Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Shots: Sanofi and J&J have discontinued the P-III (E.mbrace) study of ExPEC9V after IDMC interim analysis due to insufficient efficacy against extraintestinal pathogenic E. coli , leading to a $250M impairment charge before tax The P-III trial assessed single dose of ExPEC9V (IM) vs PBO in adults (≥60yrs.) with UTI history in past 2yrs. to prevent invasive…

ByRidhi RastogiFebruary 14, 2025

VIEWPOINTS

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

Shots: Johnson & Johnson’s (J&J) Tremfya recently received its third approval from the US FDA, supported by the pivotal QUASAR study, which demonstrated significant remission after one year of treatment in adults with moderately to severely active ulcerative colitis Tremfya is a dual-binding monoclonal antibody targeting interleukin 23 (IL-23), a cytokine responsible for inflammation At…

BySaurabh ChaubeyFebruary 3, 2025

NEWS

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Shots: The US FDA has approved sNDA for Spravato CIII nasal spray to treat MDD patients unresponsive to at least two oral antidepressants, following the FDA Priority Review Approval was based on a multicenter trial that assessed Spravato vs PBO, showing an improved MADRS total score. In a post-hoc analysis, Spravato improved all 10…

ByRidhi RastogiJanuary 22, 2025

NEWS

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Shots: FDA received NDA of TAR-200 (J&J) for the treatment of Bacillus Calmette-Guérin (BCG) -unresponsive HR-NMIBC with CIS &/or papillary tumors the application will be reviewed under RTOR pathway, following receipt of BTD in Dec 2023 The NDA was supported by the P-IIb (SunRISe-1) trial, assessing TAR-200 in patients ineligible or opting out of…

ByRidhi RastogiJanuary 17, 2025

TOP 20

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

Shots: Drug patent expiry is when a patent granted to a pharmaceutical company for a particular drug expires, allowing other companies to produce and sell generic versions Like every other utility patent, pharmaceuticals also get market exclusivity of 20 years. Some companies accept the offered period and open doors to biological drugs or biosimilars. In…

ByPrince GiriMarch 29, 2023

INSIGHTS+

Top Performing Drug of 2021 – Imbruvica (January Edition)

Active Ingredient: Ibrutinib Dosage Forms & Strengths: Capsules: 70 mg and 140 mg Tablets: 140 mg, 280 mg, 420 mg, and 560 mg Mechanism of Action: Bruton's tyrosine kinase Inhibitor (BTKi) First Approval: US (13 Nov 2013), EU (Oct 2014)  Revenue Analysis Imbruvica is an oral therapy that inhibits a protein called Bruton's tyrosine kinase. Imbruvica was one…

BySenior EditorJanuary 25, 2023

TOP 20

Top 20 Medical Device Companies Based on 2021 Revenue

Despite the severe impact of the Covid-19 pandemic in 2020, the medical device market continued to emerge with patients' more significant needs and emerging diseases In 2021, the medical device markets continued to supply personal protective equipment for the pandemic and new technological developments. Medtronic remains at the top of the ledger with total revenue…

ByPrince GiriMay 12, 2022

TOP 20

Top 20 Oncology Companies Based on 2020 Oncology Segment Revenue

Oncology is a rapidly evolving therapy area and all of the top Biopharma players are investing in the research and development of cancer therapies. In 2020- the world witnessed a major acquisition of Immunomedic by Gilead of $21B for Trodelvy Our team at PharmaShots has compiled a list of top 20 oncology companies based on…

ByPrince GiriSeptember 9, 2021

TOP 20

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

Immunology deals with the physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new advancement in the immune sector- global pharmaceuticals continue to grow in the field despite the disruption during COVID-19. As in 2019- Abbvie again secured…

ByPrince GiriAugust 12, 2021

TOP 20

Top 20 Medical Device Companies Based on 2020 Revenue

The medical devices industry is a fast-growing market driven by the complex needs of patients encouraging life science companies to develop innovative therapies to improve health and QoL In 2020- the companies have shown growth resulting from a rise in the number of healthcare facilities- healthcare expenditure- and technological advancements. Medtronic remains at the top…

ByPrince GiriMay 20, 2021

Sanofi and J&J Discontinue P-III (E.mbrace) Study of ExPEC9V for Invasive E. coli Diseases

Unlocking Approval: Chris Gasink from Johnson & Johnson in an Enlightening Conversation with PharmaShots

The US FDA Approves sNDA for J&J’s Spravato (esketamine) to Treat Major Depressive Disorder (MDD)

Johnson & Johnson Submits NDA to the US FDA for TAR-200 to Treat BCG-unresponsive high-risk non-muscle-invasive bladder cancer (HR-NMIBC)

Top 20 Drugs with US Patent Expiry in 2023 Based on Total Sales Value

Top Performing Drug of 2021 – Imbruvica (January Edition)

Top 20 Medical Device Companies Based on 2021 Revenue

Top 20 Oncology Companies Based on 2020 Oncology Segment Revenue

Top 20 Immunology Companies Based on 2020 Immunology Segment Revenue

Top 20 Medical Device Companies Based on 2020 Revenue

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