Unauthorized COVID tests attract FDA recall
To view this email as a web page, click here

Today's Rundown

Featured Story

Pfizer ends $3B drug dream despite phase 2b success, leaving Regeneron with a clear run at cardiovascular market

A big chunk of Pfizer’s plan to add $15 billion to sales just went up in smoke. Having gone over phase 2b data on cardiovascular drug vupanorsen, Pfizer has decided to return the rights to Ionis Pharmaceuticals, leaving it without a candidate it tipped to deliver peak sales of more than $3 billion.

read more

Top Stories

AstraZeneca reveals insurance fraud probe in China as officials say they've made criminal arrests

China’s healthcare fund watchdog is taking AstraZeneca to task over alleged fraud. AstraZeneca China last month met with government officials as part of an investigation into alleged insurance fraud, the company said Friday. The probe—and subsequent arrests—hinge on suspicions that AZ China staff members tampered with genetic testing results of cancer patients in order to defraud medical insurance funds.

read more

Empowered Diagnostics lands FDA Class I recall tag for 286K unauthorized COVID tests

No injuries or deaths have been reported in relation to Empowered Diagnostics' recalled COVID-19 antigen and antibody tests, but the FDA warned that both false-positive and false-negative results from either diagnostic could have serious consequences.

read more

Led by Nanopore and Exscientia, UK startups snag half of Europe's biotech VC funding in record-setting 2021

While the U.K. shattered its previous biotech venture capital funding record by 81% in 2021, the continental Europe saw private financing dip by about 12%. Genetic sequencing startup Oxford Nanopore and artificial intelligence drug discoverer Exscientia led the way in both VC fundraising and initial public offering proceeds.

read more

Pfizer signs up to promote Alex Therapeutics’ smoking cessation app in Germany

The Big Pharma’s Germany-based division will help clinically validate and then commercially launch the smoking cessation program, dubbed Elia, starting within the country.

read more

AbbVie's new migraine meds could each pull in $2B at peak thanks to class growth, analyst says

There’s plenty of growth ahead for the CGRP class of migraine meds, according to analysts at Evercore ISI who surveyed 25 neurologists. With two of the most promising drugs in the class—Ubrelvy and Qulipta—AbbVie is set to benefit.

read more

FDA commissioner nominee Califf makes ethics pledge to Sen. Warren in bid for her support: report

In exchange for Sen. Elizabeth Warren's support, Robert Califf has agreed not to seek employment or payment from the companies he crosses paths with as FDA commissioner. Califf advanced in his confirmation process earlier this month, but with opposition coming from lawmakers on either side of the aisle, his nomination is far from a sure bet.

read more

Leo Pharma picks Christophe Bourdon as CEO after one-year stint at failed Danish meme stock Orphazyme

Leo Pharma named Christophe Bourdon as its next CEO as the Danish biopharma prepares its eczema drug launch in the U.S. and undergoes a reorganization that could impact 1,000 employees over the next two years. Bourdon will depart Danish meme stock Orphazyme in March after the biotech faltered last year, with an FDA rejection and amateur trading from Redditors.

read more

Glooko adds AI-powered coaching to its digital diabetes management tools with Xbird acquisition

Adding Xbird’s machine learning AI-based analytics will help the Glooko platform better predict patients’ behavior and improve how they manage their diabetes by offering hyperpersonalized recommendations, the buyer said.

read more

Two Biogen board members depart as company struggles to get Aduhelm off the ground

Two Biogen board members, Nancy Leaming and Brian Posner, will retire next month. Meanwhile, the company continues to weather the rocky launch of its controversial Alzheimer's disease med Aduhelm.

read more

Taysha ready to engage with regulators on approval pathway for the biotech's first gene therapy in rare disease

Taysha has gathered the data it needs to start a conversation with FDA and EU regulators about the approval pathway for its first gene therapy, which the biotech hopes will become the first approved treatment for a rare neurodegenerative disease that leads to death by a patient's early twenties. 

read more

RNA sequencing spots 40% more cancer mutations in children than standard genetic tests: study

While traditional genetic diagnostics were able to spot 55 specific fusion genes in the samples, RNA testing found those plus 23 others, an improvement of over 40% compared to the standard tests.

read more