Teva Pharmaceutical (NYSE:TEVA) said last week that it hopes to win U.S. approval for its version of Mylan‘s (NSDQ:MYL) EpiPen by late 2017 or early 2018. Mylan’s EpiPen holds an estimated 94% market share in the U.S.; an alternate device from Teva could threaten the product’s dominance. Teva’s application for its epinephrine injector has been […]
Organovo launches bio-printed kidney tissue service
Organovo (PINK:ONVO), the contract research organization known for their 3D bio-printed liver tissue, announced today that it began commercial contracting for its second tissue service, the ExVive Human Kidney. The San Diego, Calif.-based group is widely recognized for their bio-printed liver tissue that pharma giants like Merck and Roche use to assess toxicity for pre-clinical […]
Chrono Therapeutics closes $48m Series B for smart nicotine patch
Hayward, Calif.-based startup Chrono Therapeutics reportedly raised $47.6m in a Series B round, led by Kaiser Permanente Ventures. The money, Chrono CEO Alan Levy told Forbes, is to fund clinical trials of a transdermal smoking cessation patch. The company is preparing for a large, Phase II efficacy study of the technology. Unlike normal nicotine patches, Chrono said […]
Takeda looks to wearables for IBD patients
Takeda Pharmaceuticals (TYO:4502) yesterday launched a wearable watch pilot program to help people suffering with inflammatory bowel disease track their symptoms. Takeda said they will roll out the program, iBData, with 100 patients tracking their daily symptoms and lifestyle factors. Then, the data is collected into a report that is shared with the patient’s doctor, […]
More Respimat data from Boehringer
Boehringer Ingelheim on Tuesday touted results from the Phase III CanoTinA asthma trial, which showed that adding tiotropium Respimat to maintenance asthma therapy in kids ages 6-11 significantly improves lung function compared to placebo. The results were presented Tuesday at the European Respiratory Society International Congress 2016 in London. This comes 1 day after results from another clinical trial […]
JDRF backs Sernova’s implant for T1D
Canadian-based drug device maker Sernova Inc. is working with the Juvenile Diabetes Research Foundation on a clinical trial of Sernova’s cell pouch system to treat hypoglycemia unawareness patients with severe type 1 diabetes. The JDRF will give $2.45 million to support a clinical trial at a transplantation center in the U.S., according to the agreement. Hypoglycemia […]
Senate panel to investigate Mylan’s EpiPen pricing
The U.S. Senate’s investigations panel is reportedly launching a “preliminary inquiry” into Mylan’s (NSDQ:MYL) pricing of the EpiPen epinephrine auto-injector. Mylan came under fire in recent weeks for raising the price of EpiPens nearly 500%, from $100 in 2008 to more than $500 this year, despite stable manufacturing costs. In late August, Sens. Amy Klobuchar […]
DelMar, Accurexa ink deal for chemotherapy combo
DelMar Pharmaceuticals and Accurexa said today that they inked a deal to collaborate on a combination chemotherapy for local treatment of brain cancer. The agreement calls for DelMar to supply the drug dianhydrogalactitol (VAL-083) as part of a combination with another chemotherapeutic, either temozolomide or carmustine, for local delivery to the tumor via Accurexa’s ACX-31 implantable […]
GlaxoSmithKline’s triple combo with Innoviva tops Symbicort Turbohaler in COPD
GlaxoSmithKline (NYSE:GSK) and Innoviva (NSDQ:INVA) yesterday touted results from a Phase III study investigating the triple-combination therapy fluticasone furoate/umeclidnium/vilanterol for patients with chronic obstructive pulmonary disease. The 1,810-patient Fulfil study is a randomized, double-blinded trial comparing once-daily FF/UMEC/VI against AstraZeneca‘s (NYSE:AZN) Symbicort Turbohaler dry powder inhaler, a twice-daily combination of budesonide and formoterol. Patients in the FF/UMEC/VI […]
Parents file lawsuit against Mylan over EpiPen ‘price-gouging’
A parent in Ohio reportedly leveled a class-action lawsuit against EpiPen maker Mylan (NSDQ:MYL) over the nearly 500% increase in the cost of the epinephrine injector since Mylan acquired the device in 2007. The suit, filed yesterday in Hamilton County Common Pleas Court, seeks an unspecified amount of damages for its 25 plaintiffs, according to Cincinnati.com. […]
Boehringer Ingelheim touts Stiolto Respimat data
Boehringer Ingelheim yesterday touted results from a Phase III trial showing that its Stiolto Respimat, a drug-device combination helps people with chronic obstructive pulmonary disease walk for longer periods of time while relieving some shortness of breath. When participants with moderate to severe COPD took Stiolto Respimat, a combination of tiotropium bromide and olodaterol, along […]
