Curated news and analysis on clinical trials, drug approvals, and medical research.
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.
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.
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 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 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 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 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 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 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 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.
A new U.S. clinical study will test whether provider-mediated communication of colorectal cancer genetic risk increases family genetic testing. The trial plans to enroll around 4,000 patients and relatives.
Alvotech said it will release first-quarter 2026 financial results on May 6, 2026, and host a webcast with live Q&A on May 7. The company said five biosimilars are already approved and marketed, with nine disclosed candidates in development.
The EMA’s CHMP recommended approval of Sanofi’s Cenrifki (tolebrutinib) for non-relapsing secondary progressive multiple sclerosis. The phase 3 HERCULES study showed reduced disability progression, while liver injury remains an identified safety risk.
Novartis received a positive CHMP opinion for Itvisma in spinal muscular atrophy patients aged 2 years and older. A European Commission decision is expected within about two months.
Recent studies described structural states of human GHRHR and de novo designed GPCR exoframe modulators targeting the dopamine D1 receptor. The findings outline new approaches for allosteric GPCR modulation and precision therapeutics.
Tempus AI signed an agreement to provide precision medicine technology to the University of Southern California. USC will gain access to molecular diagnostics, genomic profiling, clinical trial matching and AI tools.
Researchers at McMaster University said their SyntheMol-RL AI model designed a new antibiotic candidate called synthecin. In mouse wound infection models, the topical compound was highly effective against drug-resistant Staphylococcus aureus.
Moderna reported Q4 2025 revenue of $678 million, down 30%, and a net loss of $826 million, improved from a $1.1 billion loss a year earlier. The company also issued 2026 revenue and expense targets.
A preclinical study in Precision Clinical Medicine found that luteolin and astragaloside IV improved recovery after severe spinal cord injury in cell and rat models. The combined treatment reduced oxidative stress and neuroinflammation and improved motor function over five weeks.
The European Commission has launched the Bioeconomy Investment Deployment Group and outlined a €350 million package for food and biotech innovation. The measures target financing gaps that have slowed scale-up from pilot projects to industrial deployment.
