Genentech broke ground on a $700 million manufacturing facility in Holly Springs, North Carolina its first on the U.S. East Coast supporting next-generation obesity treatments and metabolic medicines as part of Roche’s broader $50 billion U.S. investment in innovation, job creation, and advanced biomanufacturing.
The CDC appointed Retsef Levi, a vocal critic of mRNA Covid-19 vaccines, to lead its Covid-19 immunization workgroup, a panel tasked with reviewing vaccine safety and effectiveness, despite controversy surrounding his past calls for vaccine withdrawal.
Shiladitya Sengupta, founder, Vyome Therapeutics, explains how the company’s strong ties in India’s biotech and healthcare sectors are helping to create innovative solutions for global markets.
New indication positions Repatha as an option for high-risk adults with elevated LDL cholesterol and no prior cardiovascular events.
Under terms of the deal, Gilgamesh could receive up to $1.2 billion as bretisilocin progresses through clinical development for the treatment of major depressive disorder.
BeOne Medicines entered a deal worth up to $950 million with Royalty Pharma selling its rights to global sales royalties of Imdelltra, securing an $885 million upfront payment and potential additional royalties, while retaining rights to other pipeline assets and future high-sales milestones.
The FDA suspended Valneva’s U.S. license for its chikungunya vaccine Ixchiq due to serious safety concerns, multiple hospitalizations, and deaths linked to chikungunya-like illness.
Shiladitya Sengupta, founder, Vyome Therapeutics, explains how the company leveraged a reverse merger with ReShape Lifesciences to streamline its path to going public while minimizing costs and complexity.
The acquisition aims to expand Kite Pharma’s capabilities in in vivo CAR T-cell therapy research and development.
A federal judge tripled damages against the pharmacy benefits manager after finding it encouraged inflated Medicare drug claims and underpaid pharmacies.
Lighthouse Pharmaceuticals receives a $49.2 million grant from the National Institute on Aging, aimed at advancing a Phase 2 clinical trial of LHP588, a novel gingipain inhibitor targeting Porphyromonas Gingivalis, aimed at slowing Alzheimer's progression in infected patients by addressing a potential microbial cause of neuroinflammation and neurodegeneration
Dawnzera is the first and only RNA-targeted prophylactic therapy to be approved for hereditary angioedema in adults and pediatric patients aged 12 years and older.
The Supreme Court has ruled 5-4 to allow the Trump administration’s NIH funding cuts to continue, impacting more than 1,700 medical research grants in areas including heart disease, HIV/AIDS, Alzheimer’s disease, and mental health.
The agreement values Mural Oncology at up to $36.2 million, with shareholders set to receive a base cash payment and potential additional consideration tied to closing net cash.
Regeneron Pharmaceuticals announced FDA extended review timelines to Q4 2025 for two regulatory submissions related to Eylea HD due to a major amendment stemming from a third-party manufacturing inspection. Despite the delay, Eylea HD remains available in the U.S., and Regeneron anticipates a swift resolution as they address manufacturing concerns and continue expanding treatment options.
The collaboration will leverage Boehringer Ingelheim’s manufacturing expertise to accelerate AnGes’ HGF gene therapy toward regulatory approval and patient access.
A joint statement lays out the framework for a potential trade agreement.
The company will be heavily investing over the next decade to build a new biopharmaceutical plant in Holly Springs, NC, creating 120 jobs and reinforcing its $55 billion pledge to strengthen US manufacturing, R&D, and innovation.
Johnson & Johnson assures no impact on current treatments for multiple myeloma.
Staff members published an open letter to the HHS Secretary following a deadly shooting earlier this month.
Rob Abbott, CEO, ISPOR, highlights how uniting regulators, payers, and academic leaders worldwide can accelerate access to innovative treatments and strengthen evidence-based healthcare.
The company is downsizing its gene therapy operations following reduced demand from a major client, even as industry reliance on CDMOs and CMOs for capacity and expertise continues to grow.
Jazz Pharmaceuticals partners with Saniona to develop SAN2355, a promising epilepsy treatment, enhancing options for neurological disorders.
The clinical hold is due to questions about BX004’s nebulizer device, temporarily pausing US enrollment in the cystic fibrosis Phase IIb trial (NCT06998043) while European dosing continues.
The regulatory body determined that PTC Therapeutics’ New Drug Application for vatiquinone did not provide sufficient evidence of efficacy in patients with Friedreich’s ataxia.
The comments came after the AAP announced its vaccine recommendations, which go against those of the CDC.
The move is likely part of the company’s goal to reduce costs as it faces increased competition in the GLP-1 space.
Ron Lanton, partner, Lanton Law, warns that ongoing lawsuits targeting vaccine policy could create ripple effects across FDA decision-making and reshape how future emergency use authorizations are granted.
Ron Lanton, partner, Lanton Law, warns that recent changes to federal vaccine recommendations could trigger extensive litigation as insurers, providers, and patients face new access and coverage challenges.
Rob Abbott, CEO, ISPOR, highlights how AI is streamlining research and improving patient care while stressing the importance of human oversight.
