Newsletter Tool

PM Tracker

Today’s Big News

Sep 6, 2024

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

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

BIOSECURE Act heads for possible vote in House of Representatives next week

Despite trial scare, Travere’s Filspari gains full FDA nod in kidney disease showdown with Novartis

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

Featured

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

By James Waldron,Eric Sagonowsky

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.

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

By Conor Hale

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.

BIOSECURE Act heads for possible vote in House of Representatives next week

By Fraiser Kansteiner

Next week, the U.S. House of Representatives is slated to consider the BIOSECURE Act, which was introduced in January and seeks to halt federal contracts with certain Chinese biotech equipment and service providers over national security concerns.

Despite trial scare, Travere's Filspari gains full FDA nod in kidney disease showdown with Novartis

By Angus Liu

A year after missing on a trial endpoint, Travere Therapeutics can breathe a sigh a relief. The FDA has converted Filspari’s conditional nod in the kidney disease IgAN into a full approval but left a liver toxicity monitoring requirement in place.

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

By Fraiser Kansteiner

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.

Madrigal maps out 'Way Forward' for MASH patients in first Rezdiffra campaign

By Andrea Park

Madrigal Pharmaceuticals broke new ground earlier this year as its Rezdiffra became the first drug approved by the FDA to treat metabolic dysfunction-associated steatohepatitis. Now, with its first marketing campaign for the drug, the company is hoping to direct patients toward that newly paved pathway.

Connect reduces China workforce, mulls strategy for potential Dupixent rival

By James Waldron

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.

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

By Kevin Dunleavy

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.

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

By James Waldron

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.

FDA elevates Medtronic laryngoscope recall over battery explosion risk

By Conor Hale

The medtech giant previously notified its customers of the issue in July, related to its McGrath MAC and MAC EMS video laryngoscopes.

Fierce podcasts

Don’t miss an episode

A look at flu vaccine manufacturing and supply

In this week's episode of "The Top Line," we’re looking at what goes into manufacturing and supply of flu vaccines.

Driving flu vaccine uptake in the post-pandemic era

Minimizing plastics use and risk in healthcare

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.

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.