Pavmed Inc. (NSDQ:PAVM) said last week it plans to extend its previously announced offering to exchange two Series W warrants for a single Series Z warrant. The offering from the New York-based company is now extended through to April 2, having previously been set to close today at midnight, according to a press release. Pavmed offered […]
Mass. Supremes: Pharma Cos. liable for generic labeling issues
Merck (NYSE:MRK) and other large brand-name pharmaceutical manufacturers could be legally liable for injuries resulting not from the use of their brand name products, but from generic versions of those drugs made by other companies, according to a new ruling from the Massachusetts Supreme Judicial Court. The court ruling could set the precedent that such brand-name […]
SEC charges Theranos, CEO Holmes with ‘Massive Fraud’
The US Securities and Exchange Commission today charged controversial blood-testing developer Theranos, founder & CEO Elizabeth Holmes and former prez Ramesh Balwani with “massive fraud” – charges which Theranos and Holmes have agreed to resolve, according to the SEC. Charges include claims that the company raised more than $700 million from investors in “an elaborate, […]
DarioHealth launches Dario blood glucose monitor on Amazon
DarioHealth (NSDQ:DRIO) said today it launched its Dario blood glucose monitoring system on the Amazon marketplace, touting that the system has already been sold through the site. The company’s blood glucose monitor, which syncs with Dario’s diabetes management app, connects via a headphone jack to a mobile device, helping diabetes patients monitor their blood glucose throughout the day. The […]
PharmaJet, Genexine ink deal for needle-free vaccine development
PharmaJet said today it inked a global license agreement with South Korean bioptherapeutics company Genexine to develop and commercialize DNA vaccines using PharmaJet’s needle-free injection system. Through the deal, Genexine will gain access to use both the PharmaJet Stratis and Tropis devices for their Phase I and Phase IIa human clinical studies. The deal also […]
Acorda Therapeutics wins FDA NDA nod for Inbrija
Acorda Therapeutics (NSDQ:ACOR) said today that the FDA accepted the New Drug Application for its Inbrija investigational inhaled levodopa product designed for treating symptoms of OFF periods in patients with Parkinson’s disease who are taking carbidopa/levodopa regimens. The approval comes with a target date of October 5, 2018, the Ardsley, N.Y.-based company said. The NDA comes supported […]
Photocure wins FDA expanded sNDA for Blue Light Cytoscopy with Cysview system
Norwegian urology-focused developer Photocure ASA said last week it won a supplemental new drug application from the FDA extending the indication for its Blue Light Cytoscopy (BLC) with Cysview to include flexible cytoscopes designed for the surveillance of patients with bladder cancer. The company touted the approval, saying it is the only combination of drugs […]
MiMedx shares tumble on internal accounting investigation, delayed 2017 earnings
MiMedx (NSDQ:MDXG) shares have lost nearly a third of their value today after the company announced it is delaying the release of its 2017 financial results due to an internal investigation into alleged issues with sales and distribution practices at the company. The Marietta, Ga.-based company said that its board’s audit committee has tapped a group of […]
India’s NPPA cuts prices on drug-eluting stents by nearly 8%
India’s National Pharmaceutical Pricing Authority cut prices on stents yet again, dropping the cost of certain stents by about 7.6%, according to a Reuters report. This time, the prices on drug releasing stents were cut from approximately $469.60 (INR ₹30,180) to $433.82 (INR ₹27,890), according to the report. The new price cap comes as somewhat […]
Cerus closes $58m public offering
Cerus (NSDQ:CERS) said today it closed a $57.5 million public offering, including the sale of additional shares as part of an underwriter’s option. The Concord, Calif.-based company said that the $57.5 million in proceeds does not include the deduction of offering expenses, and did not state how it plans to spend funds raised in the offering. […]