Bellerophon Therapeutics (NSDQ:BLPH) touted data today from a Phase II trial of pulsed, inhaled nitric oxide in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease. The 10-patient trial was designed to evaluate the effects of pulsed, inhaled nitric oxide on targeted vasodilation and the chronic effect on hemodynamics and exercise capacity. The data showed […]
Pharmaceuticals
Bioventus wins FDA nod for knee osteoarthritis pain injection
Bioventus said today that its Durolane single-injection, hyaluronic acid product won FDA approval for the treatment of pain associated with knee osteoarthritis. When a person develops osteoarthritis in their knee, the cartilage breaks down and so does the synovial fluid that provides lubrication to joint tissues. Hyaluronic acid provides cushioning and lubrication to the knee, […]
Enteris BioPharma launches endometriosis trial with oral peptide delivery tech
Enteris BioPharma, a 24-person biotech based in Boonton, N.J., last month launched a trial of its oral leuprolide endometriosis therapy, Ovarest. Ovarest is the company’s most advanced internal candidate and represents Enteris’ attempt to overcome the challenges presented by the oral delivery of peptides, according to CEO Joel Tune. The Phase IIa trial, which is […]
Sanofi wins tentative FDA nod for Admelog insulin lispro injection
Sanofi (NYSE:SNY) said today that the FDA granted the company tentative approval for its Admelog insulin lispro injection. The decision is based on physicochemical, non-clinical and clinical similarity to another, already-approved insulin lispro injection. The compound is contraindicated during hypoglycemia episodes and in patients with hypersensitivity to insulin lispro or one of its other ingredients, […]
LabCorp completes $1.2B Chiltern buy
Diagnostics company LabCorp (NYSE:LH) said today that it has closed its $1.2 billion acquisition of contract research organization Chiltern International. Chiltern is slated to fold into the company’s Covance drug development business, which conducts clinical trials for drugmakers. “The addition of Chiltern advances a key element of LabCorp’s strategy – to bring innovative medicines to patients […]
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 […]
Fresenius closes Merck biosimilar biz purchase
Fresenius Kabi said today that it closed its acquisition of Merck KGaA’s biosimilars unit. The company paid €156 million at closing ($185.7 million USD) and could pay up to €500 million ($595.2 million USD) in milestone payments, which are contingent upon meeting certain drug development targets. Previously, Fresenius announced it would pay €170 million upfront ($202.4 million […]
Investors sue Teva over $41B Actavis deal
Teva Pharmaceuticals (NYSE:TEVA) and a handful of current and former executives were hit with a lawsuit yesterday alleging that the drugmaker hid the negative fallout linked to its $40.5 billion purchase of Actavis Generics. Barry Baker, a Teva investor, claimed that the company, former CEO Erez Vigodman, ex-CFO Eyal Desheh and interim CEO Yitzhak Peterburg issued […]
SteadyMed shares tumble after FDA refuses to review Trevyent NDA
Shares in SteadyMed (NSDQ:STDY) fell more than -35% today after the company announced that the FDA will not review the new drug application for its drug-device combo product, Trevyent. The company received a refused to file letter, indicating that its NDA is incomplete and that the regulatory agency will not look it over. This is the […]
Express Scripts, other PBMs named in lawsuit over pricey EpiPens
Express Scripts (NSDQ:ESRX) and other pharmacy benefit managers have been accused of giving Mylan‘s (NSDQ:MYL) EpiPens favorable placement on drug formularies in exchange for kickbacks, according to a proposed class action filed in Kansas federal court this week. The suit was brought by people covered under Employee Retirement Income Security Act benefit plans. These consumers claim […]