Sunday, 18 February 2018
News with tag FDA  RSS
FDA vows to combat high drug prices and companies 'gaming the system'

Added: 16.02.2018 14:12 | 1 views | 0 comments

Food and Drug Administration Commissioner Scott Gottlieb said he will do everything "within my lane" to combat high drug prices and that he sees drug companies "gaming the system to try to block competition" in a multitude of ways in the marketplace.

Tags: FDA
From: rss.cnn.com

Novartis gains U.S. approval for delayed MS drug

Added: 14.02.2018 18:13 | 0 views | 0 comments

Novartis's Sandoz division has won U.S. approval for a larger dosage of its Glatopa drug for multiple sclerosis (MS) patients, ending a costly delay that allowed rival generics makers to beat it to market. The U.S. Food and Drug Administration (FDA) approved a 40 milligrams per milliliter injection of the Novartis copy of Copaxone, Teva's blockbuster medicine, Sandoz said in a statement on Tuesday. Israel-based Teva Pharmaceutical Industries began facing competition for its 40 mg version of Copaxone from Mylan in October and has been bracing for more copycat versions of its bestselling drug.

FDA warnings for pecan processor and canned sauce company

Added: 12.02.2018 5:00 | 1 views | 0 comments

A pecan shelling processor in Mississippi and acidified foods firm in Jamaica are both on notice from the Food and Drug Administration for violations of U.S. food safety laws. The FDA sent warning letters to the companies in August and November of last year and posted them for public view in recent days. Companies are allowed 15 working days to respond to FDA warning letters....

Tags: FDA
From: www.foodsafetynews.com

FDA Weaponizes 'Opioid' Label Against Kratom Consumers

Added: 09.02.2018 16:09 | 0 views | 0 comments

The agency cherry picks adverse reaction reports of deaths where kratom was present, including deaths by gunshot and hanging.

Tags: FDA, Cher
From: https:

Teva warns on 2018 profit, may face migraine drug delays

Added: 09.02.2018 12:40 | 0 views | 0 comments

Teva Pharmaceutical Industries on Thursday said its 2018 results would be weaker than expected and that it might encounter delays for an important new migraine drug, pushing the drugmaker's shares down more than 9 percent. Israel-based Teva, the world's largest generic drugmaker, is facing price erosion, fierce competition for its blockbuster multiple sclerosis drug Copaxone and a consolidating customer base, particularly in the United States. It also said that the approval and launch of its migraine drug fremanezumab, one of two drugs the company pegged to help return it to growth in the future, could be delayed by an FDA warning letter received by manufacturer Celltrion, which will supply the drug to Teva.

From: https:

Briefly: 8 straight cruises with outbreaks — FDA refuses shrimp

Added: 09.02.2018 5:01 | 1 views | 0 comments

Every hour of every day people around the world are living with and working to resolve food safety issues. Here is a sampling of current headlines for your consumption, brought to you today with the support of iwaspoisoned.com. Norovirus runs through 8th cruise in a row For the eighth consecutive voyage on Princess Cruises' Sun Princess, passengers...

From: www.foodsafetynews.com

Teva warns on 2018 profit, may face migraine drug delays

Added: 08.02.2018 22:12 | 0 views | 0 comments

Teva Pharmaceutical Industries on Thursday said its 2018 results would be weaker than expected and that it might encounter delays for an important new migraine drug, pushing the drugmaker's shares down more than 9 percent. Israel-based Teva, the world's largest generic drugmaker, is facing price erosion, fierce competition for its blockbuster multiple sclerosis drug Copaxone and a consolidating customer base, particularly in the United States. It also said that the approval and launch of its migraine drug fremanezumab, one of two drugs the company pegged to help return it to growth in the future, could be delayed by an FDA warning letter received by manufacturer Celltrion, which will supply the drug to Teva.

From: https:

Gilead vs Glaxo: See You In Court

Added: 08.02.2018 14:09 | 0 views | 0 comments

The FDA approved a much-anticipated once-daily HIV medication from Gilead Sciences, ratcheting up its battle against GlaxoSmithKline for market share. Glaxo’s response? A lawsuit.

Tags: FDA, HIV
From: https:

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