Expanding access and reducing prices for drugs to prevent HIV. Should Government enforce its patent rights against the pharmaceutical industry?

3 March 2020 - On November 6, 2019, the Department of Health and Human Services (HHS) filed a lawsuit against Gilead ...

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Drug shortages in the United States. Are some prices too low?

3 March 2020 - The US public identified lowering prescription drug prices as the top health priority for Congress in 2019.  ...

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Anti-flu pill can fight illness as soon as symptoms show

4 February 2020 - A new pill that can fight the flu as soon as symptoms strike has been approved ...

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Estimated research and development investment needed to bring a new medicine to market, 2009-2018

3 March 2020 - In this study, which included 63 of 355 new therapeutic drugs and biologic agents approved by the ...

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Alnylam announces approval of Givlaari (givosiran) in the European Union for the treatment of acute hepatic porphyria in adults and adolescents

3 March 2020 - Givlaari approved based on ENVISION Phase 3 study results showing a 74% reduction in the rate of ...

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Novartis receives Health Canada approval for Mayzent (siponimod) to treat secondary progressive multiple sclerosis with active disease

3 March 2020 - Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of people living ...

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Ayala Pharmaceuticals granted U.S. FDA fast track designation for AL101 for the treatment of recurrent or metastatic adenoid cystic carcinoma

3 March 2020 - Ayala Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to AL101 for ...

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FDA grants rare paediatric disease designation to Stealth BioTherapeutics for elamipretide for the treatment of Barth syndrome

3 March 2020 - Stealth BioTherapeutics today announced that the U.S. FDA has granted rare paediatric disease designation for elamipretide ...

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The coronavirus could help pharma reset its reputation in Washington

3 March 2020 - The coronavirus outbreak could be the pharmaceutical industry’s ticket to saving its reputation in Washington. ...

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FDA grants breakthrough therapy designation for Genentech’s Esbriet (pirfenidone) in unclassifiable interstitial lung disease

2 March 2020 - There are currently no FDA approved treatments for unclassifiable ILD, a debilitating, severe respiratory condition. ...

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Sebela Pharmaceuticals announces FDA approval of Pizensy for oral solution for the treatment of chronic idiopathic constipation in adults

2 March 2020 - Sebela seeks partner to commercialise in the U.S. ...

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'Get it done. We need it': Trump's coronavirus message to big pharma

3 March 2020 - President Donald Trump sought to show his personal engagement in the fight against coronavirus, meeting with ...

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Mallinckrodt initiates rolling submission of new drug application to the U.S. FDA for terlipressin for the treatment of patients with hepatorenal syndrome type 1

2 March 2020 - Terlipressin would be the first FDA-approved treatment option in the United States for patients with HRS-1 if ...

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Extended-release drugs could be costing U.S. health care system billions

1 March 2020 - If doctors prescribed short-acting medications that must be taken twice a day instead of once-a-day extended-release ...

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Cablivi (caplacizumab) approved by Health Canada for adults living with acquired thrombotic thrombocytopenic purpura

2 March 2020 - Cablivi is the first treatment approved in Canada for aTTP, a life-threatening blood clotting disorder. ...

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