Topic:

Clinical Trials

Latest Headlines

Latest Headlines

NEA to test 2016 public waters with up to $52M Senseonics offering

After a reverse merger in December, the blood glucose monitor implant company Senseonics is already publicly traded, albeit on the OTC markets. Now, it's filed to raise up to $51.8 million in an IPO-like offering, after which it proposes to bump up to the NYSE market and trade under the ticker symbol "SENS."

BioLineRx joins immuno-oncology scrum through Keytruda combo deal

BioLineRx has become the latest company to stake its claim for a spot on the burgeoning roster of immuno-oncology combinations. The small biotech is aiming to muscle into the sector by showing its CXCR4 antagonist BL-8040 can boost the effectiveness of Merck's Keytruda in metastatic pancreatic adenocarcinoma.

Aimmune takes peanut allergy vaccine into PhIII

Brisbane, CA-based Aimmune Therapeutics is making strides toward a peanut allergy vaccine, announcing on Monday that it enrolled the first patient in the Phase III trial of its therapeutic vaccine, AR101.

Dynavax's hep B vaccine outperforms Glaxo's jab in top-line PhIII results

The FDA has already rejected Dynavax's hepatitis B vaccine once, but the Berkeley, CA-based biotech is planning to resubmit its licensing application for the jab as it serves up promising top-line data from the third Phase III trial of Heplisav-B.

Bavarian Nordic eyes $86M Nasdaq IPO to advance cancer, infectious disease pipeline

Bavarian Nordic is turning to Nasdaq to bankroll the advance of its pipeline of infectious disease and cancer vaccines. The decision follows a breakout two-year period for the long-running company, in which alliances with Bristol-Myers Squibb and Johnson & Johnson raised investor expectations for its pipeline products.

FDA green light sets Nanobiotix up to start nanoparticle prostate cancer trial

Nanobiotix is gearing up for the first U.S.-based clinical trial of its nanoparticle therapy, NBTXR3. The FDA signed off on an IND for a clinical trial of the asset in prostate cancer late last year, setting Nanobiotix up to aim to start enrolling the first of 24 patients for the preliminary stage of the Phase I/II study.

Basilea seeks partner for PhIII antibiotic trial after canning Nasdaq IPO

Basilea Pharmaceutica has come out of talks with the FDA with a clearer idea of how it will design Phase III trials of its broad-spectrum antibiotic. But with its ambition to list on Nasdaq consigned to the scrapheap, Basilea is now steadfast in its desire to find a partner before kicking off the trials.

Acacia Pharma hits PhIII endpoint to bounce back from IPO misstep

Acacia Pharma has hit the primary endpoint in another Phase III trial of its postoperative nausea and vomiting drug. The study adds to the burgeoning pool of late-phase data on the drug, which last made headlines in 2014 when it outperformed the placebo in another Phase III trial.

Strike two: Gilead chalks up another setback for top pipeline prospect simtuzumab

Gilead has racked up its second straight setback on simtuzumab, scrapping a mid-stage study for idiopathic pulmonary fibrosis after a data monitoring group concluded that the drug wasn't working as expected.

GlySens nabs $20M Series D to back CE mark for continuous glucose monitor implant

San Diego, CA-based startup GlySens expects that its implanted continuous glucose monitor could offer convenient long-term monitoring for diabetes patients. It's been able to use its sensor implant for up to 18 months in the preclinical setting.
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