FDA hearing: psychedelics launch needs balanced regulation without limiting access
On 14 September, the FDA held a public hearing where members of the public, including healthcare providers, patients, advocates, and…
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FDA approves first gene therapy for Sanfilippo syndrome type A
With a $3.95m price tag, Fayuvi – a one-time gene therapy – is one of the most expensive drugs on…
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FDA hearing: psychedelics launch needs balanced regulation without limiting access
On 14 September, the FDA held a public hearing where members of the public, including healthcare providers, patients, advocates, and…
FDA approves first gene therapy for Sanfilippo syndrome type A
With a $3.95m price tag, Fayuvi – a one-time gene therapy – is one of the most expensive drugs on…
Novo targets oral macrocycles with $1.4bn Orbis partnership
The deal reflects a growing interest from big pharma in the compounds that bridge the gap between small molecules and…
Ona Therapeutics to develop ADC with WuXi’s payload-linker platform
The deal grants Ona Therapeutics rights to develop an ADC targeting a single undisclosed target.
Roche agrees to $1bn deal with Dualitas for bispecific antibody research
Dualitas is set to receive $36.5m upfront and could become eligible for milestone payments.
The shrinking return on investment for Nordic innovation
Nordic biopharma innovation outpaces commercialisation as regional biotechs struggle to raise the capital needed to upscale.
Novo taps Anthropic’s Claude to ‘supercharge’ R&D efforts
Anthropic said it would help Novo shorten research timelines and discover impactful medicines.
Cellares and GenomeFrontier to assess automated GF-CART01 production
The partnership aims to assist GenomeFrontier’s clinical activities for GF-CART01 in the US.
Viatris’ Wakix receives Japanese approval to treat OSAS and narcolepsy
The approval of pitolisant in Japan is based on domestic Phase III studies and international clinical research evidence.
Sling ropes in $123m for oral thyroid eye disease drug
Sling is racing to market the first oral IGF-1R blocker, which would likely provide competition to Amgen’s Tepezza.