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RSS FeedPosted by Michael Wonder on 10 May 2019
Statement from Acting FDA Commissioner on policy advancements to help bring interchangeable biosimilars to market
10 May 2019 - The U.S. FDA plays an important role in helping to address the high cost of medicines ...
Posted by Michael Wonder on 09 May 2019
Novartis confident of Zolgensma supply, calls $2 million price 'speculation'
8 May 2019 - Novartis is confident it has adequate production capacity for its Zolgensma gene therapy should regulators this ...
Posted by Michael Wonder on 09 May 2019
FDA issues draft guidance to industry on submitting real-world evidence in new drug and biologic applications
8 May 2019 - Today, the U.S. FDA published the draft guidance, Submitting Documents Using Real-World Data and Real-World Evidence ...
Posted by Michael Wonder on 08 May 2019
FDA undercuts $375,000 drug in surprise move
8 May 2019 - The US FDA created a workaround this week that effectively undercuts the $375,000 price tag of ...
Posted by Michael Wonder on 08 May 2019
They were supposed to talk about the patent system driving up drug prices. But most lawmakers got distracted by small tweaks.
7 May 2019 - If there was any hope that Congress might overhaul the way this country doles out the ...
Posted by Michael Wonder on 08 May 2019
A $2 million drug is about to hit the market
8 May 2019 -Insurers, drug makers grapple with new payment models for gene therapies that can cure diseases in one ...
Posted by Michael Wonder on 08 May 2019
FDA grants CytoDyn fast track designation for leronlimab (PRO 140) in metastatic triple-negative breast cancer, an unmet medical need
7 May 2019 - CytoDyn today announced that the U.S. FDA has granted fast track designation to leronlimab (PRO140) for ...
Posted by Michael Wonder on 08 May 2019
RedHill Biopharma submits new drug application for Talicia for H. pylori Infection
7 May 2019 - RedHill Biopharma today announced that, following a positive pre-NDA meeting held recently with the U.S. FDA, ...
Posted by Michael Wonder on 07 May 2019
In a crafty move, FDA may have found a way to dampen controversy over a $375,000 rare disease drug
6 May 2019 - The FDA just added an unexpected twist to a simmering controversy over a rare disease drug ...
Posted by Michael Wonder on 07 May 2019
Zynerba Pharmaceuticals receives fast track designation for Zygel for the treatment of behavioural symptoms associated with Fragile X syndrome
6 May 2019 - Enrolment progressing in pivotal CONNECT-FX trial of Zygel in Fragile X syndrome, with data expected in the ...
Posted by Michael Wonder on 07 May 2019
Savara announces Molgradex received fast track designation by FDA for treatment of auto-immune pulmonary alveolar proteinosis
6 May 2019 - Savara today announced that the U.S. FDA granted fast track designation for Molgradex, an inhaled formulation ...
Posted by Michael Wonder on 07 May 2019
FDA approves first treatment for children with Lambert-Eaton myasthenic syndrome, a rare auto-immune disorder
6 May 2019 - The U.S. FDA today approved Ruzurgi (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome in patients ...
Posted by Michael Wonder on 06 May 2019
Pfizer gets U.S. approval for $225,000/year heart drug
6 May 2019 - The U.S. FDA on Monday approved Pfizer's oral drug, tafamidis, to treat a rare and fatal heart ...
Posted by Michael Wonder on 06 May 2019
FDA approves new treatments for heart disease caused by a serious rare disease, transthyretin‑mediated amyloidosis
6 May 2019 - On May 3, the U.S. FDA approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment ...
Posted by Michael Wonder on 06 May 2019
Esperion announces U.S. FDA acceptance of new drug applications for both bempedoic acid and the bempedoic acid with ezetimibe combination tablet for filing and regulatory review
5 May 2019 - 21 February 2020 PDUFA target date goal for bempedoic acid and 26 February 2020 PDUFA target ...