In today’s Pharmaceutical Executive Daily, we cover the FDA lifting its clinical hold on Neurizon Therapeutics’ lead program Nuz-001, the agency’s export ban on Sun Pharma’s Halol facility, and new insights on how small biotechs can better navigate regulatory and market complexities.
Algen Biotechnologies partners with AstraZeneca to enhance AI-driven drug discovery, targeting chronic inflammatory conditions for innovative therapeutic solutions.
Chiesi Group partners with Arbor Biotechnologies to advance gene editing therapies for rare diseases, focusing on primary hyperoxaluria type 1.
Amgen introduces AmgenNow, a direct-to-patient program for Repatha, offering affordable access to life-saving cardiovascular treatment.
Stay informed on key pharmaceutical news, including FDA insights, Takeda's strategic shifts, and updated CDC COVID-19 vaccination guidelines.
CDC introduces shared-decision making for COVID-19 vaccinations, emphasizing informed consent and individual consultation with healthcare providers.
Neurizon Therapeutics advances ALS treatment as FDA lifts clinical hold on NUZ-001, paving the way for Phase II and III trials.
Dr. Jeanne Marrazzo's firing highlights concerns over political interference in health research and vaccine safety advocacy amid whistleblower allegations.
In today’s Pharmaceutical Executive Daily, we cover the FDA’s new fast-track review program for U.S.-made generics, Novartis’ FDA approval of Rhapsido for chronic spontaneous urticaria, and Halozyme’s $750 million acquisition of Elektrofi to strengthen drug delivery innovation.
Roche's Tecentriq and lurbinectedin combo gains FDA approval, significantly improving outcomes for extensive-stage small cell lung cancer patients.
Jazz Pharmaceuticals announces FDA approval of Zepzelca and Atezolizumab for extensive-stage small cell lung cancer, enhancing treatment options and survival rates.
Stay informed on key pharmaceutical news, including tariff updates, FDA shutdown risks, and insights from recent cell and gene therapy reviews.
Takeda shifts focus from cell therapy to innovative drug candidates, aiming for transformative therapies and strategic partnerships in its pipeline.
Vanda Pharmaceuticals collaborates with the FDA to expedite reviews for Hetlioz and Tradipitant, aiming to resolve ongoing disputes and approvals.
FDA continues essential operations during the funding lapse, focusing on public health safety while halting new drug applications and submissions.
In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s resubmission of its BLA for Awiqli, the FDA’s approval of Kedrion’s Qivigy for primary humoral immunodeficiency, and Eli Lilly’s decision to halt development of a muscle-preserving weight-loss therapy.
Novartis gains FDA approval for Rhapsido, the first oral BTK inhibitor for Chronic Spontaneous Urticaria, offering new hope for patients.
Halozyme Therapeutics acquires Elektrofi for $750 million, enhancing drug delivery technology with Hypercon's innovative microparticle approach for biologics.
Craig Thompson, CEO of Cerevance touches on the NETSseq platform and how it shapes Cerevance's approach to the drug discovery strategy.
In today’s Pharmaceutical Executive Daily, we cover AbbVie’s new API manufacturing site in Illinois, AstraZeneca’s plan to harmonize its global stock exchange listings, and reports that President Trump will announce a government-run direct-to-patient drug purchasing website.
Kedrion Biopharma celebrates FDA approval of Qivigy, enhancing treatment options for primary immunodeficiency while committing to significant U.S. investments.
Novo Nordisk aims to revolutionize diabetes care with Awiqli, a potential once-weekly insulin, resubmitted for FDA approval after addressing previous concerns.
Craig Thompson, CEO of Cerevance discusses the key scientific and clinical insights that lead to Cerevance's pursuit of Solengepras.
In today’s Pharmaceutical Executive Daily, we cover the impact of Novo Nordisk layoffs on its hometown in Denmark, GSK’s appointment of Luke Miels as its next CEO, and the FDA’s approval of Regeneron’s Evkeeza for children with homozygous familial hypercholesterolemia.
Genmab's acquisition of Merus for $8 billion enhances its oncology portfolio, promising growth and innovative therapies like Petosemtamab for cancer treatment.
GSK appoints Luke Miels as CEO designate, set to lead the company into a pivotal growth phase starting January 2026.
In today’s Pharmaceutical Executive Daily, we cover the White House’s push for a Most Favored Nation drug pricing model, the FDA’s approval of Eli Lilly’s Inluriyo for ESR1-mutated metastatic breast cancer, and President Trump’s call for steep tariffs on branded pharmaceuticals.
Crinetics Pharmaceuticals celebrates FDA approval of Palsonify, the first oral treatment for acromegaly, enhancing patient care and outcomes.
Regeneron's Evkeeza gains FDA approval for treating young children with homozygous familial hypercholesterolemia, addressing a critical health need.
In today’s Pharmaceutical Executive Daily, we cover Glenmark’s billion-dollar exclusive licensing deal with Hengrui, Harmony Biosciences’ trial setback for Zygel, and the CDC’s unanimous vote to broaden COVID-19 vaccine recommendations.
