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Home » Newsletters » BioWorld

BioWorld

June 19, 2018

View Archived Issues

Regulatory front

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

Financings

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

Other news to note

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

Clinical data for June 18, 2018

Read More

Regulatory actions for June 18, 2018

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MedPAC blasts low-value care, such as PCI for stable CAD

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

Aussie nonprofit gains FDA approval, along with PRV for river blindness drug

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

Genomics could improve diagnosis, treatment of soft tissue tumors in infants

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

Evotec more than doubles anti-infectives work, closes Sanofi asset transfer deal

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

Hvivo seeking partner for large phase III on positive field trial data for Flu-v

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

Agios ACTIVATEs pivotal program for AG-348 in PK deficiency

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

Early SMA therapy data bolsters PTC shares

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

Conference data: European Hematology Association (Stockholm)

Read More

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