Regulatory

Four tips for midsized companies when entering new global markets.

Sonam Dubey, a partner at Beghou Consulting, discusses the potential impact of a possible ban on direct-to-consumer advertising amid policy and government agency overhauls in the US.

Approval of Opdivo plus Yervoy combination was based on results from the Phase III CheckMate-9DW trial, which demonstrated significantly improved overall survival and overall response rate in patients with unresectable or metastatic hepatocellular carcinoma.

Full approval of Vitrakvi was based on results from three clinical trials in patients with unresectable or metastatic NTRK fusion-positive solid tumors.

As the physical products we use evolve to become increasingly complex, traditional products liability frameworks may not always fit to provide remedies for harm that can result from using novel product types.

Approval of the Opdivo plus Yervoy combination regimen was based on results from the Phase III CheckMate-8HW trial, which was the largest immunotherapy study in patients with previously untreated, unresectable, or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

Brimochol PF, a combination of brimonidine and carbachol, was found to enhance depth of focus and visual acuity in clinical trials among patients with presbyopia.

The survey also suggests that Medicaid is broadly popular amongst all Americans, regardless of political affiliation.

Results from Phase II studies demonstrated that rilzabrutinib showed clinically meaningful outcomes in patients with warm autoimmune hemolytic anemia and IgG4-related disease.

Results from the Phase III SPACE trial show that Ajovy significantly reduced monthly migraines in pediatric patients between six and 17 years of age.

Eli Lilly CEO David Ricks to the BBC: “It feels like it'll be hard to come back from here."

Marcel Botha, CEO of 10XBeta, explore the role collaboration between private industry, government agencies, and research institutions plays in strengthening pandemic preparedness and ensuring medical device resiliency.

BIIB080 marks the first antisense oligonucleotide targeting tau to enter clinical development for the treatment of Alzheimer disease.

Marcel Botha, CEO of 10XBeta, discusses lessons from The Spiro Wave project that can be applied in creating more agile and responsive systems for future public health emergencies.

Matthew Yelovich, partner at Cleary Gottlieb, discusses the appeals of Elizabeth Holmes and Ramesh "Sunny" Balwani and the Ninth Circuit's recent affirmation of their convictions.

Qfitlia is the first FDA-approved antithrombin-lowering therapy indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients over 12 years of age with hemophilia A or B.

Approval of Imfinzi marks the first and only perioperative immunotherapy indicated for muscle-invasive bladder cancer.

As part of the Fast Track designation, Sanofi is set to launch a Phase I/II trial to evaluate the immunogenicity and safety of its novel mRNA vaccine in preventing chlamydia.

Marcel Botha, CEO of 10XBeta, discusses shortcomings in the US's emergency plans for rapid innovation and manufacturing during public health crises, highlighting the need for innovation pipelines, supply chain resilience, and regulatory clarity.

Approval of Vykat XR marks the first treatment indicated for hyperphagia in patients with Prader-Willi syndrome.

Blujepa marks the first new oral antibiotic to gain FDA approval for uncomplicated urinary tract infections in nearly 30 years.

Fanhalta marks the first and only treatment for C3 glomerulopathy to gain FDA approval.

Peter Ax, founder & CEO of UpScriptHealth, discusses the impact of tariffs on the pharmaceutical industry and how digital health platforms could potentially help offset them.

The Project Farma president discusses various ways the tariffs could impact the industry and how businesses can prepare or react.

Dr. Dina Radenkovic, CEO of Gameto, discusses the key considerations for bringing iPSC-based fertility treatments to market from a regulatory and manufacturing perspective.