FY 2016 generic approvals by FDA: a new record under GDUFA

12 October 2016 - The US FDA published final Fiscal Year 2016 abbreviated new drug application (ANDA) approvals earlier this ...

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FDA fast track designation and first subject dosing with lead candidate CC8464/ASP1807 for the management of neuropathic pain associated with iSFN

13 October 2016 - Chromocell Corporation and Astellas Pharma Inc. announced today that the U.S. FDA has granted fast track ...

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Drug coupons: helping a few at the expense of everyone

12 October 2016 - When a furore erupted over the rapidly rising price of EpiPens this summer, the drugmaker Mylan ...

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Novel drugs for depression

13 October 2016 - A new generation of drugs could change the way depression is treated. ...

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Substantial rebates negotiated in Medicare Part D

12 October 2016 - A new QuintilesIMS Institute research brief takes a first-of-its-kind look at Part D costs after accounting ...

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Valeant hiked lead poisoning drug price by 2,700 per cent: report

11 October 2016 - Valeant Pharmaceuticals hiked the price of a widely used treatment for life-threatening cases of lead poisoning ...

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Undermining value-based purchasing — lessons from the pharmaceutical industry

12 October 2016 - In 2015, the U.S. Department of Health and Human Services announced a goal of linking at ...

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FDA grants QIDP and fast track designations to VT-1161 for treatment of recurrent vulvovaginal candidiasis

12 October 2016 - Viamet Pharmaceuticals today announced that the U.S. FDA has granted Qualified Infectious Disease Product and fast ...

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Improved quality of Medicare health and drug plans means great news for Medicare beneficiaries

12 October 2016 -  The Centers for Medicare & Medicaid Services is preparing for the annual Medicare Open Enrollment, which ...

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What experimental drug? Most companies don’t post compassionate use policies

11 October 2016 - As patients clamour for greater access to experimental medicines, a survey released Tuesday finds that ...

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Battling rising drug prices is like 'whac-a-mole,' says hospital executive

11 October 2016 - Inpatient hospital drug costs rose about 38% to $990 per patient admission between 2013 and 2015, ...

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FDA grants priority review to Roche's Lucentis for mCNV

11 October 2016 - The U.S. FDA has granted priority review for Roche drug Lucentis (ranibizumab) for treating myopic choroidal ...

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ICER releases corrected evidence report on treatments for non-small-cell lung cancer

7 October 2016 - PD-1 value-based price benchmarks are updated while the main conclusions of the analysis remain unchanged. ...

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Elbit Imaging announces that Gamida Cell has received FDA breakthrough therapy designation for Nicord

10 October 2016 - Elbit Imaging announced today that it was informed by Gamida Cell, an indirect associate of the ...

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Anthem says will not cover Sarepta's approved Duchenne drug

7 October 2016 - Health insurer Anthem said it will not cover Sarepta Therapeutics Inc's medicine to treat patients with ...

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