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Global Biotechnology & Pharmaceutical Markets1 month ago3 steps for taking on Novartis in radiopharma: Curium up first
To successfully challenge Novartis on two planned fronts, Curium will need to overcome the unique challenges posed by radiopharmaceutical supply to get products to patients and...
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Regulatory Intelligence & Drug Approvals1 month agoFDA slams GLP-1 compounder over risk of contaminating drugs ‘with filth’
FDA inspectors found evidence that the compounding pharmacy was making versions of Eli Lilly’s tirzepatide and Novo’s semaglutide “regularly or in inordinate amounts” at a site...
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Manufacturing, Supply Chain & Infrastructure1 month agoNovo targets 10-fold jump in oral Wegovy manufacturing capacity by 2030
With sales of the oral GLP-1 medicine rising quickly, executives reassured investors that Novo has secured production capacity to support continued growth.
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Capital, M&A & Industry Strategy1 month agoWestern licensing deals for Chinese radioligand therapies to jump in 2027, Sleuth forecasts
Deals for Chinese radiopharmaceutical assets have been rare to date and there is a limited pool of potential Western buyers available, Sleuth said.
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Regulatory Intelligence & Drug Approvals2 months agoFDA warning letter accuses Bausch & Lomb of lacking commitment to remediation
After reviewing Bausch & Lomb’s response to its observations, the FDA questioned whether the company is committed to implementing significant design remediations.
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Global Biotechnology & Pharmaceutical Markets2 months agoSamsung Biologics inks $262M manufacturing deal with European pharma company
The agreement, which runs through 2033, comes as Samsung Biologics continues to expand its large manufacturing footprint in South Korea.
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Capital, M&A & Industry Strategy2 months agoNovartis’ board faces investor scrutiny after M&A misfires and R&D flops
Back-to-back failures of multiple late-phase trials have raised questions about how Novartis has deployed capital in pursuit of drugs to drive growth through the 2030s.
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Manufacturing, Supply Chain & Infrastructure2 months agoSandoz plans ‘vast and vertically integrated’ supply chain to support 100-biosimilar vision
The company is investing billions of dollars to construct a European biosimilar hub capable of supporting the rapid expansion of its portfolio.
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Synthetic Biology, Genomics & Advanced Therapeutics2 months agoModerna and Merck’s mRNA success fuels focus on ‘scaling out and scaling down’
After mastering mass-market mRNA production during the pandemic, the industry now needs to achieve the timely delivery of individualized vaccines to thousands of patients.
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
