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Pfizer recalls migraine drug for possible microbial contamination

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Pfizer has recalled two lots of migraine drug Relpax after finding those lots “may not meet Pfizer’s in-house microbiological specification for the potential presence” of two kinds of bacteria.

Pharma in review: trending stories 8/16/19

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pharma manufacturing news in review

Sanofi wins appeal for Jevtana patent

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A federal appeals court affirmed the validity of Sanofi's first patent on prostate-cancer drug, Jevtana, and also overturned a ruling against a later patent on a method of administering it.

Ovarian cancer drug hits main goal in new study

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An AstraZeneca treatment scored an important victory in the quest to offer new treatments for ovarian cancer.

Top Novartis scientists exited company ahead of data scandal

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More details are emerging about the months leading up to Novartis’s admission that data results for its gene therapy Zolgensma were manipulated.

Eli Lilly psoriasis drug bests J&J rival

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The drugmaker's Taltz beat out Johnson & Johnson's Tremfya at achieving total skin clearance after 12 weeks of treatment.

FDA expands Regeneron's Eylea approval

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The blockbuster eye med is now indicated for an Injection prefilled syringe, which will provide physicians with a new way to administer the treatment with fewer preparation steps.

Amgen wins Enbrel patent protections — for now

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Amgen has fought off a patent challenge from Novartis to its blockbuster anti-inflammatory, Enbrel.

GSK announces leadership changes

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GlaxoSmithKline announced that Jack Bailey, President U.S. Pharmaceuticals, has decided to step down from his role at the end of the year.

Natco Pharma API plant hit with Form 483

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Natco Pharma has received a Form 483 with six observations from the U.S. FDA for the drugmaker's active pharmaceutical ingredient facility located outside Hyderabad, India.

Regeneron drug boosts survival of Ebola to 90 percent

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A new study has shown that a pair of experimental treatments could dramatically increase the chances of surviving Ebola.

Bayer pays $600M for stem cell therapy developer

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Bayer has acquired BlueRock Therapeutics in a deal valued at $600 million that will give the drugmaker a platform to research and develop new stem cell therapies.

Synthorx founder mysteriously leaves Scripps Research

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A lead scientist at La Jolla’s Scripps Research has left the biomedical institute

After several acquisitions, Cambrex is now on track to be bought

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One of the industry’s leading small-molecule CDMOs is being acquired for $2.4 billion.

Teva’s CFO resigns in the midst of ongoing financial woes

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Teva Pharmaceuticals announced this week that its chief financial officer is stepping down.

FDA says Novartis gene therapy drug application contains manipulated data

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On May 24, the FDA approved Zolgensma, a gene therapy product intended to treat children less than two years of age with spinal muscular atrophy but was informed recently by the product’s manufacturer about a data manipulation issue that impacts the accuracy of certain data.

GSK drops Ebola vaccine development

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The vaccine candidates will be transferred to the Sabin Vaccine Institute in Washington

Novo Nordisk buys Purdue Pharma plant

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In an attempt to streamline its supply chain of diabetes drugs in the U.S., Novo Nordisk has scooped up a plant from Purdue Pharma.

Roche’s Tecentriq clears new hurdle in bladder cancer

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Roche’s Tecentriq is showing new promise as an early treatment for bladder cancer.

States probe Eli Lilly over insulin prices

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Eli Lilly has been hit with a subpoena from the New York Attorney General’s Office over the pricing and sales of its insulin treatments.

Union says Takeda employees treated unfairly during merger

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Takeda Pharma's Korean labor union said Takeda employees faced unfair changes in their jobs and roles during the Takeda Korea and Shire Korea merger.

Fujifilm drops $890M on Danish biologics campus

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Fujifilm has acquired a large-scale biologics site near Copenhagen, Denmark.

Oklahoma guns for $17B settlement in J&J opioid litigation

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Oklahoma’s attorney general has made a final attempt to hold Johnson & Johnson’s feet to the fire for its role in the opioid epidemic.

Pharma in review: trending stories 8/2/19

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pharma manufacturing news in review

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