Drug Development
The company also stands to gain from recent regulatory FDA guidance aimed at streamlining the development of non-opioid painkillers, Jefferies analysts suggested.
FEATURED STORIES
Following the hard-won success of early anti-amyloid drugs, a new generation of Alzheimer’s modalities—from tau-targeting gene silencers to blood-brain barrier delivery platforms—is entering the pipeline to anchor future combination therapies.
Three years after the accelerated approval of its anti-amyloid Alzheimer’s therapy, Biogen—neck and neck in the market with Eli Lilly and its Kisunla offering—is focused on a near-term FDA decision for a subcutaneous induction dose of Leqembi, a presymptomatic readout in 2028 and a clutch of next-generation candidates.
BMO analysts say Eli Lilly is well-positioned to maintain its lead in the ballooning weight loss space, predicting “strengthening leadership in obesity and beyond” as portfolios expand and patient access improves.
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Zymeworks increased its stake in the company to 6.9%, slightly under 4 million shares, and options with shares popped 13% after the original bid and are up another 10%.
Axcella is prioritizing its clinical development portfolio to focus on its investigative assets for COVID-19 and non-alcoholic steatohepatitis (NASH) after abrupt leadership resignations.
Mirati Therapeutics’ adagrasib is going up against Amgen’s Lumakras in the KRAS race, and according to Friday pre-market trading, the results shared Thursday don’t seem to be enough for investors.
Two therapies for different cancers are moving forward in development following positive outcomes in their clinical trials ahead of the ASCO’s annual meeting in early June 2022.
On June 5, the FDA is expected to decide the fate of Acer Therapeutics’ experimental treatment for Urea Cycle Disorders (UCDs), ACER-001. CEO Chris Schelling spoke with BioSpace.
Two researchers affiliated with Northwestern University have discovered a new drug that may outperform existing treatments for amyotrophic lateral sclerosis (ALS).
ZYESAMI, (aviptadil), being assessed by NRx Pharmaceuticals, failed a review conducted by the Data Safety and Monitoring Board (DSMB), with the board recommending that arm of the trial cease.
Pfizer announced the FDA has granted its combinatorial therapeutic ervogastat/clesacostat Fast Track Designation that is intended for the treatment of NASH with liver fibrosis.
Research is emerging showing a causal link between COVID-19 and diabetes. Dr. Brian Fertig, M.D., founder and president of the Diabetes & Osteoporosis Center in New Jersey, spoke with BioSpace.
The FDA’s Vaccines and Related Biological Products Advisory Committee is set to review clinical data on June 7 and potentially suggest approval of NVX-CoV2373.