UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Shots: The recommendation was supported by the P-III studies (BE HEARD I and BE HEARD II) assessing the safety and efficacy of Bimzelx 1014 patients with PsA evaluating bimekizumab vs. PBO at week 16 Both trials met their 1EPs & 2EPs measured by HiSCR50 and HiSCR75 respectively at wk. 16. Clinical responses were sustained up…

ByDipanshu DixitMarch 22, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in January 2024

Shots: The EMA approved 2 BLA and 6 New Chemical Entities in January 2024, leading to treatments for patients and advances in the healthcare industry In January 2024, the major highlighted drugs were Padcev to treat Bladder Cancer and Eylea for the treatment of Age-related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) PharmaShots has…

BySenior EditorFebruary 21, 2024

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in December 2023

Shots: The EMA approved 3 BLA while 4 New Chemical Entities in December 2023, leading to treatments for patients and advances in the healthcare industry In December 2023, the major highlighted drugs were Jempreli to treat dMMR/MSI-H Primary Advanced or Recurrent Endometrial Cancer and Zilbrysq for the treatment of Generalized Myasthenia Gravis PharmaShots has compiled a list of a…

BySaurabh ChaubeyJanuary 23, 2024

NEWS

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Shots: The approval was supported by the P-III (MycarinG) study evaluating the safety, efficacy & tolerability of Rystiggo (7 or 10mg/kg) vs PBO in gMG patients. The 1EP of the study includes a change in MG-ADL score at Day43 & 2EPs include a change in MG-C score, QMG, patient-reported outcomes at Day43 and AEs The…

ByDipanshu DixitJanuary 8, 2024

INSIGHTS+

Insights+: The US FDA New Drug Approvals in October 2023

Shots: The US FDA approved 5 NDAs & 9 BLAs in October 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 98 novel products in 2023 In October 2023, the major highlights drugs were Velsipity (Etrasimod) approved for Ulcerative Colitis, and Bimzelx (bimekizumab) for the Treatment of Adults…

BySenior EditorNovember 15, 2023

THOUGHTSPOT

Social Media Listening in Pharmaceutical Industry

Shots: When it comes to embracing new-age technologies, the pharmaceutical industry always remains on the front foot. Galvanized by novel technological advances and innovations, the pharmaceutical industry is forging ahead at a momentous pace Social media listening fosters the use of leveraging several social media platforms to gather insights, resolve queries, carry out online market…

BySaurabh ChaubeyAugust 8, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in June 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 4 Biologic Drugs in June 2023, leading to treatments for patients and advances in the healthcare industry In June 2023, the major highlights drugs were Jardiance approval for CKD patients, Briumvi (ublituximab-xiiy) for relapsing forms of multiple sclerosis PharmaShots has compiled a list of a…

BySenior EditorJuly 28, 2023

INSIGHTS+

Insights+: The US FDA New Drug Approvals in June 2023

Shots: The US FDA approved 12 NDAs and 3 BLA in June 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 69 novel products in 2023 In June 2023, the major highlights drugs were Talzenna + Xtandi approval for prostate cancer, Rystiggo for generalized myasthenia gravis PharmaShots…

BySenior EditorJuly 19, 2023

INSIGHTS+

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Shots: The EMA approved 7 New Chemical Entity (NCE) and 5 Biologic Drugs in February 2023, leading to treatments for patients and advances in the healthcare industry In February 2023, the major highlights drugs were Forxiga’s Approval for symptomatic chronic heart failure, Fintepla for adjunctive treatment of seizures associated with lennox-gastaut syndrome PharmaShots has compiled…

BySenior EditorMarch 23, 2023

EXCLUSIVE

Iris Loew-Friedrich, CMO and Head of Development Solutions at UCB Shares her Thoughts on the Launch of New Innovators Campaign

Shots: Iris shared the specifics of the launch of the UCB’s Innovators campaign. The campaign spotlights the R&D employees’ perspectives on innovation and aims to highlight why innovation is a key driving force at UCB for bettering the lives of patients She gave her thoughts on how UCB is adopting innovative AI programs that use…

BySenior EditorMarch 6, 2023

UCB’s Bimzelx Receives CHMP’s Positive Opinion to Treat Moderate to Severe Hidradenitis Suppurativa

Insights+: EMA Marketing Authorization of New Drugs in January 2024

Insights+: EMA Marketing Authorization of New Drugs in December 2023

UCB Receives the EC’s Approval for Rystiggo (rozanolixizumab) for the Treatment of Adults with Generalized Myasthenia Gravis (gMG)

Insights+: The US FDA New Drug Approvals in October 2023

Insights+: EMA Marketing Authorization of New Drugs in June 2023

Insights+: The US FDA New Drug Approvals in June 2023

Insights+: EMA Marketing Authorization of New Drugs in February 2023

Iris Loew-Friedrich, CMO and Head of Development Solutions at UCB Shares her Thoughts on the Launch of New Innovators Campaign

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