Moderna’s dual Covid-flu vaccine poised for EMA approval on positive CHMP take
The European Medicines Agency’s (EMA) drug review committee has taken a positive stance on granting marketing authorisation to Moderna’s combination …
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FDA approves Ascendis Pharma’s weekly Yuviwel for paediatric dwarfism
The US Food and Drug Administration (FDA) has granted accelerated approval to Ascendis Pharma’s Yuviwel (navepegritide) for the treatment of …
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Sanofi receives CHMP recommendation for Dupixent expansion in Europe
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion …
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BioMarin receives FDA approval for Palynziq use in adolescents
BioMarin Pharmaceutical has received the US Food and Drug Administration (FDA) approval for its supplemental biologics licence application (sBLA) for …
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How America’s former steel heartland secured a $3.5bn Eli Lilly facility
Surveying Lehigh Valley’s historical industrial sites along the Lehigh River evokes a bygone era when the region was home to …
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Boehringer inks $500m Sitryx deal, secures CPNV-driven Hernexeos approval
Boehringer Ingelheim has revamped its portfolio and pipeline by inking a immunology-focused licensing deal with Sitryx Therapeutics worth more than …
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Generate Biomedicines secures $400m IPO in flurry of February listings
Generate Biomedicines has raised $400m in one of the largest biotech initial public offerings (IPO) since 2024, signalling renewed investor …
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Asahi Kasei to acquire Aicuris Anti-infective Cures for $920.7m
Asahi Kasei has signed a definitive agreement to acquire all issued shares of German-based Aicuris Anti-infective Cures for approximately €780m …
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Podcast: Rare Disease Day: FDA guidance allowing advancement
It’s been a busy year for rare disease developers, with the US Food and Drug Administration (FDA) releasing several new …
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Quotient and Ipsen extend partnership for ultra-rare disease therapy
Quotient Sciences has extended its commercial partnership with Ipsen, focusing on the production of Sohonos (Palovarotene) for fibrodysplasia ossificans progressiva …
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Rare disease developers applaud clarity in FDA guidance
Stakeholders in the rare disease development community say that new guidance documents, released by the US Food and Drug Administration …
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Nonprofit models support strategic boldness to develop gene therapies for rare diseases
Non-profit organisations play a crucial role in supporting rare disease therapy development and rescuing shelved programmes, where commercial interest may …
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MHRA and police seize 2,000 illegal weight loss drugs after raiding criminal facility
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has raided two sites in the Midlands as the agency looks …
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IQVIA to acquire Charles River drug discovery assets
IQVIA Holdings has signed an agreement to acquire selected discovery service assets from Charles River Laboratories, aiming to expand its …
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Novo Nordisk and Vivtex collaborate for oral medicines development
Novo Nordisk and Vivtex have entered a partnership focused on developing next-generation oral biologic therapies to treat obesity, diabetes and …
