Magazine: Made in the USA
A combination of US government incentives, supply chain disruptions, and geopolitical tensions are prompting increased investment in US manufacturing. In …
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Outlook Therapeutics wins FDA approval for Lytenava in wet AMD
Following years of regulatory setbacks that saw multiple rejections, Outlook Therapeutics has secured US Food and Drug Administration (FDA) approval …
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Biointron introduces RushData platform for AI-driven antibody discovery
Biointron Biological has launched RushData, a new platform to support the process of antibody discovery for pharmaceutical and biotechnology companies …
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Kenvue’s Tylenol with Naproxen gains FDA approval
The US Food and Drug Administration (FDA) has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter (OTC) fixed-dose combination of acetaminophen …
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Adult epilepsy market to reach $17.bn across 7MM by 2035
The adult epilepsy market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) …
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Kenvue’s Tylenol with Naproxen gains FDA approval
The US Food and Drug Administration (FDA) has approved Kenvue’s Tylenol with Naproxen, the first over-the-counter (OTC) fixed-dose combination of acetaminophen …
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Adult epilepsy market to reach $17.bn across 7MM by 2035
The adult epilepsy market across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) …
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Sanofi abandons eczema drug approval efforts in another blow to OX40 class
Sanofi has chosen not to file for approval or continue the development of its immunology therapy, amlitelimab, in atopic dermatitis …
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BeOne to invest $300m in US manufacturing facility expansion
BeOne Medicines is set to invest $300m in expanding its manufacturing and research operations at the Princeton West Innovation Campus …
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FDA grants fast track designation for Lundbeck’s Lu AH69593
Lundbeck has secured fast track designation from the US Food and Drug Administration (FDA) for its investigational treatment, Lu AH69593, …
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GSK secures first lung cancer approval, validating $10.6bn Nuvalent bet
Just days after completing a $10.6bn takeover of lung cancer biotech Nuvalent, GSK is already reaping the rewards with Jideytro …
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Affinia Therapeutics receives FDA orphan drug designation for AFTX-201
Affinia Therapeutics has received the US Food and Drug Administration (FDA) orphan drug designation for AFTX-201, a treatment in development …
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Evogene and ELEO to develop new oral PCSK9 inhibitors
Evogene and ELEO have entered a scientific collaboration aimed at discovering and developing new oral small-molecule inhibitors targeting the Proprotein …
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Crystalys banks $130m to progress gout drug, plan for commercial readiness
Crystalys Therapeutics has secured $130m in a Series B raise to push its gout therapy, dotinurad, further down the pipeline, …
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Speciality versus diversity: the four-way CDMO race in outsourced HPAPI manufacturing
Known for their low-dose therapeutic efficacy and high target affinity, HPAPIs are in high demand by biopharma companies, which often …
