TherapeuticsMD (NSDQ:TXMD) is negotiating with the FDA over the proposed label for its investigational, applicator-free estradiol vaginal capsule, TX-004HR, the company reported today. The softgel capsule is designed to treat moderate-to-severe vaginal pain experienced during sex, a symptom of vulvar and vaginal atrophy in women who have undergone menopause. The FDA is slated to make a […]
Pharmaceuticals
Mimetas lands $21m for organ-on-a-chip tech
Mimetas said today that it raised $20.5 million in a Series B round from a syndicate of investors in Asia and Europe. The Netherlands-based company intends to use its newly-acquired funds to support global commercialization efforts for its OrganoPlate organ-on-a-chip drug-testing platform. Mimetas added that it hopes to broaden its product portfolio and establish tissue […]
Delcath registers $10m offering
Delcath Systems (NSDQ:DCTH) proposed offering up to $5 million in units and $5 million in pre-funded units this week to fund the company’s clinical and commercial operations. The New York-based company plans to offer 500,000,000 units made up of Series C units with one share of common stock and Series E warrants to buy one share […]
Illumina, Loxo Oncology partner for next-gen pan-cancer companion diagnostics
Illumina (NSDQ:ILMN) and Loxo Oncology (NSDQ:LOXO) are teaming up to develop a multi-gene panel for broad tumor profiling. The two companies ultimately hope to sell a next-gen sequencing-based companion diagnostic that will boast a pan-cancer indication. Illumina and Loxo plan to seek approval for a version of Illumina’s TruSight Tumor 170 test as a companion […]
Companies push back against allegations of FCA violations over excess at-home blood testing
A 70-year-old former Marine is taking a group of companies to court over their at-home blood testing services, arguing that the industry players broke the law by requiring patients to conduct weekly tests. The companies then submit these bills to Medicare for reimbursement, even asking to be repaid for services that weren’t rendered, according to […]
Tandem inks distro deal in Italy for insulin pump
Tandem Diabetes Care (NSDQ:TNDM) has signed a distribution deal with Movi SpA to commercialize Tandem’s t:slim X2 insulin pump in Italy. The San Diego, Calif.-based company said today that Movi is slated to run sales, marketing and customer training for Tandem’s products in Italy, according to the terms of the agreement. “Partnering with experienced insulin pump […]
AstraZeneca taps Owlstone’s breath biopsy device to identify asthma, COPD biomarkers
Pharmaceutical giant AstraZeneca (NYSE:AZN) inked a deal with Owlstone Medical to use the diagnostics company’s breath biopsy device to identify biomarkers for asthma and chronic obstructive pulmonary disease, the companies announced today. Owlstone’s ReCiva breath sampler, which has CE Mark clearance in the E.U., captures volatile organic compounds in a patient’s breath. A VOC profile can […]
Embolx wins $2m NIH grant for pressure-directed embolization therapy
Embolx said today that it landed a $2 million grant from the National Cancer Institute to fund development of its next-generation Sniper balloon occlusion microcatheter. The Sunnyvale, Calif.-based medical device company has developed a drug-delivery system that administers therapies into targeted areas of the body by controlling pressure. Embolx’s Sniper balloon is designed to treat cancerous […]
Study: PET imaging agent could help predict depression drug’s efficacy
Researchers have identified a positron emission tomography imaging agent that could identify the patients that are more likely to benefit from a drug designed to treat major depressive disorder, according to a study published this month in The Journal of Nuclear Medicine. The C-DASB tracer targets a protein, 5-HTT, found in the part of a person’s […]
CVS offers discount to uninsured for overdose reversal drug
CVS Health (NYSE:CVS) announced yesterday that it plans to offer a discount for Narcan, the nasal spray designed to reverse the effects of opioid overdoses, to customers who do not have insurance. The company said it will cut the cost of Narcan from its list price of $125 to $94.99 – the lowest price available for […]