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Sep 13, 2024
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...
Sep 13, 2024
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...
Sep 13, 2024
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,...
Sep 13, 2024
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...
Sep 13, 2024
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 of...
Sep 13, 2024
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...
Sep 12, 2024
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...
Sep 12, 2024
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...
Sep 12, 2024
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...
Sep 12, 2024
On 12 September 2024, Ono Pharmaceutical and Bristol-Myers Squibb announced they submitted a supplemental application in Japan for Ono’s Opdivo® (nivolumab) and BMS’s Yervoy® (ipilimumab) in combination therapy, to expand use to unresectable advanced or recurrent...
Sep 12, 2024
On 12 September 2024, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) as monotherapy for treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient...
Sep 11, 2024
On 11 September 2024, Sanofi and Regeneron announced that a confirmatory phase 3 study of Dupixent® (dupilumab) met the primary and key secondary endpoints for treatment of patients with uncontrolled, biologic-naïve chronic spontaneous urticaria (CSU) receiving...
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