Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Shots:The EC has granted conditional approval to Ziihera in 30 EEA states for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) BTC adults, who were previously treated with ≥1L of therapyApproval was based on P-IIb (HERIZON-BTC-01) trial assessing Ziihera in 87 pts, where Arm 1 (n=80: 18 had IHC 2+…

ByRidhi RastogiJuly 2, 2025

News

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Shots:The US FDA has accepted sNDA & granted priority review seeking full approval of Zepzelca (lurbinectedin) + atezolizumab (Tecentriq) as a 1L therapy for ES-SCLC patients whose disease remains stable after initial treatment with atezolizumab, carboplatin, and etoposide (PDUFA: Oct 07, 2025)The sNDA was based on P-III (IMforte) trial results, showing Zepzelca +…

ByDipanshu DixitJune 11, 2025

News

Jazz Pharmaceuticals’ Zanidatamab Secures the CHMP Positive Opinion to Treat HER2+ Biliary Tract Cancer (BTC)

Shots:The CHMP has recommended conditional marketing approval of zanidatamab for the treatment of inoperable locally advanced or metastatic HER2+ (IHC 3+) biliary tract cancer (BTC) adults, who were previously treated with ≥1L of therapy; EC’s potential approval will be valid in 30 EEA statesOpinion was based on P-IIb (HERIZON-BTC-01) trial to assess anti-tumor…

ByRidhi RastogiApril 28, 2025

News

Jazz Pharmaceuticals to Acquire Chimerix for ~$935M

Shots:Jazz Pharmaceuticals to acquire Chimerix for ~$935M at a price of $8.55 per share in cash. Upon completion in Q2’25, Jazz will acquire remaining shares via second-step merger Acquisition will strengthen Jazz’s rare oncology presence through development & launch of Chimerix’s lead asset, dordaviprone, while adding durable revenue potential with patent protection through…

ByRidhi RastogiMarch 6, 2025

INSIGHTS+

The US FDA New Drug Approvals in November 2024

Shots: PharmaShots has compiled a list of US FDA-approved drugs in the month of November 2024 The US FDA has approved a total of 5 new drugs including 4 new molecular entities and 1 biologic leading to the treatment of patients and advances in the healthcare industry The major highlighted drug was Jazz Pharmaceuticals’ Ziihera…

ByDipanshu DixitDecember 10, 2024

INSIGHTS+

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 versionsLike 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 commercializationWhen 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 optionsGreg spoke about the new online series sponsored by Jazz Pharmaceuticals and how it benefits people with EpilepsyThe interview summarizes the vital role of caregivers in the lives of those living with epilepsySmriti: 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

Jazz Pharmaceuticals’ Ziihera (Zanidatamab) Secures the EC’s Conditional Approval to Treat HER2+ Biliary Tract Cancer (BTC)

Jazz Pharmaceuticals Reports the US FDA’s sNDA Acceptance and Priority Review of Zepzelca + Atezolizumab for ES-SCLC

Jazz Pharmaceuticals’ Zanidatamab Secures the CHMP Positive Opinion to Treat HER2+ Biliary Tract Cancer (BTC)

Jazz Pharmaceuticals to Acquire Chimerix for ~$935M

The US FDA New Drug Approvals in November 2024

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

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