Life Sciences
Top stories summarized by our editors
6/20/2018

Caladrius Biosciences' CD34+ cell therapy for refractory angina treatment was given regenerative medicine advanced therapy status by the FDA.

Full Story:
Seeking Alpha
More Summaries:
Caladrius Biosciences, FDA
6/20/2018

Amphastar Pharmaceuticals' abbreviated new drug application for isoproterenol hydrochloride injection, USP 0.2 mg/mL, available in 1 mL and 5 mL vials, was approved by the FDA. The drug is therapeutically equivalent to Valeant Pharmaceuticals' Isuprel, which is indicated for uses including treatment of mild or transient heart block episodes that do not need electric shock or pacemaker treatment.

Full Story:
Seeking Alpha
More Summaries:
FDA, Amphastar Pharmaceuticals
6/20/2018

A biologics license application was filed with the FDA by Alexion using a rare disease priority review voucher for orphan drug-tagged ALXN1210, being developed to treat patients with paroxysmal nocturnal hemoglobinuria. The submission was backed by data from two late-stage studies, in which treatment with ALXN1210 every eight weeks showed non-inferiority to Soliris treatment every two weeks on all primary and key secondary endpoints.

Full Story:
RTT News
6/20/2018

The investigational drug quizartinib was found to extend survival in adults with relapsed acute myeloid leukemia and FLT3 internal tandem duplication compared with salvage chemotherapy in 367 patients, based on data from a Phase III study presented at the European Hematology Association's annual meeting. Median overall survival of those treated with quizartinib was 6.2 months versus 4.7 months for patients treated with standard salvage chemotherapy.

6/20/2018

Kingdom Farms and owner Kieran Moran have had a civil lawsuit filed against them by the US Attorney's Office in Chicago, accusing them of selling meat and poultry products that were mislabeled and misbranded. The complaint alleges that the company used federal marks of inspection on its products without authorization and was discovered selling about 115 pounds of adulterated and misbranded meat products that did not undergo federal inspection, among other allegations.

Full Story:
Meat & Poultry Online
6/20/2018

ReShape Lifesciences has been notified by the US Patent and Trademark Office that it will receive a patent for its Gastric Vest System, a device designed to promote weight loss in patients with obesity.

Full Story:
Seeking Alpha
More Summaries:
Trademark Office
6/20/2018

The HipGrid Nine fit attachment system has been launched by OrthoGrid Systems for use in outpatient total hip replacement surgeries. The patent-protected system, intended to be integrated with C-arm systems, can be controlled intraoperatively by surgeons and can fully function with any implant system.

More Summaries:
OrthoGrid Systems
6/20/2018

Ablynx's outstanding shares, warrants and convertible bonds were fully acquired by Sanofi after the June 12 expiration of a squeeze-out procedure that began May 22.

Full Story:
PharmaBiz (India)
More Summaries:
Sanofi, Ablynx
6/20/2018

A round of Series B funding pulled in $116.9 million for Freeline Therapeutics. The company anticipates data within a year from an ongoing Phase I/II trial of FLT180a for the treatment of patients with hemophilia B.

Full Story:
BioCentury
More Summaries:
Freeline Therapeutics
6/20/2018

The USDA recently invited public comments on the proposed National Bioengineered Food Disclosure Standard, and it notes there is no evidence that links biotech food and health risk. The department said that the government's mandate to label biotech foods "is not expected to have any benefits to human health or the environment."

More Summaries:
Department of Agriculture, USDA