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Mar 28, 2024

Akebia's Vafseo finally gets its shot at the US chronic kidney disease market after FDA approval

Boundless Bio boldly goes public with $100M IPO

Exact Sciences posts positive data for its capsule-on-a-string test for esophageal cancer

Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

Ironwood spies new frontier for $1B GLP-2 analog in exploratory phase 2 rare disease trial

Johnson & Johnson gets a new opportunity to contest science in talc litigation

Featured

Akebia's Vafseo finally gets its shot at US chronic kidney disease market after FDA approval

By Zoey Becker

Akebia earned a second chance for its oral chronic kidney disease-related anemia med after appealing the FDA's 2022 complete response letter with a formal dispute.

Boundless Bio boldly goes public with $100M IPO

By James Waldron

Boundless Bio is bringing in $100 million from its IPO as the precision oncology company becomes the latest biotech to go public in 2024.

Exact Sciences posts positive data for its capsule-on-a-string test for esophageal cancer

By Conor Hale

The Oncoguard Esophagus test, developed with the Mayo Clinic, searches for DNA biomarkers tied to esophageal adenocarcinoma and Barrett’s esophagus.

Intelligence officials warned lawmakers WuXi AppTec furnished China with client's intellectual property: Reuters

By Fraiser Kansteiner

An alleged development in the national security crackdown against WuXi AppTec and a handful of other Chinese companies in the U.S. suggests intelligence officials and lawmakers may have good reason to be concerned about the CDMO’s potential political ties to its home country.

Ironwood spies new frontier for $1B GLP-2 analog in exploratory phase 2 rare disease trial

By Nick Paul Taylor

Ironwood Pharmaceuticals’ stargazing has identified a new frontier for apraglutide by generating early clinical evidence that the GLP-2 analog plays nicely with Incyte’s Jakafi in a rare disease. The company acquired the molecule last year through its $1 billion takeover of VectaBio.

Johnson & Johnson gets a new opportunity to contest science in talc litigation

By Kevin Dunleavy

Johnson & Johnson will get a do-over in its defense against more than 50,000 lawsuits claiming that the company’s iconic baby powder can cause ovarian cancer. A New Jersey court ruled on Wednesday that J&J can contest the scientific findings that back those cases.

High prices on GLP-1 meds, insulin pens raise barriers to access in lower-income countries: MSF

By Zoey Becker

Médecins Sans Frontières urged GLP-1 drug makers to "relinquish their stranglehold" on the products and license the meds to generics makers to boost access.

Gilead pays $43.5M for early-phase IL-12 prospect from Xilio as biotech reduces head count

By Nick Paul Taylor

Gilead is bucking the trend in IL-12, handing Xilio Therapeutics $43.5 million upfront to get into the space after seeing rivals such as AstraZeneca and Bristol Myers Squibb retreat from the cytokine. Xilio shared the news alongside details of plans to pull back from another program and lay off 21% of its staff.

Ypsomed hands off insulin pen needle business to focus on smart pump, autoinjector development

By Conor Hale

Ypsomed sold its operations to the global medtech manufacturer and distributor MTD Group, which maintains production facilities in Italy and Poland.

Amneal pulls 4 lots of antibiotic vancomycin due to potentially overfilled, extra-potent bottles

By Zoey Becker

Overfilled bottles can cause the product to be extra potent, which leaves patients at risk for renal function declines. The manufacturing error happened during the manual bottle filling stage, according to the FDA's recall notice.

Pfizer shifts creative business to Publicis in latest marketing move

By Andrea Park

Less than a year after divvying up its marketing work between two firms, Publicis Groupe and Interpublic Group, Pfizer is tweaking the distribution of duties among the pair.

Fierce podcasts

Don’t miss an episode

SXSW Insights: The future of AI in healthcare

This week on “Podnosis,” we explore the pressing questions surrounding AI’s role in healthcare. From clinician trust to algorithm accuracy and patient privacy, there’s significant uncertainty about AI’s potential and impact in the healthcare sector, a topic that garnered considerable attention at this year’s South by Southwest conference.

'The Top Line': A closer look at European biotech investment in 2024

'Podnosis': Why are some failing hospitals such appealing investments?

'The Top Line': Inclusivity in psoriasis trials with Takeda

Resources

Whitepaper

Pediatric Clinical Trials: Considerations for Enrollment and Retention

Explore the nuanced approaches necessary for successful pediatric drug development.

CNS Market Outlook, 2024

This paper assesses the current state of the broad CNS market, reviewing key expectations for 2024. It addresses Alzheimer’s disease, biomarkers, and advances in psychiatry in detail. It also provides a high-level look at the pain market and the evolving regulatory environment.

Presented by Blue Matter, strategic consultants in the life sciences