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…

BySaurabh ChaubeySeptember 18, 2024

NEWS

Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin)

Shots: The CHMP has granted positive opinion to Tuznue, a biosimilar version of Herceptin (trastuzumab) for the treatment of HER2+ve early & metastatic breast cancer as well as HER2+ve metastatic gastric cancer The recommendation was supported by the data showing similarity b/w Tuznue vs Herceptin under P-I & P-III trials to evaluate the PK profile,…

ByDipanshu DixitJuly 31, 2024

NEWS

STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU

Shots: The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply…

ByDipanshu DixitJuly 22, 2024

INSIGHTS+

New Drug Designations – April 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 11 small molecules, 7 biologics, 7 cell & gene therapies, 1 antiviral, 1 peptide and 3 devices Lisata Therapeutics’ LSTA1 received ODD this month and was granted with…

BySenior EditorMay 30, 2024

INSIGHTS+

New Drug Designations – March 2024

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the FDA, MHRA and EC. This month’s report includes designations allotted to 10 small molecules, 6 biologics, 5 cell & gene therapy, 1 recombinant fusion protein, 2 actineoplastics, 1 antidepressant, 1 drug conjugate, 1 analgesic and 6 devices Trellis Bioscience's…

BySenior EditorApril 30, 2024

INSIGHTS+

New Drug Designations – September 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, and China. This month’s report includes 10 biological drugs, 15 small molecules, 5 cell and gene therapies, 4 devices, 1 vaccine and 1 microbiota MicuRx’ Contezolid and Contezolid acefosamil, focused on the treatment of Diabetic…

BySenior EditorOctober 16, 2023

INSIGHTS+

New Drug Designations – August 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, Japan, and China. This month’s report includes 8 biological drugs, 13 small molecules, 4 cell and gene therapies, 3 diagnostic tests and 5 devices Genprex’ Reqorsa, focused on the treatment of SCLC, is the drug to receive ODD…

BySenior EditorSeptember 18, 2023

INSIGHTS+

New Drug Designations – July 2023

Shots: PharmaShots' designation report provides a concise overview of several drugs and their designations by the US FDA, the EU, China, and Korea. This month’s report includes 7 biological drugs, 10 small molecules, 8 cell and gene therapies, 1 radiopharmaceutical, 2 microbiota and 1 diagnostic test MyoPax’ Satori-01, focused on repairing the Exstrophy-Epispadias Complex sphincter…

BySenior EditorAugust 21, 2023

THOUGHTSPOT

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

Shots: With the healthcare sector moving ahead with its technological advances, there is still an unexplored section in therapeutics that requires much more attention. Through innovations, life science companies have evolved to make breakthrough discoveries in many focus areas, but when it comes to the rare disease segment, all our endeavors seem to be bleak…

BySaurabh ChaubeyMarch 14, 2023

INSIGHTS+

Disease of the Month: Age-Related Macular Degeneration

Introduction: AMD, an eye disease that can cause of loss of eyesight/blur vision mostly in people ≥50 years of age and it is the leading cause of visual impairment worldwide. It occurs when the part of the retina (macula) is damaged. Patients lose their central vision and cannot see fine details The three stages of…

BySenior EditorFebruary 9, 2023

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

Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin)

STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU

New Drug Designations – April 2024

New Drug Designations – March 2024

New Drug Designations – September 2023

New Drug Designations – August 2023

New Drug Designations – July 2023

Getting on with Rare Disease Therapeutic Options (Orphan Disease Therapies)

Disease of the Month: Age-Related Macular Degeneration

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