CRISPR-Vertex's gene editing 1st to get FDA adcomm

Today’s Big News

Oct 27, 2023

‘We knew it was there’: AbbVie CEO says company favored internal work over potential Daiichi deal


Sanofi reports setbacks to Denali, Kymab and Principia assets, delivering mix of misses and halts


After reaching FDA first, CRISPR-Vertex's gene editing therapy will get 'benign' review by committee


PTC's plans crash into regulatory reality as FDA demands data on 2 candidates, delaying filing


Medicenna shifts to Toronto state of mind as Nasdaq listing lapses


Chutes & Ladders—J&J's medtech chief exits after almost 30 years


First-in-class small molecule halts breast and ovarian cancer growth in mice

The Top Line Podcast: Don’t miss out on the newest episode. Listen now.

 

Featured

‘We knew it was there’: AbbVie CEO says company favored internal work over potential Daiichi deal

AbbVie CEO Rich Gonzalez says the company was aware of the potential for an ADC transaction with Daiichi that Merck ultimately pounced on, electing to prioritize internal work instead.
 

Top Stories

Sanofi reports setbacks to Denali, Kymab and Principia assets, delivering mix of misses and halts

Sanofi has reported setbacks to a trio of candidates bought in by its business development team, halting (PDF) work or posting negative data on assets picked up from Denali Therapeutics, Kymab and Principia Biopharma.

After reaching FDA first, CRISPR-Vertex's gene editing therapy will get 'benign' review by committee

A historic moment in pharmaceuticals will happen next week: an FDA advisory committee is set to review the first-ever CRISPR gene editing-based therapy, Vertex Pharmaceuticals and CRISPR Therapeutics’ exa-cel for sickle cell disease.

You Need to De-Risk Your Clinical Trials with Independent Experts

The FDA and EMA recommend EACs and DMCs be independent from sponsors and CROs. Our industry expert shares how and when to select the right EAC providers and more to de-risk your clinical trials.

PTC's plans crash into regulatory reality as FDA demands data on 2 candidates, delaying filing

PTC Therapeutics is keeping its regulatory teams busy. In its third-quarter results, the biotech reported pushback against its plans to seek approval for two molecules based on existing data—and saw its share price fall more than 20% in the wake of the update.

Medicenna shifts to Toronto state of mind as Nasdaq listing lapses

Medicenna Therapeutics is letting its Nasdag listing lapse after determining the effort to stay on the New York stock exchange was not worth it. The company is also executing a management shakeup as it retreats to Canada.

Chutes & Ladders—J&J's medtech chief exits after almost 30 years

Johnson & Johnson’s year of transition and restructuring is not slowing down, this time marked by the departure of a longtime key executive.

First-in-class small molecule halts breast and ovarian cancer growth in mice

The small molecule, which indirectly targets the tough-to-drug MYC gene, worked even better when combined with PARP 1/2 inhibitor talazoparib.

'The Top Line': A look at the FDA's Aduhelm approval and the potential for regulatory bias

In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.  

Apple Watch faces another possible sales ban in Masimo pulse oximetry patent fight

For the second time in the last year, the U.S. International Trade Commission has determined that Apple violated a competitor’s patents in a health-tracking feature of its popular Apple Watch, setting up the devices for a potential ban in the U.S.

Novartis claims ex-staffer jumped to Takeda with 'thousands' of sensitive files

Novartis believes a former employee of its Egyptian affiliate made off with thousands of files before jumping ship to Takeda. Now, the Swiss pharma giant wants a peek at Takeda’s business records to find out whether its confidential information has been used improperly.

Employers should be finding ways to invest in workers' vitality, Cigna says. Here's why

Despite reporting slightly worse physical and mental health, Americans are feeling more optimistic about their vitality, according to a new analysis from the Cigna Group, which concludes that employers can play a key role in addressing these challenges.

Fierce Pharma Asia—Merck inks $4B Daiichi tie-up, trims Kelun deal; AstraZeneca's ADC letdown

In a busy week for the antibody-drug conjugate (ADC) field, Merck signed a three-drug deal with Daiichi Sankyo but abandoned two preclinical assets from Kelun-Biotech. Meanwhile, AstraZeneca and Daiichi's TROP2 ADC disappointed in a lung cancer trial. And GSK in-licensed an ADC from China's Hansoh Pharma.
 
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'The Top Line': A look at the FDA's Aduhelm approval and the potential for regulatory bias

In this episode of “The Top Line,” we delve into the FDA's controversial approval of Aduhelm, a drug for Alzheimer's disease, despite an independent advisory committee's resounding rejection. The decision has sparked questions about potential bias within the regulatory body.  
 

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