Contract development & manufacturing organization Althea, an Ajinomoto company, announced today the launch of a new, high-performance sterile vial filling line. The Optima VFVM 7000 aseptic fill finish line adds to Althea’s drug product manufacturing capabilities and enables the company to work with larger batch sizes and a broader range of filling volumes – up […]
Titan wins FDA nod to study Parkinson’s implant
Titan Pharmaceuticals (NSDQ:TTNP) said today that the FDA cleared the investigational new drug application for its ropinirole implant designed to treat the symptoms of Parkinson’s disease. The Phase I/II trial, which is slated to enroll 20 patients with idiopathic Parkinson’s disease, will transition patients taking oral ropinirole to Titan’s ropinirole implant for three months of treatment, […]
Shareholder suit against Alere stays alive
A Massachusetts federal judge dismissed most of a securities fraud class action case against Alere (NYSE:ALR) yesterday, saying that the complaint did not support the claim that Alere senior management had prior knowledge of the company’s alleged wrongdoing. U.S. district judge Patti Saris did, however, allow one part of the complaint to move into discovery. The […]
Propeller Health, GSK expand collaboration for connected inhaler
Propeller Health and GlaxoSmithKline (NYSE:GSK) said today that the two companies are planning to commercialize GSK’s Ellipta inhaler with Propeller’s clip-on medication sensor and software platform. The companies first announced their partnership in 2015 and in November last year the pair won 510(k) clearance from the FDA to market the Propeller plaftform with the Ellipta dry […]
Tandem Diabetes launches t:lock Connector for its insulin pumps
Tandem Diabetes Care (NSDQ:TNDM) said today that it launched the t:lock Connector for its insulin pump cartridges and infusion sets. The connector, which is produced and supplied by Unomedical, has a small inner cavity. San Diego-based Tandem said this feature reduces the amount of insulin used while filling an infusion set and lessens the time required […]
Cel-Sci raises $3.5m for head and neck cancer immunotherapy
Cel-Sci (NYSE:CVM) said today that it inked an agreement with institutional investors for a $3.5 million registered direct offering. The company said it plans to offer 1.75 million shares of common stock at $2.00 apiece. In a private placement, Cel-Sci will issue warrants to buy up to 1.75 million shares of common stock. For each share […]
Bonti kicks off Ph2 trial for neurotoxin pain-reliever
Privately-held biotech Bonti said today that it launched the Lantern clinical program, evaluating its intramuscular neurotoxin injection as a non-opioid pain reliever. The first clinical trial, Lantern-1, is a Phase II study designed to assess the safety and efficacy of EB-001 in patients undergoing elective breast augmentation. The botulinum neurotoxin is characterized by a fast […]
Diabetes app developer DarioHealth closes $5m private placements
Digital health company DarioHealth (NSDQ:DRIO) said today that it closed a $5 million private placement with new and existing investors for shares of the company’s common stock and shares of the company’s Series B convertible preferred stock. The Israel-based company said current shareholders accounted for 58% of the securities sold in the offerings. DarioHealth issued […]
Sirtex swings to a loss after ‘challenging’ year
Shares in Australian cancer treatment developer Sirtex Medical (ASX:SRX) plunged more than 15% yesterday after the company posted a net loss of -A$26.9 million in 2016, compared to a profit of A$54 million the year before. Sirtex has faced a barrage of obstacles this year, including a number of clinical trials that failed to meet primary […]
Omeros closes $68m public offering
Biopharma company Omeros (NSDQ:OMER) said that it closed a $68.3 million underwritten public offering last week, selling 3 million shares of its common stock at $22.75 apiece. After deducting fees and other expenses, Omeros said it is slated to reel in $63.6 million from the offering. The company plans to use its newly-acquired funds to […]