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Viewpoints_Jacqueline Nielsen_Tahi Ahmadi
VIEWPOINTS

Unlocking Approval: Jacqueline Nielsen from AbbVie & Tahi Ahmadi from Genmab in a Riveting Conversation with PharmaShots

Shots: Recently, the EMA’s CHMP adopted a positive opinion by recommending conditional marketing authorization for AbbVie and Genmab’s Tepkinly for the treatment of R/R Follicular Lymphoma Today at PharmaShots, we have Jacqueline Nielsen, Head of Hematologic Oncology Affairs at AbbVie, and Tahi Ahmadi, EVP and CMO at Genmab, shedding light on this conditional marketing authorization…
September 18, 20240Comments

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Disease of the Month – Systemic Lupus Erythematosus
INSIGHTS+

Disease of the Month – Systemic Lupus Erythematosus

Shots: Systemic lupus erythematosus (SLE) is an autoimmune disorder where the body's immune system targets and damages healthy tissues In this reprise of our Disease of the Month report, we present an enlightening description of SLE with a thorough study of epidemiology, market size, disease management, potential medicines, patient advocacy groups, and the key players involved   For a…
September 18, 20240Comments

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News

Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta)

  Shots: The P-III study assessing safety & efficacy of HLX11 vs Perjeta (pertuzumab) in addition to trastuzumab & docetaxel (Q3W, 4 cycles) as a neoadjuvant regimen for treating patients, randomized 1:1, with HER2+/HR- locally advanced breast cancer has reached the 1EP The 1EP of the trial includes total pathological complete response (tpCR) rate as…
September 18, 20240Comments

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News

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

  Shots: The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025 The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from…
September 18, 20240Comments

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Accord Healthcare
News

Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

Shots: The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025 The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the…
September 18, 20240Comments

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Viewpoints_Ahsan Arozullah
VIEWPOINTS

Astellas at ASCO 2024: Ahsan Arozullah in an Illuminating Dialogue Exchange with PharmaShots

Shots: At ASCO 2024, Astellas Pharma presented 16 abstracts across several types of cancers with unmet medical needs Today at PharmaShots, we have Ahsan Arozullah Sr. VP, Head of Oncology Development, shedding light on the advancement Astellas’ oncology portfolio for urothelial carcinoma, gastric cancer, and prostate cancer Ahsan talks about the presented results from studies…
September 16, 20240Comments

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Roche
News

Roche Reports the US FDA’s Approval of Ocrevus Zunovo for Treating Relapse and Progressive Multiple Sclerosis 

Shots:    The US FDA has approved Ocrevus Zunovo (ocrelizumab & hyaluronidase-ocsq), a twice-a-year, 10-minute SC injection, to treat relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS) The approval was supported by the pivotal P-III (OCARINA) study assessing the PK, safety, clinical & radiological efficacy of the Ocrevus SC vs IV in patients (n=236)…
September 13, 20240Comments

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Eli Lilly
News

Eli Lilly’s Ebglyss (Lebrikizumab-lbkz) Receives the US FDA’s Approval for Treating Moderate-to-Severe Atopic Dermatitis 

Shots:    The US FDA has approved Ebglyss to treat moderate-to-severe AD in adults & children (≥12yrs.) weighing 88 pounds (40kg). Lilly holds its exclusive rights outside the EU, while Almirall has licensed rights in the EU The approval was supported by P-III (ADvocate 1 & 2) studies of Ebglyss alone and P-III (ADhere) study of…
September 13, 20240Comments

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