Mesoblast's off-the-shelf stem cell therapy, remestemcel-L, achieved the primary goal of its Phase III US trial showing 69% of 55 pediatric patients with potentially fatal acute graft-versus-host disease responding to the treatment. Mesoblast plans to file for regulatory approval with the FDA based on six-month safety and efficacy data from the trial.
Evofem Biosciences' Amphora, or L-lactic acid, citric acid and potassium bitartrate, vaginal gel, which is indicated to prevent urogenital chlamydia in female patients, was given fast-track status by the FDA. The company has an ongoing Phase IIb/III study of Amphora for the indication.
Eyenovia will commence in 2019 a late-stage study of MicroPine, a microtherapeutic formulation of atropine, in patients with progressive myopia. The FDA has said Eyenovia needs to have only one instead of two pivotal late-stage trials for the drug to support its marketing application.
The FDA granted approval to India-based Lupin's oseltamivir phosphate for oral suspension, a generic version of Roche Holding's Tamiflu, for the treatment of patients ages 2 weeks and older with acute, uncomplicated influenza A and B who have been symptomatic for up to 48 hours, and as prophylaxis in patients ages 1 year or older with influenza A and B.
Human trials for Medigene's lead candidate, MDG1011, a T-cell receptor-modified cancer immunotherapy, was granted clearance by German regulators. The Phase I/II study will be a combined safety and feasibility trial to test the efficacy of the immunotherapy in an estimated 92 patients diagnosed with acute myeloid leukemia, multiple myeloma or myelodysplastic syndrome.
Any application to withdraw coronary stents from the market in India will not be disallowed by the National Pharmaceutical Pricing Authority, the regulator said Wednesday. Manufacturers and importers are required to inform the regulator about such plans at least six months before the expected date of product withdrawal and "follow ceiling price in such a manner and till such a time prescribed [by] the government," the regulator noted.
The Eversense Now remote monitoring app was launched by Senseonics in Europe, the Middle East and Africa, where its Eversense XL continuous glucose monitoring system is available. The app enables sharing of glucose data with up to five family members or friends of CGM users -- a feature that is currently available only to users of iOS mobile phones.
An application for a medical device license was submitted by Tandem Diabetes Care to Health Canada for its t:slim X2 insulin pump. The company, which aims to release the product in the country in the second half of the year, said the device will come with a 24-hour clock and will have the ability to display English and French.
A round of Series C funding brought in $50 million for Oric Pharmaceuticals. The company anticipates completion of an early-stage study of lead candidate ORIC-101 in healthy patients in the first half of the year and intends to assess the candidate in cancer patients later in 2018.
Oncolytic immunotherapy firm Viralytics will be purchased by Merck for $394 million. Under the deal, Merck will gain Cavatak, which is currently in early-stage and midstage trials in combination with Merck's Keytruda for the treatment of patients with cancer, including melanoma and bladder, lung and prostate cancers, with results expected next quarter.
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