Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

Shots: Gilead has entered into a strategic collaboration with LEO Pharma to develop the latter’s small molecule oral STAT6 programs targeting various inflammatory disorders As per the terms, Gilead secures worldwide rights to develop, manufacture & commercialize LEO’s preclinical STAT6 inhibitors & degrading proteins, with LEO having the option to co-commercialize them for dermatology…

BySenior EditorJanuary 13, 2025

NEWS

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

Shots: The CHMP has recommended Seladelpar + ursodeoxycholic acid (UDCA) to treat PBC in those with inadequate response or as monotx. in those intolerants to UDCA. The EC’s decision is expected in Q1’25 Opinion was based on a P-III (RESPONSE) study assessing seladelpar (10mg, QD, oral) vs PBO in PBC patients (n=193). It showed…

ByDipanshu DixitDecember 13, 2024

NEWS

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

Shots: Gilead’s Livdelzi (Seladelpar) as monotx. or in combination with ursodeoxycholic acid (UDCA) has received accelerated approval for adults unable to tolerate UDCA or with inadequate response to UDCA, respectively. Not recommended for individuals with decompensated cirrhosis The approval was based on a P-III (RESPONSE) study showing 62% vs 20% (Livdelzi vs PBO) composite biochemical…

ByDipanshu DixitAugust 14, 2024

INSIGHTS+

PharmaShots’ Key Highlights of First Quarter 2024

Shots: The first quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Gilead's acquisition of CymaBay Therapeutics for an aggregate of ~$4.3B This quarter also showcased multiple clinical trial results including Axsome Therapeutics P-III results for AXS-12 and BMS'…

BySenior EditorApril 1, 2024

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

THOUGHTSPOT

Social Media Listening in Pharmaceutical Industry

Shots: When it comes to embracing new-age technologies, the pharmaceutical industry always remains on the front foot. Galvanized by novel technological advances and innovations, the pharmaceutical industry is forging ahead at a momentous pace Social media listening fosters the use of leveraging several social media platforms to gather insights, resolve queries, carry out online market…

BySaurabh ChaubeyAugust 8, 2023

INSIGHTS+

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

Shots: The EMA approved 3 New Chemical Entity (NCE) and 7 Biologic Drugs in May 2023, leading to treatments for patients and advances in the healthcare industry In May 2023, the major highlights drugs were Breyanzi’s Approval for relapsed or refractory large B-cell lymphoma, Ultomiris (ravulizumab) for neuromyelitis optica spectrum disorder PharmaShots has compiled a…

BySenior EditorJune 26, 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+

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

Shots: The 41st Annual J.P. Morgan Healthcare Conference took place on 09 – 12 January 2023 in San Francisco, CA, USA. It is the largest and most informative healthcare investment symposium in the industry, bringing together a cohort of industry leaders, emerging fast-growing companies, innovative technology creators, and members of the investment community The major announcement…

BySenior EditorJanuary 19, 2023

INSIGHTS+

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

Shots: The US FDA approved 8 NDAs and 5 BLA in December 2022, leading to treatments for patients and advances in the healthcare industry. The CDER and CBER approved 86 novel products in 2022 In December 2022, the major highlights drugs were Krazati (adagrasib) approval for non-small cell lung cancer with a KRASG12C mutation, Sunlenca…

BySenior EditorJanuary 18, 2023

Gilead and LEO Pharma Join Forces to Develop STAT6 Program for Multiple Inflammatory Disorders

Gilead Receives CHMP’s Positive Opinion of Seladelpar to Treat Primary Biliary Cholangitis (PBC)

US FDA Grants Accelerated Approval to Gilead’s Livdelzi (Seladelpar) to Treat Primary Biliary Cholangitis (PBC)

PharmaShots’ Key Highlights of First Quarter 2024

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

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

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

Insights+: Key Takeaways of J.P. Morgan Healthcare Conference 2023 Based on Therapeutic Areas

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

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