FDA rejects Regeneron’s pre-filled Eylea HD syringes amid filling facility woes
The US Food and Drug Administration (FDA) has rejected a prefilled syringe version of Regeneron's ophthalmology blockbuster Eylea HD (aflibercept), …
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GSK forges pact with Empirico for respiratory siRNA in $745m deal
GSK has signed a licensing deal with Empirico for its respiratory disease-focused silent interfering RNA (siRNA), EMP-012. The UK-based big pharma …
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Aldeyra reshuffles pipeline, culling asset despite Phase II success
Aldeyra Therapeutics has reshuffled its pipeline, terminating the development of a Phase II asset despite meeting its endpoints in alcohol-associated …
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ESMO 2025: Data, decisions, and the future of oncology
This year’s congress showcased remarkable progress across multiple fronts, from next-generation immunotherapies and antibody-drug conjugates (ADCs) to the accelerating role of AI-driven …
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Japan’s MHLW grants orphan status to Kyowa and Orchard’s MLD therapy
Japan's Ministry of Health, Labor and Welfare (MHLW) has granted orphan regenerative medicine product designation to Kyowa Kirin and Orchard …
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Lifecore and PolyPeptide link for US peptide manufacturing
Lifecore Biomedical and PolyPeptide Laboratories have entered a partnership agreement to deliver an integrated, end-to-end peptide manufacturing solution for US …
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The threshold debate in Norway
The Norwegian pharmaceutical sector is preparing for long-awaited adjustments to the country’s cost-effectiveness willingness to pay (WTP) thresholds for medicines. Controversially, …
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GLP-1RA microdosing trend continues despite “anecdotal evidence”
Found Health has become the latest telehealth company to offer a microdosing programme with weight loss jabs, despite an absence …
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Podcast: Managing complexities and challenges in early-phase clinical trials
Among the many challenges for clinical trial project teams, logistics is one of the most critical and complex. From project …
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Companies in all sectors ‘should pay constant attention to geopolitics’ – analysis
Geopolitical risk is no longer remote from day-to-day business concerns as it has historically tended to be, a new report …
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Novartis Q3: new drugs step up as generics squeeze Entresto
Fast growth for recently label-expanded drugs fuelled Novartis’ Q3 performance, despite headwinds from generic competition affecting more established blockbusters. Net sales …
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Turning bottlenecks into breakthroughs in gene therapy manufacturing
In late 2023, the first CRISPR-based gene therapy for sickle cell disease patients Casgevy, received the seal of approval from …
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Hemab closes $157m in funding for bleeding disorder treatments
Hemab Therapeutics has concluded an oversubscribed Series C funding round, raising $157m to further develop therapies for bleeding disorders. The investment …
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MSD receives FDA approval for Winrevair’s updated indication
MSD has received US Food and Drug Administration (FDA) approval for an updated indication of Winrevair (sotatercept-csrk) for injections of …
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Organon CEO stands down amid contraceptive sales malpractice probe
Organon CEO Kevin Ali has stepped down from his leading position at the company, following its board’s discovery of sales …
