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Showing 15 posts of 1442 posts found.

Shire image

Generic approval for Shire’s hyperactivity drug

June 26, 2012
Sales and Marketing ADHD, Adderall XR, FDA, IMS Health, Impax, Shire, Teva

US regulators have delivered a blow to Shire by allowing Actavis Group to produce a generic version of its hyperactivity …

News
FDA image

FDA looks to start supply chain security programme

June 26, 2012
Manufacturing and Production CDER, FDA, OMB, ORA, manufacturing

The FDA has submitted a formal application to start a supply chain security pilot programme for overseas manufacturers of finished …

News
Eliquis image

FDA delays Eliquis approval

June 26, 2012
Sales and Marketing BMS, Eliquis, FDA, Pfizer, Xarelto

The FDA has asked Pfizer and Bristol-Myers Squibb for more information about its key blood thinner Eliquis. The US regulator …

News
Xarelto image

FDA rejects licence extension for Xarelto

June 26, 2012
Sales and Marketing ACS, Bayer, FDA, J&J, JJ, Pradaxa, Xarelto

The FDA has set a Complete Response Letter to Bayer and J&J over its blood thinner Xarelto. The firms, which …

News
Pfizer image

Pfizer Gaucher drug rejected by CHMP

June 25, 2012
Sales and Marketing Elelyso, FDA, Gaucher, Pfizer, Shire, Vpriv

A European committee has refused marketing authorisation for Pfizer’s Gaucher disease drug Elelyso, as a competitor drug has exclusivity to …

News
Akzo Nobel image

Akzo Nobel’s Mexican API plant all clear

June 19, 2012
Manufacturing and Production API, Akzo Nobel, FDA, manufacturing

Akzo Nobel has brought a manufacturing facility for active pharmaceutical ingredients in Mexico that failed an inspection last year back …

News
Pfizer image

FDA holds up Pfizer’s rare disease drug tafamidis

June 19, 2012
Research and Development, Sales and Marketing FDA, Pfizer, rare disease, tafamidis

The FDA has sent Pfizer a Complete Response Letter about its rare disease drug tafamidis meglumine. The US regulator is …

News
Merck image

Merck’s sleep aid drug meets goals

June 15, 2012
Research and Development, Sales and Marketing FDA, Merck, insomnia, sleep disorder, suvorexant

Merck’s novel insomnia drug suvorexant has improved patients’ ability to fall asleep, according to new data from two Phase III …

News

Sanofi submits key MS pill for approval

June 12, 2012
Research and Development, Sales and Marketing Bayer, EMA, FDA, Genzyme, Lemtrada, MS, Sanofi

Sanofi has submitted its multiple sclerosis pill Lemtrada for regulatory reviews in the US and Europe. Lemtrada (alemtuzumab), originally developed …

News

FDA approves Roche’s breast cancer drug

June 11, 2012
Sales and Marketing EMA, FDA, Perjeta, Roche, breast cancer

US regulators have approved Roche’s new breast cancer drug after granting it a priority review to speed up the process. …

News
ASCO

Herceptin successor impresses at ASCO

June 6, 2012
Research and Development, Sales and Marketing ASCO, Cancer, EMILIA, FDA, Roche, T-DM1

Roche’s new ‘smart bomb’ breast cancer drug T-DM1 has impressed at this year’s ASCO conference in Chicago. The trial showed it …

News

AMRI wins new contract for rehabilitated facility

June 6, 2012
Manufacturing and Production AMRI, Carduium Therapeutics, FDA, Taylor

Albany Molecular Research Inc (AMRI) has won a contract to fill a newly-approved product into sterile syringes at its facility …

News

Pharma relieved as Senate backs FDA fees

May 30, 2012
Business Services, Manufacturing and Production, Research and Development, Sales and Marketing FDA, PDUFA, PhRMA, US

The US Senate has approved a law that will continue to allow pharma firms to help fund the FDA.  The …

News

Latest FDA warning letters cite Tedec-Meiji, BMP Pharma

May 28, 2012
Manufacturing and Production BMP Pharma, FDA, Tedec-Meiji Farma

Spanish drugmaker Tedec-Meiji Farma and German active pharmaceutical ingredient (API) producer BMP Pharma both feature in the latest crop of …

News

Plavix loses US patent protection

May 18, 2012
Sales and Marketing BMS, FDA, Lipitor, Pfizer, Plavix, Sanofi

Sanofi and Bristol-Myers Squibb’s blood thinner Plavix has lost its patent protection in the US.  The drug, which made $6.6 …

News
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