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Johnson& Johnson
NEWS

Johnson & Johnson’s Sirturo Gains the CHMP’s Positive Opinion to Treat Multidrug-Resistant Tuberculosis 

Shots:  The CHMP has granted positive opinion to the company’s Sirturo (bedaquiline) and recommended approving its Type II variation plus transitioning its conditional marketing authorization into a standard marketing authorization  The opinion was based on the data from P-III (STREAM) stage 2 trial assessing the safety & efficacy of bedaquiline-containing regimen to treat MDR-TB, depicting…
April 29, 2024

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Johnson& Johnson
NEWS

Johnson & Johnson Gains the CHMP’s Positive Opinion for Rybrevant (Amivantamab) as a 1L Treatment of NSCLC  

Shots:  The company's Rybrevant + CT (carboplatin & pemetrexed) has gained the CHMP’s positive opinion as a 1L therapy for NSCLC associated with activating EGFR exon 20 insertion mutations   The opinion was based on the P-III (PAPILLON) trial assessing the safety & efficacy of Rybrevant + CT vs CT in NSCLC patients (n=308) with EGFR…
April 26, 2024

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J&J
NEWS

Johnson & Johnson’s Opsynvi (macitentan and tadalafil) Receives the US FDA’s Approval for the Treatment of Pulmonary Arterial Hypertension 

Shots:   The approval was based on the results from the P-III (A DUE) clinical trial evaluating the safety & efficacy of Opsynvi vs macitentan/tadalafil monotx. in patients with PAH (WHO FC II or III). The 1EP was a change from baseline in Pulmonary Vascular Resistance (PVR) at 16wks.  The study depicted a greater reduction…
March 22, 2024

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Insights+ Key Biosimilars Events of August 2023
INSIGHTS+

Insights+ Key Biosimilars Events of August 2023

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients During the month of August, Sandoz’ Tyruko (biosimilar, natalizumab) received the US FDA’s…
September 6, 2023

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Insights+ Key Biosimilars Events of June 2023
INSIGHTS+

Insights+ Key Biosimilars Events of June 2023

Shots: Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patients During the month of June, Samsung Bioepis presented results of SB12…
July 5, 2023

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Thoughtspot_senior_editor
THOUGHTSPOT

8 Major Reasons Behind the Soaring Layoffs in the Pharmaceutical Industry

Shots: In the wake of International Labour Day, PharmaShots presents a detailed take on the recent layoffs in the Pharmaceutical Sector with an illustrative graphical analysis Like any sector, the pharmaceutical industry operates on some nuance and intricate aspects that ensure smooth operations. Factors like digitalization, patent expiry, growing competition, and others put direct or…
May 1, 2023

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Insights+: An Analysis of the Growth of Biopharma Companies in the Last 20 Years (2003-2022)
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…
April 13, 2023

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