LONDON – The multiple causes and heterogeneous patient population have confounded yet another dry eye disease study, with Topivert Pharma Ltd. reporting TOP-1630 failed to meet the primary endpoint in the THEIA-1 phase IIb/III trial. Read More
As expected, Rhythm Pharmaceuticals Inc. rolled out positive top-line results from two pivotal, phase III trials evaluating setmelanotide, the company's melanocortin-4 receptor (MCR4R) agonist, for the treatment of pro-opiomelanocortin (POMC) and leptin receptor (LEPR) deficiency obesities. Read More
With a $33 million series B round now under his belt, Glycomine Inc.'s CEO said serendipity is a large part of what brought the company to study glycosylation disorders, a rare disease that affects about 1,000 people. Read More
BEIJING – Shenzhen-listed Chinese firm Nanjing Hicin Pharmaceutical Co. Ltd. has in-licensed an isocitrate dehydrogenase (IDH) inhibitor known as I111b from Italian oncology specialist Nerviano Medical Sciences Srl (NMS) to develop and commercialize the drug globally for patients with acute myeloid leukemia (AML). Read More
Myriad Genetics is hoping to soon add prostate cancer to the growing list of indications for use of its BRACAnalysis CDx in combination with Lynparza (olaparib), following the announcement of positive results in a subset of prostate cancer patients. Read More
HONG KONG – Aiming to accelerate its biopharmaceutical R&D and marketing approvals, South Korea's Ministry of Food and Drug Safety (MFDS) and Ministry of Health and Welfare recently announced the Proposal of Advanced Regenerative Medicine and Advanced Biopharmaceuticals Safety and Support Act had passed the country's National Assembly plenary session at the beginning of August and will come into force in a year's time. Read More
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Intercept Pharmaceuticals Inc., of New York, posted second-quarter sales of liver disease drug Ocaliva (obeticholic acid) totaling $65.9 million, marking a growth of 53% over the prior quarter. Read More
Caladrius Biosciences Inc., of Basking Ridge, N.J., and Cognate Bioservices Inc., of Memphis, Tenn., signed a manufacturing agreement for the production of CLBS-14, Caladrius' CD34-positive cell therapy. Read More
Obseva SA, of Geneva, said it closed a $75 million senior secured credit facility with Oxford Finance LLC. The nondilutive financing agreement provides funds in three tranches, with the initial $25 million available upon closing. Read More
If the Trump administration wants to move forward with the Safe Importation Action Plan it announced last week, the FDA needs to reinstate unannounced inspections of drug manufacturing facilities in other countries, Sen. Chuck Grassley (R-Iowa) said Tuesday in a letter to Acting FDA Commissioner Ned Sharpless and Health and Human Services (HHS) Secretary Alex Azar. Read More
