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Today's Big News

Sep 28, 2022

Eisai and Biogen’s phase 3 Alzheimer’s win puts amyloid back in the driver’s seat, for now

It's a hit: Eisai springs 'major surprise' with phase 3 win for Biogen-partnered Alzheimer's drug

Out of Context: CEO says now not the time to build a 'big independent biotech' 

Pheon nabs $68M to ready clinical launch based on ADC-featured pipeline

TCR2's cell therapy racks up 22% response rate in heavily pretreated solid tumor patients

Nykode hits early-stage goals for pan-variant COVID shot, but future plans murky

 

Featured

Eisai and Biogen’s phase 3 Alzheimer’s win puts amyloid back in the driver’s seat, for now

Eisai and Biogen's recent phase 3 victory has once again placed the spotlight on amyloid beta. A slate of late-stage drugs, including lecanemab, are targeting amyloid plaque buildup to treat Alzheimer's.
 

Top Stories

It's a hit: Eisai springs 'major surprise' with phase 3 win for Biogen-partnered Alzheimer's drug

Eisai’s phase 3 clinical trial of Biogen-partnered Alzheimer’s disease candidate lecanemab has hit its primary and key secondary endpoints. The result, which analysts called a “major surprise,” gives a big boost to the partners as they head toward an accelerated approval decision in January.

Enhancing Patient Engagement with THREAD’s eCOA Solution

One aspect of study design to consider when building better research experiences for patients is a genuinely patient-centered eCOA (electronic clinical outcome assessment) program. Here are some tips for ensuring that your eCOA is built with the needs of patients in mind and able to deliver the kind of engagement necessary for successful trials.

Agilex Biolabs expands GLP Toxicology capacity with the commissioning of its new purpose designed testing facility

Australia’s largest and most technologically advanced provider of regulated bioanalysis and toxicology studies increases capacity by 500% with addition of new in-vivo facility in Brisbane

Out of Context: CEO says now not the time to build a 'big independent biotech'

Context Therapeutics is “cutting all excess fat” so it can stay afloat through 2024, putting nonessential activities on hold to “focus on blocking and tackling for the time being,” CEO Martin Lehr has told Fierce Biotech.

Pheon nabs $68M to ready clinical launch based on ADC-featured pipeline

Pheon is nabbed $68 million in series A funds to launch its antibody-drug conjugate-focused pipeline. The company says the money will help fund a proof-of-concept study of its lead asset.

TCR2's cell therapy racks up 22% response rate in heavily pretreated solid tumor patients

TCR2 Therapeutics has reported updated data from a phase 1 clinical trial of gavo-cel, linking the T-cell therapy to a 22% response rate in solid tumor patients who received the treatment after chemotherapy depletion.

Nykode hits early-stage goals for pan-variant COVID shot, but future plans murky

Nykode Therapeutics has taken aim at the holy grail of COVID-19 shots: a pan-variant vaccine that would eliminate the need for redesigning vaccines every time a new dominant variant comes around.

FDA hands Philips its 5th Class I recall of the year for faulty ventilators

Philips’ respiratory device-focused Respironics business has been in the hot seat for well over a year now, ever since it identified a potentially fatal safety issue with the sound-muffling foam of around 5.5 million of its CPAP and BiPAP machines and other ventilators.

A perfect storm: Europe's generic industry weighs cuts to output amid energy crisis, pricing pressures and more

A confluence of public health emergencies, armed conflict and historic pricing pressures are taking a toll on Europe’s supply of cheaper, off-patent medicines. In particular, soaring gas and electricity costs are threatening to upend certain manufacturers’ operations lest the EU intervene, the companies warned.

CRO Emmes buys visual-exam-focused Clinical Edge

Emmes snapped up Clinical Edge for an undisclosed price, extending the Maryland-based CRO’s string of acquisitions to five in just under two years.

MHRA raises concerns with switching between long-acting J&J, Novartis and Takeda drugs

The U.K. drug regulator has told healthcare professionals to exercise caution when considering switching between long-acting attention-deficit/hyperactivity disorder therapies from companies including Johnson & Johnson, Novartis and Takeda.

BioIVT continues spending spree with acquisition of biospecimen collection network Fidelis Research

BioIVT has bought Fidelis Research for an undisclosed price, marking the second acquisition for the biological specimens and services firm this month.
 
Fierce podcasts

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'Podnosis': Broadening artificial intelligence's scope in healthcare, how payers can invest in social needs

This week on "Podnosis," we talk about how AI is helping patients and what’s standing in the way of more widespread use. We also chat about how payers have invested in bringing on expertise necessary to tackle social determinants of health
 

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