Delaware-based Ablative Solutions has raised $4 million as part of a $10 million round, according to regulatory filings. The company is developing the Peregrine System, an infusion catheter that delivers diagnostic and therapeutic agents to the perivascular space surrounding blood vessels. The 510(k)-cleared device includes three microneedles that remain within radiopaque guide tubes prior to […]
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FDA wants Fresenius to hire a consultant to fix long-standing CGMP woes
The FDA issued a warning letter to one of Fresenius‘ (NYSE:FMS) drug manufacturing plants in India last week, citing concerns that the company has not adequately addressed a sterility problem noted during previous inspections. It’s not the first time that the Kalyani, India-based manufacturing firm has been hit with a warning. In its letter to […]
Frequency touts first-in-human safety study for hearing loss therapy
Frequency Therapeutics has finished a first-in-human study of its progenitor cell activation therapy, FX-322, in nine adults with severe to profound sensorineural hearing loss. The company’s candidate is a combination of small molecules that are designed to activate progenitor cells and trigger the formation of new hair cells in the inner ear. The patients enrolled in […]
Pear Therapeutics raises $50m for digital substance use disorder therapies
Pear Therapeutics said today that it closed a $50 million Series B round to help commercialize its prescription digital substance abuse therapies. Temasek led the round and was joined by 5AM Ventures, Jazz Venture Partners, Novartis (NYSE:NVS) and others. In September, the company’s reSET therapy became the first prescription digital therapeutic approved by the FDA. One […]
Inovio lands $23m in collab with ApolloBio for HPV immunotherapy
Inovio Pharmaceuticals (NSDQ:INO) has inked an amended collaboration and licensing deal with ApolloBio for its DNA immunotherapy product designed to treat the pre-cancers caused by human papillomavirus. The exclusive partnership is limited to China, Hong Kong, Macao and Taiwan, but it could also include the Republic of Korea over the next three years, Inovio reported. In […]
DelMar Pharma wins fast track status for glioblastoma drug
DelMar Pharmaceuticals (NSDQ:DMPI) said today that the FDA granted its lead product candidate, VAL-083, fast track status for approval as a therapy for recurrent glioblastoma. The designation applies to a Phase II trial with the University of Texas MD Anderson Cancer Center and a Phase III trial in patients whose disease has progressed after treatment with […]
Medtech stories we missed this week: Dec. 29, 2017
From NanoVibronix’s new Indian regulatory and distribution agreement to Guided Therapeutics’s Turkish distribution deal, here are five medtech stories we missed this week but thought were still worth mentioning. 1. NanoVibronix inks deal with Indian regulatory and distribution consultant NanoVibronix announced in a Dec. 20 press release that it has signed Morulaa HealthTech as its regulatory […]
Nemaura readies CE Mark submission for non-invasive glucose monitor
Nemaura Medical (OTC:NMRD) finished the European clinical trial program for its non-invasive glucose monitoring system earlier this month and reported that it’s preparing to submit the product for CE Mark clearance in the E.U. The company’s clinical trial program in Europe included 75 patients who wore sugarBeat continuously for up to 14 hours over 7 consecutive […]
TherapeuticsMD submits NDA for hormone therapy to treat vasomotor symptoms
TherapeuticsMD (NSDQ:TXMD) has submitted its bio-identical hormone therapy to the FDA for approval as a treatment for moderate-to-severe vasomotor symptoms due to menopause. The company’s investigational combination of estradiol and progesterone is delivered in a single, oral soft-gel capsule. Shares in TherapeuticsMD fell earlier this month after the company announced that the FDA accepted its resubmitted […]
How this biotech plans to go up against big pharma with its eye disease products
Shankar Musunuri has spent time in both the pharmaceutical world and the biotech arena – after 15 years at Pfizer (NYSE:PFE), he went on to launch several biotech start-ups. As co-founder, chairman & chief executive of Ocugen, he is looking to bring eye disease products to the patients that big pharma’s drugs have left out. “There’s […]