AstraZeneca canceled its combination of PD-L1 durvalumab and CTLA-4 medication tremelimumab in pancreatic ductal carcinoma.
For the pharmaceutical industry, 2016 brought new blockbusters onto the market to ease the pain of patent expirations.
R&D success and M&A activity loom as large swing factors for the bio sector in 2017 with the regulatory arena potentially at its most amenable for years.
Nearly two decades ago, the promise of precision medicine began making its mark on the pages of medical journals – along with speculation that “therapy with the right drug at the right dose in the right patient” – would define the future of medical treatment.
There was a significant drop-off in NME approvals by FDA in 2016, but there were not enough new drug applications with user fee goals to reach the lofty 2015 total.
Amgen Inc. said its potent cholesterol fighter Repatha significantly reduced the risk of heart attacks, strokes and death in patients with heart disease.
Lilly has closed off another avenue for solanezumab, its once-promising experimental therapy for Alzheimer’s disease, after scrapping another Phase III study.
Danish drugmaker Lundbeck is betting that shark antibodies may offer a new way of getting drugs into the brain to fight Alzheimer’s and other diseases, after successful early research with privately owned U.S. biotech firm Ossianix.
The prescribing label for Biogen’s big-selling oral multiple sclerosis drug Tecfidera has been updated to include a warning of potential liver injury.
Greenphire and Exostar announced a partnership that facilitates the adoption, accessibility and use of clinical research site payment solutions.
Natural Compound Found in Herbs, Vegetables Could Improve Treatment of Triple-Negative Breast Cancer in Women
University of Missouri researchers have found that luteolin, a natural compound found in herbs such as thyme and parsley, and vegetables such as celery and broccoli, could reduce the risk of developing metastasis originating from triple-negative breast cancer in women.
Bristol-Myers Squibb will not to seek accelerated U.S. approval for a combination of its two immunotherapy drugs as an initial treatment for lung cancer.
Alcobra Ltd. said it would abandon evaluating its only experimental drug to treat attention deficit hyperactivity disorder (ADHD) after a failed late-stage study.
People recovering from depression but struggling with its effect on memory, concentration and cognitive function may benefit from the stimulant modafinil, according to results of a small study.
Biogen’s staggering price tag for the spinal muscular atrophy drug Spinraza is likely to further ignite the controversies of drug pricing.
Merck & Co. has pulled ahead of rivals in the race to combine immunotherapy with other drugs as a treatment for lung cancer,.
Vaccination skeptic Robert F. Kennedy Jr. said he would chair a presidential panel to review vaccine safety and science at U.S. President-elect Donald Trump’s request.
Drug developer Otonomy Inc. said its drug to treat acute otitis externa (AOE), an infection in the outer ear canal, met the main goal in a late-stage trial.
Inotek Pharmaceuticals Corp. said its experimental glaucoma treatment failed a late-stage study, citing a stronger-than-expected placebo effect.
2016 turned out to be a disappointing one for new drug approvals with the U.S. Food and Drug Administration clearing just 22 new medicines for sale, the lowest number since 2010 and sharply down on 2015’s tally of 45.
OPKO Health Inc. said its experimental drug for GHD in adults failed to provide a statistically significant benefit over a placebo in a late-stage study.
A Harvard professor has retracted research that was once considered a breakthrough in diabetes research.
Anthera Pharmaceuticals Inc. said its drug to treat certain cystic fibrosis patients failed a late-stage study, sending the company’s shares tumbling nearly 70 percent in after-hours trading.
Seattle Genetics said four people died in trials testing its experimental cancer drug, prompting the U.S. FDA to impose a clinical hold on several early-stage studies.