Arrowhead Pharmaceuticals Inc., of Pasadena, Calif., said it closed its private offering with investors, including Orbimed, RA Capital Management, Perceptive Advisors, RTW Investments and certain other institutional investors. About 7.63 million shares of common stock were issued at a price of $5.90 apiece. Gross proceeds totaled $45 million. Read More
Endo International plc, of Dublin, said based on an Aug. 11 discussion with the FDA, it is withdrawing its supplemental NDA relating to specific abuse-deterrent labeling for Opana ER (extended-release oxymorphone) without prejudice to re-filing. The company said it plans to continue collecting and analyzing epidemiological data. Opana ER is an opioid agonist approved for the management of pain severe enough to require daily, around-the-clock opioid treatment and for which alternative treatment options are inadequate. Read More
The FDA completed a comprehensive review of the safety information relevant to the investigational small-molecule inhibitor of fatty acid amide hydrolase (FAAH) from Bial-Portela & Ca. SA, of Sao Mamede do Coronado, Portugal, linked to one death and five hospitalizations of volunteer subjects in a phase I trial at a France hospital early this year. Read More
Acacia Pharma Group plc, of Cambridge, U.K., reported results from a pivotal phase III study testing Baremsis (amisulpride injection, formerly APD421) for the treatment of established postoperative nausea and vomiting (PONV), which the firm said further support efficacy previously shown in PONV alone, and in combination with standard antiemetics in phase III prophylaxis studies. The study compared two doses of Baremsis, a dopamine D2/D3 antagonist antiemetic, against placebo in patients with established nausea and/or vomiting after surgery, who had not previously received any prophylactic antiemetics. ) Read More
Even if Wall Street scratches off the soon-to-report, longshot phase III SEAMLESS trial in acute myeloid leukemia (AML), Cyclacel Pharmaceuticals Inc. may have value aplenty in an early stage pair of other clinical programs. But home-run hopes die hard and biotech is full of surprises – such as Vyxeos, the late-stage AML winner in March for Celator Pharmaceuticals Inc. Read More
Immunotherapy developer Tapimmune Inc., which began life back in 2000 as Genemax Corp., quietly inked a series of deals and kept its head down during the formative years of the immuno-oncology (I-O) field. Read More
A single compound was able to rid mice of three separate parasitic infections, opening the possibility of developing a relatively broad-spectrum approach against the three, which are collectively known as kinetoplastids. Read More
Building a successful biotechnology company requires that its executives make decisions to help navigate a smooth path around barriers that could easily hinder progress. There is no doubt that running a biopharma company involves plenty of risks in an ever-changing financial and regulatory landscape. Read More
While its name obviously reflects its work in the field of hearing loss, Oricula Therapeutics Inc.'s biggest impact could actually be in the antibiotics space, focusing its efforts amid the recent global call to action on tackling antimicrobial resistance. Read More
