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Intercept's liver med Ocaliva takes heat at FDA expert meeting, as hopes for full approval dim

Fierce Pharma

Looking to assess whether Ocaliva met its postmarketing requirements after a 2016 accelerated approval in the autoimmune disease primary biliary cholangitis, an FDA council of outside experts nearly unanimously rejected Intercept’s hopes for a full approval.

FDA 223
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Intercept's Ocaliva approval in jeopardy after FDA flags concerns in advisory committee briefing doc

Fierce Pharma

The regulator specifically raised an eyebrow at the post-marketing trials Intercept has used in a bid to keep hold of the accelerated approval it won back in 2016.

FDA 234
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Sanofi prevails over Boehringer Ingelheim in legal battle over Zantac liabilities

Fierce Pharma

When Sanofi made an asset swap with Boehringer Ingelheim in 2016, the French company acquired BI’s healthcare business, which included heartburn medicine Zantac. | In an asset swap with Boehringer in 2016, Sanofi gained U.S. marketing rights to the treatment.

Medicine 265
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Pfizer settles gender pay discrimination allegations at NYC headquarters

Fierce Pharma

The accusations centered on the company's compensation of 86 female employees in 2015 and 2016. Department of Labor that it underpaid certain women who were employed at the company’s New York City headquarters. |

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Bluebird taps Lonza to boost manufacturing capacity for its gene therapies Zynteglo, Skysona

Fierce Pharma

Bluebird and Lonza recently amended their production contract for the second time since the deal was announced in summer of 2016. As bluebird bio’s pricey gene therapy launches take flight, the company is boosting manufacturing capacity with Swiss CDMO Lonza.

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Social medical: The social media buzz around ASCO 2016

pharmaphorum

As a snapshot, 2014 saw 40,000 tweets and 140m+ impressions over the conference days, 2015 grew to 60,000 tweets and 250m+ impressions and the 2016 buzz is already louder and more plentiful than last year.

Media 52
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Sandoz hitches its wagon to biosimilars, predicting $3B in sales from pipeline products over next 5 years

Fierce Pharma

Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline | Novartis’ generics and biosimilars unit Sandoz—soon to be spun off as a stand-alone company—has seen a decline in revenue every year since 2016.

Sales 227