Privately held Theraclone Sciences Inc., of Seattle, has signed a multiyear research and development collaboration with Pfizer Inc. for the company's in situ therapeutic antibody rescue (I-STAR) technology. The deal makes Theraclone eligible to receive up to $632 million in research funding and milestone payments upon the achievement of discovery, development, regulatory and commercialization milestones, plus undisclosed royalties on future. Pfizer will be responsible for preclinical and clinical development of the antibodies.
Pfizer and Medivation announced
results from two Phase 3 trials of the investigational drug dimebon
(latrepirdine*) in patients with Alzheimer`s disease (AD). In the CONNECTION
trial, dimebon did not meet its co-primary or secondary efficacy endpoints
compared to placebo. Co-primary endpoints were measures of cognition and global
Dr. David Hung, president and chief executive officer of Medivation, described the results as "unexpected" and said they are "disappointed". That's not good. Pfizer is under a lot of pressure to replace sales from Lipitor, which goes off patent next year.
Pfizer announced that the U.S. Food and Drug Administration (FDA) has not yet completed its review of the Biologics License Application (BLA) for Prevnar 13, (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), the Company`s candidate 13-valent pneumococcal conjugate vaccine.
As a result, the review will continue beyond the prescription drug user fee (PDUFA) action date of December 30, 2009.
Pfizer announced the discontinuation of A4021016 (also known as ADVIGO 1016), a Phase 3 trial examining the effects of investigational compound figitumumab (CP-751,871) as first-line treatment in patients with advanced non-adenocarcinoma non-small cell lung cancer due to the study meeting predefined boundaries for early termination.
An analysis by an independent Data Safety Monitoring Committee (DSMC) showed that the addition of figitumumab to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone.
Pfizer Inc. announced that the Food and Drug Administration (FDA) issued a Complete Response letter regarding the company’s New Drug Application (NDA) for Lyrica (pregabalin) capsules CV as a monotherapy treatment for generalized anxiety disorder (GAD). The FDA determined that the data contained in the NDA were insufficient to support approval.
“We are disappointed with the FDA’s decision and will work with the agency to determine next steps,” said Steve Romano, vice president, Medical Affairs Head, Primary Care Business Unit. “Given the chronic nature of GAD and the number of patients who continue to experience anxiety symptoms despite treatment, there is a clear unmet need for new and different treatment options.”
Pfizer said Tuesday it had reached an agreement to license the worldwide rights to a treatment for Gaucher disease, a rare genetic disorder, from Protalix, an Israeli biotechnology company.
This deal would put Pfizer into competition with Cerezyme, Genzyme’s biggest-selling product.
Pfizer said Monday it will cease research-and-development activities in Research Triangle Park and Sanford as part of a major restructuring. The announcement comes less than three weeks after the pharmaceutical giant officially brought Wyeth into the fold. The restructuring will trim the number of R&D sites at Pfizer to five main locations and nine specialized units, down from 20 sites at the close of the Wyeth deal Oct. 16.
Pfizer Inc. on Tuesday posted a higher third-quarter profit despite the recession, as sharp cost cuts made up for a dip in sales.
The maker of cholesterol fighter Lipitor, impotence treatment Viagra and smoking cessation drug Chantix slashed costs on everything from manufacturing and marketing to research and development to produce a profit of $2.88 billion. That was up 26 percent from $2.28 billion a year earlie
Pfizer Inc. has won U.S. and Canadian regulatory approval for its $68 billion acquisition of Wyeth. The companies plan on closing the deal tomorrow.
Pfizer won U.S. clearance after agreeing to sell half of Wyeth’s animal health business to Boehringer Ingelheim GmbH within 10 days of the acquisition’s closing, the Federal Trade Commission said today in a statement.
Pfizer agreed in January to buy Wyeth in a stock-cash transaction that would give it access to the depression treatment Effexor and pneumonia vaccine Prevnar.
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