MedImmune‘s FluMist, the only needle-free flu vaccine available in the U.S., has regained the support of an expert panel at the Centers for Disease Control & Prevention. The Advisory Committee on Immunization Practices has voted to recommend the nasal spray’s use, reversing a two-year-old decision to keep the product out of clinics due to efficacy […]
Express Scripts to include Novo Nordisk’s once-weekly diabetes drug on 2018 formulary
Express Scripts, one of the nation’s largest pharmacy benefit managers, reportedly plans to include Novo Nordisk‘s (NYSE:NVO) once-weekly Type II diabetes, Ozempic, on its 2018 formulary. The move puts Ozempic directly in competition with Eli Lilly‘s (NYSE:LLY) once-weekly Trulicity drug. Both products will also go up against AstraZeneca‘s (NYSE:AZN) once-weekly Bydureon medication. All three drugs […]
Pieris Pharmaceuticals prices $44m public offering
Pieris Pharmaceuticals (NSDQ:PIRS) today priced an underwritten public offering of 5.5 million shares of its common stock at $8.00 per share. The company said it expects to generate $44 million from the offering, which it will use to fund the pre-clinical and clinical development of its pipeline. The offering also includes a 30-day option for underwriters […]
Rani Therapeutics nabs $53m for robotic pill injection tech
Rani Therapeutics has raised $53 million to support manufacturing as it gears up for clinical trials of its robotic pill technology. New investors like GeneScience Pharmaceuticals and Shire (NSDQ:SHPG) joined existing investors like Alphabet’s GV, Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN). Rani Therapeutics, an InCube Lab spin-out started in 2012, has developed a capsule that delivers an intestinal injection […]
TapImmune brings therapeutic vaccines into the clinic for ovarian, breast cancer
In the past decade, new innovations and well-funded research have heralded in the era of immunotherapy. The pace of change within the field has amazed Peter Hoang, the chief executive of a Jacksonville, Fl.-based company working to develop therapeutic vaccines for cancer. “15 years ago, if you or I walked into a venture capitalist’s office, […]
AstraZeneca wins FDA nod to remove boxed warning from asthma drug label
After reviewing results from trials involving more than 41,000 asthma patients, the FDA has agreed to remove the boxed warning of serious asthma-related outcomes for AstraZeneca‘s (NYSE:AZN) Symbicort product. Patients using Symbicort, which combines an inhaled corticosteroid and a long-acting beta2-adrenergic agonist in a single inhaler, did not experience a significant increase in the risk […]
FDA clears AstraZeneca’s once-weekly Type II diabetes drug-device combo
AstraZeneca (NYSE:AZN) said today that the FDA approved its once-weekly exenatide drug in a single-dose auto-injector for adults with Type II diabetes whose blood sugar is uncontrolled on one or more oral drugs. The company’s drug, Bydureon, is formulated with a continuous-release microsphere delivery system designed to provide consistent levels of exenatide, according to AstraZeneca, to […]
Oral drug delivery startup raises $39m for robotic pill
San Jose, Calif.-based Rani Therapeutics has some seriously big-name backers: Alphabet (NSDQ:GOOGL), Novartis (NYSE:NVS) and AstraZeneca (NYSE:AZN) have all invested in the startup. This month, the company raised $38.7 million as part of a $126.5 million offering of equity and options or warrants, according to an SEC filing. So far, 12 investors have contributed to the offering. Rani […]
Adherium launches next-gen monitor for AstraZeneca’s Turbuhaler
Adherium Ltd. (ASK:ADR) said today that it launched a next-gen version of its SmartTurbo adherence monitor for AstraZeneca‘s (NYSE:AZN) Turbuhaler. The company’s monitor features usability improvements to make the device’s installation and removal easier for older patients with COPD. It also includes larger buttons to help patients access features like audio and visual reminders, battery monitoring […]
Adherium wins 510(k) clearance for smart inhaler monitoring device
Adherium Ltd. (ASK:ADR) said today that it won 510(k) approval from the FDA for its inhaler monitoring device, SmartTouch for Symbicort. The device was cleared for use with AstraZeneca‘s (NYSE:AZN) Symbicort aerosol inhaler. The Melbourne, Australia-based company’s product installs directly onto a patient’s inhaler to monitor and boost medication adherence. The device records the time and […]
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