BioSpace: Biotech, Pharmaceutical and Clinical Research News
2 days ago · BioSpace is the digital hub for life science news and insights on biotech, pharmaceutical and clinical research. Find the latest stories, podcasts, trackers and special editions on topics such as cell and gene therapy, obesity, AI and more.
FDA News: Approvals, Adcomms, Complete Response Letters and …
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
Thermo Fisher to Lay Off 160 in Massachusetts, Close ... - BioSpace
2 days ago · Follow along as BioSpace tracks the job cuts and restructuring initiatives in the biopharma industry throughout 2024. See the list of companies that have announced layoffs, reorganizations, and strategic changes in the past month.
Novavax Shares Slide as FDA Pauses COVID/Flu Vaccine Candidates
2 days ago · The FDA placed a clinical hold on Novavax's combo COVID-19/influenza and standalone influenza vaccines after a report of a serious adverse event of motor neuropathy in a trial participant. The company said it is working with the FDA to resolve the matter and start the Phase III trial as soon as possible.
Big Pharma’s Interest Grows in Evolving Cell and Gene ... - BioSpace
Oct 9, 2024 · Learn how large pharmaceutical companies are investing, collaborating and commercializing cell and gene therapies, which can be costly and complex. Find out the latest trends, deals and data in the sector from experts and stakeholders at the 2024 Cell & Gene Meeting on the Mesa.
Concentra Spies New Target After Kezar’s Lupus Trial Hold
Oct 9, 2024 · Concentra Biosciences, a biotech investment firm, wants to acquire Kezar Life Sciences after its lupus trial was halted due to four patient deaths. The offer is $1.10 per share in cash and includes a contingent value right for Kezar's programs.
Lilly’s Cholesterol Pill Shows Early Promise in Phase I Study
Aug 29, 2023 · Muvalaplin is an oral pill that disrupts the formation of lipoprotein (a), a cholesterol variant linked to cardiovascular risks. The first-in-human trial showed that muvalaplin was safe and reduced Lp (a) levels by up to 65% in 24 hours.
With Myriad Recent Approvals in Cancer, The Era of ... - BioSpace
Oct 14, 2024 · Bispecific antibodies are immunotherapies that target two antigens and could replace Keytruda as the backbone of solid tumor treatment. Learn about the benefits, challenges and clinical data of this emerging class of drugs from AstraZeneca, Summit and others.
Teva to Pay $450M in Settlement With DOJ Over Kickback and
Oct 11, 2024 · Teva Pharmaceuticals agreed to pay $450 million to resolve claims that it paid kickbacks to boost Copaxone sales and conspired with other generics makers to fix drug prices. The settlement includes a $225 million deferred prosecution agreement and a $25 million fine for the price-fixing allegation.
New Therapies Are Set to Upend the Alpha-1 Antitrypsin
Oct 28, 2024 · Alpha-1 antitrypsin deficiency is a genetic disorder that affects the liver and/or lungs. Approximately 1 in 3,500 people have two abnormal SERPINA1 genes for the alpha-1 antitrypsin (AAT) protein and are at risk of serious organ damage due to AATD.. While M-AAT is produced in healthy humans to inhibit neutrophil elastase in the lungs, AATD patients produce Z-AAT, which does not inhibit ...