FDA approves Eylea biosimilars

Today’s Big News

May 20, 2024

Sanofi and Regeneron update trial data, strengthening case for Dupixent in COPD


Third Rock, J&J neuroscience spinout Rapport is first biotech to outline summer IPO plans


Regulatory tracker: FDA approves Eylea biosimilars from Biocon Biologics, Biogen


Boston Scientific's modular, wireless heart rhythm implant approach clears clinical study

 

Featured

Sanofi and Regeneron update trial data, strengthening case for Dupixent in COPD

At the American Thoracic Society international conference, one of the major themes is the advance of new therapies for COPD. On Monday, Sanofi and Regeneron had their answer to Amgen and AstraZeneca's presentation from the day before.
 

Top Stories

Third Rock, J&J neuroscience spinout Rapport is first biotech to outline summer IPO plans

The new year burst of biotech IPOs may have sputtered out months ago, but Rapport Therapeutics is a reminder that companies are still willing to test the waters of the public markets.

Regulatory tracker: FDA approves Eylea biosimilars from Biocon Biologics, Biogen

In this tracker, Fierce Pharma is recording the regulatory progress of in-market products, including expansions into key geographies and new indications. Some of these updates may not meet the bar for standalone stories, but we think they are still worth mentioning.

Boston Scientific's modular, wireless heart rhythm implant approach clears clinical study

A six-month trial showed that Boston Scientific’s pairing of modular, wireless implants for managing discordant cardiac rhythms—and correcting dangerous ones—could be a successful approach, and the devicemaker has its heart set on an FDA approval for the system in 2025.

AstraZeneca places $1.5B bet on end-to-end ADC manufacturing in Singapore

Riding high on its Daiichi Sankyo-partnered antibody drug conjugate (ADC) Enhertu—and banking on an approval for its next ADC contender datopotamab durextecan this winter—AstraZeneca is placing a big bet on the cancer-fighting technology as it blueprints a massive manufacturing investment in Asia.

Gilead's new liver disease med continues to deliver the goods ahead of FDA verdict

Three months after spending $4.3 billion on CymaBay Therapeutics for its primary biliary cholangitis med, Gilead Sciences has presented a fresh slice of data as a reminder of seladelpar’s potential while an FDA decision is pending.

Pfizer unit wins $107.5M verdict in cancer-drug patent case against AstraZeneca

Pfizer's Wyeth subsidiary and licensee Puma Biotechnology sued AstraZeneca in 2021 for alleged patent infringement related to AZ's marketing of cancer blockbuster Tagrisso.

Taking on pharma giants, Endeavor links IPF drug to improved lung function in phase 2

Endeavor BioMedicines has linked its Hedgehog inhibitor to improved lung function in a phase 2a idiopathic pulmonary fibrosis (IPF) study, sending a sonic pulse through a sector currently dominated by drugs that only slow the decline of the disease..
 
Fierce podcasts

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Advancements in cell & gene therapy manufacturing (Part II)

This week’s episode of “The Top Line” is the second part of a three-part series exploring the latest advancements in cell and gene therapy manufacturing.

 

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Branded Digital Companions in Biopharma

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Designing Patient-Centered Endpoint in Rare Disease Trials

To make every rare disease trial count, we design patient-centric, relevant strategies for sponsors and caregivers to produce impactful results every time.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK