Basilea Pharmaceutica Ltd., of Basel, Switzerland, started enrollment in the first of its two planned phase III registration studies of the ceftobiprole. The first study evaluates the safety and efficacy of the antibiotic in the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI).  Read More

Asit Biotech SA, of Brussels, Belgium, said it raised a second €2.1 million (US$2.6 million) tranche in connection with the private placement approved by the shareholders' meeting in December.  Read More

Helix BioPharma Corp., of Richmond Hill, Ontario, said that following board approval it is exploring a partnership, alliance, joint development or licensing transaction of its L-DOS47 drug product candidate currently in clinical trials for the treatment of nonsquamous small-cell lung cancer.  Read More

The Agency for Healthcare Research and Quality (AHRQ) has published a report on the definition of treatment-resistant depression (TRD), and the absence of a consensus definition seems to inhibit efforts to deal with a condition that imposes as much as $48 billion in societal costs each year in the U.S., a figure certain to rise as the opioid epidemic plays out. Read More

Blockchain, the transaction-following technology that got its fame as a way to follow the movements of cryptocurrencies such as Bitcoin, is making its way into the pharmaceutical industry, proving its potential uses are far-flung. Read More

HONG KONG – Celltrion Inc., of Incheon, South Korea, recently received marketing approval from the European Commission for its biosimilar trastuzumab, Herzuma. Based on Roche Holding AG and Genentech Inc.'s targeted therapy, Herceptin, Herzuma is cleared for marketing in the 28 member states of the European Union (EU), in addition to Norway, Liechtenstein and Iceland. Read More

Durham, N.C.-based Dova Pharmaceuticals Inc., a small rare disease company gearing up for the potential launch of a pre-registration drug for treating thrombocytopenia, has priced an underwritten public offering expected to raise as much as $80.9 million. Funds from the offering, in which shares will be sold at $32 each, would support a potential June launch of avatrombopag in the U.S. for patients with chronic liver disease, and work to expand the drug's approved uses to the treatment of a broader population of patients with thrombocytopenia. Read More

Coralville, Iowa-based Kempharm Inc. has won FDA approval for Apadaz for the short-term management of acute pain. The drug is an immediate-release combination of Kempharm's hydrocodone prodrug, benzhydrocodone, and acetaminophen (APAP). It's the first prodrug of hydrocodone/acetaminophen to be approved by FDA. Read More

DUBLIN – The EMA has diverged sharply from the FDA in denying approval of Puma Biotechnology Ltd.'s breast cancer drug, Nerlynx (neratinib). The EMA's Committee on Human Medicinal Products (CHMP) formally issued a negative opinion on the Puma application last week, on the grounds that it was uncertain that the modest clinical benefit seen in clinical trials – 94 percent of patients on the drug remained relapse-free for two years vs. 92 percent of patients on placebo – would be repeated in clinical practice. The drug, moreover, has a high burden of gastrointestinal side effects, including severe diarrhea, which can be difficult to manage. Read More

"Pairing solid commercial execution with a pipeline that has been consistently and rapidly replenished, and now increasing profitability," Raymond James analyst Laura Chico found "much to like" in the latest earnings report from Biomarin Pharmaceutical Inc. Read More

Excessive standardization of preclinical conditions has been identified as a cause of poor reproducibility, because it made it more likely that results were valid only under the exact experimental conditions in which they were obtained. While most causes of poor reproducibility, including low statistical power, "p" hacking and publication bias, are poor scientific practice, standardization of experimental conditions is considered a desirable scientific practice.  Read More