Contravir Pharmaceuticals Inc., of Edison, N.J., said new studies of its hepatitis B virus-optimized cyclophilin inhibitor CRV431 show that it blocks the interaction between hepatitis B surface antigen (HBsAg), a key HBV protein, and cyclophilin A, an important cellular protein. Read More

Corvus Pharmaceuticals Inc., of Burlingame, Calif., reported interim results from its phase I/Ib study, showing that treatment with CPI-444 as a single agent and in combination with Tecentriq (atezolizumab, Roche Holding AG) was well-tolerated and resulted in antitumor activity in patients with multiple types of advanced solid tumors, including those resistant or refractory to prior treatment with anti-PD-1 or anti-PD-L1 antibodies. Read More

CSL Behring LLC, of King of Prussia, Pa., announced the publication in the New England Journal of Medicine of results from the Compact study, a pivotal phase III trial evaluating the safety and efficacy of CSL830 (C1-esterase inhibitor [C1-INH] human replacement therapy) for the prevention of hereditary angioedema (HAE) attacks. Read More

Veloxis Pharmaceuticals A/S, of Copenhagen, said its capital has been increased by 1 million new shares with a nominal value of DKK0.10 (US1.4 cents) each corresponding to nominally DKK100,000 as a consequence of the exercise of warrants by former employees of the company granted under the warrant program. Proceeds to the company will amount to DKK350,000 (US$50,167). Read More

SHANGHAI – At the recent China Healthcare Investment Conference (CHIC) – where investors and Chinese biotech CEOs meet up to try and make their investment dreams come true – the theme was growth vs. innovation. Whether innovation stems from growth or growth comes from other drivers, both appear to be significantly helped along by the recent spate of CFDA regulatory reforms. Read More

The Senate hearing dealing with FDA user fees covered much of the predictable ground, but Sen. Richard Burr (R-N.C.), a frequent critic of the agency, gave voice to the prospect that the user fee-authorizing legislation would incorporate a clawback mechanism for appropriations should the agency fail to meet the goals of the next set of user fee agreements. Read More

LONDON – Members of parliament scrutinizing the Brexit process have called for a standalone agreement to be made to protect the rights of EU27 nationals living in the U.K. and British citizens in mainland Europe as soon as negotiations on the terms of the U.K.'s exit from the EU begin. Read More

WASHINGTON – Researchers at Yale University have received conditional approval for a clinical trial that will test whether isocitrate dehydrogenase (IDH)-mutated tumors might respond better to poly-ADP ribose polymerase (PARP) inhibitors than to IDH inhibitors. Read More

With clinical news pouring from pharma giants matching up the indoleamine 2,3-dioxygenase 1 (IDO1) blocker mechanism with PD-1 immune checkpoint inhibitors, Newlink Genetics Corp.'s interim results from NLG2103 – a phase II study evaluating its IDO pathway blocker indoximod as a combo candidate in advanced melanoma – seemed to take a back seat. Read More

Ten months after an FDA complete response letter (CRL) set back efforts by Teva Pharmaceutical Industries Ltd. to gain its first approval for Austedo (deutetrabenazine), an agency review has finally led to approval for the orphan-designated drug, a treatment for chorea – involuntary, random and sudden, twisting and/or writhing movements – associated with Huntington's disease (HD). Read More

Shares of Paratek Pharmaceuticals Inc. (NASDAQ:PRTK) spiked to a two-year high of $25 after the company reported that its lead candidate, omadacycline, met FDA primary and secondary endpoints and EMA co-primary endpoints in the phase III OPTIC (Omadacycline for Pneumonia Treatment in the Community) trial in patients with community-acquired bacterial pneumonia (CABP). Read More