Pfizer hunts for Paxlovid sibling

Editor’s Note: Getting ready for #ASH22? Fierce Pharma will talk to Dr. Naveen Pemmaraju at MD Anderson in a Twitter chat about the latest advances in blood cancer. Search #FierceTalksASH starting at 4pm ET on Dec. 8 to join the conversation. Our team will also be on site in New Orleans to bring you fresh data from the annual conference.

Today's Big News

Dec 6, 2022

KRAS battle heats up as Mirati pressures Amgen with Keytruda combo show in lung cancer


In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program


Pfizer's search for Paxlovid's COVID-busting sibling leads to low-profile antiviral biotech


AbbVie offers up to $335M for connection with HotSpot's preclinical small-molecule program


Gossamer touts phase 2 win but analysts aren't breaking out the champagne


Editas teases tiny sickle cell sample in effort to climb back into gene editing's upper echelon


Alzheimer's test could diagnose 'disease of exclusion' a lot earlier


Women, Asian and Black participants underrepresented in COVID-19 clinical trials, researchers find

 

Featured

KRAS battle heats up as Mirati pressures Amgen with Keytruda combo show in lung cancer

In a potential key battleground for KRAS inhibitors that involves combination with Merck's PD-1 king Keytruda, Mirati's adagrasib appears to be pulling ahead of Amgen’s first-to-market Lumakras in the latest clinical data revelation. But Mirati's stock price still tanked.
 

Top Stories

In fresh blow to floundering PI3K space, FDA feedback drives MEI, Kyowa to halt blood cancer program

The dominoes keep falling in the PI3K space. After meeting with the FDA, Kyowa Kirin and MEI Pharma have stopped development of their B-cell malignancy prospect zandelisib outside of Japan.

Pfizer's search for Paxlovid's COVID-busting sibling leads to low-profile antiviral biotech

Pfizer’s COVID-19 drug Paxlovid has rapidly grown into a $22 billion-a-year mega blockbuster. Now, the Big Pharma wants to develop a sibling to the antiviral—and has identified Clear Creek Bio as an ally that can help make it happen.

AbbVie offers up to $335M for connection with HotSpot's preclinical small-molecule program

AbbVie has formed a connection with HotSpot, inking a global licensing option deal for the biotech’s preclinical small-molecule allosteric therapy and extending the opportunity to make up to $295 million in biobucks.

Gossamer touts phase 2 win but analysts aren't breaking out the champagne

Gossamer bio is celebrating a phase 2 win after a series of fails, but analysts aren't popping the champagne just yet.

Editas teases tiny sickle cell sample in effort to climb back into gene editing's upper echelon

Editas is looking to bounce back after shelving its top asset, touting an extremely small sample size of sickle cell patients treated with its gene editing therapy.

Alzheimer's test could diagnose 'disease of exclusion' a lot earlier

Researchers have developed an assay that detects the toxic oligomers that drive Alzheimer’s disease progression. The peptide that makes the test work could one day be used as a treatment.

Women, Asian and Black participants underrepresented in COVID-19 clinical trials, researchers find

Women, Asian and Black participants were underrepresented in more than 100 clinical trials for COVID-19 drugs and vaccines, a new analysis has found. Meanwhile, Hispanic and Latino participants were overrepresented, according to the study published in JAMA Internal Medicine Monday.

Neuralink under federal investigation for animal testing practices: Reuters

Months after Neuralink shot down allegations of “horrific abuse” in its animal testing practices, the U.S. Department of Agriculture’s inspector general has reportedly opened an investigation into the accusations against Elon Musk’s brain-computer interface company.

Worldwide names Duprat to head early-phase business unit

Worldwide Clinical Trials named Pete Duprat to head its growing early-phase business unit, which includes the CRO’s recently expanded Bioanalytical Center of Excellence in Austin, Texas.

EpiPen litigation comes back to haunt Teva a decade after initial settlements

In the latest legal entanglement, Teva is accused of stalling the rollout of its generic EpiPen in a quid pro quo with the epinephrine injector’s owner, Viatris. In return for the epinephrine launch delay, Viatris promised not to undercut Teva’s branded narcolepsy med Nuvigil with its own generic, according to court documents filed earlier this month.

Lung damage found in 11% of severe COVID survivors

Eleven percent of people who’ve been hospitalized with COVID-19 have damaged lungs, according to a new study.
 
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'The Top Line': The initial reactions to Biogen's new CEO, plus this week's headlines

This week on “The Top Line,” we discuss the current state of Biogen and recent investor reactions to the new hire. Plus we cover the week's news including: What Albert Bourla said that has him in hot water, a $3.5 million drug, and we tease a possible major acquisition. 
 

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A Strategy to Standardize Process Characterization & Late Phase Development

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