FDA panel mixed on Medtronic, ReCor renal denervation tech

Today’s Big News

Aug 24, 2023

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


Cabometyx study ends early after researchers see 'dramatic' benefits in pancreatic cancers, Exelixis says


Evaluating renal denervation rivals, FDA advisory panel backs ReCor, shuns Medtronic


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


Dräger hit with another Class I recall over possible contaminants in pediatric ventilators


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

 

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

Cabometyx study ends early after researchers see 'dramatic' benefits in pancreatic cancers, Exelixis says

Exelixis' drug proved its worth in treating advanced pancreatic and extra-pancreatic neuroendocrine tumors, so much so that an independent board unanimously recommended an early stop.

Evaluating renal denervation rivals, FDA advisory panel backs ReCor, shuns Medtronic

Both companies hope their approaches will enter a multibillion-dollar market, as each looks to offer a drug-free procedure that makes a dent in stubbornly high blood pressure.

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.

Dräger hit with another Class I recall over possible contaminants in pediatric ventilators

For the fourth time this year, German devicemaker Dräger’s portfolio of respiratory devices is the target of a recall deemed Class I by the FDA.

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.

After high-profile snub, Akebia plots vadadustat resubmission at FDA

After the “extreme disappointment” of vadadustat’s anemia snub in March 2022—plus a partnership gone awry and a formal dispute with the FDA—Akebia Therapeutics has dusted itself off and readied for a second bid at approval.

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. 

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%.

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.
 
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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

 

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