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Sep 17, 2024
On 17 September 2024, GlaxoSmithKline (GSK) announced that Japan’s Ministry of Health has accepted for review a new drug application for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus...
Sep 17, 2024
On 17 September 2024, Daiichi Sankyo and MSD announced positive results from a Phase 3 trial of their antibody drug conjugate, patritumab deruxtecan (HER3-DXd). In the trial (HERTENA-Lung02), patritumab deruxtecan showed statistically significant improvement in...
Sep 17, 2024
Formycon has announced that it will present study data for Fymskina (FYB202), biosimilar to Janssen’s Stelara® (ustekinumab), at the 2024 European Academy of Dermatology and Venerology Congress (25 to 28 September in Amsterdam) and the 2024 United European...
Sep 16, 2024
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...
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...
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