J&J, Alcon ink $75M in settlements

Today's Big News

Oct 14, 2022

New Biden order wants CMMI to test payment models that tackle high drug prices  

Flying glass fears force Exela to recall 49 lots of metabolic acidosis injection 

Alcon, J&J Vision settle for $75M in contact lens price-fixing case 

FDA scraps AdComm for Reata's rare disease candidate, leaving analysts squinting at the tea leaves  

Takeda's Qdenga nears approval in EU, and beyond, thanks to special regulatory pathway  

UnitedHealth bracing for Medicaid redeterminations to resume   

Invivyd faces C-suite departures, commercial layoffs as turmoil continues at rebranded Adagio  

A green revolution: FDA hands down emergency OK to plant-based surgical face mask  

Despite pandemic slowdown, biosimilars keep gaining market share in the US, Amgen report says  

Enliven Therapeutics, troubled Imara set to merge with Roche-backed $165M fundraise  

CommonSpirit Health: Ransomware attack responsible for ongoing IT outages 

Omics startup Pleno prospers with $40M funding round 

FDA’s liver safety request set to delay decision on Travere’s kidney drug

 

Featured

New Biden order wants CMMI to test payment models that tackle high drug prices

President Biden issued an executive order calling on the Center for Medicare and Medicaid Innovation to test new payment models that can help lower drug prices.
 

Top Stories

Flying glass fears force Exela to recall 49 lots of metabolic acidosis injection

Lacerations aren’t typically the sort of side effect one associates with a faulty drug, but in Exela Pharma Sciences’ case, the threat has prompted a mass recall of an injectable used to treat a kidney disease complication.

Alcon, J&J Vision settle for $75M in contact lens price-fixing case

More than half a decade after it began, a class-action lawsuit accusing several contact lens manufacturers of anticompetitive price fixing has finally come to a close.

FDA scraps AdComm for Reata's rare disease candidate, leaving analysts squinting at the tea leaves

The omaveloxolone saga has delivered yet another twist. Having previously put an advisory committee meeting on hold, the FDA has now scrapped plans to convene experts to discuss Reata Pharmaceuticals’ candidate altogether, leaving analysts to argue over whether the change is a good or bad omen.

Takeda's Qdenga nears approval in EU, and beyond, thanks to special regulatory pathway

After more than a decade of research, Takeda's dengue vaccine is inching closer to authorization in Europe and dengue-affected countries through the EU-M4all program. Today, the vaccine made big headway with a positive opinion from a key regulatory committee in Europe.

UnitedHealth bracing for Medicaid redeterminations to resume

UnitedHealth Group beat the Street with $5.3 billion in profit for the third quarter, according to the company's earnings report released Friday morning.

Invivyd faces C-suite departures, commercial layoffs as turmoil continues at rebranded Adagio

A month after a full rebrand from Adagio to Invivyd, the biotech is already facing a double-hit of C-suite departures and is at the same time also culling commercial roles as a continued effort to distance itself from the struggles of its COVID-19 antibody.

A green revolution: FDA hands down emergency OK to plant-based surgical face mask

Not a moment too soon, the FDA has bestowed an emergency use authorization upon a new medical-grade face mask that’s made of plant-based materials and is compostable.

Despite pandemic slowdown, biosimilars keep gaining market share in the US, Amgen report says

In terms of approvals and launches, the biosimilars industry experienced a slowdown during the pandemic. But in the lab, there has been no such stagnation in the development of the copycats. This willingness of companies to pursue the development of biosimilars in increasing numbers bodes well for the industry's future, Amgen said in its "2022 Biosimilar Trends Report."

Enliven Therapeutics, troubled Imara set to merge with Roche-backed $165M fundraise

Enliven Therapeutics and Imara are combining forces to push Enliven’s precision oncology pipeline forward in a new merger deal accompanied by a Roche-backed $165 million fundraise.

CommonSpirit Health: Ransomware attack responsible for ongoing IT outages

CommonSpirit Health is now characterizing the interruption of IT services across several of its hospitals as a ransomware attack. The system said it has engaged law enforcement and outside cybersecurity specialists to aid its forensics investigation.

Omics startup Pleno prospers with $40M funding round

Collecting $15 million less than six months ago, the San Diego startup Pleno raised another $40 million to further its efforts to get its multi-omics platform off the ground and grow its team.

FDA’s liver safety request set to delay decision on Travere’s kidney drug

The FDA has sunk Travere Therapeutics’ hopes of winning approval for its kidney disease candidate this year by requesting changes to the proposed risk evaluation mitigation strategy that are expected to delay the PDUFA date by three months.
 
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'The Top Line': The most productive pharmas, Biogen's shift in leadership

This week on "The Top Line," we talk about our latest analysis on the world’s most productive biopharmas. We also discuss Biogen's tumultuous year and who it is considering for a new CEO.
 

Resources

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Orally Inhaled & Nasal Drug Delivery: A Pipeline of Opportunities

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