Recent BioBlast® Updates

NZ’s Pharmac Proposes Provisional Partnership with AstraZeneca to Fund Treatment of Cancer & Respiratory Conditions

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...

New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in UK for COPD

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...

New Formulation Alert: Genentech’s Tecentriq Hybreza™ (Atezolizumab) is First Subcutaneous Anti-PD-(L)1 Inhibitor Approved in US

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...

New Indication Alert: Dupixent® Approval for EoE Extended to Patients Over 1 Year Old in Canada

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...

Ono and BMS Apply for Opdivo®/Yervoy® Combo for Colorectal Cancer in Japan

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...

New Indication Alert: MSD’s Keytruda® (Pembrolizumab) Approved in Canada for MSI-H or dMMR Solid Tumours

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...

Sanofi and Regeneron to Submit New Data to Support sBLA for Dupixent® (Dupilumab) to Treat CSU

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...

New Indication Alert: J&J’s Tremfya® (Guselkumab) FDA-Approved for UC

Sep 11, 2024

Following a March 2024 sBLA submission, and the successful results of a phase 3 study reported in May 2024, the FDA has approved Johnson & Johnson’s Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis (UC)....

Bio-Thera and Biogen Tocilizumab Phase 3 Switching Study

Sep 11, 2024

On 11 September 2024, Bio-Thera Solutions and Biogen published results from their phase 3 switching study for Tofidence™ (BAT1806/BIIB800), biosimilar to Roche’s Actemra®/RoActemra® (tocilizumab). The study showed that comparable clinical efficacy, safety,...

Approval Alert: Celltrion’s Biosimilar Ustekinumab Approved in AU

Sep 11, 2024

The Australian Therapeutic Goods Administration (TGA) has approved Celltrion’s SteQeyma® (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab). SteQeyma is approved for a 130 mg/26 mL concentrate for solution for infusion vial to treat moderate to severe plaque...

Iconovo Commences Development of Intranasal Semaglutide

Sep 10, 2024

On 10 September 2024, Swedish CDMO, Iconovo, announced that it has commenced developing an intranasally inhaled form of semaglutide for treatment of obesity. The product will reportedly use an improved form of Iconovo’s existing intranasal inhaler “ICOone Nasal®”....

Eli Lilly Reports Positive Phase 3 Results for Weekly Insulin Injections

Sep 10, 2024

On 10 September 2024, Eli Lilly announced that it met the primary endpoints for A1C (blood glucose measurement) reduction in the QWINT-2 (type 2 diabetes) and QWINT-5 (type 1 diabetes) trials for once weekly insulin efsitora alfa. The results were simultaneously...

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Recent BioBlast® Updates

NZ’s Pharmac Proposes Provisional Partnership with AstraZeneca to Fund Treatment of Cancer & Respiratory Conditions

New Indication Alert: Sanofi and Regeneron’s Dupixent® Approved in UK for COPD

New Formulation Alert: Genentech’s Tecentriq Hybreza™ (Atezolizumab) is First Subcutaneous Anti-PD-(L)1 Inhibitor Approved in US

New Indication Alert: Dupixent® Approval for EoE Extended to Patients Over 1 Year Old in Canada

Ono and BMS Apply for Opdivo®/Yervoy® Combo for Colorectal Cancer in Japan

New Indication Alert: MSD’s Keytruda® (Pembrolizumab) Approved in Canada for MSI-H or dMMR Solid Tumours

Sanofi and Regeneron to Submit New Data to Support sBLA for Dupixent® (Dupilumab) to Treat CSU

New Indication Alert: J&J’s Tremfya® (Guselkumab) FDA-Approved for UC

Bio-Thera and Biogen Tocilizumab Phase 3 Switching Study

Approval Alert: Celltrion’s Biosimilar Ustekinumab Approved in AU

Iconovo Commences Development of Intranasal Semaglutide

Eli Lilly Reports Positive Phase 3 Results for Weekly Insulin Injections

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