Drug and Device Development

U.S. scientists take step toward creating artificial life

U.S. scientists take step toward creating artificial life

Published 29/11/2017

A scientist does research in a lab in San Diego, California April 26, 2009. REUTERS/Mike BlakeCHICAGO (Reuters) - In a major step toward creating artificial [more…]

Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

Novartis gets FDA breakthrough status for Tafinlar, Mekinist combination

Published 23/10/2017

Novartis on Monday said the U.S. Food and Drug Administration has granted breakthrough therapy status to the combination of Tafinlar and Mekinist to treat patients with BRAF V600-positive stage III melanoma following surgery. [more…]

Regeneron-Sanofi drug succeeds mid-stage study

Regeneron-Sanofi drug succeeds mid-stage study

Published 16/10/2017

Regeneron Pharmaceuticals Inc and Sanofi SA said on Monday their drug to treat inflammation in the esophagus, mainly caused by food allergies, met the main goal of a mid-stage study. [more…]

Exelixis drug improves overall survival in liver cancer patients

Exelixis drug improves overall survival in liver cancer patients

Published 16/10/2017

Exelixis Inc's drug to treat a type of liver cancer improved overall survival in patients in a late-stage study that prompted an independent expert group to recommend no further trial, sending the company's shares soaring 31 percent. [more…]

U.S. NIH, 11 drugmakers partner to accelerate cancer therapy research

U.S. NIH, 11 drugmakers partner to accelerate cancer therapy research

Published 12/10/2017

The Trump Administration threw its support behind a public-private partnership with 11 drug companies to advance a new class of drugs that uses the body's immune system to fight cancer. [more…]

Flexion`s knee pain drug gets FDA nod, shares hit life high

Flexion`s knee pain drug gets FDA nod, shares hit life high

Published 06/10/2017

Flexion Therapeutics Inc said its injectable drug to treat osteoarthritis-related knee pain was approved by the U.S. Food and Drug Administration, sending the drug developer's shares soaring to a record high in regular trading on Friday. [more…]

FDA aims to speed up arrival of complex generic drugs

FDA aims to speed up arrival of complex generic drugs

Published 02/10/2017

The U.S. Food and Drug Administration on Monday announced a series of measures designed to speed to market generic versions of complex drugs such as Mylan NV's emergency EpiPen in an effort to address the rising cost of pharmaceuticals. [more…]

Trial data suggest new typhoid shot could halve infection rate

Trial data suggest new typhoid shot could halve infection rate

Published 28/09/2017

A new typhoid vaccine developed by privately-held Bharat Biotech proved safe and highly immunogenic in a study and could be used to prevent millions of infections if it succeeds in final-stage clinical trials, researchers said on Friday. [more…]

PTC Therapeutics Duchenne drug may work, data inconclusive: FDA panel

PTC Therapeutics Duchenne drug may work, data inconclusive: FDA panel

Published 28/09/2017

PTC Therapeutics Inc's experimental drug to treat Duchenne muscular dystrophy, a devastating degenerative disease that mostly affects young boys, may work but the company will need to do more work to prove it, an advisory panel to the U.S. Food and Drug Administration concluded on Thursday. [more…]

FDA declines to approve J&J arthritis drug sirukumab

FDA declines to approve J&J arthritis drug sirukumab

Published 22/09/2017

The U.S. Food and Drug Administration has declined to approve Johnson & Johnson's rheumatoid arthritis drug sirukumab, saying additional clinical data is needed to further evaluate its safety, the company said on Friday. [more…]