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RSS FeedPosted by Michael Wonder on 17 May 2021
US Supreme Court denies Sandoz petition to review biosimilar Erelzi (etanercept-szzs) case
17 May 2021 - Decision not to review Federal Circuit July 2020 ruling continues to prevent Sandoz launch of more affordable ...
Posted by Michael Wonder on 17 May 2021
Biogen hopes Alzheimer’s drug mired in controversy earns FDA nod
13 May 2021 - After scores of failures, regulators are set to rule on aducanumab, which promises to slow dementia. ...
Posted by Michael Wonder on 17 May 2021
Optimising managed access: lessons from the Cancer Drugs Fund
14 May 2021 - The desire, opportunity, and willingness to increase access to potentially life saving cancer treatments has mounted in ...
Posted by Michael Wonder on 17 May 2021
TGA weighs over the counter contraceptive pill plan
17 May 2021 - The nation’s medicines regulator is looking at a plan to give Australians more freedom to access ...
Posted by Michael Wonder on 17 May 2021
Adamis Pharmaceuticals resubmits Zimhi new drug application to FDA for the treatment of opioid overdose
17 May 2021 - Adamis Pharmaceuticals today announced that the new drug application was resubmitted to the U.S. FDA for ...
Posted by Michael Wonder on 17 May 2021
Quality, access, and the use of real world data by payers: where are we now? Where do we want to be in the future?
15 May 2021 - One of the biggest challenges payers face today is determining the value of innovative therapies in diseases ...
Posted by Michael Wonder on 15 May 2021
Apellis announces U.S. FDA approval of Empaveli (pegcetacoplan) for adults with paroxysmal nocturnal hemoglobinuria
14 May 2021 - Empaveli was superior to Soliris for the change from baseline in haemoglobin level at Week 16 in ...
Posted by Michael Wonder on 14 May 2021
‘More reimbursement needed for hepatocellular carcinoma’
14 May 2021 - “Unlike other cancers, hepatocellular carcinoma is mostly diagnosed non-invasively. But this has not been reflected in ...
Posted by Michael Wonder on 14 May 2021
Making cancer treatments affordable today won’t hurt tomorrow’s innovation
12 May 2021 - Congress is about to debate legislation—the Lower Drug Costs Now Act (H.R.3)—that would give Medicare the ...
Posted by Michael Wonder on 14 May 2021
NICE says final ‘no’ to BMS’ Zeposia for multiple sclerosis
14 May 2021 - NICE has issued a final “no” to Bristol-Myers Squibb’s oral MS drug Zeposia (ozanimod), in a ...
Posted by Michael Wonder on 14 May 2021
ICER releases draft evidence report on therapies for atopic dermatitis
14 May 2021 - Public comment period now open until 11 June 2021; requests to make oral comment during public meeting ...
Posted by Michael Wonder on 14 May 2021
Colorectal cancer patients with rare mutations to benefit from life-extending treatment
14 May 2021 - NICE recommends pembrolizumab for colorectal cancer patients with rare mutations. ...
Posted by Michael Wonder on 14 May 2021
PharmaEssentia resubmits application to the U.S. FDA for ropeginterferon alfa-2b-njft to treat polycythemia vera
14 May 2021 - PharmaEssentia today announced the resubmission of its biologics license application to the U.S. FDA, seeking approval for ...
Posted by Michael Wonder on 14 May 2021
Migraine drug Emgality to be listed on PBS, saving sufferers thousands of dollars
13 May 2021 - People living with migraine will no longer face the financial headache of forking out thousands of ...
Posted by Michael Wonder on 14 May 2021
Japan’s Ministry of Health, Labour and Welfare grants priority review for enfortumab vedotin new drug application
14 May 2021 - New drug application, submitted in March, is for locally advanced or metastatic urothelial cancer that has ...