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Reuters

 •  February 17

U.S. regulators have proposed lowering the bar for clinical trial success for experimental Alzheimer’s drugs to better align with the current emphasis on the need to treat people when they are in the earliest stages of the brain-wasting disease.Medicines tested to treat Alzheimer’s have had a dismal track record, and the Food and Drug...

Reuters

 •  February 13

ZURICH (Reuters) - 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...

Reuters

 •  February 8

LONDON (Reuters) - GlaxoSmithKline has won another reprieve for its blockbuster Advair lung drug after U.S. regulators delayed approval of a generic copy from Novartis’s Sandoz division. The Swiss drugmaker said in an emailed statement on Thursday it had received a so-called complete response letter from the U.S. Food and Drug Administration (FDA)...

Reuters

 •  February 8

(Reuters) - The U.S. Food and Drug Administration on Wednesday approved Biktarvy, Gilead Sciences Inc’s once-daily, triple-combination tablet for treatment of HIV infection, paving the way for the biotech company to capture more of the multibillion-dollar HIV drug market. Biktarvy combines new integrase inhibitor bictegravir with Descovy, an older...

Reuters

 •  January 30

(Reuters) - The U.S. Food and Drug Administration is asking manufacturers of a common opioid medicine to change the way the drug is packaged, as part of efforts to deter its abuse amid an opioid epidemic in the United States. The FDA said on Tuesday it sent letters to manufacturers of diarrhea medicine loperamide, asking them to ensure that...

Reuters

 •  January 29

(Reuters) - Japan’s Takeda Pharmaceutical Co Ltd said on Monday the U.S. Food and Drug Administration had granted ‘fast track’ status to its vaccine for the mosquito-borne Zika virus, which erupted as a major public hazard in Brazil three years ago. The drug, TAK-426, is currently being tested on 240 patients between the ages of 18 and 49 and is in...

Reuters

 •  January 27

(Reuters) - A costly new Roche Holding AG drug to treat the bleeding disorder hemophilia A could significantly reduce healthcare expenses for certain patients, a draft report from an independent U.S. nonprofit organization that evaluates clinical and cost effectiveness of new medicines said on Friday. The drug, Hemlibra, or emicizumab, was approved...

Reuters

 •  January 26

ZURICH (Reuters) - Fears U.S. President Donald Trump could damage the drugs industry have not been realized and the administration’s efforts to accelerate new medicine approvals will bolster the sector, the chairman of Swiss drugmaker Roche said. “The U.S. Food and Drug Administration (FDA) wants to trim the time it takes for drugs to be approved,”...

Reuters

 •  January 23

(Reuters) - An electronic product made by Philip Morris International Inc that heats rather than burns tobacco contains lower levels of harmful and potentially harmful compounds than cigarettes, a preliminary review by the U.S. Food and Drug Administration (FDA) concluded on Monday. Laboratory data showed that the aerosol produced by the product,...

Reuters

 •  January 19

(Reuters) - The head of the U.S. Food and Drug Administration on Thursday said it is preparing a new, more restrictive policy targeting what drugs compounding pharmacies can produce that do not go through the agency’s approval process. FDA Commissioner Scott Gottlieb said the agency in March will issue draft guidance with new criteria for...