R3 Vascular nets $87M for dissolving PAD stent

Today’s Big News

May 17, 2024

Amgen's 'watershed' lung cancer drug nabs FDA nod in deadly, tough-to-treat form of the disease


Erasca lays off 18% while swapping out KRAS program for fresh anti-tumor options


R3 Vascular raises $87M to test its bioresorbable scaffold for blocked arteries below the knee


New AbbVie photo exhibit captures psoriasis patients—including 'Scandal' star Katie Lowes—feeling 'Clearly Me'


FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo


Bayer lifts lid on pivotal data ahead of filings to challenge Astellas for menopause market


Karius snares FDA breakthrough tag for genomic infectious disease blood test

 

Featured

Amgen's 'watershed' lung cancer drug nabs FDA nod in deadly, tough-to-treat form of the disease

Seven months after Amgen’s chief medical officer referred to trial results for the company's investigational lung cancer immunotherapy as a “watershed moment,” the FDA has signed off on Imdelltra (tarlatamab) to treat patients with extensive-stage small-cell lung cancer (ES-SCLC).
 

Top Stories

Erasca lays off 18% while swapping out KRAS program for fresh anti-tumor options

Erasca is spending a combined $22.5 million upfront to import fresh preclinical KRAS and molecular glue assets while clearing space in its own pipeline and laying off 18% of its employees in the process.

R3 Vascular raises $87M to test its bioresorbable scaffold for blocked arteries below the knee

On the heels of a groundbreaking FDA approval for a major medtech, a Silicon Valley startup is shaping up to be a possible competitor.

New AbbVie photo exhibit captures psoriasis patients—including 'Scandal' star Katie Lowes—feeling 'Clearly Me'

AbbVie’s newest psoriasis awareness-raising campaign is taking the skin condition out of the spotlight.

FDA snubs another China-made PD-1 with rejection of Elevar, Hengrui's liver cancer combo

China-made PD-1 inhibitors continue to struggle at the FDA. This week, the U.S. agency rejected Elevar Therapeutics and Jiangsu Hengrui Pharma's PD-1 combination in liver cancer.

Bayer lifts lid on pivotal data ahead of filings to challenge Astellas for menopause market

Bayer’s master plan for its OASIS program is coming together, with the German drugmaker posting phase 3 data that suggest it could challenge Astellas for a recently unlocked menopause market.

Karius snares FDA breakthrough tag for genomic infectious disease blood test

After picking up $100 million in venture capital cash earlier this month, Karius is adding another feather to its cap with a breakthrough designation from the FDA.

Baxter unveils plummy new branding for kidney care spinout Vantive

As it prepares to push its kidney care portfolio out of the nest, Baxter International isn’t branching out too widely with the new company’s branding materials.

After Covis' Makena pull, EU regulator flags safety and efficacy problems with similar preterm birth drugs

A committee of the European Medicines Agency on Friday called for the withdrawal of preterm birth drugs containing 17-hydroxyprogesterone caproate (17-OHPC), citing safety and efficacy concerns.

Chutes & Ladders—Atai appoints co-CEO and a Fierce goodbye

Atai Life Sciences, one of the leading shareholders in psilocybin drug developer Compass Pathways, is swapping CEOs.

First Wave BioPharma comes ashore with new name as it prepares for phase 3 trial

The company formerly known as First Wave BioPharma has found itself on dry land with a decidedly non-aquatic new moniker.

Very rare COVID vaccine-related blood clots share genes with condition linked to common cold

The rare, deadly blood clots triggered by an autoimmune response to the COVID-19 vaccines from Johnson & Johnson and AstraZeneca seem to be caused by a gene that’s also responsible for an unusual but almost identical reaction to the virus that causes the common cold. The findings could have implications for future vaccines.
 
Fierce podcasts

Don’t miss an episode

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.

 

Resources

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Comprehensive Cell Solutions: Focus on Cellular Therapy Collections

Precision collection of cell therapy source material doesn’t happen by chance. Our new whitepaper illuminates the science and strategies for successful apheresis.
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In Vitro Antibodies – Next-Gen Science Delivers Optimized Candidates

Learn how Specifica’s in vitro antibody discovery platform can deliver better antibodies than traditional immunization approaches.
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Branded Digital Companions in Biopharma

This paper defines “digital companions” in biopharma, explores their value from the patient & company perspectives, & outlines a process for successfully fielding a new digital companion.
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Vaccine Development Challenges in Facing Influenza and COVID-19

Explore the complex considerations of vaccine development for influenza and COVID-19, including the challenges posed by viral evolution and the importance of ongoing research in this paper by vaccine expert, Dr. Lisa Kierstead.
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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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Patient Engagement Series

Discover the secrets behind successful patient engagement
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Antibody Profiling: Decoding the Humoral Immune System

Antibody biomarkers are redefining precision medicine, from diagnosing diseases earlier to stratifying patients – download your FREE white paper today!
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Straight to Market in an Autoinjector

The use of prefilled syringes to administer biotherapeutics is beginning to gain traction because they offer a range of stability, efficacy, and patient safety benefits. Download this white paper to learn how Lonza has developed a novel workflow to ensure confidence regarding functionality in PFS and autoinjectors.
 

Industry Events

On Helix

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