Despite a rough ride on the capital markets, particularly in the second half of the year, the biopharmaceutical sector had no difficulty in attracting capital. According to BioWorld data, the $67.1 billion that was raised by global companies from public and private sources in 2018 was just shy of the leading total of $68.4 billion generated in 2015 and places it firmly in second place in terms of totals raised in the history of the industry. Read More
The U.S. federal government shutdown is well into its fourth week, and the FDA budget is still taking a substantial hit as the White House and House Democrats wrangle over immigration policy. FDA Commissioner Scott Gottlieb has taken to Twitter frequently in recent days, stating that while a number of functions have ground to a halt, the agency will focus on safety and thus continue its work on drug and device recalls and routine inspections, the latter of which has been expanded beyond the for-cause inspections initially announced by the agency. Read More
LONDON – Verona Pharma plc published data showing its dual action bronchodilator, ensifentrine (RPL-554), can provide additional benefits for chronic obstructive pulmonary disorder (COPD) patients who are considered to be achieving maximum bronchodilation from existing dual or triple therapies. Read More
HONG KONG – South Korean pharmaceutical companies Bridge Biotherapeutics Inc. and Daewoong Pharmaceutical Co. Ltd. have forged a partnership to develop a drug candidate targeting pellino proteins for treating ulcerative colitis (UC). Read More
LONDON – Swiss researchers have uncovered a potential new route to preventing metastasis, after succeeding in harvesting intact circulating tumor cell (CTC) clusters that are the precursors of metastases, from the blood of breast cancer patients. Read More
PERTH, Australia – After nearly 40 years, New Zealand is preparing new legislation to regulate drugs and devices that would replace the Medicines Act 1981. Read More
The road to the U.S. market may be opening up for Amgen Inc.'s Evenity (romosozumab), an osteoporosis candidate that received a complete response letter in 2017 after it unexpectedly raised cardiovascular concerns in a pivotal trial. Read More
Mesoblast Ltd, of Melbourne, Australia, has drawn down a further $15 million from its $75 million four-year credit facility with Hercules Capital Inc. It said the funds will be used primarily to ramp up its commercialization programs, including building out a targeted sales force for remestemcel-L, an experimental therapy for acute graft-vs.-host disease for which Mesoblast plans to soon submit a rolling biologics license application to the FDA. Read More
Rogcon Biosciences Inc., of New Haven, Conn., partnered with Prometheus Research to support the creation of a clinical data registry to assist a planned international natural history study of patients with SCN2A mutations, which Rogcon said are the most common cause of neurodevelopmental disease including epilepsy and autism. Read More
The EMA issued a revised guideline Monday on evaluating antibacterial drugs to better align data requirements for clinical trials. The revision reflects extensive discussions among regulators in the EU, Japan and the U.S. to help sponsors of the drugs design clinical trials that meet the evidence needs of multiple regulatory agencies. Read More
