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FDA

Showing 15 posts of 1442 posts found.

Ariad files new blood cancer drug with the FDA

July 31, 2012
Research and Development, Sales and Marketing Ariad, CML, EMA, FDA, Glivec, blood cancer

Ariad has filed its investigational blood cancer drug ponatinib with the FDA and hopes for an accelerated review. The US …

News
J&J image

J&J expects consent decree to extend through ‘most of 2013’

July 30, 2012
Manufacturing and Production FDA, J&J, JJ, McNeil, OTC, recall

Johnson & Johnson has said it expects the production capacity issues affecting two plants covered by a consent decree with …

News

The fight over ‘Obamacare’ goes on

July 26, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, Medicaid, Obama, Obamacare, Romney, US, healthcare

The recent ruling by the US Supreme Court which upheld President Obama’s healthcare reforms could save the country around $84 …

Feature
Forest labs image

FDA approves Forest’s COPD drug

July 25, 2012
Sales and Marketing COPD, FDA, Forest, Tudorza Pressair

US regulators have approved Forest Laboratories’ new chronic obstructive pulmonary disease (COPD) drug. Tudorza Pressair (aclidinium bromide) has been given …

News
Velcade image

Speedy approval for Onyx’ multiple myeloma drug

July 24, 2012
Research and Development, Sales and Marketing FDA, Janssen, Kyprolis, Onyx, Takeda, Velcade

Onyx’ Kyprolis has gained an accelerated approval by the FDA to treat patients with late-stage multiple myeloma.  Kyprolis (carfilzomib), a …

News
Michael Ball

Supplier defect blamed in Hospira recall case

July 24, 2012
Manufacturing and Production FDA, Hospira, Michael Ball

Hospira has concluded that a supplier defect was the root cause of its recall of four cancer drugs in the …

News
Ercros image

Spanish API supplier Ercros warned by FDA

July 17, 2012
Manufacturing and Production Ercros, FDA, GMP

Spanish chemical supplier Ercros SA has been sent a warning letter from the FDA after an inspection picked up a …

News
Xarelto image

Priority review for Xarelto’s new indications

July 10, 2012
Manufacturing and Production, Research and Development, Sales and Marketing Bayer, Boehringer, Eliquis, FDA, Janssen, Pradaxa, Xarelto

Xarelto is to be given a FDA fast-track review for a range of anti-blood clotting uses. Xarelto (rivaroxaban) gained its …

News
FDA image

FDA warns of toxins in glycerin source

July 10, 2012
Manufacturing and Production FDA, glycerin, jatropha curcas, toxins

The FDA has asked pharma companies to make sure that glycerin and other ingredients used in their products are not …

News
FDA image

Janssen submits tuberculosis pill to FDA

July 4, 2012
Research and Development, Sales and Marketing Bedaquiline, FDA, J&J, JJ, Janssen, tuberculosis

Janssen has submitted its investigational tuberculosis pill bedaquiline for review by the FDA. The firm is seeking a licence for …

News

FDA approves Astellas’ leaky bladder drug

July 3, 2012
Sales and Marketing Astellas, FDA, Myrbetriq, bladder, urology

The FDA has approved Astellas’ new overactive bladder disorder drug Myrbetriq.   Myrbetriq (mirabegron), the first drug in its class, works …

News
LaMattina image

John LaMattina: FDA tries to disavow role in higher hurdles for new drugs

July 2, 2012
Business Services, Manufacturing and Production, Medical Communications, Research and Development, Sales and Marketing FDA, John LaMattina, Pfizer, US, discovery, drug

As evidenced by various blog posts that I have written over the past year (e.g., “Why Doesn’t the FDA Get …

Feature
FDA image

FDA clears Arena and Eisai’s obesity drug

June 28, 2012
Sales and Marketing Arena, Belviq, Eisai, FDA, Qnexa, Roche, obesity

Eisai and Arena’s Belviq has gained FDA approval, making it the first obesity drug to be approved in over ten …

News

Amylin withheld safety data, says FDA

June 27, 2012
Research and Development, Sales and Marketing Amylin, Bydureon, Byetta, FDA, lilly

The US medicines regulator says Amylin held back data relating to the safety of its diabetes drug Bydureon. The allegation …

News
Roche image

Roche’s Perjeta increases survival

June 27, 2012
Research and Development, Sales and Marketing EMA, FDA, Herceptin, Perjeta, Roche, breast cancer

Roche’s new drug Perjeta has scored another trial success by increasing overall survival in certain breast cancer patients. The new …

News
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