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The regulator has placed a clinical hold on RAPT Therapeutics’ drug zelnecirnon, which was being investigated in atopic dermatitis and asthma, after a patient experienced liver failure.

Two surprise companies, Vertex Pharmaceuticals and Regeneron Pharmaceuticals, made GlobalData’s list with 41.4% and 21.8% market capitalization growth, respectively.

While AstraZeneca discontinued its Phase IIb trial for tozorakimab, the pharma’s zibotentan—if approved—could be “an optimal treatment of choice” for patients with diabetic kidney disease, finds a new report from GlobalData.

The European Commission granted marketing authorization in the EU to treat patients 16 years of age and older with moderately to severely active ulcerative colitis.

With the investment in the plant, Daiichi Sankyo is looking to create new laboratories for its antibody-drug conjugates used to develop and manufacture therapies for breast, lung and stomach cancers.

In a late-stage study, Tagrisso induced a “statistically significant and highly clinically meaningful improvement” in progression-free survival in patients with unresectable stage III, EGFR-mutated non-small cell lung cancer.

A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.

The companies’ Biologics License Application for antibody-drug conjugate datopotamab deruxtecan has been accepted by the FDA for locally advanced or metastatic nonsquamous non-small cell lung cancer.

Almirall will have exclusive global rights to develop and commercialize the anti-IL-21 monoclonal antibody NN-8828 in several fields, including immune inflammatory dermatological indications.

In a Phase II study, Sanofi and Denali’s RIPK1 inhibitor SAR443820/DNL788 failed to meet the primary endpoint of improved functional performance in amyotrophic lateral sclerosis patients.

The regulator’s approval means AstraZeneca’s Tagrisso can now be used in combination with chemotherapy for locally advanced or metastatic EGFR-mutated non-small cell lung cancer patients.

The Icelandic biotech Thursday said that it has settled its grievances with Johnson & Johnson regarding its Stelara biosimilar in markets with regulatory approval.

• Appointment strengthens medical, regulatory, and commercial leadership as Company prepares to complete early market access regulatory filings in the U.S., U.K, Europe and Australia in anticipation of OST-HER2 approval decisions expected by year-end 2026 • Upcoming FDA Pre-BLA meeting will focus on the use of recent seroconversion biomarker data as a key surrogate clinical efficacy endpoint to support a BLA for OST-HER2 under the Accelerated Approval Program • Commercialization and reimbursement preparations well underway for the U.S., U.K., and Europe in parallel with ongoing partnership discussions

• Quarterly revenue up 8% year over year; Annual revenue guidance range remains at $42-$48 million • CDMO fragrance and Saffron projects reach successful milestones; First quarter CDMO revenue grew 135% YoY • VINIA brand customer base grows to 90,000 active users as of the end of April • Two-lens framework enacted in Q1 to optimize performance across CDMO and D2C businesses

Business development appointment is aligned with securing long-term customers for development and manufacturing partnerships

Another major milestone in its continuous global IP strategy, advancing protection of VIVI Cap Smart across international markets Highlights Granted Patent covers the design of VIVI Cap Smart™ across major international, growing market Strengthens the Company’s intellectual property position in one of the world’s largest healthcare and consumer markets Supports commercialization strategy and strategic discussions with appliance manufacturers Design term extends through May 16, 2039 Company enters into financing arrangement to support inventory build for growing portfolio