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Capital, M&A & Industry Strategy2 days agoSanofi targets late-phase and commercial M&A to offset looming Dupixent decline
Focused on ensuring growth beyond Dupixent, Sanofi wants to acquire derisked assets that may benefit from the French pharma’s commercial capabilities, executives said on Friday as...
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Regulatory Intelligence & Drug Approvals3 days agoHHS clears compounding pharmacies to manufacture 6 unapproved peptides
Under the interim policy, officials do not intend to take action against sites that produce the peptides.
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Clinical Trials & Development4 days agoGenmab’s cancer bispecific delivers early survival win in ‘exceedingly positive’ Phase 3 readout
Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
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Clinical Trials & Development4 days agoGenmab’s cancer bispecific delivers early OS win in ‘exceedingly positive’ Phase 3 readout
Analysts hailed the Phase 3 head and neck cancer results as a big victory for an asset central to Genmab’s growth plans.
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Clinical Trials & Development6 days agoGenmab’s ADC beats survival expectations in Phase 3 ovarian cancer trial
Extending both progression-free and overall survival, Genmab’s Rina-S “sets a high bar for future competition” in a market served by AbbVie, analysts said.
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Capital, M&A & Industry Strategy1 week agoRoche flags ‘final opportunity’ for Germany to reestablish as a reliable investment location
Following the withdrawal of billions of dollars in investments from Boehringer Ingelheim and Eli Lilly, German lawmakers have proposed a clause to the country’s healthcare reforms...
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Manufacturing, Supply Chain & Infrastructure2 weeks agoFDA accuses Baxter leaders of ‘inadequate’ oversight after finding GMP failings
The recurrence of violations at multiple sites led the FDA to conclude that Baxter management must improve its oversight and control of manufacturing.
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Clinical Trials & Development2 weeks agoNovo’s CagriSema achieves 25% weight loss in women, driven by younger patients
Posthoc analyses in women divided by menopausal status show how Novo’s next-generation GLP-1 drug affects key cohorts of patients.
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Global Biotechnology & Pharmaceutical Markets2 weeks agoSanofi breaks ground on insulin plant after securing German government support
The European Commission approved Germany’s financial support after assessing the risks of Sanofi stopping insulin API production at the Frankfurt campus.
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Regulatory Intelligence & Drug Approvals2 weeks agoFDA issues warning over Eurofins’ selective recording that ‘compromises’ data
Inconsistent reporting at a Pennsylvania site affected microbiological analyses of components and drug products that analytical testing service provider Eurofins ran for customers.
Widespread atropine use fails to sway FDA advisors on Sydnexis data
At least 11 PDUFAs on FDA’s November docket
FDA Grants Accelerated Approval to Voceryq (doruxapapogene ralaplasmid and lalikinogene sifuplasmid-gxfd) for Recurrent Respiratory Papillomatosis
Novartis buys Synnovation’s PI3Kα inhibitors for $3 billion
Novartis to pay $2B upfront to take next-gen PI3Kα inhibitor from Synnovation
