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

Shots: The EMA approved 5 New Chemical Entity (NCE) and 6 Biologic Drugs in August 2023, leading to treatments for patients and advances in the healthcare industry In August 2023, the major highlight drugs were Aquipta (atogepant) approved for the preventive treatment of migraine in adults & Opdivo (nivolumab) as an adjuvant treatment for completely…

BySenior EditorSeptember 28, 2023

INSIGHTS+

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

Shots: The EMA approved 9 New Chemical Entity (NCE) and 5 Biologic Drugs in July 2023, leading to treatments for patients and advances in the healthcare industry In July 2023, the major highlights drugs were Soliris approval for refractory generalised myasthenia gravis and Trodelvy for pre-treated HR+/HER2- metastatic breast cancer PharmaShots has compiled a list…

BySenior EditorAugust 24, 2023

VIEWPOINTS

Tahi Ahmadi and Asud Khaliq Share their Views on EPKINLY (epcoritamab) U.S. FDA Approval in DLBCL

Shots: Tahi and Asud initiated the conversation with an overview of EPKINLYTM (epcoritamab) and its approval by the U.S. FDA to treat R/R DLBCL They then spoke about the study design and results from the EPCORE NHL-1 P-I/II trial that served as the basis for the U.S. FDA approval of EPKINLY. EPKINLY is being co-developed and co-commercialized by Genmab and AbbVie. Both companies are evaluating…

BySenior EditorAugust 2, 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+

PharmaShots’ Key Highlights of Second Quarter 2023

Shots: The second quarter of 2023 highlights multiple clinical trial results, approvals, and numerous deals. There are major alliances in this quarter which include Merck acquired Prometheus for ~$10.8B and Astellas entered into a definitive agreement to acquire Iveric Bio for ~$5.9B The second quarter of the year also showcases multiple approvals of the therapies…

BySenior EditorJuly 3, 2023

INSIGHTS+

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

Shots: The US FDA approved 15 NDAs and 3 BLA in May 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 54 novel products in 2023 In May 2023, the major highlights drugs were, Ayvakit approval for Indolent Systemic Mastocytosis, Rinvoq for Active Crohn's Disease PharmaShots has…

BySenior EditorJune 21, 2023

THOUGHTSPOT

Intelligent Automation in Pharmaceutical Industry (AI & ML)

Shots: Driven by the influx of life-changing innovations and technological advances, the pharmaceutical industry is forging ahead at a momentous pace. With the impelling Pharma 4.0, automation has now been embedded in various aspects of current business practices Delving deeply into the importance of automation, primarily focusing on AI & ML, PharmaShots unveils its eight-step…

BySaurabh ChaubeyJune 6, 2023

INSIGHTS+

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

Shots: The EMA approved 8 New Chemical Entity (NCE) and 3 Biologic Drugs in April 2023, leading to treatments for patients and advances in the healthcare industry In April 2023, the major highlights drugs were Rinvoq’s Approval for active Crohn's Disease, Opzelura for non-segmental vitiligo with facial involvement in adults and adolescents PharmaShots has compiled…

BySenior EditorMay 25, 2023

INSIGHTS+

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

Shots: The US FDA approved 6 NDAs and 4 BLA in April 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 36 novel products in 2023 In April 2023, the major highlights drugs were, Trikafta approval for children with cystic fibrosis, Qalsody for the treatment of amyotrophic…

BySenior EditorMay 17, 2023

INSIGHTS+

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

Shots: With the indispensable transformations carried out over the years, the biopharma industry witnessed miraculous changes in operations, technology, and innovation. Such as inclination towards the Pharma 4.0 model, adoption of a multimodal building approach, and dependence on contract manufacturing While major companies like Johnson & Johnson, Roche, and Pfizer dominated the biopharma industry with…

BySenior EditorApril 13, 2023

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

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

Tahi Ahmadi and Asud Khaliq Share their Views on EPKINLY (epcoritamab) U.S. FDA Approval in DLBCL

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

PharmaShots’ Key Highlights of Second Quarter 2023

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

Intelligent Automation in Pharmaceutical Industry (AI & ML)

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

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

Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)

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