Seagen

PharmaShots Weekly Snapshots (July 12 – 16, 2021)

Eli Lilly Signs an Agreement with Banner Alzheimer’s Institute to Evaluate Donanemab in P-III TRAILBLAZER-ALZ 3 Trial for Alzheimer’s Disease Published: July 16, 2021 | Tags: Eli Lilly, Banner Alzheimer’s Institute, Donanemab, P-III, TRAILBLAZER-ALZ 3 Trial, Alzheimer Disease AcelRx Signs a License Agreement with Aguettant to Commercialize Dzuveo in EU and for Two Pre-Filled Syringe …

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PharmaShots Weekly Snapshots (June 07 – 11, 2021)

Vertex and CRISPR Therapeutics Present New Data of CTX001 from 22 Patients with TDT and SCD at EMA 2021 Published: June 11, 2021 | Tags: Vertex, CRISPR Therapeutics, CTX001, TDT, SCD, EMA 2021 AbbVie Reports Results of Four-Year Follow-Up Analysis in P-III CLL14 Trial for Venclyxto/Venclexta to Treat Chronic Lymphocytic Leukemia Published: June 11, 2021 …

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SpringWorks and Seagen Enter into a Clinical Collaboration to Evaluate Nirogacestat + SEA-BCMA for R/R Multiple Myeloma

Shots: The companies will evaluate SpringWorks’ nirogacestat (GSI) + Seagen’s SEA-BCMA (Ab targeting BCMA) in patients with RRMM. The companies anticipate commencement of the study in H2’21 Seagen to sponsor & conduct a P-I study to evaluate the safety, tolerability, and preliminary efficacy of the combination, and will assume all costs of study, other than …

SpringWorks and Seagen Enter into a Clinical Collaboration to Evaluate Nirogacestat + SEA-BCMA for R/R Multiple Myeloma Read More »

PharmaShots Weekly Snapshots (May 17 – 21, 2021)

BeiGene Reports Results of Tislelizumab + CT in P-III RATIONALE 309 Study as 1L Treatment for Recurrent or Metastatic Nasopharyngeal Cancer Published: May 21, 2021 | Tags: BeiGene, Tislelizumab, CT, P-III, RATIONALE 309 Study, Recurrent, Metastatic Nasopharyngeal Cancer Aurinia to Present Results of Lupkynis (voclosporin) in AURORA 2 Continuation Study for Lupus Nephritis at EULAR …

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PharmaShots Weekly Snapshots (Apr 19 – 23, 2021)

BMS’ Opdivo + Yervoy and Onureg Receive EC’s CHMP Positive Opinion for MPM and AML Published: Apr 23, 2021 | Tags: BMS, Opdivo, Yervoy, Onureg, Receive, EC, CHMP, Positive Opinion, MPM, AML Gilead Reports NDA Submission of Filgotinib to PMDA for Ulcerative Colitis in Japan Published: Apr 23, 2021 | Tags: Gilead, Reports, NDA, Submission, …

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Astellas, Seagen seek speedy reviews of Padcev in bladder cancer

The next milestone in Seagen and Astellas’ bid to build their antibody-drug conjugate (ADC) Padcev into a blockbuster will come in August, when the FDA concludes an accelerated review of two bladder cancer filings.  One of the filings is to convert the ADC’s current conditional approval as a later-line therapy for urothelial cancer in patients …

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Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots: The first sBLA is based on the P-III EV-301 trial assessing Padcev vs CT in ~ 600 patients with LA or mUC prior treated with PD-1/L1 inhibitor and platinum-based therapy. The first sBLA seeks to convert PADCEV’s accelerated approval to regular approval The second sBLA is based on cohort 2 of the P-II EV-201 …

Astellas and Seagen Report the US FDA’s Acceptance of Two sBLA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Read More »

Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer

Shots: The MAA is based on the P-III EV-301 trial which involves assessing Enfortumab Vedotin vs CT in ~ 600 patients with LA/m-UC, prior treated with Pt.-based CT and a PD-1/L1 inhibitor The 1EPs of the trial is OS and 2EPs include PFS, ORR, DoR, DCR as well as the assessment of safety/tolerability and QoL …

Astellas and Seagen Report EMA’s Acceptance of MAA for Enfortumab Vedotin to Treat Locally Advanced or Metastatic Urothelial Cancer Read More »

PharmaShots Weekly Snapshots (Feb 15- 19, 2021)

RedHill Signs a Manufacturing Agreement with Cosmo for Movantik and RHB-204  Published: Feb 19, 2021 | Tags: RedHill, Signs, Manufacturing, Agreement, Cosmo, Movantik, RHB-204 Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer Published: Feb 19, 2021 | Tags: Astellas, Seagen, Reports, Submission, …

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Astellas/Seagen prepare full US filing of bladder cancer drug Padcev

Astellas and Seagen have the data they need for a full licence for their bladder cancer drug Padcev in the US, based on trial results announced over the weekend. To recap, Padcev (enfortumab vedotin) was quickly okayed by the FDA in December 2019 in advanced urothelial cancer on the basis of phase 2 response data …

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Seagen and Genmab file ‘trojan horse’ drug with FDA for cervical cancer

Seagen and Genmab have announced they have filed their antibody-drug conjugate tisotumab vedotin with the FDA for patients with recurrent or metastatic cervical cancer. The companies are asking for an accelerated approval based on phase 2 data, which will have to be confirmed by data from a larger trial that will provide survival data. The …

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Top 20 Life Sciences Deals of 2020 by Total Deal Value

Life sciences companies are gearing up to enter new markets as they look to secure their positions after a spate of M&A, licensing, and research partnerships in 2020 Artios partnered with Merck with an option to license up to 8 oncology programs proving to be the highest valued deal of 2020 with a total deal …

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MacroGenics’ HER2 breast cancer drug Margenza approved in US

MacroGenics’ HER2-targeted breast cancer drug Margenza has been approved by the FDA, challenging several recently approved drugs with a narrow efficacy edge over Roche’s Herceptin in data gathered so far in advanced disease. Margenza (margetuximab) won FDA approval in combination with chemotherapy to treat metastatic HER2-positive breast cancer after at least two previous rounds of …

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