induced Demyelination Model
Researchers discovered that clemastine fumarate activates lipophagy in oligodendrocyte progenitor cells (OPCs), clearing lipid droplets that impede differentiation. In vitro, the drug enhanced OPC maturation and removed myelin debris, while in a cuprizone‑induced mouse model it restored myelin integrity and...
Ecnoglutide Approval Intensifies Competition in China GLP-1 Obesity Market
China's National Medical Products Administration approved Sciwind Biosciences' Ecnoglutide injection, marking the country's fifth GLP‑1 obesity therapy. The drug demonstrated a 15.4% average weight loss in the Phase III SLIMMER trial, with over 90% of participants achieving at least 5%...
9th Annual Corporate Compliance & Transparency in Life Sciences Conference
The 9th Annual Corporate Compliance & Transparency in Life Sciences Conference convenes more than 20 compliance leaders, legal experts, and industry innovators for a single-stage event. Attendees will experience over 15 hands‑on presentations and case studies, targeting actionable strategies for...
Accumulus Technologies Launches the Accumulus Connector, Delivering Live Integration Across Regulatory Systems
Accumulus Technologies launched the Accumulus Connector, extending its platform into customers’ existing pharma and biotech systems for live, bi‑directional regulatory communication. The Connector provides real‑time, one‑click global submissions to more than 70 national regulators, eliminating manual data reconciliation. By integrating...
Japan's Drug Prices Are Creating Problems for Washington and Tokyo Alike
President Donald Trump and Japanese Prime Minister Sanae Takaichi discussed a $40 billion U.S. nuclear investment and pledged cooperation on drug‑pricing reform. Japan plans a 4% cut to total drug spending, further lowering reimbursements for new medicines. The article warns that...
Anesthetics as Emerging Therapeutics for Post-Traumatic Stress Disorder (PTSD): Bridging Bench and Bedside
A recent Molecular Psychiatry review highlights anesthetics as a promising new class of therapeutics for post‑traumatic stress disorder (PTSD). It outlines how NMDA‑receptor antagonists, α2‑adrenergic agonists, GABA‑A modulators and certain opioids can modulate fear circuitry and memory reconsolidation. Pre‑clinical models...
HIV Remains Suppressed in Some Patients After Treatment Withdrawal
Scientists at Gladstone Institutes identified two host genes, DDIT4 and ZNF254, that act as molecular locks keeping HIV dormant after antiretroviral therapy (ART) cessation. Multi‑omic analysis of 75 participants from analytical treatment interruption trials linked higher expression of these genes,...
FDA Drug Safety Communication: Avandia (Rosiglitazone) Labels Now Contain Updated Information About Cardiovascular Risks and Use in Certain Patients
The FDA has added explicit cardiovascular risk information, including heart‑attack warnings, to the labeling and Medication Guide for rosiglitazone (Avandia) and its combination products. The revised label restricts use to patients already on the drug or those whose blood sugar...
Market Shifts Powering the Growth of Sterile Injectable Manufacturing
The sterile injectable contract manufacturing market is rapidly evolving as demand surges for both large‑scale biologics and niche, small‑batch therapies. Leading CDMOs are responding by expanding production capacity, building global redundancy, and investing heavily in specialized talent. Development and pre‑commercial...
Timeline of Selected FDA Activities and Significant Events Addressing Substance Use and Overdose Prevention
Since 1995 the FDA has moved from approving standard opioid products to implementing a comprehensive regulatory regime aimed at curbing misuse and overdose. Key milestones include the 2007 authority to require Risk Evaluation and Mitigation Strategies (REMS), a series of...
CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
The FDA’s Center for Drug Evaluation and Research (CDER) launched the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) to create a regulatory pathway for emerging manufacturing technologies. FRAME focuses on four priority technologies—end‑to‑end continuous manufacturing, distributed manufacturing (including non‑traditional sites),...
More Data Support Investigational Drug Combo for HIV Therapy
Phase 3 data presented at the 2026 Conference on Retroviruses and Opportunistic Infections show that the doravirine‑islatravir (DOR/ISL) two‑drug regimen met non‑inferiority criteria versus the standard bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) triple‑pill. At week 48, 91.8% of participants on DOR/ISL achieved viral suppression compared...
BTK Inhibition in CLL: Comparing Brukinsa and Jaypirca Approaches
BTK inhibitors have become the cornerstone of chronic lymphocytic leukemia therapy, replacing traditional chemotherapy. Brukinsa (zanubrutinib) is a second‑generation irreversible inhibitor that offers high selectivity and strong efficacy in treatment‑naïve or early‑relapse patients, with reduced cardiovascular risk. Jaypirca (pirtobrutinib) is...
