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Tuesday, August 6, 2019

FDA accepts Rockwell’s application for IV Triferic

Rockwell Medical (NASDAQ:RMTI) is up 9% premarket on light volume in reaction to its announcement that the FDA has accepted for review its marketing application for an intravenous (IV) formulation of TRIFERIC (ferric pyrophosphate citrate), first approved in the U.S. in January 2015 as a hemodialysate (mixed with bicarbonate) for the maintenance of hemoglobin in dialysis patients. The IV formulation would allow dialysis centers to administer TRIFERIC to patients regardless of how bicarbonate is delivered.
The agency’s action date is March 28, 2020.

Merck KGaA Buys German Lab Data Company

Merck KGaA (MRK.XE) said Tuesday that it has acquired a German laboratory-data company called BSSN Software for an undisclosed amount.
BSSN’s technology collects and converts scientific data from more than 200 lab instruments into a unified format, Merck KGaA said.
The deal should boost Merck KGaA’s digital laboratory productivity business, it said.

Glaxo ends development of Ebola vaccine, hands work to U.S. institute

British drugmaker GlaxoSmithKline is giving up its work on developing three potential vaccines against the deadly Ebola and Marburg viruses, despite an ongoing Ebola outbreak in Democratic Republic of Congo.

While Ebola is a deadly and contagious disease, it is also still relatively rare, making the potential market for a vaccine sporadic and very likely unprofitable. This poses a dilemma for drug companies: With no real prospect of a financial return, can they justify the investment in expensive development and trials.
GSK’s vaccine candidates – two designed to protect against Ebola and one against the Marburg virus – will be transferred to the Sabin Vaccine Institute in Washington, D.C., the British drugmaker said in a statement. There is no financial element to the agreement, a spokesman said.
The transfer agreement will see Sabin continue to develop the candidate vaccines, one of which – a potential Ebola shot known as ChAd3 – has been through mid-stage, Phase II, trials in Africa and could possibly be used to halt or limit future Ebola epidemics.
“Enabling Sabin to build on the scientific progress GSK has delivered up to Phase II increases the likelihood these candidate vaccines may help prevent potential future outbreaks,” Thomas Breuer, chief medical officer of GSK Vaccines, said in a statement.
GSK had put its Ebola vaccine work on hold after it was unable to progress the product through final stage, or Phase III, clinical trials towards the end of the 2014-16 epidemic, due to a dwindling number of Ebola cases.
U.S. drugmakers Merck and Johnson & Johnson are also developing potential vaccines against Ebola, and have made more progress with them than GSK had in clinical trials.
The Merck shot, known as VSV EBOV, is currently being used in the ongoing Ebola outbreak in Congo, which was last month declared an international health emergency by the World Health Organization (WHO).
The disease has killed more than 1,800 people in the Congo outbreak which began a year ago and has become the second-worst on record.
GSK said Sabin had agreed a collaboration deal with the Vaccine Research Center at the U.S. National Institute of Allergy and Infectious Diseases (NIAID) to further develop the vaccine candidates.
The ChAd3 shot was originally developed by NIAID in collaboration with the Swiss-based firm Okairos, which was bought by GSK in 2013. All three experimental vaccines have shown promise in safety trials after being administered to more than 5,000 adults and 600 children, GSK said.

Diabetes drug maker Novo Nordisk buys pill factory in North Carolina

Novo Nordisk said on Tuesday it had bought a factory in North Carolina that would assist in manufacturing and packaging its new once-daily pill for treating type 2 diabetes.

The tablet version of its diabetes drug, known as semaglutide, is an important growth prospect for the Danish drugmaker, which faces pressure on prices from competitors and U.S. lawmakers, who have been critical of rising drug costs.
Novo, the world’s biggest producer of diabetes drugs, said the new plant near Durham would receive shipments of the active pharmaceutical ingredient needed to produce the pill from another factory under construction in North Carolina.
“We want to build manufacturing capacity in the United States so that we can establish a local U.S. supply chain for oral semaglutide and other future oral products,” Novo Nordisk vice president Henrik Steen Jensen told Reuters.
Novo submitted its oral semaglutide drug for approval in the United States in March and hopes to begin local production in 2021, Jensen said.
The tablet, which Novo currently produces only in Denmark, belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production.
So far, all have been via injection and a pill would make it quicker and easier for diabetics to take their medication.
Novo said it bought the plant in Durham from Purdue Pharma but did not disclose the price or capacity.

Insulet raised to Overweight from Neutral by JPMorgan

Target to $155 from $120

Cigna upped to Outperform from Market Perform by Bernstein

https://www.benzinga.com/stock/CI/ratings

Arvinas started at Overweight by Cantor

Target $42