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RSS FeedPosted by Michael Wonder on 04 Aug 2024
Genomic medicines can cost $3 million a dose. How to make them affordable.
1 August 2024 - The treatments are marvels of innovation. Their pricing must be inventive, too. ...
Posted by Michael Wonder on 04 Aug 2024
How to tell if Biden drove a hard bargain in Medicare drug price negotiations
30 July 2024 - The deadline for announcing how much Medicare lowered drug prices in the first year of negotiation is ...
Posted by Michael Wonder on 03 Aug 2024
FDA has accepted a BLA for bentracimab, the first and only ticagrelor reversal agent, for filing and priority review
2 August 2024 - SFJ Pharmaceuticals, sponsor of the bentracimab biologics license application, and SERB Pharmaceuticals (SERB), who acquired exclusive ...
Posted by Michael Wonder on 03 Aug 2024
Novo Nordisk latest drugmaker to face setback in IRA litigation
1 August 2024 - A federal court backed the Biden administration’s Medicare drug price negotiation program on Wednesday, the latest ...
Posted by Michael Wonder on 03 Aug 2024
Drugs in rare paediatric disease priority review voucher program have similar revenue to brand drugs
2 August 2024 - Drugs issued rare paediatric disease priority review vouchers that were redeemed had revenues that were similar ...
Posted by Michael Wonder on 03 Aug 2024
Bayer submits new drug application to US FDA for elinzanetant for the treatment of moderate to severe vasomotor symptoms associated with menopause
1 August 2024 - The new drug application includes data from the Phase 3 studies OASIS 1, 2 and 3 ...
Posted by Michael Wonder on 03 Aug 2024
FDA approves additional indication for Fibryga for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency, potentially ushering in a new standard of care
1 August 2024 - Octapharma has announced the expanded approval of fibryga, fibrinogen (human) lyophilised powder for Reconstitution, for fibrinogen replacement ...
Posted by Michael Wonder on 02 Aug 2024
FDA approves first gene therapy to treat adults with metastatic synovial sarcoma
2 August 2024 - The US FDA approved Tecelra (afamitresgene autoleucel), a gene therapy indicated for the treatment of adults with ...
Posted by Michael Wonder on 02 Aug 2024
Supernus resubmits NDA for SPN-830 apomorphine infusion device
1 August 2024 - Supernus Pharmaceuticals today announced it has resubmitted its new drug application for its apomorphine infusion device ...
Posted by Michael Wonder on 02 Aug 2024
Adverum Biotechnologies announces FDA regenerative medicine advanced therapy designation granted for ixo-vec for the treatment of wet AMD
1 August 2024 - Adverum Biotechnologies today announced that the US FDA has granted regenerative medicine advanced therapy designation for ...
Posted by Michael Wonder on 01 Aug 2024
FDA expands endometrial cancer indication for dostarlimab-gxly with chemotherapy
1 August 2024 - Today, the FDA approved dostarlimab-gxly (Jemperli, GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab-gxly, for ...
Posted by Michael Wonder on 01 Aug 2024
Guardant Health’s FDA approved Shield blood test now commercially available in US as a primary screening option for colorectal cancer
1 August 2024 - FDA approval announced earlier this week makes Shield first blood test that is approved for primary screening ...
Posted by Michael Wonder on 01 Aug 2024
Corvus Pharmaceuticals granted FDA fast track designation for soquelitinib for treatment of patients with relapsed or refractory peripheral T-cell lymphoma
1 August 2024 - Soquelitinib registrational Phase 3 clinical trial in PTCL advancing toward initial enrollment in Q3, 2024. ...
Posted by Michael Wonder on 01 Aug 2024
Achieve Life Sciences announces FDA grants breakthrough therapy designation to cytisinicline for the treatment of e-cigarette or vaping nicotine dependence
31 July 2024 - Achieve Life Sciences announced today that the US FDA has granted breakthrough therapy designation for cytisinicline for ...
Posted by Michael Wonder on 01 Aug 2024
Immuneering granted FDA fast track designation for IMM-1-104 in first-line pancreatic cancer
31 July 2024 - IMM-1-104 fast track designation now granted for the treatment of both first and second-line pancreatic ductal adenocarcinoma. ...