Paying for prescription drugs in the new administration

2 March 2021 - In a national survey in January 2020 involving 1011 participants, the second-ranked domestic priority for members of ...

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FDA releases a new plan to bring its data skills up to speed

4 March 2021 - When Ram Iyer started his new job at the Food and Drug Administration in 2020, he ...

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FDA accepts Dupixent (dupilumab) for review in children with moderate to severe asthma

4 March 2021 - Submission supported by data demonstrating Dupixent significantly reduced severe asthma attacks and is the only biologic to ...

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MedAlliance receives fourth FDA breakthrough device designation for sirolimus drug eluting balloon in treatment of de novo coronary lesions

4 March 2021 - MedAlliance has now been awarded breakthrough status for SELUTION SLR, its sustained limus release DEB catheter, in ...

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U.S. FDA expands approval of Pfizer's Lorbrena as first-line treatment for ALK positive metastatic lung cancer

3 March 2021 - Approval is based on CROWN trial, which showed a 72% reduction in risk of progression or ...

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PHARMAC swapping epilepsy drugs 'cannot be discounted' as a cause of deaths — neurologist

4 March 2021 - An Auckland paediatric neurologist says PHARMAC's decision to switch to a generic version of an epilepsy drug ...

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The PHARMAC non-review?

4 March 2021 - The recently announced PHARMAC review is fatally flawed.  ...

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NICE rejects rare blood cancer treatment Poteligeo in final appraisal

4 March 2021 - The UK’s NICE has not recommended Kyowa Kirin’s Poteligeo for the treatment of adults living with ...

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EMA starts rolling review of the Sputnik V COVID-19 vaccine

4 March 2021 - EMA’s CHMP has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine developed by Russia’s ...

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Strongbridge Biopharma announces submission of new drug application for Recorlev (levoketoconazole) for the treatment of endogenous Cushing’s syndrome to the U.S. FDA

2 March 2021 - Recorlev (levoketoconazole) new drug application is supported by previously reported positive and statistically significant results from the ...

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On Target Laboratories announces U.S. FDA acceptance and priority review of new drug application for pafolacianine sodium injection for identification of ovarian cancer during surgery

3 March 2021 - On Target Laboratories today announced that the U.S. FDA has accepted its new drug application for priority ...

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Oblato announces fast track designation of OKN-007 for diffuse intrinsic pontine glioma from the FDA

3 March 2021 - Oblato announces that the FDA granted fast track designation of OKN-007, the proprietary drug for diffuse intrinsic ...

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Cancer patient told palliative care only option after being rejected PHARMAC funding

2 March 2021 - The drug-buying agency was placed under an independent review today after the Prime Minister said she ...

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PHARMAC ripe for reassessment

3 March 2021 - New Zealand’s drug buying agency PHARMAC has long been, simultaneously, a good thing in itself and ...

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Oyster Point Pharma announces FDA acceptance for filing new drug application for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease

2 March 2021 - Prescription Drug User Fee Act target action date is 17 October 2021. ...

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