Health Canada grants NOC for AstraZeneca’s breast cancer therapy
Health Canada has issued a notice of compliance (NOC) for AstraZeneca’shuman epidermal growth factor receptor 2 (HER2)-directed antibody drug conjugate …
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FDA looks to simplify biosimilar development with new draft guidance
The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar …
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Magazine: Cleanroom chronicles
With tighter regulations around biopharma manufacturing and the emergence of advanced therapies, cleanroom design is being fundamentally reshaped. This month's …
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Novo Nordisk locks horns with Pfizer in late bid for Metsera
Pfizer’s agreed takeover Metsera could be in jeopardy, after Novo Nordisk submitted a rival bid to acquire the obesity biotech. Novo …
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Eli Lilly ramps up orforglipron production with $1.2bn Puerto Rico site expansion
Eli Lilly will invest more than $1.2bn into its manufacturing site in Puerto Rico, as the drugmaker looks to assemble …
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Dewpoint receives FDA orphan drug designation for DPTX3186
Dewpoint Therapeutics has received the US Food and Drug Administration’s (FDA) orphan drug designation (ODD) for DPTX3186, a small-molecule condensate …
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From pilot to production: Scaling lyophilization with confidence
Lyophilization is a vital tool to maintain product quality, extend shelf life, and protect delicate compounds. Many parenteral formulations and …
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Pfizer and Roche place $10bn bets on obesity and liver disease therapies as Trump tightens grip on drug pricing and manufacturing
Two of the world’s largest pharmaceutical companies, Pfizer (New York, US) and Roche (Basel, Switzerland), have unveiled more than $10bn …
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Seres to obtain $3.6m from CARB-X for SER-155 development
Seres Therapeutics is to receive up to $3.6m in further non-dilutive funding from the international non-profit partnership, Combating Antibiotic-Resistant Bacteria …
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Elevara explores CDK4/6 inhibition for the treatment of rheumatoid arthritis
Backed by $70m in Series A funding, Elevara Medicines has launched to advance its CDK4/6 inhibitor, which belongs to a …
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Eli Lilly and NVIDIA to build pharma’s “most powerful” supercomputer
Eli Lilly and NVIDIA will build a new supercomputer to accelerate drug discovery and shorten development cycles, marking one of …
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CPHI 2025: time for European biopharma to double down on innovation
Investors are urging Europe’s biopharma companies to embrace the continent’s long-established specialisation as an innovation hub as the route to …
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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 …
