Cardiology Licensing Regulation 
XTalks
FEBRUARY 12, 2025
LIB Therapeutics has announced that the FDA has accepted its Biologics License Application (BLA) for lerodalcibep, a novel investigational treatment aimed at reducing low-density lipoprotein cholesterol (LDL-C) in a broad patient population. Over 2,400 patients have continued in the 72-week open-label extension trial.
pharmaphorum
JUNE 1, 2021
Novo Nordisk – which is already active in stem cell therapies with a candidate in early development for type 1 diabetes – is on the hook for up to $598 million in total licensing and milestone payments plus royalties on sales if HS-001 reaches the market. Other readouts give grounds for optimism.
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pharmaphorum
JULY 6, 2021
The US regulator issued Novartis with a complete response letter (CRL) for inclisiran in December, citing “unresolved facility inspection-related conditions” at a third-party manufacturing site run by Corden Pharma near Milan, Italy.
The Pharma Data
DECEMBER 12, 2020
It plays a crucial role in many inflammatory and autoimmune diseases across multiple therapy areas, including haematology, nephrology, neurology, metabolic disorders, cardiology, ophthalmology and acute care. Any failure to comply with this restriction may constitute a violation of such laws or regulations. Morgan Cazenove) (“J.P.
pharmaphorum
APRIL 23, 2021
Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . Amarin said that Vazkepa is one of the first drugs filed and licensed through the MHRA’s new “Reliance” route following the end of the Brexit transition period.
Cloudbyz
AUGUST 16, 2024
FDA regulations that establish the criteria for electronic records and electronic signatures. The cost of implementing an eCRF system can vary depending on several factors, including: Licensing Fees: Ongoing costs for using the software, which may be subscription-based or one-time fees. What are the regulatory requirements for eCRFs?
The Pharma Data
OCTOBER 29, 2020
ALXN2060 (AG10) – Eidos: Alexion holds an exclusive license to develop and commercialize ALXN2060 (AG10) in Japan. Enrollment is underway in two parallel Phase 3 studies – one in patients with Mayo stage IIIa disease and one in patients with Mayo stage IIIb disease. Eidos is currently evaluating AG10 in a Phase 3 study in the U.S.
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