Drugs

Preclinical data support Evaxion’s platform behind CMV vaccine candidate

Tue, 14 Jul 2026 09:00:00 -0400

Human cytomegalovirus (CMV) is a clinical challenge in infants and immunocompromised individuals, since no licensed vaccine exists. Vaccine development is complex due to several factors, including viral latency, genomic complexity and immune evasion, among others. Evaxion A/S recently presented data on its proprietary AI-immunology platform used to create the EVX-V1 vaccine for CMV infection.

TICTACs remodel TAMs, reduce tumor burden and metastasis

Tue, 14 Jul 2026 09:00:00 -0400

In a recent study, scientists from Stanford University and collaborators aimed to develop a platform for specific tumor-immune cell targeting, focusing on tumor-associated macrophages (TAMs), with the eventual goal of interfacing with existing immune checkpoint inhibitor technologies.

Takeda's mezagitamab adds quality-of-life gains to ITP responses

Mon, 13 Jul 2026 12:00:00 -0400

Takeda Pharmaceutical Co. Ltd.’s anti-CD38 antibody mezagitamab (TAK-079) is showing benefits beyond platelet restoration, with new data suggesting the candidate may improve quality of life for patients with chronic immune thrombocytopenia (ITP) and sustain those gains after treatment ends.

Korea targets generics, innovation in drug pricing overhaul

Mon, 13 Jul 2026 12:00:00 -0400

South Korea is moving ahead with its biggest reform of drug review and pricing in more than a decade, reflecting a wider shift across Asian markets to reward innovation and tighten controls on generics.

JAKs or better: Q32 ups ante in AA with IL-7 antibody phase II

Mon, 13 Jul 2026 12:00:00 -0400

The clinically proven promise of an alopecia drug, without the risks of black box-bearing JAK inhibitors yet with powerful efficacy, led shares of Q32 Bio Inc. (NASDAQ:QTTB) to close July 13 at $21.38, up $10.17, or 90.7%.

SL Science seeks US orphan drug designation for γδ T-cell therapy

Mon, 13 Jul 2026 09:00:00 -0400

SL Science Holding Ltd. has submitted an orphan drug designation request to the FDA for its γδ T-cell therapy product, Vδ2+ γδ T cells, for the treatment of glioblastoma multiforme.

Engineered CAR Ts block birch pollen allergy

Mon, 13 Jul 2026 09:00:00 -0400

A new strategy based on regulatory T cells (Tregs) engineered with chimeric antigen receptors (CARs) has shown that cell therapies can be directed against soluble allergens to control inflammation. The findings open a potential path toward the development of antigen-specific cell therapies for allergies caused by pollen, food allergens or dust mites.

HLB, Hengrui receive third US FDA rejection on liver cancer combo

Fri, 10 Jul 2026 12:00:00 -0400

The U.S. FDA declined to approve, for a third time, an investigational liver cancer drug regimen comprising HLB Co. Ltd.’s rivoceranib and Jiangsu Hengrui Pharmaceutical Co. Ltd.’s camrelizumab, reportedly citing issues from a drug manufacturing facility inspection.

Combination locked out in ATTR-CM? ‘Dead,’ expert says

Fri, 10 Jul 2026 12:00:00 -0400

The synergy – or lack of it – between knockdown drugs and stabilizers in treating transthyretin (TTR)-mediated amyloid cardiomyopathy (ATTR-CM) became one of the topics for debate in the aftermath of the phase III fizzle with gene silencer Wainua (eplontersen), advanced by Astrazeneca plc and Ionis Pharmaceuticals Inc.

Microbial ecology reshapes cancer care, diagnostics and therapies

Fri, 10 Jul 2026 09:00:00 -0400

Cancer researchers are increasingly turning to the microbiome to understand why some patients respond well to treatment while others face severe complications. Gut microbial communities shift during intensive therapies such as bone marrow transplantation, and those changes influence infection risk, immune recovery and long‑term survival. New advances in microbial sequencing and engineering redefine this community as a measurable clinical parameter that can be monitored, modeled, and even therapeutically reshaped to improve outcomes in oncology and other conditions.

Apertura Gene Therapy enters CRADA for Niemann-Pick disease

Fri, 10 Jul 2026 09:00:00 -0400

Apertura Gene Therapy has entered into a cooperative research and development agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development and the National Human Genome Research Institute.

Atsena selects ATSN-401 clinical candidate for Stargardt disease

Fri, 10 Jul 2026 09:00:00 -0400

Atsena Therapeutics Inc. has selected a lead clinical candidate for ATSN-401, a gene therapy for Stargardt disease. ATSN-401 is now advancing in IND-enabling studies.

ARPA-H program supports advances for rare genetic diseases

Fri, 10 Jul 2026 09:00:00 -0400

The Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services, has announced the teams for the THRIVE (Treating Hereditary Rare diseases with In Vivo prEcision genetic medicines) program. With a commitment of up to $160 million over 5 years, THRIVE aims to accelerate solutions for rare genetic pediatric diseases across multiple technological approaches, clinical trial designs and deployment models.

Ionis, AZ shares down on unexpected Wainua flop in cardiomyopathy

Thu, 09 Jul 2026 12:00:00 -0400

News of the unexpected phase III failure of the gene silencing drug Wainua (eplontersen) in the treatment of transthyretin-mediated amyloid cardiomyopathy sent Astrazeneca plc’s shares (NYSE:AZN) down $10.88 to close July 9 at $178.40.

COVID-19 injuries, posting of CRLs on HHS’ 2027 rulemaking agenda

Thu, 09 Jul 2026 12:00:00 -0400

What appears to be a routine item on a routine list of the U.S. Department of Health and Human Services’ (HHS) proposed rulemakings for the next fiscal year is being seen as anything but routine, given HHS Secretary Robert Kennedy’s stance on vaccines and several commonly used drugs.

Forte, First Tracks soar on CD122 success in vitiligo; celiac next

Thu, 09 Jul 2026 12:00:00 -0400

Encouraging phase I data this week of new treatments for vitiligo, a chronic autoimmune disorder that destroys melanocytes, drove investor excitement, with Forte Biosciences Inc. the latest company to disclose a statistically significant benefit.

Grant supports Rybodyn’s antibody therapies for lung cancer

Thu, 09 Jul 2026 09:00:00 -0400

Rybodyn Inc. has been awarded $1.3 million from the U.S. Department of War to advance preclinical development of two novel antibody-based therapies for lung cancer.

Urogen’s UGN-501 gains IND clearance for bladder cancer

Thu, 09 Jul 2026 09:00:00 -0400

Urogen Pharma Ltd. has obtained IND approval from the FDA for UGN-501, a next-generation investigational oncolytic virus. A phase I study evaluating intravesical administration of UGN-501 in patients with non-muscle invasive bladder cancer (NMIBC) is expected to begin in the fourth quarter.

Island Pharma targets Ebola species lacking approved treatments

Wed, 08 Jul 2026 12:00:00 -0400

Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare opportunity to collect prospective human data in an active filovirus emergency.

Astrazeneca nabs PDE3/4 inhibitor for COPD in $2.1B Sino deal

Wed, 08 Jul 2026 12:00:00 -0400

Astrazeneca plc has added a dual PDE3/4 inhibitor candidate to its chronic obstructive pulmonary disease (COPD) portfolio via a deal worth up to $2.1 billion with Chia Tai Tianqing Pharmaceutical Group Co. Ltd., a Sino Biopharmaceutical Ltd. subsidiary.

Beijing Mabworks Biotech discloses new DLL3-targeting ADCs