FDA Drug Safety Communication: Safety Review Update of Recombinant Human Growth Hormone (Somatropin) and Possible Increased Risk of Death
The FDA updated its safety review of recombinant human growth hormone (somatropin) after the French SAGhE study raised concerns about a possible increased risk of death. The agency identified significant design flaws in the study and found no supporting evidence...
Rheumatology Enters the Gut-Brain-Immune Axis
Healio’s latest editorial highlights the expanding role of GLP‑1 receptor agonists in immune‑mediated inflammatory diseases, emphasizing weight‑independent anti‑inflammatory mechanisms. Emerging data suggest central nervous system GLP‑1 activation can modulate peripheral immunity, linking the gut‑brain‑immune axis. The FDA’s recent approval of...
Takeda, Lilly Rejected by Supreme Court on Actos Fraud Lawsuit
The U.S. Supreme Court denied Takeda Pharmaceutical and Eli Lilly’s request to block a racketeering lawsuit, allowing a class action alleging the companies concealed Actos’s link to bladder cancer to proceed. The suit targets tens of thousands of insurers and other...
Contributor: How Much? Addressing Medicines’ Cost and Value
The article argues that drug pricing debates must focus on aligning prices with the full value medicines deliver to patients and society. It critiques current health technology assessment (HTA) practices for using narrow benefit definitions, which can depress prices and...
The Six Biotech Companies in Portugal You Should Know About in 2026
Portugal’s biotech sector is gaining momentum, highlighted by BIO‑Europe Spring in Lisbon. Six home‑grown companies—Beat Therapeutics, BSIM Therapeutics, Exogenus, Immunethep, Mondego Bio and TechnoPhage—are advancing novel therapies ranging from DDR inhibitors for pancreatic cancer to exosome‑based wound treatments and bacteriophage...
Reimagining Migraine Treatment: Alon Ironi of Theranica on Nerivio’s Journey to Nationwide Coverage
Theranica’s Nerivio, a remote electrical neuromodulation (REN) device, has secured nationwide coverage for roughly 130 million lives through Blue Cross Blue Shield plans. The therapy’s dual acute and preventive indications offer a drug‑free alternative that expands access to underserved groups such...
STAT+: Pharmalittle: We’re Reading About Iran War’s Impact on Pharma Supply Chain, a Pfizer Lyme Vaccine, and More
The ongoing Iran‑Israel conflict has not yet crippled global pharmaceutical supply chains, but it threatens the modest 0.3% of worldwide drug output and 0.6% of active‑pharmaceutical‑ingredient (API) production that originates in the region. Disruptions to key shipping lanes, especially the...
FDA Warns of Seizure Risk with some Parkinson’s Drugs
The FDA’s recent safety alert warns that high‑dose levodopa/carbidopa regimens can provoke seizures when patients develop vitamin B6 deficiency. Fourteen post‑marketing cases, including two fatalities, involved doses exceeding 1,000 mg daily and featured focal‑onset seizures that generalized. Vitamin B6 supplementation halted...
Kali Therapeutics Partners with Sanofi for KT501 in a ~$1.2B Deal
Kali Therapeutics has signed a license agreement with Sanofi granting the French giant exclusive worldwide rights to KT501, a next‑generation tri‑specific T‑cell engager aimed at B‑cell‑mediated autoimmune diseases. The deal provides Kali with $180 million in upfront and near‑term payments and...
Henlius Receives NMPA IND Clearance for HLX18 (Biosimilar, Opdivo)
Henlius announced that China’s National Medical Products Administration (NMPA) has granted IND clearance for HLX18, a biosimilar of Opdivo (nivolumab), targeting resected solid tumours. The company also reported first‑patient dosing in Phase I trials for HLX17 (Keytruda biosimilar) and HLX13...
Xilio Therapeutics Announces Pipeline and Business Updates and Fourth Quarter and Full Year 2025 Financial Results
Xilio Therapeutics reported a strong cash position of $137.5 million, extending its runway to the end of 2027, and highlighted significant pipeline advances. The company plans to file an IND for its bispecific PD‑1/masked IL‑2 candidate XTX501 in mid‑2026 and start...
Pyxis Oncology Provides Business Update and Reports Fourth Quarter and Full Year 2025 Financial Results
Pyxis Oncology announced completion of target enrollment for its Phase 1 MICVO monotherapy study in recurrent/metastatic head and neck cancer, enrolling roughly 40 patients. Interim CEO Thomas Civik highlighted promising early efficacy, with a 46% objective response rate as monotherapy and a...
STAT+: Insmed Drug Benefits Patients with Rare, Bacterial Lung Disease, Study Shows
Insmed announced that a Phase 3 trial showed adding its inhaled antibiotic Arikayce to standard therapy significantly improved respiratory symptoms and boosted culture conversion rates in patients with newly diagnosed mycobacterium avium complex (MAC) lung infection. The study met its primary...
