France’s Sanofi said two late-stage Phase III clinical trials of its LixiLan diabetes drug had met their targets, readying it for approval in the United States in August and Europe in early 2017.
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.
The Biotechnology Industry Organization released a report titled: Emerging Therapeutic Company Investment and Deal Trends. BIO Industry Analysis says more than 90 percent of the biopharma industry is composed of small, emerging companies. According to BIO President Jim Greenwood and E. Cartier Esham, Ph.D., executive VP of BIO’s Emerging Companies Section, it is important for the trade association to better understand early-stage investor and deal-making trends in order to determine where scientific or policy issues may be affecting the ability to maintain a robust pipeline of innovative medicines.
Dupilumab, Regeneron/Sanofi Dupilumab is the first systemic therapy to demonstrate positive Phase III results in patients with moderate-to-severe atopic dermatitis. The serious, chronic inflammatory skin disease is marked by widespread rash, itching and associated psychosocial comorbidities. Dupilumab inhibits interleukin-4 and interleukin-13, which are small anti-inflammatory proteins secreted by cells that are thought to play a […]
Here are five company stocks that some industry analysts say are under the radar and/or could be a great bargain in 2016 per BioSpace.com sources …
Immunocore was recognized as SCRIP Awards 2015’s Biotech of the Year. Immunocore is a world-leading biotech company developing novel T cell receptor (TCR) based biological drugs for the treatment of cancer, viral infections and autoimmune disease.
An experimental drug for RA from Johnson & Johnson and GlaxoSmithKline slowed joint damage and improved symptoms of the disease, meeting the main goals of a large, late-stage trial.
Obesity rates for U.S. women and teens are on the rise, according to two new studies from the U.S. Centers for Disease Control and Prevention (CDC) published in JAMA.
Biogen Inc.’s keenly watched experimental drug for treating multiple sclerosis failed to meet the main goal of improving some symptoms in a mid-stage study.
It’s a challenge to find and select the right consultants for a clinical study or drug trial.
GlaxoSmithKline is on track to file its three-in-one inhaled lung drug for U.S. approval by the end of 2016 rather than during first-half 2018 as initially planned.
San Rafael, California-based BioMarin Pharmaceutical announced that it is abandoning its Kyndrisa (drisapersen) program for Duchenne muscular dystrophy (DMD).
GlaxoSmithKline’s new inhaled drug Breo proved significantly better than standard care in a large British study that tested it in everyday use after the failure of another big trial in 2015.
Novartis’s heart failure drug Entresto will be subjected to a battery of new trials as the Swiss drugmaker seeks to boost the medicine after a disappointing introduction.
Oramed Pharmaceuticals’ experimental oral insulin succeeded in significantly reducing night-time blood glucose in a midstage trial.
Drugs targeting DNA repair mechanisms inside cells are showing real promise for a range of tumors.
The World Health Organization has recommended a speedier, cheaper treatment plan for patients with superbug forms of TB.
Boehringer Ingelheim gains option to exclusive rights to a new lead compound for schizophrenia.
Biopharma company Chimerix reported top-line results from an interim analysis of the AdVise trial of brincidofovir for serious adenovirus (AdV) infection.
A second baby with aggressive leukemia has been treated in London with “designer immune cells” developed by Cellectis and, six months after treatment, she remains in remission.
People with very poor vision may benefit from using a device that recognizes faces, money and text, a small study suggests.