Pfizer eyes immunogenicity study for group B strep vax

Today’s Big News

Aug 24, 2023

Roche's KRAS data suggest potential edge over Amgen and Mirati, but the jury remains out


Wilbur Ross' SPAC backtracks on merger with Alzheimer's-focused biotech


Pfizer steers group B strep vax towards late-stage immunogenicity study over complex efficacy trial


Alloksys fails to stop kidney injury in heart surgery patients, but subgroup spurs phase 3 plans

The Top Line Podcast: don’t miss out on the newest episode where we discuss ASCO data, rising health tech stars, and more. Listen now.

 

Featured

Roche's KRAS data suggest potential edge over Amgen and Mirati, but the jury remains out

Roche has provided fresh evidence that its KRAS inhibitor divarasib is a threat to Amgen and Mirati. The results of an early-phase monotherapy clinical trial suggest divarasib may improve on the response rate and durability of its more advanced rivals, but the jury remains out for now.
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Top Stories

Wilbur Ross' SPAC backtracks on merger with Alzheimer's-focused biotech

Don’t count on the triumphant return of biotech SPAC deals quite yet. Despite Wilbur Ross’ own blank check company making one of the first SPAC announcements for the sector this year, it turns out that deal has now died.

Pfizer steers group B strep vax towards late-stage immunogenicity study over complex efficacy trial

Given the challenges of running an efficacy study for a group B streptococcus (GBS) vaccine, Pfizer's top vaccine executive hopes that regulators will allow an immunogenicity study for approval instead, just as they have for the New York pharma's meningitis B and pneumococcal vaccines. 

Alloksys fails to stop kidney injury in heart surgery patients, but subgroup spurs phase 3 plans

Alloksys Life Sciences’ enzyme-based drug candidate has failed to reduce the rate of acute kidney injury in patients undergoing cardiac surgery. But, while the phase 2b missed its primary endpoint, the Dutch biotech seized on an efficacy signal in a subgroup to make the case for moving into phase 3 immediately.

'Far too speculative': Amgen fights FTC's request for injunction against $28B Horizon merger

The Federal Trade Commission is trying to block Amgen’s proposed $28 billion acquisition of Horizon Therapeutics. Amgen has a lot to say as the case plays out in court.

FDA OKs Fresenius dialysis software to guide patients, caregivers through at-home sessions

The GuideMe software is meant to speed up the patient training process and make it easier while also giving users more confidence as they transition from in-clinic to at-home dialysis sessions.

Ferring inks $500M deal with Royalty Pharma on new bladder cancer gene therapy

Royalty Pharma has signed a deal with Ferring Pharmaceuticals to collect royalties on bladder cancer drug Adstiladrin. Royalty will pay $300 million up front and $200 million in a potential milestone tied to Ferring meeting certain manufacturing goals. New York City-based Royalty will receive 5.1% of net sales of Adstiladrin in the U.S. Upon payment of the milestone, the royalty will jump to 8%.

Fewer, but larger, healthcare data breaches reported in 2023 with hackers often targeting 3rd parties

An analysis of 308 reported data breaches suggests cyberattackers have shifted their focus from email phishing to network servers as well as to vulnerabilities in the healthcare supply chain.

Cellares unveils $255M investment round with Bristol Myers among those in the fold

Cell therapy manufacturing innovator Cellares has revealed a $255 million series C investment round to complete construction of its facility in Bridgewater, New Jersey. One of the investors is major cell therapy player Bristol Myers Squibb.
 
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'The Top Line': Cannes Lions, top paid CEOs, and a drug shortage

This week on "The Top Line," we discuss the trends seen at Cannes Lions, the top compensated CEOs in the industry, and the cancer drug shortage

 

Resources

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Key Drivers of Sales Force Strategy in Oncology

In oncology, traditional methods for determining sales force size & structure are no longer appropriate. This paper describes the multiple drivers of sales strategy in oncology markets today.
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Reduce chemical lead times with just-in-time delivery

Learn how the right chemical inventory strategy helped save a mid-size CDMO millions of dollars while securing a stable supply of products with just-in-time delivery.
 
 

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