Avalo Therapeutics Reports 2025 Financial Results and Recent Business Updates
Avalo Therapeutics announced its 2025 financial results, reporting $98.3 million in cash and short‑term investments that should fund operations into 2028. Research and development expenses jumped to $50.1 million, driven by the Phase 2 LOTUS trial of abdakibart (AVTX‑009) for hidradenitis suppurativa. The...
'Zombie' Cells Created by Transplanting Genomes Into Dead Bacteria
Researchers have revived a dead bacterial cell by transplanting the complete genome of Mycoplasma capricolum into a chemically inactivated host, creating the first living synthetic bacterium assembled from non‑living parts. The experiment builds on the 2010 landmark where a synthetic...
STAT+: Pfizer’s Lyme Vaccine Shows Efficacy, but Misses Key Statistical Hurdle
Pfizer and Valneva’s experimental Lyme vaccine cut the risk of infection by more than 70% in a late‑stage trial, offering a promising preventive tool for a disease that affects roughly 476,000 Americans annually. The study, however, missed its primary statistical...
STAT+: Apogee Therapeutics Data Show Long-Acting Eczema Drug Induced Relief with Less Frequent Injections
Apogee Therapeutics reported that its experimental long‑acting eczema biologic, zumilokibart, achieved sustained skin‑clearance in a mid‑stage trial. Seventy‑five percent of patients receiving the drug every three months and 85 % of those dosed every six months maintained an EASI‑75 response after...
IntraBio Reports the US FDA’s sNDA Submission of Aqneursa for Ataxia-Telangiectasia
IntraBio has filed a supplemental New Drug Application (sNDA) with the U.S. FDA seeking approval of Aqneursa (levacetylleucine) for Ataxia‑Telangiectasia (A‑T). The filing is supported by a Phase III trial that met its primary and key secondary endpoints and demonstrated a...
HUTCHMED Initiates P-III Trial of HMPL-760 + R-GemOx for R/R Diffuse Large B-Cell Lymphoma in China
HUTCHMED has launched a Phase III trial of HMPL‑760 combined with R‑GemOx in relapsed/refractory diffuse large B‑cell lymphoma (DLBCL) patients in China, dosing the first patient on March 20, 2026. The study will enroll approximately 240 patients who have failed first‑line therapy and...
A Targeted Nanozyme for STING Activation Improves BiTEs Therapy Outcomes in Colorectal Cancer
Researchers engineered a tumor‑targeted nanozyme, MnO2‑dsDNA@BiTE/APT, that simultaneously delivers a double‑strand DNA STING agonist and a PD‑L1/CD3 bispecific T‑cell engager. The MnO2 carrier releases Mn2+ ions, activating the STING pathway, while the surface‑bound BiTE recruits T cells to cancer cells....
Dizal Reports the P-III (WU-KONG28) Trial Results on Zegfrovy (Sunvozertinib) in EGFRm NSCLC
Dizal announced topline results from its Phase 3 WU‑KONG28 trial, comparing oral once‑daily Zegfrovy (sunvozertinib) to platinum‑based chemotherapy as first‑line treatment for advanced NSCLC with EGFR exon 20 insertion mutations. The study met its primary endpoint, demonstrating a statistically significant improvement in...
Mesoporous Silica Nanoparticles‐Based Formulations for Enhanced Oral Delivery of Peptide Drugs: A Case Study on Insulin
Researchers engineered mesoporous silica nanoparticles (MSN) to encapsulate insulin and co‑formulated them with succinylated β‑lactoglobulin into pH‑responsive tablets. Surface grafting with polyethylene glycol and phosphonate groups boosted insulin solubility by roughly 2.5‑fold and stabilized the particles in gastrointestinal fluids. The...
US Weight Loss Drugmakers Slash Prices in Fight to Win Customers
U.S. weight‑loss drugmakers are slashing GLP‑1 prices to win cash‑pay customers as insurers balk at coverage. Eli Lilly reduced Zepbound’s monthly cost by $50‑$100, bringing it to $299, while Wegovy now sells for $149 a month, far below its $1,600 launch...
Powering the Next Wave of Cell Therapy: From iPSC-Derived Cells to In Vivo Reprogramming
Induced pluripotent stem cells (iPSCs) are being engineered into diverse therapeutic cell types, while in vivo reprogramming aims to convert resident cells directly within patients, eliminating traditional cell‑manufacturing steps. Both strategies depend on precise recombinant growth factors, cytokines, extracellular matrix proteins...
