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

VIEWPOINTS

Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

Shots: Gina gave her views on the acceptance of the sBLA by the US FDA and the validation of the Type II Variation Marketing Authorization Application by the EMA for Opdivo as monotherapy for the treatment of patients with completely resected stage IIB or IIC melanoma She also spoke on the epidemiology of melanoma and…

BySenior EditorMay 16, 2023

INSIGHTS+

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

Shots: The EMA approved 4 New Chemical Entity (NCE) and 5 Biologic Drugs in March 2023, leading to treatments for patients and advances in the healthcare industry In March 2023, the major highlights drugs were Reblozyl’s Approval for anemia in adult patients with non-transfusion-dependent beta thalassemia, Pombiliti for late-onset pompe disease PharmaShots has compiled a…

BySenior EditorApril 27, 2023

VIEWPOINTS

Daniel Quirk, SVP, Head of US Medical Affairs at Bristol Meyers Squibb Shares his Views on the US FDA Approval of Sotyktu

Shots: Daniel started the discussion by speaking about the epidemiology of plaque and briefed about SOTYKTU approved for the treatment of moderate-to-severe Plaque Psoriasis He also elaborated on the results from the P-III registrational studies POETYK PSO-1 and POETYK PSO-2 The interview also talks about how BMS is advancing its product portfolio to deliver innovative…

BySenior EditorApril 17, 2023

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2023

Shots: The first quarter of 2023 highlights major acquisitions in the pharma and biotech industry along with multiple approvals. Meanwhile, Selecta and Sobi reported P-III trial (DISSOLVE I & II) results of SEL-212 for chronic refractory gout Starting with the latest acquisitions, Pfizer acquired Seagen for ~$43B. The first quarter of the year also showcases…

BySenior EditorApril 3, 2023

INSIGHTS+

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

Shots: The EMA approved 3 New Chemical Entity (NCE) and 5 Biologic Drugs in January 2023, leading to treatments for patients and advances in the healthcare industry In January 2023, the major highlights drugs were Xofluza’s Approval for influenza, Dupixent for eosinophilic esophagitis PharmaShots has compiled a list of a total of 8 new drugs…

BySenior EditorFebruary 23, 2023

INSIGHTS+

J.P. Morgan Special: Dealmaker 2022 – Top M&A Deal of Roche (Part 01)

Shots: Roche was the top dealmaker in 2022 with a completion of 31 deals with multiple pharma, biotech companies, and universities for a total deal value of $13.55B The highest deal was secured by Roche under its development and commercialization collaboration with Poseida for the R&D of multiple existing and novel cell therapies for the…

BySenior EditorJanuary 5, 2023

INSIGHTS+

PharmaShots’ Key Highlights of Fourth Quarter 2022

Shots: The fourth quarter of 2022 highlights approvals, multiple clinical trial results, and numerous deals. There are major alliances in this quarter which include Johnson & Johnson acquired Abiomed for ~$16.6B, Takeda entered into an agreement to acquire NDI-034858 from Nimbus Therapeutics for ~$6B In the fourth quarter of the year, BeiGene’s Brukinsa received EC’s…

BySenior EditorDecember 29, 2022

INSIGHTS+

Top Performing Drug of 2021 – Opdivo (December Edition)

Active Ingredient: Nivolumab Strength: 40 mg/4 mL, 100 mg/10 mL, & 240 mg/24 mL solution in a single-dose vial Dosage Form: Injection Mechanism of Action: Programmed cell death-1 receptor antagonists (PD-1) First Approval: US (22 Dec 2014), EU (19 Jun 2015)  Revenue Analysis of Opdivo BMS’ Opdivo gives tough competition to other drugs in the…

BySenior EditorDecember 22, 2022

INSIGHTS+

Disease of the Month: AIDS

“Putting Ourselves to the Test: Achieving Equity to End HIV” -Theme of the year 2022 Introduction: HIV/AIDS is one of the top 10 cause of mortality. It is a chronic, epidemic disease caused by human immunodeficiency virus (HIV), a virus that infect WBC’s CD4 T-cell of the immune system. HIV, a type of retrovirus that isn't…

BySenior EditorDecember 20, 2022

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

Gina Fusaro, VP, Development Program Lead at BMS Shares her Views on the Acceptance of sBLA by the US FDA and the EMA Validation on MAA for Opdivo

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

Daniel Quirk, SVP, Head of US Medical Affairs at Bristol Meyers Squibb Shares his Views on the US FDA Approval of Sotyktu

PharmaShots’ Key Highlights of First Quarter 2023

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

J.P. Morgan Special: Dealmaker 2022 – Top M&A Deal of Roche (Part 01)

PharmaShots’ Key Highlights of Fourth Quarter 2022

Top Performing Drug of 2021 – Opdivo (December Edition)

Disease of the Month: AIDS

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