Skip to content Skip to footer
Subscribe Now
Alvotech & Advanz Pharma
NEWS

Alvotech and Advanz Pharma Team Up to Commercialize AVT06/AVT29 (Biosimilar, Eylea) in Europe

  Shots:  Alvotech has signed an exclusive partnership agreement with Advanz Pharma to supply and commercialize AVT06 (2mg, Low dose) and AVT29 (8mg, High dose), biosimilars of Eylea  As per the agreement, Alvotech will develop & supply the biosimilars and receive an upfront plus subsequent development & commercialization milestones. Advanz Pharma will handle registration &…
June 18, 2024

Read more

NEWS

Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab) 

Shots:  Alvotech & STADA expand their strategic collaboration covering AVT03, biosimilar of Prolia/Xgeva (denosumab), to treat osteoporosis & cancer-related bone loss, respectively  As per the agreement, AVT03 will be developed & manufactured by Alvotech at its state-of-the-art facility while STADA becomes marketing authorization holder with semi-exclusive commercial rights across the EU, incl. Switzerland & the…
June 11, 2024

Read more

Ipsen
NEWS

Ipsen’s Iqirvo (Elafibranor) Gains the US FDA’s Accelerated Approval for Treating Primary Biliary Cholangitis 

Shots:  The US FDA has granted accelerated approval to Iqirvo (80mg tablets) in addition to ursodeoxycholic acid (UDCA) to treat PBC adults having inadequate response to UDCA or as monotx. in UDCA intolerant patients. Full approval depends on (ELFIDENCE) confirmatory trial  The approval was based on a P-III (ELATIVE) study assessing the safety & efficacy…
June 10, 2024

Read more

Geron
NEWS

Geron’s Rytelo (Imetelstat) Gains the US FDA’s Approval to Treat Myelodysplastic Syndromes (MDS) with Transfusion-Dependent Anemia 

Shots:  The US FDA has approved Rytelo to treat low- to intermediate-risk MDS with transfusion-dependent (TD) anemia adults who did not respond to, lost response, or are not eligible for erythropoiesis-stimulating agents (ESA)  The approval was supported by the P-III (IMerge) study of Rytelo vs PBO, depicting a 39.8% vs 15.0% RBC-TI rate for 8wks.…
June 6, 2024

Read more

Insights+ Key Biosimilars Events of May 2024
INSIGHTS+

Insights+ Key Biosimilars Events of May 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 May, Teva & Alvotech launched Simlandi injection Treat Multiple Indications. Our…
June 4, 2024

Read more

Astrazeneca
NEWS

AstraZeneca’s Tagrisso Receives the CHMP’s Positive Opinion for Treating EGFR-Mutated advanced Lung Cancer 

      Shots:  The CHMP’s positive opinion of Tagrisso + pemetrexed & Pt-based CT as a 1L treatment of locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) EGFRm NSCLC with exon 19 deletions or exon 21 (L858R) mutations was based on P-III (FLAURA2) study  The P-III (FLAURA2) study assessed Tagrisso (80mg, oral, QD) + CT [pemetrexed…
June 3, 2024

Read more

NEWS

SIFI Reports the CHMP’s Positive Opinion of Akantior (Polihexanide) to Treat Acanthamoeba Keratitis 

Shots:  The CHMP grants a positive opinion to Akantior for treating acanthamoeba keratitis based on the P-I & P-III studies. The final decision is anticipated in Aug 2024, to be valid across the EU incl. Iceland, Liechtenstein & Norway   The P-I trial determined the effect of different polihexanide concentrations vs PBO among healthy individuals (n=90)…
May 31, 2024

Read more

Abbvie
NEWS

AbbVie Reports the CHMP’s Positive Opinion of Skyrizi (Risankizumab) to Treat Ulcerative Colitis 

     Shots:  The CHMP grants a positive opinion to Skyrizi for treating moderate to severely active UC in adults with inadequate or lost response and were intolerant to conventional or biologic therapy. Final decision is anticipated in Q3’24  The positive opinion was based on the P-III (INSPIRE) study, assessing Skyrizi (induction treatment: 1200mg, IV, 0,4…
May 31, 2024

Read more

Load more