Gene Therapies for Hearing Loss Strike an Encouraging Note in Embattled Modality
Gene‑therapy candidates for hereditary hearing loss are gaining traction as safety concerns ease with localized delivery. Regeneron’s DB‑OTO and Eli Lilly’s AK‑OTOF have each demonstrated clinically meaningful hearing improvements in early‑stage trials, positioning them as frontrunners for the first approved deafness...
9 Months In, FDA’s New Priority Voucher Program Still Clouded With Uncertainty
The FDA’s National Priority Voucher (CNPV) program, launched in June 2025, promises to cut drug review times from 10‑12 months to just one or two months for products that meet defined national priorities. Early successes include Johnson & Johnson’s Tecvayli/Darzalex...
NADPH Oxidase-1 Suppression Prolongs the Antidepressant-Like Effect of Ketamine
Researchers introduced K‑4, a novel AMPA‑receptor positive allosteric modulator, which produced rapid and sustained antidepressant‑like effects in treatment‑resistant depression rat models. Bulk RNA‑seq revealed that K‑4 markedly down‑regulated NADPH oxidase‑1 (NOX‑1) in the medial prefrontal cortex and lateral habenula. Pharmacological...
FDA Drug Safety Communication: Revised Recommendations for Celexa (Citalopram Hydrobromide) Related to a Potential Risk of Abnormal Heart Rhythms with...
The FDA issued a Drug Safety Communication clarifying that citalopram (Celexa) should not be prescribed above 40 mg daily because higher doses significantly prolong the QT interval and can trigger fatal Torsade de Pointes. The label now mandates a maximum of...
FDA Drug Safety Communication: Updated Information About the Risk of Blood Clots in Women Taking Birth Control Pills Containing Drospirenone
The FDA has updated labels for drospirenone‑containing oral contraceptives after reviewing epidemiologic studies that suggest a potentially higher risk of venous thromboembolism compared with other progestins. The new warnings note that some studies report up to a three‑fold increase in...
FDA Drug Safety Communication: New Warning and Contraindication for Blood Pressure Medicines Containing Aliskiren (Tekturna)
The FDA issued a drug safety communication on April 20, 2012, adding a contraindication for aliskiren‑containing antihypertensives when combined with ACE inhibitors or ARBs in patients with diabetes, and a warning for those with moderate to severe renal impairment. The...
FDA Drug Safety Communication: Updated Information on Drug Interactions Between Victrelis (Boceprevir) and Certain Boosted HIV Protease Inhibitor Drugs
The FDA issued an updated Drug Safety Communication warning that co‑administration of Victrelis (boceprevir) with ritonavir‑boosted HIV protease inhibitors—atazanavir, darunavir, or lopinavir/ritonavir—is not recommended for patients co‑infected with hepatitis C and HIV. The interaction lowers blood concentrations of both drugs,...
FDA Drug Safety Communication: Safety Review Update of Cancer Drug Revlimid (Lenalidomide) and Risk of Developing New Types of Malignancies
The FDA added a safety warning to Revlimid (lenalidomide) after clinical trials showed a markedly higher incidence of second primary malignancies in newly diagnosed multiple myeloma patients. Pooled data revealed a three‑fold increase (7.9% vs 2.8%) in cancers such as...
FDA Drug Safety Communication: Cefepime and Risk of Seizure in Patients Not Receiving Dosage Adjustments for Kidney Impairment
The FDA issued a Drug Safety Communication reminding clinicians to adjust cefepime doses for patients with creatinine clearance ≤ 60 mL/min. Non‑convulsive status epilepticus has been linked to inappropriate dosing, with 59 reported cases since 1996, 58 of which involved renal dysfunction...
FDA Drug Safety Communication: Seizure Risk for Multiple Sclerosis Patients Who Take Ampyra (Dalfampridine)
The FDA issued a Drug Safety Communication warning that dalfampridine (Ampyra), approved to improve walking in multiple sclerosis patients, carries a significant seizure risk, especially shortly after therapy initiation. Post‑marketing data show most seizures occur within days‑to‑weeks and in patients...
FDA Drug Safety Communication: FDA Recommends Against Use of Revatio (Sildenafil) in Children with Pulmonary Hypertension
The FDA issued a drug safety communication recommending that Revatio (sildenafil) not be prescribed to children aged 1‑17 for pulmonary arterial hypertension. A long‑term pediatric trial of 234 patients showed no exercise benefit and a three‑fold increase in mortality at...
Could Ozempic Help People Whose Cancer Has Spread to the Brain?
A large retrospective analysis of over 19,000 patients with cancer, type 2 diabetes and brain metastases found that those prescribed GLP‑1 receptor agonists such as Ozempic or Wegovy experienced a 37% reduction in three‑year mortality compared with matched controls. The survival...