Researchers from the University of Massachusetts Amherst have designed a nanoparticle delivery system to assist the gene-editing tool known as CRISPR/Cas9 across the cell membrane and into the cell nucleus, effectively avoiding the cell’s natural defense mechanisms. The team’s work was published in ACS Nano. “CRISPR has two components: a scissor-like protein called Cas9, and an […]
Aura Biosciences wins FDA nod for light-activated ocular melanoma treatment
Aura Biosciences said today that the FDA approved its Investigational New Drug Application for the company’s light-activated viral nanoparticle conjugates for the treatment of ocular melanoma. The federal watchdog’s approval allows Cambridge, Mass.-based Aura to move forward with initial clinical tests of AU-011. The Phase Ib open-label clinical trial, which is currently enrolling, is designed to […]
FDA accepts Intarcia’s NDA for diabetes drug-device combo
Intarcia Therapeutics said today that the FDA accepted its New Drug Application for the 1st drug to use Intarcia’s Medici drug delivery system to treat Type II diabetes. The Medici drug-device combo delivers exenatide subcutaneously using a match-sized osmotic pump placed under the skin in an in-office procedure. The subcutaneous delivery system uses technology to stabilize proteins, peptides, antibody fragments […]
Pulmatrix raises $3m in direct offering
Pulmatrix (NSDQ:PULM) said today that unnamed institutional investors agreed to purchase approximately $3.3 million of shares of common stock in a direct offering. The company said it plans to sell 950,000 shares at $3.50 apiece. Pulmatrix expects the offering, which will close next week, to bring in $3.0 million in proceeds to use for general […]
Amgen tops Q4 earnings, touts Repatha cardiovascular outcomes
Shares in Amgen (NSDQ:AMGN) rose today after the pharmaceutical company met expectations on Wall Street with its 4th quarter results and touted data from a trial for its cholesterol drug, Repatha. The Thousand Oaks, Calif.-based company posted profits of $1.94 billion, or $2.59 per share, on sales of $5.97 billion for the 3 months ended Dec. 31, for bottom-line […]
Federal investigators subpoena Biogen over MS drug prices
Biogen (NSDQ:BIIB) said on Thursday that it received a subpoena in December last year from federal investigators about the prices of its top-selling multiple sclerosis drugs, Tecfidera, Avonex, Tysabri and Plegridy. In its annual regulatory filing, the company wrote that the investigators inquired about “government price reporting, rebate payments and Biogen’s co-pay assistance programs.” While Cambridge, Mass.-based Biogen said […]
Acuitas touts lipid-nanoparticle delivery of mRNA vaccine for Zika
Acuitas Therapeutics touted preliminary data that evaluated its messenger RNA vaccine for the Zika virus. The company uses a lipid-nanoparticle delivery system to introduce its mRNA vaccine into cells. The team’s work, which was published in Nature, showed that a single low-dose immunization with its vaccine triggered an immune response in animals and protected them from infection at […]
Braeburn pulls the plug on $150m IPO, citing market conditions
Braeburn Pharmaceuticals pulled its plans for a $150 million initial public offering yesterday, citing unstable market conditions. The Princeton, N.J.-based company 1st announced plans to go public in late December and in mid-January, Braeburn said it planned to raise $150 million by offering 7,692,308 shares of its common stock at $18.00 to $21.00 apiece. The company […]
Nordisk tumbles on lowered outlook
Shares in Novo Nordisk (NYSE:NVO) fell -9% this morning after the pharmaceutical company missed expectations on Wall Street with its 4th quarter results and lowered its outlook for 2017. The Danish company posted profits of 8.7 billion Danish kroner, or $1.26 billion USD, on sales of 29.57 billion kroner for the 3 months ended Dec. 31, for bottom-line growth of […]
Surmodics raises guidance, beats Q1 earnings
Shares in Surmodics (NSDQ:SRDX) rose today after the medical device maker met expectations on Wall Street with its fiscal 2017 1st quarter results. The Eden Prairie, Minn.-based company posted profits of $2.3 million, or 17¢ per share, on sales of $17.8 million for the 3 months ended Dec. 31, for bottom-line loss of -13.3% on […]