TOP HEADLINES

Featured Story

  • FDA warning letter says Marck plant plagued by faked records and dead frogs

    The FDA in March issued an import alert against a Marck Biosciences sterile manufacturing plant in Kheda, India. A July warning letter posted today explains why. Employees recorded data for functions that were not performed. Records, if kept at all, were often put on "scratch paper." The bathroom was filled with mold and an exit loading dock was littered with dead and decaying frogs. Read more >>

Sanofi shipping new malaria treatment manufactured from 'semisynthetic artemisinin'

French drugmaker Sanofi has released its first batches of a malaria treatment made from semisynthetic artemisinin using a new manufacturing process that will allow it to make tons of the ingredient and so help stabilize its volatile global market.

Sun Pharma recalls nearly 500,000 bottles of antibiotics

After releasing an earnings report that showed strong growth in the U.S., India's Sun Pharmaceuticals is recalling nearly 500,000 bottles of antibiotics, a fourth recall since announcing its $4 billion deal to buy compatriot Ranbaxy Laboratories and fix its ongoing quality faux pas.

Big Pharma stands back as little guys work on plant-based drugs and manufacturing

When it comes to manufacturing, Big Pharma prefers traditional plants to living plants. While drugs manufactured from plants like tobacco have been in the news because several makers of Ebola drug candidates are using the process, the method has not been embraced by any of the major players.

Fuji expands its cell manufacturing in U.S. and U.K.

Fujifilm Diosynth Biotechnologies is adding a 2000-L single-use bioreactor at its plants in Research Triangle Park, NC, in the U.S. and Billingham in the U.K. to expand its cell culture manufacturing.

U.S. health emergency facilities ready to produce Ebola drugs

Since the H1N1 pandemic scare revealed the shortcomings of U.S. production capacity when faced with an emergency, the Department of Health and Human Services (HHS) has invested in facilities to bolster defenses. With the death toll from Ebola now nearing 1,000, the plants are ready to switch to producing a drug or vaccine to protect people against the virus.

MORE NEWS

From Our Sister Sites

FiercePharmaMarketing

What makes a 5-year exclusivity period? Under U.S. law, it's the 5 years after FDA starts the clock ticking. Eisai has no qualms about that. But the Japanese drugmaker says the agency started that clock much too soon for two of its products--and it's suing the FDA to change that.

FiercePharmaMarketing

AbbVie's waiting for FDA approval on a hepatitis C combo therapy. OraSure makes a rapid test to detect the virus. And professional truck drivers in the U.S. are more than 5 times as likely as other Americans to have it.