(Reuters) — Top insulin maker Novo Nordisk (NYSE:NVO) slashed its long-term profit growth forecast today, signaling no let-up in its struggles to crack the U.S. market to which its chief executive said its commitment would not waver. The Danish firm’s shares fell by as much as 19% to a 30-month low, wiping more than $15 billion off […]
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FDA OKs stem cell-gene therapy trial for ALS
The FDA approved a combination stem cell-gene therapy clinical trial to test the treatment’s ability to slow the progression of amyotrophic lateral sclerosis. It’s the 1st clinical trial to use neural stem cells to deliver a particular protein in the hopes of slowing ALS progression, according to researchers at the ALS clinic at Cedars-Sinai Medical […]
Litmus Health looks to bring wearables to drug development
Litmus Health said yesterday that it launched its clinical data science platform into public beta. The company hopes to use big data from wearables and connected devices to help inform endpoints for Phase I & II clinical trials. The goal of its platform, according to Litmus, is to get pharmaceuticals to market faster by putting […]
Monaghan Medical touts Aerobika study
Monaghan Medical yesterday touted data from a 6-month retrospective study showing that its Aerobika device reduced drug use for treatment of chronic obstructive pulmonary device. The Syracuse, N.Y.-based company says its oscillating positive expiratory pressure therapy device is designed to expand the airways, help expel mucus to the upper airways and aid in drug deposition. The […]
Jivana Biotechnology raises $1m for targeted cancer therapy
Jivana Biotechnology raised $1 million for its preclinical work using targeted RNA-based therapies to treat a variety of cancers, according to a regulatory filing the Oak Park, Ill.-based company submitted this week. The minimum investment from an outside investor was $50,000, the company reported, and it used an estimated $125,000 for payments to its executive […]
Kaleo plans 2017 U.S. relaunch for EpiPen competitor Auvi-Q
Kaléo Inc. said today that it plans to relaunch its Auvi-Q injector for emergency allergy treatment in the U.S. during the 1st half of 2017, according to Reuters. The Richmond, Va.-based company’s device was recalled last year after concerns about the accuracy of delivered dose. Sanofi (NYSE:SNY) made and licensed the Auvi-Q device from Kaléo, but returned rights to […]
PharmaJet, Vaccibody collaborate on needle-free HPV vaccine
PharmaJet and Vaccibody inked a collaborative deal to provide needle-free injection tech for the development of a human papillomavirus vaccine. HPV is the cause of virtually all cervical cancer, according to the National Cancer Institute, and just 2 types of HPV, 16 and 18, are responsible for about 70% of all cases. PharmaJet’s device is […]
Researchers boost stem cell programming with gene mutation
Researchers discovered a way to increase the efficiency of stem cell programming using research on a rare genetic disease, according to a study published in the Proceedings of the National Academy of Sciences. Induced pluripotent stem cells are created from skin cells and can be transformed into any type of cell in the body. Using existing […]
Targazyme wins FDA clearance for Phase II bone marrow stem cell study
Targazyme said today that it will begin enrolling patients in a Phase II clinical study to evaluate TZ101-fucosylated bone marrow stem cells in cancer patients, after the FDA granted the San Diego-based company investigational new drug clearance. The treatment is designed to use blood-forming stem cells from bone marrow to restore the body’s ability to make blood […]
UCB’s Cimzia AutoClicks pen hits the U.K. market
UCB (EBR:UCB) said today that its Cimzia AutoClicks pre-filled pen is available in the U.K., after the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended the device for all approved indications, including rheumatoid arthritis and axial spondyloarthritis. The Belgian company partnered with OXO to develop the pen, based on technology licensed from Bespak. The AutoClicks […]
