21 APR 2024 | US | Xbrane to Resubmit BLA for Ranibizumab Biosimilar following FDA CRL
On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Compl...
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By Naomi Pearce, Chantal Savage, Faran Shahzad | Apr 22, 2024
21 APR 2024 | US | Xbrane to Resubmit BLA for Ranibizumab Biosimilar following FDA CRL
On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Compl...
By Naomi Pearce, Helen Macpherson | Apr 22, 2024
SARB Management Group Pty Ltd T/A Database Consultants Australia v Vehicle Monitoring Systems Pty Limited [2024] FCAFC 6
Date:
Court:
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By Bioblast Editor | Apr 21, 2024
On 21 April 2024, Swedish biosimilar developer Xbrane announced that the FDA issued a Complete Response Letter (CRL) regarding its BLA for ranibizumab biosimilar XlucaneTM. The issues identified primarily concern (a) the analytical methods for the reference standard; and (...
By Bioblast Editor | Apr 19, 2024
On 19 April 2024, Merck (known as MSD outside Canada and the US) announced that Health Canada has approved Keytruda® (pembrolizumab) as a 1st line treatment for locally advanced unresectable or metastatic HER2 negative gastric cancer or gastroesophageal junction adenocarcin...
By Bioblast Editor | Apr 19, 2024
On 19 April 2024, Alvotech announced that it has entered a long-term agreement with an unnamed strategic partner to market in the US its high concentration interchangeable adalimumab-ryvk (AVT02), biosimilar to AbbVie’s Humira®, which received FDA approval in February 2023....
By Bioblast Editor | Apr 18, 2024
On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).
This follows the FDA’s acceptance of Takeda’s BLA for ENTYVI...
By Bioblast Editor | Apr 18, 2024
On April 2024, Korean Biomedical Review reported that Celltrion won the Denmark national tender for its subcutaneous infliximab formulation, Remsima SC®. Remsima SC® (infliximab) will be supplied in Denmark for one year by Celltrion’s Danish subsidiary. This subsidia...
By Bioblast Editor | Apr 17, 2024
On 17 April 2024, Biocon announced that it signed an exclusive licensing and supply agreement for generic Ozempic® (semaglutide) in Brazil. Biocon will develop, manufacture and supply the semaglutide product and Biomm is responsible for regulatory and commercialisation str...
By Bioblast Editor | Apr 16, 2024
On 16 April 2024, Alvotech announced the US has approved SELARSDI™ (ustekinumab-aekn), biosimilar to Stelara®(ustekinumab), for both adult and paediatric use. Selarsdi™ was developed by Alvotech and will be commercialised by Teva in the US.
This is the second US biosi...
By Bioblast Editor | Apr 16, 2024
The Korea Biomedical Review reports that, on 16 April 2024, Merck Sharp & Dohme (MSD) announced that it obtained approval in Korea for an expanded indication for its Keytruda® (pembrolizumab) as a combination therapy with chemoradiotherapy for treating FIGO (Internation...
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