While active pharmaceutical ingredients (APIs) and finished drugs escaped the additional 25 percent tariff the U.S. government imposed last week on hundreds of Chinese imports, many diagnostics and medical devices weren't so fortunate. Read More
Galmed Pharmaceuticals Ltd., of Tel Aviv, Israel, said it intends to sell ordinary shares in an underwritten public offering to raise aggregate proceeds of approximately $75 million. Read More
Microbiotica Ltd., of Cambridge, U.K., said it entered an agreement with University of Adelaide as part of its program to develop a defined bacterial product for ulcerative colitis (UC). Read More
The Medicare Payment Advisory Commission (MedPAC) issued its annual June series of reports to Congress on Medicare spending, and the data report takes aim at purportedly low-value items and services, including percutaneous intervention in patients with stable coronary artery disease (CAD). The controversy is not new, but the appearance of that consideration in the MedPAC report seems certain to apply more pressure on the combination of angioplasty and stenting, a mainstay of the cardiology devices sector. Read More
PERTH, Australia – Melbourne-based Medicines Development for Global Health (MDGH) became the first not for profit company to register a drug through the FDA's tropical disease priority review program. Read More
LONDON - Whole genome sequencing of soft tissue tumors in infants has revealed mutations in the EGFR and BRAF kinase gene, opening up the possibility of repurposing targeted drugs to treat those tumors. Read More
DUBLIN – Sanofi SA and Evotec AG formally completed their previously disclosed deal, under which the latter firm will take on a raft of early stage anti-infective programs from the big pharma firm. Hamburg-based Evotec is getting $60 million up front plus a commitment for continued funding from Paris-based Sanofi, which will retain option rights on each of the programs. Responsibility for a Sanofi research unit in Lyon, which employs 100 scientists, will transfer to the German firm, more than doubling its footprint in anti-infectives research. Read More
LONDON – Hvivo plc announced positive results from a phase IIb field study of its universal flu vaccine, Flu-v, and said that in combination with data from a phase IIb challenge study the product is now ready for phase III development. Read More
As Agios Pharmaceuticals Inc. awaits an FDA decision on ivosidenib (AD-120) in relapsed or refractory acute myeloid leukemia (r/r AML) – the isocitrate dehydrogenase 1 mutant, or IDH1m, inhibitor is under priority review with an Aug. 21 PDUFA date – the company moved AG-348, its selective small-molecule activator of the pyruvate kinase-R (PKR) enzyme, into a second phase III trial that will lay the groundwork for another potential filing. The randomized, double-blind, placebo-controlled trial is expected to enroll approximately 80 adults with pyruvate kinase (PK) deficiency who do not receive regular blood transfusions, seeking to show that AG-348 produces sustained increase in hemoglobin (Hb) in those individuals. Read More
Updated interim data on an experimental spinal muscular atrophy (SMA) therapy co-developed by PTC Therapeutics Inc., Roche Holding AG and the SMA Foundation show that more than 90 percent of the 21 babies enrolled in the first part of an open-label study experienced a greater than four-point increase on a test designed to measure motor milestone development of patients with SMA type 1. Read More
