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

Shots: The US FDA approved 5 NDAs and 2 BLA in July 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 76 novel products in 2023 In July 2023, the major highlights drugs were Beyfortus (nirsevimab) approval for the prevention of RSV lower respiratory tract disease in…

BySenior EditorAugust 16, 2023

INSIGHTS+

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

Shots: The US FDA approved 5 NDAs and 5 BLA in February 2023, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 19 novel products in 2023 In February 2023, the major highlights drugs were, Tezspire (tezepelumab) approval for severe asthma, Altuviiio for hemophilia A PharmaShots has compiled…

BySenior EditorMarch 15, 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+

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+

Insights+: The US FDA New Drug Approvals in October 2022

The US FDA approved 1 NDAs and 2 BLA in October 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 66 novel products in 2022 In October 2022, the major highlights drugs were Tecvayli’s approval for relapsed or refractory multiple myeloma, Furoscix for congestion in chronic heart…

BySenior EditorNovember 17, 2022

INSIGHTS+

Top Performing Drug of 2021 – Biktarvy (October Edition)

Active Ingredient: bictegravir, emtricitabine, and tenofovir alafenamide Strength: 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF/ 30 mg of BIC, 120 mg of FTC, and 15 mg of TAF Dosage Form: Tablet Mechanism of Action: HIV reverse transcriptase inhibitors First Approval: US (07 Feb 2018), EU (25 Jun 2018) Revenue1 Gilead's HIV drug, Biktarvy has…

BySenior EditorOctober 27, 2022

INSIGHTS+

Top Performing Drug of 2021 – Eylea (September Edition)

Active Ingredient: Aflibercept Strength: 2 mg (0.05 mL) Dosage Form: Injection (intravitreal) Mechanism of Action: VEGF-A and PlGF inhibitors First Approval: US (18 Nov 2011), EU (27 Nov 2012) Revenue1 EYLEA net sales represent a significant portion of the total revenues for both Regeneron and Bayer. Both companies jointly commercialize the product Regeneron records net product sales of EYLEA in…

BySenior EditorSeptember 22, 2022

INSIGHTS+

Top Performing Drug of 2021 – Stelara (August Edition)

Active Ingredients: Ustekinumab Strength: 45 mg/0.5 mL or 90 mg/mL (SC), 130 mg/26 mL (IV) Dosage Form: Injection Mechanism of Action: Interleukin 12 & 23 inhibitor First Approval: US (25 Sep, 2009), EU (16 Jan, 2009) Revenue1 Stelara is the leading blockbuster drug of Johnson & Johnson. Stelara contributed 9.7% of the Company's total revenues for 2021. Stelara up took…

BySenior EditorAugust 25, 2022

INSIGHTS+

Top Performing Drug of 2021 – Eliquis (July Edition)

Active Ingredients: Apixaban Strength: 2.5 mg and 5 mg Dosage Form: Tablet Mechanism of Action: Factor Xa inhibitors First Approval: US (Dec 28, 2012), EU (May 18, 2011) Revenue1 Eliquis is a leading novel oral anticoagulant of BMS. The revenue for BMS continued to grow due to Eliquis and other recently launched new products. BMS and Pfizer jointly develop and…

BySenior EditorJuly 28, 2022

VIEWPOINTS

PharmaShots Interview: In Conversation with ViiV Healthcare’s Sr. VP, Kimberly Smith, Where she Shares Insights on the US FDA Approval for Label Update of its Lead Candidate in HIV

Shots: Kimberly talked about the approval for label update of ViiV’s lead candidate in HIV, and how an optional oral lead-in will be efficient for people receiving it Kimberly also spoke about ViiV’s collaboration with Janssen for the commercialization of the product The interview gives an understanding of the different treatment options for HIV and…

BySenior EditorJune 29, 2022

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

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

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

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

Insights+: The US FDA New Drug Approvals in October 2022

Top Performing Drug of 2021 – Biktarvy (October Edition)

Top Performing Drug of 2021 – Stelara (August Edition)

Top Performing Drug of 2021 – Eliquis (July Edition)

PharmaShots Interview: In Conversation with ViiV Healthcare’s Sr. VP, Kimberly Smith, Where she Shares Insights on the US FDA Approval for Label Update of its Lead Candidate in HIV

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