Calls grow to bring CAR-T cell therapy into New Zealand’s public health system
Calls are growing to bring CAR-T cell therapy to New Zealand as the current trial is set to end later this year. There is no clear path to public availability.
News & Analysis
Curated news and analysis on clinical trials, drug approvals, and medical research.
Study suggests blood protein score may measure salivary gland inflammation in Sjögren’s disease
A study suggests a 16-protein blood test, the Sjögren’s protein score, may measure salivary gland inflammation without biopsy. The score correlated with glandular inflammation, antibodies, and extraglandular disease features.
Merck Wins FDA Approval for KEYTRUDA Regimen in PD-L1-Positive Platinum-Resistant Ovarian Cancer
Merck received FDA approval in early February 2026 for KEYTRUDA and KEYTRUDA QLEX in PD-L1-positive platinum-resistant ovarian cancer. The decision marks the first approval of a PD-1 inhibitor regimen for this setting.
Isomorphic Labs Advances AI-Designed Cancer Drug Toward Human Trials
Isomorphic Labs said one AI-designed drug, ISM8969, has FDA clearance for human clinical trials. The company’s initial pipeline focuses on oncology candidates.
Zocilurtatug pelitecan shows responses in pretreated extrapulmonary neuroendocrine carcinomas
Zocilurtatug pelitecan showed an overall response rate of 38.2% and a disease control rate of 55.9% in 34 patients with pretreated extrapulmonary neuroendocrine carcinomas. Grade 3 or higher treatment-emergent adverse effects occurred in 30.4% of patients.
Everest Medicines launches VELSIPITY in Mainland China after NMPA approval
Everest Medicines launched VELSIPITY in Mainland China after NMPA approval on February 2, 2026. The first prescription was issued at The First Affiliated Hospital of Sun Yat-sen University.
Medtronic reports interim Sphere-9 VT data and receives FDA breakthrough designation
Medtronic reported interim Affera Sphere-9 data showing 65.5% of VT patients were free from recurrence at six months. The FDA granted Breakthrough Device designation for Sphere-9 and approved a U.S. pivotal IDE.
Nanoparticle gene editing restores CFTR function in cystic fibrosis lab model
Researchers developed a lipid nanoparticle gene-editing approach that inserted a full CFTR gene into airway cells and restored 88% to 100% of normal channel function in a cystic fibrosis lab model.
Study links tirzepatide use to lower diabetic retinopathy risk
A study in Ophthalmology found tirzepatide use was associated with lower 12-month risk of new or progressive diabetic retinopathy versus lifestyle intervention alone. The analysis included about 174,000 matched patients.
Canada Energy Regulator backs Westcoast Energy's Sunrise pipeline expansion
Canada’s energy regulator recommended approval of Westcoast Energy’s Sunrise Expansion Program in British Columbia. The project is intended to meet anticipated demand from the Woodfibre LNG facility starting in 2027.
HHS Budget Hearings, Medicare Fraud Review and PBM Reform Mark US Health Policy Week
US health policy activity this week included HHS FY 2027 budget hearings, a House review of Medicare fraud and bipartisan discussion of PBM reform. President Trump also issued an executive order on mental illness treatments, and CMS and FDA announced the RAPID pathway.
India’s generic semaglutide rollout shifts focus beyond price
Generic semaglutide launched in India as Novo Nordisk’s patent expired, with prices starting below Rs 1,300 a month. Doctors and companies said device quality, cold chains and patient support will also shape sales.
Support for sharing health data for AI hinges on safeguards, consent and public benefit
A U.K. focus-group study found support for sharing health data for AI is conditional on public benefit, safeguards and meaningful consent. The findings come as Europe tightens control over biomedical datasets under data-sovereignty policies.
BioNTech heads into May with earnings, shareholder vote and oncology pipeline focus
BioNTech enters May with first-quarter earnings due May 5 and a May 15 shareholder vote on a capital increase. The company is pushing its oncology pipeline as COVID-19 vaccine sales decline.
Oncotelic highlighted in editorial on biotech valuation and advancing drug pipelines
Oncotelic Therapeutics said it was featured in an editorial on how advancing drug pipelines are driving biotech valuation. The company cited its oncology pipeline, AI-enabled platform and 45% stake in GMP Bio.
Quanterix to report first-quarter 2026 financial results on May 6
Quanterix said it will host a conference call on May 6, 2026, at 4:30 p.m. E.T. to discuss first-quarter 2026 financial results. A press release will be issued after the market closes the same day.
ImmunityBio launches ANKTIVA in Saudi Arabia after accelerated lung cancer approval
ImmunityBio has commercially launched ANKTIVA in Saudi Arabia for approved bladder and metastatic non-small cell lung cancer indications. The launch follows accelerated approval in lung cancer and extends the drug’s commercial rollout in MENA.
WHO prequalifies Novartis Coartem Baby for newborn malaria treatment
WHO has prequalified Coartem Baby, the first malaria treatment developed for newborns and young infants weighing 2 to 5 kilograms. The decision opens access through public procurement and donor-funded programs.
Moderna shares rise after earnings beat as FDA flu vaccine setback weighs on outlook
Moderna shares rose after the company reported quarterly results that beat earnings and revenue estimates. The stock move came as investors also weighed an FDA refusal-to-file for its mRNA flu vaccine and ongoing funding concerns.
BridgeBio shares rise on Phase 3 FORTIFY data for BBP-418 in LGMD2I/R9
BridgeBio shares rose 2.10% to $69.41 after Phase 3 FORTIFY interim data for oral BBP-418 in LGMD2I/R9 showed broad efficacy and placebo-matched safety. The company plans a U.S. FDA filing in H1 2026.
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