Iterum's approval bid confronts resistance concerns

Today’s Big News

Sep 6, 2024

Lykos CEO steps down, the latest move in a string of chaotic changes


Zenas, Bicara set out to raise $180M+ in separate IPOs to fund autoimmune, cancer prospects


FDA concerned Iterum’s urinary tract infection drug could cause antimicrobial resistance 


Connect reduces China workforce, mulls strategy for potential Dupixent rival


Astellas unveils Massachusetts lab that will be shared with biotechs, academia researchers


Psyence pays $500k to acquire fellow psilocybin biotech Clairvoyant and phase 2 AUD asset


Chutes & Ladders—BMS vet answers Foghorn's call for CBO


Crestone's antibiotic cures C. diff infections and prevents recurrence better than vancomycin in phase 2

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Featured

Lykos CEO steps down, the latest move in a string of chaotic changes

Lykos CEO and founder Amy Emerson is stepping down, with Chief Operating Officer Michael Mullette taking over the top spot on an interim basis.
 

Top Stories

Zenas, Bicara set out to raise $180M+ in separate IPOs to fund autoimmune, cancer prospects

Zenas Biopharma has set out ambitions for a $200 million IPO to fund further studies of its Bristol Myers Squibb-partnered bifunctional antibody in an array of autoimmune indications. Meanwhile, cancer-focused biotech Bicara is seeking to land a similar haul to fund its own bifunctional antibody.

FDA concerned Iterum’s urinary tract infection drug could cause antimicrobial resistance

Iterum’s sulopenem, which was initially rejected by the US regulator in 2021 as a treatment for uncomplicated urinary tract infections, is back for another swing, with a target decision date set for October 25. On Monday, an FDA advisory committee will put sulopenem under its microscope, fleshing out concerns that “inappropriate use” of the treatment could cause antimicrobial resistance, according to an FDA briefing document.

Fierce Biotech Editor-in-Chief Ayla Ellison Talks Shop with Michelle Benz on the Future of Biotech.

Join Fierce Biotech Editors at Fierce Biotech Summit on Sept. 30-Oct.1 in Boston to learn, connect, and innovate with your industry peers.

Connect reduces China workforce, mulls strategy for potential Dupixent rival

In a year that has already seen Connect Biopharma walk away from a Pfizer collaboration and halt its preclinical work, the biotech is now in the process of “significantly reducing” its presence in China.

Astellas unveils Massachusetts lab that will be shared with biotechs, academia researchers

Astellas Pharma has cut the ribbon on a new life sciences center in Massachusetts that will house 400 team members and an incubator lab.

Psyence pays $500k to acquire fellow psilocybin biotech Clairvoyant and phase 2 AUD asset

Psyence Biomedical is paying $500,000 in shares to acquire fellow psilocybin-based biotech Clairvoyant Therapeutics and its phase 2-stage alcohol use disorder (AUD) candidate.

Chutes & Ladders—BMS vet answers Foghorn's call for CBO

Anna Rivkin, Ph.D., was named Foghorn Therapeutics’ first chief business officer as the company continues to build out its leadership team.

Crestone's antibiotic cures C. diff infections and prevents recurrence better than vancomycin in phase 2

The bacterium Clostridioides difficile is one of the most common infections picked up in hospitals, and, even once it’s cleared from the body, patients have a 1 in 6 chance of catching it again within a couple of months. It also often resists antibiotic treatment, leaving it free to infect the colon and cause diarrhea, nausea, fever and, in severe cases, sepsis and death.

J&J ordered to pay $1B over fallout from Auris robotic surgery deal

A judge said the company didn't live up to the promises made in its 2019 acquisition, over milestone payments linked to the development of Auris' surgical robot.

Fierce Pharma Asia—Astellas' plant closure, lab debut; China's probe into AstraZeneca staffers

Astellas is closing a gene therapy manufacturing facility in South San Francisco. But across the country, the company opened a new R&D center in Massachusetts. Chinese authorities detained several current or former AstraZeneca employees. And more.

GSK posts COPD win for Nucala as Sanofi-Regeneron rival Dupixent nears delayed FDA decision

On Friday, GSK said that its IL-5 antibody Nucala plus inhaled maintenance therapy lowered the annualized rate of moderate or severe exacerbations among chronic obstructive pulmonary disease (COPD) patients for up to 2 years. Nucala is already approved in a range of respiratory conditions, but a COPD nod could present another big opportunity for the drug.
 
Fierce podcasts

Don’t miss an episode

Minimizing plastics use and risk in healthcare 

In this week's episode of "Podnosis," two experts break down the history of plastics use in the healthcare sector and what it would take for an organization to phase them out.
 

Resources

Whitepaper

Building a “Best Practice” Commercial Organization in Biopharma

We interviewed dozens of biopharma leaders on the critical success factors for building a Best Practice commercial organization. This report shares what we learned.
Whitepaper

Epilepsy Clinical Trials

Finding an effective epilepsy treatment can be arduous. Download this brochure to delve into how IQVIA's expertise and innovative strategic approach can streamline the clinical trial process, helping to get new therapies to patients who need them sooner.
 

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On Helix

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

 

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