MHRA approves needle-free adrenaline nasal spray for anaphylaxis
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted approval for EURneffy, an adrenaline (epinephrine) nasal spray for …
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GSK’s Blenrep faces setback as FDA cancer committee votes against approval
The US Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep (belantamab …
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Astellas and KISED link to support Korean pharma startups
Astellas Pharma has entered a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED) to …
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ADCs on the rise: MilliporeSigma, Lonza invest in manufacturing while BioNTech adds CMOs ahead of FDA filing
Pharmaceutical companies and manufacturers, including MilliporeSigma (Burlington, US), Simtra BioPharma Solutions (Parsippany, US), Carbogen AMCIS (Bubendorf, Switzerland), and BioNTech (Mainz, …
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FDA approves GSK’s prefilled syringe presentation of Shingrix
The US Food and Drug Administration (FDA) has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled …
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Astellas and KISED link to support Korean pharma startups
Astellas Pharma has entered a memorandum of understanding (MoU) with the Korea Institute of Startup and Entrepreneurship Development (KISED) to …
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ADCs on the rise: MilliporeSigma, Lonza invest in manufacturing while BioNTech adds CMOs ahead of FDA filing
Pharmaceutical companies and manufacturers, including MilliporeSigma (Burlington, US), Simtra BioPharma Solutions (Parsippany, US), Carbogen AMCIS (Bubendorf, Switzerland), and BioNTech (Mainz, …
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FDA approves GSK’s prefilled syringe presentation of Shingrix
The US Food and Drug Administration (FDA) has approved GSK's Shingrix vaccine (recombinant zoster vaccine or RZV) in a prefilled …
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Can rare disease research in the US thrive under the new administration?
In 2024, 50% of the novel drugs approved by the FDA had an orphan drug designation. In the last two …
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Ten years of Rare Pediatric Disease Designation: impact on drug approvals
Due to concerns surrounding its effectiveness, the US Food and Drug Administration (FDA) ended the Rare Pediatric Disease Designation (RPDD) …
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Sarepta Therapeutics to cut 500 jobs amid restructuring
Sarepta Therapeutics is set to cut 500 jobs as part of its restructuring and pipeline prioritisation plan, which is expected …
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Thermo Fisher acquires Sanofi’s steriles manufacturing site in US
Thermo Fisher Scientific has signed an agreement for the acquisition of Sanofi’s steriles manufacturing site located in Ridgefield in the …
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PEPFAR funding protection offers “hope” for people living with HIV
The White House’s decision to safeguard $400m in President's Emergency Plan for AIDS Relief (PEPFAR) funding to support the global …
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UK government targets manufacturing as it eyes £41bn life science sector growth
The UK Government will enhance manufacturing and commercialisation as it looks to harness the value of the life sciences sector …
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GSK’s Blenrep US comeback hindered by eye safety concerns
GSK’s plan to bring blood cancer drug Blenrep (belantamab mafodotin) back to markets has hit a stumbling block, after the …
