Patience is wearing thin on Capitol Hill, both with drug companies that insist on maintaining high U.S. list prices and with congressional inaction on what's "one helluva problem," as Sen. John Kennedy (R-La.) described those prices at a Senate Judiciary Committee hearing Tuesday. Read More
DUBLIN – Inhaled drug delivery specialist Vectura Group plc could be adding at least $89.7 million to its coffers after a U.S. jury found that its partner, Glaxosmithkline plc, infringed a Vectura patent in three of its Ellipta-branded products for respiratory disease. Read More
PERTH, Australia – Australia's largest venture capital firm, Brandon Capital Partners, has raised AU$210 million (US$147 million) for a new medical research fund that will invest in early stage discoveries linked to Medical Research Commercialization Fund (MRCF) members, a network of more than 50 medical research institutes and hospitals across Australia and New Zealand. Read More
PHILADELPHIA – "We've gone from no randomized controlled trial to three," Sean Pittock told reporters at the American Academy of Neurology (AAN) annual meeting this week. "It's a glorious example of what you can do with precision medicine." Read More
DUBLIN – Promethera Biosciences SA raised €39.7 million (US$44.4 million) in a series D funding round to progress clinical development of its lead cell therapy, Hepastem, in acute-on-chronic liver failure (ACLF) and nonalcoholic steatohepatitis (NASH), as well as to fund scale-up of its manufacturing capabilities and preclinical development of earlier-stage programs. Read More
What could become the first nonsurgical therapy for ptosis, or droopy eyelid, inched closer to an NDA submission with upbeat top-line phase III efficacy results from Study 202, Osmotica Pharmaceuticals plc's test of RVL (oxymetazoline hydrochloride ophthalmic solution 0.1%), supplemented by new long-term phase III safety data, known as Study 203. Read More
Cancer Prevention Pharmaceuticals Inc. (CPP) and its partner, Mallinckrodt plc, said Tuesday the phase III trial of CPP-1X/sulindac in patients with the orphan disease familial adenomatous polyposis (FAP) did not meet its primary endpoint. Mallinckrodt doesn't plan to pursue the program's commercialization. Read More
Autism spectrum disorder, like many developmental and degenerative brain disorders, has multifactorial causes. But researchers are focusing particularly on damage that occurs late in pregnancy during the third trimester; that is when the fetal cerebellum develops, which is the region of the brain that is known to be tied to autism spectrum disorder (ASD). Read More
Shares of Catalyst Pharmaceuticals Inc. tumbled 40% Tuesday on word that the FDA had cleared Ruzurgi (amifampridine) for treating pediatric patients with Lambert-Eaton myasthenic syndrome (LEMS). Catalyst, of Coral Gables, Fla., currently markets its LEMS treatment, Firdapse (amifampridine phosphate), for adult patients but has come under congressional scrutiny for its hefty $375,000 annual price tag, particularly since the active drug was once available to patients for free. Read More
Bioasis Technologies Inc., of Guilford, Conn., said it intends to complete a nonbrokered private placement of units at a price of CA28 cents (US20 cents) per unit, for gross proceeds of about CA$1 million. Proceeds will be used to support ongoing research and development, clinical development, manufacturing and other activities in respect of the company's clinical development pipeline and for working capital and general corporate purposes. Read More
Renalytixai plc, of New York, is collaborating with University Medical Center Groningen, the Netherlands, to evaluate Kidneyintelx on samples from more than 3,500 patients with type 2 diabetes to determine if Kidneyintelx can predict the best therapies for the treatment of diabetic kidney disease. Renalytixai plans to launch Kidneyintelx in its CLIA laboratory facilities in the U.S. in the second half of 2019. Read More
La Jolla Pharmaceutical Co., of San Diego, reported that for the three months ended March 31, Giapreza, a vasoconstrictor indicated to increase blood pressure in adults with septic or other distributive shock, had net product sales of $4.4 million, compared to $800,000 for the same period in 2018. Read More
