FDA to review Moderna’s flu jab on agency pivot
Following its previous refusal to review Moderna’s seasonal flu vaccine, mRNA-1010, the US Food and Drug Administration (FDA) has changed …
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Novo expands injectable Wegovy offering with European higher dose approval
The European Commission (EC) has approved a higher dose of Novo Nordisk’s Wegovy (semaglutide), marking a win for the drugmaker …
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Evogene and QUT partner on AI-based cancer therapies
Evogene has partnered with Queensland University of Technology (QUT) in Australia to progress the development of AI-driven small molecule cancer …
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The China factor: US pharma group campaigns for increased competitiveness
In the race to lead the innovation narrative, the US healthcare industry needs to actively consider systemic changes to contend …
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J&J’s Rybrevant Faspro gains FDA approval for new dosing in NSCLC
Johnson & Johnson (J&J) has received the US Food and Drug Administration (FDA) approval for a new monthly dosing schedule for …
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SLE and LN market expected to reach $5.9bn across 7MM by 2034
A notable growth in the systemic lupus erythematosus (SLE) and lupus nephritis (LN) market across the seven major markets (7MM; …
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RNA-targeting small molecules: a new frontier of drug discovery
While small molecules have long been the cornerstone of the pharmaceutical industry, there is increasingly a demand for innovative precision …
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Pricing and reimbursement delays continue to impact biopharma revenue streams
Delays in obtaining pricing and reimbursement (P&R) have been identified as key hurdles holding back the pharmaceutical industry, according to …
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Pharma companies venture further afield in search of R&D
With manufacturing onshoring a continuing point of discussion in the industry, many pharma companies went the opposite way for R&D …
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Teijin and Aska Pharmaceutical to co-develop gynaecological drugs
Teijin Pharma has signed a joint research agreement with Tokyo-based Aska Pharmaceutical to develop small-molecule drug candidates for gynaecological diseases. The …
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ExCellThera secures German NUB Status 1 listing for Zemcelpro
ExCellThera and its wholly owned subsidiary Cordex Biologics have received a Status 1 listing from the Neue Untersuchungs- und Behandlungsmethoden …
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Eli Lilly builds orforglipron cache to avoid previous GLP-1RA shortages
In a bid to avoid previous shortages of injectable glucagon-like peptide-1 receptor agonists (GLP-1RAs), Eli Lilly has already started to …
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PTC pulls Translarna NDA after unfavourable FDA feedback
PTC Therapeutics has chosen to withdraw its resubmitted new drug application (NDA) for Duchenne muscular dystrophy (DMD) therapy, Translarna (ataluren), …
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OEB 6: The new standard in high-potent molecule manufacturing?
In recent years, the pharmaceutical industry has seen a significant increase in the development of highly potent active pharmaceutical ingredients …
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FDA issues complete response letter to Disc Medicine’s bitopertin NDA
Disc Medicine has received a complete response letter (CRL) from the US Food and Drug Administration (FDA) concerning its new …
