Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC)

Shots: The US FDA’s accelerated approval of Ziihera (50mg/mL, IV) was based on P-IIb (HERIZON-BTC-01) study in patients (n=87) with HER2+, locally advanced unresectable or metastatic BTC across 2 arms, based on tumor IHC status Efficacy in 62 HER2+ BTC patients (arm 1 of HERIZON-BTC-01) showed a 52% ORR & 14.9mos. mDoR. Continued approval depends…

ByDipanshu DixitNovember 20, 2024

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

TOP 20

Top 20 Life Sciences Deals of 2022 by Total Deal Value

Shots: The technological advancement, shared cost, and the pursuit of combined extensive research are amongst the few pragmatic and mutual benefits that come with collaborations. Moreover, the risks involved in drug development plans get minimalized by opening the doors to new opportunities and commercialization When it comes to life science collaborations, companies seek beyond the…

ByPrince GiriFebruary 8, 2023

VIEWPOINTS

Michael G. Chez and Greg Grunberg Share Insights from “The Care Giver” Series Based on Epilepsy

Shots: Dr.Chez talked about the challenges faced in epilepsy diagnosis and its various treatment options Greg spoke about the new online series sponsored by Jazz Pharmaceuticals and how it benefits people with Epilepsy The interview summarizes the vital role of caregivers in the lives of those living with epilepsy Smriti: Can we talk about Epilepsy in…

BySenior EditorAugust 22, 2022

INSIGHTS+

Insights+: The US FDA New Drug Approvals in July 2020

The US FDA has approved multiple NDAs and BLAs in July 2020, leading to treatments for patients and advances in the health care industry. The Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 59 novel products so far in 2020, including 8 in July 2020. Additionally,…

BySenior EditorAugust 27, 2020

INSIGHTS+

Insights+: Key Deals of J.P. Morgan Healthcare Conference 2020

The 2020 JP Morgan Healthcare Conference was loaded with insights from key pharma companies. An analysis of events and catalysts that were announced or updated at the conference these days are included. Our PharmaShots team summarized the key deals which were presented during the updates from companies from Jan 13 to Jan 16, 2020. Date…

BySenior EditorFebruary 7, 2020

Jazz Pharmaceuticals’ Ziihera (Zanidatamab-hrii) Secures the US FDA’s Accelerated Approval to Treat HER2-Positive (IHC 3+) Biliary Tract Cancer (BTC)

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

Top 20 Life Sciences Deals of 2022 by Total Deal Value

Michael G. Chez and Greg Grunberg Share Insights from “The Care Giver” Series Based on Epilepsy

Insights+: The US FDA New Drug Approvals in July 2020

Insights+: Key Deals of J.P. Morgan Healthcare Conference 2020

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