The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

Shots: The US FDA has granted accelerated approval to Ojemda for treating r/r pLGG patients (≥6mos.) with BRAF fusion/rearrangement or BRAF V600 mutation. It further obtained FDA’s rare pediatric disease priority review voucher The approval was based on the P-II (FIREFLY-1) study assessing the efficacy (arm 1, n=77) & safety (arm 2, n=60) of Ojemda.…

ByDipanshu DixitApril 23, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in March 2024

Shots: The EC approved 1 Biologic and 11 New Chemical Entities in March 2024, leading to treatments for patients and advances in the healthcare industry In March 2024, the major highlighted drugs were Novartis’ Fabhalta to treat PNH and UCB’s Bimzelx for the treatment of Adults with Moderate to Severe Hidradenitis Suppurativa PharmaShots has compiled…

ByDipanshu DixitApril 22, 2024

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Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders

Shots: The EC has granted marketing authorization for Pyzchiva (Biosimilar, Stelara) to treat autoimmune disorders in gastroenterology, dermatology, and rheumatology The approval was based on P-I & P-III studies of Pyzchiva vs Stelara. P-I trial assessing the PK, safety, tolerability & immunogenicity in healthy volunteers, and P-III trial assessing the efficacy, safety & PK profile…

ByDipanshu DixitApril 22, 2024

NEWS

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Shots: ImmunityBio’s Anktiva + Bacillus Calmette-Guérin (BCG) has received the US FDA’s approval to treat BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) and with/without papillary tumors. The US availability is anticipated by mid-May 2024 The approval & BTD was based on the study of 77 evaluable patients depicting a CR rate…

ByDipanshu DixitApril 22, 2024

NEWS

Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US

Shots: Alvotech entered into a long-term agreement with Teva Pharmaceuticals to expand access to newly US FDA-approved higher concentration Adalimumab-ryvk, an interchangeable biosimilar to Humaira in US market The partnership agreement aims to broaden access and further availability assurance of biologics for patients at affordable prices in the US and globally Following commercialization collaboration between…

ByDipanshu DixitApril 16, 2024

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Insights+: The US FDA New Drug Approvals in March 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of March 2024 The US FDA approved a total of 14 drugs including 12 new molecular entities and 2 biologics leading to the treatments for patients and advances in the healthcare industry The major highlighted drug was BeiGene’s Tevimbra for treating Advanced…

ByDipanshu DixitApril 15, 2024

NEWS

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra; IV) to Treat Chronic Autoimmune diseases

Shots: The company has launched Tyenne (biosimilar, Actemra) in the US, to treat chronic autoimmune diseases; got approved on Mar 05, 2024 Tyenne, an Interleukin-6 (IL-6) receptor antagonist developed by using Fresenius’ analytical & manufacturing technologies to treat several autoimmune diseases incl. rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic…

ByDipanshu DixitApril 15, 2024

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Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications

Shots: Teva Pharmaceuticals and mAbxience have signed a strategic licensing agreement across various markets incl. the EU and the US to develop a biosimilar product that is under development as a treatment for various oncology indications As per the agreement, mAbxience will develop and produce the candidates by utilizing the knowledge of biosimilar development &…

ByDipanshu DixitApril 4, 2024

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Insights+ Key Biosimilars Events of March 2024

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency   Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients   During March, Sandoz received the US FDA’s approval for Wyost & Jubbonti.…

ByDipanshu DixitApril 3, 2024

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Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China

Shots: The NMPA approved Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg), an anti-RANKL mAb, to treat unresectable giant cell tumors of the bone or resectable’s which may lead to severe functional impairment Maiweijian vs XGEVA (original product) has shown similarity in PK, PD, clinical efficacy and safety in patients with solid tumor bone metastases The P-I &…

ByDipanshu DixitApril 3, 2024

Dipanshu Dixit

The US FDA Grants Accelerated Approval to Day One’s Ojemda for Treating Pediatric Low-Grade Glioma (pLGG)

Insights+: EMA Marketing Authorization of New Drugs in March 2024

Samsung Bioepis Receives EC’s Marketing Authorization for Pyzchiva (Biosimilar, Stelara) to treat Autoimmune disorders

ImmunityBio’s Anktiva Receives the US FDA’s Approval to Treat Non-Muscle Invasive Bladder Cancer (NMIBC)

Alvotech and Teva Pharmaceuticals Collaborate to Expand Access for Adalimumab-ryvk (Interchangeable Biosimilar, Humaira) in US

Insights+: The US FDA New Drug Approvals in March 2024

Fresenius Kabi Launches Tyenne (Biosimilar, Actemra; IV) to Treat Chronic Autoimmune diseases

Teva Pharmaceuticals and mAbxience Join Hands to Develop Biosimilar Candidates for Treating Oncology Indications

Insights+ Key Biosimilars Events of March 2024

Mabwell’s Maiweijian (Biosimilar, Denosumab; 120mg) Receives the NMPA approval for Marketing Authorization in China

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