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FDA, EMA Accept Regulatory Filings for Talazoparib

The U.S. Food and Drug Administration and the European Medicines Agency accepted for regulatory review Pfizer’s approval applications for talazoparib.

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Breast cancer screening failure may have shortened 270 lives in England

As many as 270 women in England may have died prematurely of breast cancer because of an IT failure that led to 450,000 patients missing out on routine screening appointments.

 

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Stock Dives as Celldex Cuts 20% of Staff After Phase II Breast Cancer Failure

Celldex Therapeutics reported that the company’s Phase IIb trial of glembatumumab vedotin (glemba) failed in a trial of metastatic triple-negative breast cancer. Celldex has filed with the U.S. Securities and Exchange Commission that it’s cutting about 20 percent of staff.

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FDA declines to approve Pfizer biosimilar

Pfizer Inc. said on Monday U.S. regulators declined to approve the company’s biosimilar of Roche’s blockbuster treatment for breast cancer, Herceptin, and sought additional technical information.

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Eli Lilly Shows Off More Verzenio Data at AACR

Eli Lilly unveiled final data from the MONARCH 3 study that helped the drug garner FDA approval in February 2018 for the treatment of some breast cancer patients.

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U.S. FDA allows 23andMe to sell test for 3 mutations of breast cancer gene

The U.S. Food and Drug Administration on Tuesday allowed genetic testing company 23andMe to market directly to consumers its test that will help assess three mutations in a common type of breast cancer gene.

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EU panel recommends against nod for Puma drug

A European Medicines Agency panel recommended against approving Puma Biotechnology’s lead breast cancer drug, an outcome the U.S drugmaker signaled in January 2018.

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11 Most Innovative Life Science Companies in the World

Fast Company recently published The World’s 50 Most Innovative Companies 2018, topping off its edition of the top 350 most innovative companies. Here is a look at the life science companies that made the list.

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Seattle Genetics Snaps Up Cascadian in $614 Million Buyout Deal

Bothell, Washington-based Seattle Genetics announced it is buying Seattle-based Cascadian Therapeutics for about $614 million.

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Europe unlikely to OK Puma breast cancer drug

Puma Biotechnology Inc. said a European regulatory panel indicated it was unlikely to provide a positive opinion on the company’s breast cancer drug.

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