Asked whether U.S. regulators might change their minds about guidance on the regulatory path for bempedoic acid to lower low-density lipoprotein C (LDL-C), Esperion Therapeutics Inc. CEO Tim Mayleben said “the answer is that we don’t know. We know what we know today. That’s probably a question better addressed to the FDA and what they’re planning.” Read More

Adding the investigational advanced breast cancer candidate, abemaciclib, to the already-approved drug fulvestrant, reduced the risk of disease worsening or death for women with hormone-receptor-positive, HER2-negative disease more than adding a placebo, Eli Lilly and Co. reported. Read More

LONDON – Ergomed plc has started the phase IIb trial of Peprostat, the first synthetic peptide hemostat, which it said will offer faster clotting while removing concerns around plasma-derived thrombin products. Read More

BARCELONA, Spain – Even if the myriad uncertainties that have accompanied the arrival of the Trump administration in the U.S. mean that business as usual may no longer be possible for many biopharma firms, they still have business to conduct. And that was foremost in the mind of delegates arriving at Barcelona’s International Convention Center (CCIB) Monday. Read More

BARCELONA, Spain – The new U.S. president has been in office for two months. During that time, he has – among other moves – pledged to reduce regulatory hurdles during a meeting with biopharma execs, sent biopharma stocks falling on a tweet on drug pricing, nominated an industry-friendly Scott Gottlieb as FDA commissioner and last week released a proposed White House budget for fiscal 2018 that calls for a $15.1 billion bite out of the Health and Human Services budget, including nearly $6 billion from the NIH. Read More

A Chinese study has reported a promising new approach to the prevention and treatment of cholesterol gallstone disease (CGD), by reducing the biliary output of cholesterol via activation of constitutive androstane receptors (CAR), which are present in tissues of the liver and small intestine. Read More

Nektar Therapeutics Inc. looked to take the upper hand in partnering talks for NKTR-181, its mu-opioid agonist, after the molecule proved its mettle in a phase III study in more than 600 patients with moderate to severe chronic low back pain who were new to opioid therapy. Read More

The U.S. Health Resources and Services Administration (HRSA) wants to push back the implementation of a final rule issued in January that sets the calculation of the ceiling price for the 340B drug pricing program and imposes a “knowing and intentional” standard in determining whether civil monetary penalties should be assessed when a drug company overcharges a 340B provider. Read More

Mallinckrodt plc, of Staines-Upon-Thames, U.K., reported that it closed the sale of its intrathecal therapy business to Piramal Critical Care, the U.K. arm of Piramal Enterprises Ltd., for about $203 million. Read More

Provectus Biopharmaceuticals Inc., of Knoxville, Tenn., agreed to an exclusive definitive financing commitment term sheet from a group of stockholders, known as Group B, in place of a previously submitted unsolicited proposal from a separate group of stockholders. Read More

Janssen Pharmaceuticals Inc., reported that patients with venous thromboembolism (VTE) taking Xarelto (rivaroxaban) who received either 10 mg or 20 mg once daily over an extended time period, had significantly fewer recurrent blood clots and similar rates of major bleeding compared to those taking 100 mg of aspirin once daily. Read More