New York-based Hoth Therapeutics Inc. said preliminary preclinical data on a topical nanoparticle formulation of the endocannabinoid anandamide it licensed from Zylö Therapeutics Inc. represents "a positive step toward underlining the transformative potential" of the early stage therapy for the skin disease cutaneous lupus erythematous.
Pediatric gene editing specialist Logicbio Therapeutics Inc. has revealed an FDA clinical hold on a planned phase I/II trial of its lead candidate, LB-001, an investigational therapy for rare inherited metabolic disorder methylmalonic acidemia (MMA).
A high-profile test of two experimental medicines in people with autosomal dominant Alzheimer’s disease (ADAD), a rare inherited form of the disease, found that neither drug significantly slowed rates of cognitive decline vs. placebo, the primary endpoint.
Crowned by a potential cure for severe hemophilia A, that could become the most expensive drug ever, a new list of 11 medicines expected to generate $1 billion-plus in annual sales by the end of 2024 or earlier throws into stark relief the growing tension between medical innovation and society's ability to pay for it. The 2020 Cortellis Drugs to Watch list, including medicines both approved and likely to be, points to a future of ongoing conflict between payers and industry spurred by fundamental disagreements.
A little more than two years after first licensing U.S. commercial rights to the Nucynta (tapentadol) pain drug franchise from Depomed Inc., specialty pharma Collegium Pharmaceutical Inc. is acquiring those rights from Depomed successor Assertio Therapeutics Inc. for $375 million in cash, less royalties paid to Assertio in 2020. The deal, which includes both extended-release (ER) and immediate-release formulations of the drug, is expected to close by Feb. 14. It will be financed with $325 million in committed debt financing.
Sanofi SA said an investigational Bruton's tyrosine kinase (BTK) inhibitor it licensed from Principia Biopharma Inc. in 2017 significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging, meeting the trial's primary endpoint.
Modest revenue growth and a 2020 outlook that left analysts uninspired about its near-term prospects pushed Gilead Sciences Inc. shares (NASDAQ:GILD) down about 2% to close Feb. 5 at $65.87, despite growing sales of its HIV medicine, Biktarvy (bictegravir, emtricitabine and tenofovir alafenamide), and what CEO Daniel O'Day called "a sense of urgency" around further business development.
The National Institute of Allergy and Infectious Diseases has stopped a late-stage HIV vaccine study it sponsored after an interim review by the trial's independent data and safety monitoring board (DSMB) found the regimen failed to prevent HIV.
A survey of nearly 100 biotech companies by the Biotechnology Innovation Organization (BIO) has found the industry still has important work to do before achieving overall gender parity and racial diversity, especially in executive and board roles. While showing "progress in some areas, we know that as an industry, we can do better," said Helen Torley, chair of BIO’s Workforce Development, Diversity and Inclusion (WDDI) Committee and president and CEO of Halozyme Therapeutics Inc.
The World Health Organization (WHO) has declared a "public health emergency of international concern" over the global outbreak of novel coronavirus (2019-nCoV), reversing a week-ago decision by its International Health Regulations Emergency Committee. The move comes "not because of what is happening in China, but because of what is happening in other countries," said WHO Director General Tedros Adhanom Ghebreyesus, noting his confidence in China’s capacity to control the outbreak. "Our greatest concern is the potential for the virus to spread to countries with weaker health systems, and which are ill-prepared to deal with it," he said.
