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Recent BioBlast® Updates

Acceptance Alert: CSPC Pharmaceutical’s Ustekinumab Biosimilar Accepted by China’s NMPA

Nov 26, 2024

On 26 November 2024, CSPC Pharmaceutical Group Limited (CSPC) announced that its biologic license application for ustekinumab (biosimilar to Johnson & Johnson’s Stelara®) was accepted by the People’s Republic of China's National Medical Products Administration...

Approval Alert: Celltrion’s Omlyclo® Is Australia’s First Approved Omalizumab Biosimilar

Nov 26, 2024

On 26 November 2024, Celltrion’s Omlyclo®, biosimilar to Genentech's and Novartis' Xolair® (omalizumab) was approved in Australia. Omlyclo® is the first omalizumab biosimilar approved in Australia. Omylclo® was approved in Australia for two presentations: 75 mg/0.5...

New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India

Nov 26, 2024

On 26 November 2024, The Economic Times reported that AstraZeneca has received approval from India's Central Drugs Standard Control Organisation (CSDCO) to market Lynparza® (olaparib) in India. The CDSCO granted approval for the use of Lynparza® in combination with...

FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma

Nov 25, 2024

On 25 November 2024, GlaxoSmithKline (GSK) announced that the FDA has accepted its BLA for Blenrep® (belantamab mafodotin) in combination with BorDex (bortezomib plus dexamethasone) or PomDex (pomalidomide plus dexamethasone) for the treatment of patients with...

New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Chronic ITP in Children

Nov 22, 2024

On 22 November 2024, Chugai (a Roche subsidiary) and Zenyaku Kogyo announced that their co-marketed Rituxan® (rituximab) has been approved by the Japanese Ministry of Health, Labour and Welfare for chronic idiopathic thrombocytopenic purpura (ITP) in children (IV...

J&J Seeks FDA Approval for SC Induction Regimen of Tremfya® (Guselkumab) in Ulcerative Colitis

Nov 22, 2024

On 22 November 2024, Johnson & Johnson submitted a supplemental Biologics License Application to the FDA seeking approval of a subcutaneous (SC) induction regimen of Tremfya® (guselkumab) for the treatment of adults with moderately to severely active ulcerative...

Celltrion Denosumab Biosimilars First to be Approved in Korea

Nov 22, 2024

On 22 November 2024, Celltrion announced that the Korean Ministry of Food and Drug Safety has approved its Stoboclo™ (CT-P41, denosumab) and Osenvelt™ (CT-P41, denosumab), biosimilars to Amgen’s Prolia® and Xgeva®, respectively. Stoboclo™ and Osenvelt™ are the first...

Replimune Submits BLA for RP1 with Nivolumab for Melanoma

Nov 21, 2024

On 21 November 2024, Replimune announced that it has submitted a biologics license application (BLA) to the FDA for RP1 (vusolimogene oderparepvec, a genetically modified oncolytic strain of HSV-1 virus) in combination with Opdivo® (nivolumab) for the treatment of...

JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara® (Ustekinumab)

Nov 20, 2024

We reported on 26 August 2024 that JAMP had filed an application in the Canadian Competition Tribunal seeking leave to bring an action under the Competition Act regarding Stelara®

Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer

Nov 20, 2024

On 20 November 2024, Jazz Pharmaceuticals announced that the US FDA has granted accelerated approval of Ziihera® (zanidatamab-hrii) for the treatment of adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer, as detected...

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval

Nov 20, 2024

On 20 November 2024, Pfizer announced that the European Commission (EC) has approved its Hympavzi™ (marstacimab) for the routine prophylaxis of bleeding episodes in patients 12 years of age and older weighing at least 35 kg with severe haemophilia A without FVIII...

New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

Nov 20, 2024

On 20 November 2024, UCB announced that Bimzelx® (bimekizumab-bkzx) was approved by the FDA as the first IL-17A and IL-17F inhibitor for adults with moderate to severe hidradenitis suppurativa. This follows the recommendation of the EMA’s Committee for Medicinal...

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Recent BioBlast® Updates

Acceptance Alert: CSPC Pharmaceutical’s Ustekinumab Biosimilar Accepted by China’s NMPA

Approval Alert: Celltrion’s Omlyclo® Is Australia’s First Approved Omalizumab Biosimilar

New Indication Alert: AstraZeneca Receives Approval to Market Lynparza (Olaparib) in India

FDA Accepts BLA for GSK’s Blenrep® Combination Treatment for Multiple Myeloma

New Indication Alert: Chugai/Zenyaku’s Rituximab Approved in Japan for Chronic ITP in Children

J&J Seeks FDA Approval for SC Induction Regimen of Tremfya® (Guselkumab) in Ulcerative Colitis

Celltrion Denosumab Biosimilars First to be Approved in Korea

Replimune Submits BLA for RP1 with Nivolumab for Melanoma

JAMP Loses Canadian ‘Abuse of Dominance’ Application Against Janssen Regarding Stelara® (Ustekinumab)

Approval Alert: FDA Approves Jazz Pharmaceutical’s Ziihera® (Zanidatamab-hrii) for Biliary Tract Cancer

Approval Alert: Pfizer’s Hympavzi™ (Marstacimab) Receives EU Approval

New Indication Alert: FDA Approves UCB’s Bimzelx® (Bimekizumab-bkzx) as First IL-17A/IL-17F Inhibitor for Hidradenitis Suppurativa

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