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This Week

Oct 18, 2024

Thermo Fisher plant in North Carolina flagged for contamination, air bubble issues in FDA inspection


Deep learning AI model scans 'dark matter' of genomic data to find 70,000 never-before-seen RNA viruses 


In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list


Sanofi flunks midphase multiple sclerosis study, dealing another blow to Denali pact


J&J jettisons several programs, ends seltorexant work in Alzheimer's disease


Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months


CMR Surgical lands FDA clearance for Versius robot amid CEO swap

 

Featured

Thermo Fisher plant in North Carolina flagged for contamination, air bubble issues in FDA inspection

The agency flagged multiple observations at the company's Patheon CDMO subsidiary's Greenville, North Carolina, plant after a May inspection.
 

Top Stories

Deep learning AI model scans 'dark matter' of genomic data to find 70,000 never-before-seen RNA viruses

To find RNA viruses hiding in genomic “dark matter,” researchers took advantage of one thing they all have in common: the RNA polymerase enzyme.

In win for compounders, FDA will review its decision to put Eli Lilly's tirzepatide on shortage list

Four days after a compounding industry group filed a lawsuit against the FDA for removing Eli Lilly’s tirzepatide products from its shortage list, the U.S. regulator is taking a second look at its decision.

Sanofi flunks midphase multiple sclerosis study, dealing another blow to Denali pact

Sanofi has stopped a phase 2 trial of the Denali Therapeutics-partnered oditrasertib in multiple sclerosis. The French drugmaker tore the RIPK1 inhibitor trial from its list of active studies after failing to meet its primary and secondary endpoints, dealing a further blow to a collaboration with a troubled history.

J&J jettisons several programs, ends seltorexant work in Alzheimer's disease

Johnson & Johnson is jettisoning several programs, with three of the culls taking place in the neuroscience field.

Pfizer doubles down with its 2nd FDA hemophilia approval in 6 months

For the second time in six months, the FDA approved a Pfizer treatment for hemophilia. On Friday the U.S. regulator signed off on Hympavzi, an anti-tissue factor pathway inhibitor for patients age 12 and older with hemophilia A or B.

CMR Surgical lands FDA clearance for Versius robot amid CEO swap

CMR Surgical obtained a de novo clearance from the FDA for its Versius surgical system, allowing its modular laparoscopic robot to enter U.S. shores.

Johnson & Johnson eases initial Stelara blows with strong Darzalex, Carvykti growth

The company picked up a record $3 billion in quarterly sales for its multiple myeloma powerhouse Darzalex as it grooms Tremfya to take on Stelara's market dominance.

FDA puts Novavax's phase 3 plan for pair of vaccine programs on hold over nerve disease case

A phase 2 combination COVID-flu vaccine trial wrapped up in July 2023, with the “spontaneous” report of a patient developing motor neuropathy received last month.

Sanofi's Dulcolax crowns 'Pooping Princesses' to fight constipation-causing stigma among girls and women

A new campaign from Opella, Sanofi’s consumer health unit, is a royal flush.
 
Fierce podcasts

Don’t miss an episode

How HIV prevention stays out of reach for many

This week on "Podnosis," reporters discuss HIV’s impact in the South, inequitable access to PrEP and share stories from affected patients.
 

Resources

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Navigating the Path to Medication Adherence: Overcoming 8 Key Challenges

Navigating the Path to Medication Adherence: Overcoming 8 Key Challenges
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Switching Treatments: Pharma's Opportunity to Drive Action

Open up unexpected opportunities. This digital story offers pharma marketers proactive strategies for helping patients discover and switch to treatments, even if they aren’t actively looking to make a change.
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Accelerating Alzheimer's Therapy Innovation: The Power of Blood-Based Biomarkers

Blood-based biomarker testing presents a promising solution to improve access to critical early risk assessment along with a pathway towards accelerated clinical trials for Alzheimer's Disease.
 

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On Helix

Date: ‌4 ‌July ‌2024 ‌- ‌Location: ‌Babraham ‌Research ‌Campus, ‌Cambridge ‌UK

 

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