Vtv Therapeutics Inc., of High Point, N.C., reported results from the phase Ib portion of Simplici-T1, a phase Ib/II trial testing TTP-399 in patients with type 1 diabetes. Over one week of daily dosing in five patients, the drug was well-tolerated and improved or maintained glycemic control while reducing or simplifying patients' insulin regimen. Read More

Exelixis Inc., of South San Francisco, said partner Ipsen SA, of Paris, received a positive opinion from the EMA's Committee for Medicinal Products for Human Use for Cabometyx (cabozantinib) 20 mg, 40 mg and 60 mg for the first-line treatment of adults with intermediate- or poor-risk advanced renal cell carcinoma.  Read More

Cure Pharmaceutical Corp., of Oxnard, Calif., secured a $1 million bridge financing from accredited investors for working capital and to fund a potential up-listing to Nasdaq.  Read More

Citing a recent Health and Human Services (HHS) Office of Inspector General (OIG) report that found Medicaid may have lost $1.3 billion in base and inflation-adjusted rebates for the top 10 potentially misclassified drugs from 2012 to 2016, Republican and Democratic leaders of the Senate Finance Committee and the House Energy and Commerce Committee wrote to the Centers for Medicare & Medicaid Services (CMS) to voice their concerns about the misclassification of prescription drugs under the rebate program. Read More

LONDON – A rapid, high-precision method for diagnosing sepsis by assessing the behavior of neutrophils in a single drop of blood was reported by researchers at Massachusetts General Hospital last week. Read More

The underlying science required for cell-based organ augmentation and replacement is advancing rapidly. The approaches to creating and growing populations of specialized cells, shaping more complex cellular structures and incorporating materials designed to minimize immune interactions have proliferated and grown increasingly sophisticated. Read More

Type I diabetes (T1D) is an autoimmune disease that results in the destruction of insulin-producing pancreatic beta cells by killer T cells. However, most of the killer T cells that patrol the pancreas during diabetes do not recognize any pancreatic antigens. The assumption has been that even the nonspecific T cells contribute to disease progression by contributing to tissue damage. Researchers from the La Jolla Institute of Allergy and Immunology have reported that the opposite is true.  Read More

LONDON – Astrazeneca plc can finally look forward to a return on its $2.7 billion purchase of Lokelma, after the orally administered hyperkalemia treatment broke through a series of regulatory setbacks to win approval in Europe. Read More

NMD Pharma A/S, a Danish biotech developing therapies for severe neuromuscular disorders, has landed a €38 million (US$46.9 million) series A financing. Proceeds from the round are expected to back proof-of-concept studies for an oral therapy targeting the orphan neuromuscular disorder myasthenia gravis and, in the critical care setting, an I.V. therapy for the reversal of muscular blockade in connection with surgery. The studies are expected to take three to five years to complete. Read More

Handling the anxiety of patients about cancer risks with biologics for inflammatory bowel disease (IBD) on the one hand while battling miserly insurance companies on the other: such is the life of a gastroenterologist, said Scott Becker, in practice for 28 years. Read More

LONDON – The Brexit process took a significant step forward on Friday with the EU agreeing to terms on a draft transition agreement which, rather than calling time when the U.K. leaves in March 2019, will give companies until the end of 2020 to complete preparations. Read More

The threat of drug-resistant superbugs is no secret, and neither is the fact that the development of new antibiotics faces commercialization challenges as well as scientific ones. Read More