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Late-stage data from two studies showed Novartis’ BTK inhibitor remibrutinib improves symptoms of chronic spontaneous urticaria. The company will file for regulatory approval in 2024.

Following an FDA approval and a Phase III flop, Mirati CEO David Meek has resigned in a “mutually agreed” decision, the company announced late Tuesday as it searches for a permanent replacement.

The biotech company is looking to forge a path to profitability by scaling up the commercial uptake of Zynteglo and winning the FDA’s approval for its lovo-cel gene therapy for sickle cell disease.

The vaccine maker cut 25% of staff amid post-pandemic business challenges in May, but resurgent sales and an updated COVID-19 shot may prove a turning point.

Employers in the industry find they need to offer perks such as higher pay, more impressive job titles and hybrid or remote work to stay competitive.

Eli Lilly reported second-quarter revenue of over $8.3 billion, a 28% increase versus Q2 2022, beating estimates of $7.58 billion. The company Tuesday raised its full-year guidance by $2.2 billion.

Data from a Phase III study released Tuesday found that Novo Nordisk’s Wegovy lowered the risk of cardiovascular complications and death by 20% versus placebo in overweight and obese adults.

Last month, the agency hired a new director for the Office of Therapeutic Products, but both leadership and support staff positions remain open.

As biopharma companies look to prove price setting provisions in the Inflation Reduction Act are unconstitutional, lawmakers unveil legislation to further reduce drug costs.

The new legislation could increase healthcare spending overall while reducing biopharma’s return on investment on biologic drugs.

Despite failing a previous late-stage study, VistaGen’s fasedienol finally scored a win by meeting its primary endpoint and strongly easing distress among patients with social anxiety disorder.

Following a handful of clinical failures and changes to its leadership, FibroGen is trying to chart a more positive path forward by focusing on four strategic areas.

• 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