Skip to content Skip to footer
Subscribe Now
Regeneron
NEWS

Regeneron’s Ordspono (Odronextamab) Receives the EC’s Approval to Treat R/R Follicular Lymphoma and Diffuse Large B-cell Lymphoma 

     Shots:    The EC has approved Ordspono for treating r/r FL or r/r DLBCL in patients who have progressed after ≥2L of systemic therapy  Approval was supported by Ordspono’s P-I (ELM-1; n=60) trial in patients with CD20+ B-cell malignancies, incl. those who progressed post CAR-T therapy & P-II (ELM-2; n=128) trial for 5 B-cell lymphoma…
August 24, 2024

Read more

NEWS

Moderna’s mRESVIA (mRNA-1345) Vaccine Gains the EC’s Approval to Prevent Lower Respiratory Tract Disease (LTRD) 

Shots:    The EC’s approval of mRESVIA (mRNA-1345) vaccine to prevent LTRD due to RSV infection among adults was supported by P-III (ConquerRSV) trial in adults (n=37,000; ≥60yrs.) & is valid across EU plus as Iceland, Liechtenstein & Norway  Primary analysis (3.7mos. median follow-up) depicted vaccine efficacy (VE) of 83.7%, published in the NEJM. Supplementary analysis…
August 23, 2024

Read more

Johnson& Johnson
NEWS

Johnson & Johnson’s Balversa (Erdafitinib) Receives the EC’s Approval to Treat Urothelial Carcinoma 

Shots:    The EC has approved Balversa (oral, QD) monotx. for treatment-experienced adults with inoperable or metastatic urothelial carcinoma (mUC) having susceptible FGFR3 genetic alterations  Approval was supported by results of cohort 1 from the P-III (THOR) trial assessing the safety & effectiveness of Balversa (n=136) vs CT (n=130) to treat mUC with select FGFR alterations…
August 23, 2024

Read more

Bio-Thera New
NEWS

Bio-Thera Solutions Expands its Partnership with Pharmapark for BAT2306 (Biosimilar, Cosentyx) Across Russia and Other Countries

Shots:  Pharmapark will hold exclusive distribution, and marketing rights & filing for BAT2306 (Secukinumab bsm) which has finished the P-I & P-III study globally and plans to submit applications for approval to the NMPA, EMA & FDA.  Under the terms of the agreement, BAT2306 will be developed & supplied by Bio-Thera at its Guangzhou, China…
August 16, 2024

Read more

NEWS

EMA Accepted the Marketing Application of Alvotech’s AVT06 a Biosimilar of Eylea (aflibercept) 

Shots:  Alvotech reported EMA’s acceptance of its marketing application for AVT06, a biosimilar to Eylea used to treat eye disorders, and reported global sales of $5.9B. The company expects its marketing approval in Q3’25  Alvotech will develop and supply the AVT06, while Advanz Pharma will register and have exclusive commercialization rights in Europe except for…
August 15, 2024

Read more

Takeda
NEWS

Takeda Reports the EC’s Approval of Adzynma to Treat Congenital Thrombotic Thrombocytopenic Purpura (cTTP) 

Shots:    The EC has approved Adzynma (recombinant ADAMTS13) to treat ADAMTS13 deficiency in cTTP adults & children. Adzynma is also being assessed under P-IIb study for immune-mediated thrombotic thrombocytopenic purpura (iTTP)  Approval was based on the P-III study assessing Adzynma to treat cTTP, published in the NEJM, with patients receiving Adzynma (40IU/kg, IV, weekly) or…
August 7, 2024

Read more

New Drug Designations - June 2024
INSIGHTS+

New Drug Designations – June 2024

Shots:   PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, NMPA and EMA. This month’s report includes designations allotted to 7 small molecules, 5 biologics, 8 cell & gene therapies, 2 recombinant fusion protein, and 3 devices   This month, ChromaDex’s Nicotinamide Riboside Chloride received US FDA’s ODD &…
July 30, 2024

Read more

Bio-Thera New
NEWS

 Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications 

Shots:    The EMA has granted approval to the company’s Avzivi (bevacizumab), a biosimilar version of Avastin. Sandoz is responsible for marketing the drug across the EU  The license and commercialization agreement b/w Bio-Thera and Sandoz was signed in Sep 2021, under which Bio-Thera had the development and manufacturing rights while Sandoz secured the commercialization…
July 30, 2024

Read more

Astellas
NEWS

Astellas Reports the CHMP’s Positive Opinion of Zolbetuximab to Treat Gastric and Gastroesophageal Junction Cancer 

  Shots:    The CHMP has granted positive opinion to zolbetuximab + CT, with the decision anticipated in Oct 2024 & applicable across the whole EU plus Iceland, Liechtenstein & Norway. Other worldwide regulatory applications are under review  Opinion was supported by 2 P-III studies assessing zolbetuximab plus mFOLFOX6 [SPOTLIGHT (n=565)] & CAPOX [GLOW (n=507)] vs PBO…
July 29, 2024

Read more

NEWS

Novaliq’s Vevizye (Ciclosporin) gains the CHMP’s Positive Opinion to Prevent Moderate to Severe Dry Eye Disease (DED) 

Shots:   The CHMP has granted a positive opinion to Vevizye in moderate to severe dry eye disease adults treated with tear substitutes based on (ESSENCE-1 & ESSENCE-2) trials involving >1500 patients  Vevizye showed improved ocular surface health, with a reduction in corneal fluorescein staining at D15 (~71.6% responded within 4wks.); additional benefits were observed at…
July 29, 2024

Read more

Load more