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On 13 September 2024, Regeneron and Sanofi announced that their Dupixent® (dupilumab) has received FDA approval as an add-on maintenance treatment for patients aged 12-17 with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).  This follows the FDA’s...

On 13 September 2024, Eli Lilly announced that its Ebglyss® (lebrikizumab-lbkz) received FDA approval for adults and children 12 years and older with moderate-to-severe atopic dermatitis (eczema) that is not well controlled despite treatment with topical prescription therap...

On 13 September 2024, Glaxo Smith Kline (GSK) announced that China’s National Medical Products Administration (NMPA) granted Breakthrough Therapy Designation (BTD) for its Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) for treatme...

On 13 September 2024, Korea Biomedical Review reported that Korea-based Alteogen has submitted a domestic marketing authorisation application for its ALT-L9, biosimilar to Regeneron’s Eylea® (aflibercept), for treatment of nAMD.

This follows Alteogen’s subsidiary, Al...

On 13 September 2024, Celltrion announced it has won the contract to supply Herzuma® (trastuzumab), biosimilar to Roche’s Herceptin®, to the Brazilian Federal Government to the end of 2025.  Celltrion will supply 660,000 vials of the biosimilar during the fifth consecutive ...

The TGA website has been updated to include a number of new originator applications for the months of July and August 2024.

The following expanded indications are being sought for MSD’s Keytruda® and BMS’s Opdivo®:

BMS’s Opdivo® (nivolumab) for the treatment...

On 13 September 2024, Pharmac, the New Zealand Pharmaceutical Management Agency, announced a proposal to fund four new cancer and respiratory treatments through a provisional partnership with AstraZeneca, commencing 1 January 2025.  The proposal includes the following Astra...

On 12 September 2024, PM Live reported that Sanofi and Regeneron’s Dupixent® (dupilumab) has been approved by the UK Medicines Healthcare products Regulatory Agency (MHRA) as an add-on maintenance treatment for chronic obstructive pulmonary disease (COPD).

This follo...

On 12 September 2024, Genentech (a member of the Roche Group) announced that its Tecentriq Hybreza™  (atezolizumab and hyaluronidase-tqjs) received FDA approval, and is the first and only US approved PD-(L)1 inhibitor for subcutaneous (SC) administration.

Genentech s...

On 12 September 2024, Sanofi and Regeneron announced that Health Canada has approved Dupixent® (dupilumab) for the treatment of patients aged 1 year and older, weighing at least 15 kg, with eosinophilic esophagitis (EoE).  This approval expands the initial Health Canada app...