American Life Sciences Innovation Council

In case you missed it: FDA & FDAOncology, patients, @ASCO @RareDiseases @IAmBiotech & others discussed the Accelerated Approval Program - 30 Years On: Insights and Experiences. #AcceleratedApproval #OCEProjectConfirm

Gilead Sciences said that a large clinical trial of its drug Trodelvy achieved its primary goal of delaying tumor growth in women with the most common form of breast cancer. buff.ly/3sOf1cJ #breastcancer

New Phase 3 data shared at #ECCO2022 show an investigational Lilly medicine achieved the primary and all key secondary endpoints in a clinical trial of people living with moderately-to-severely active ulcerative colitis. Learn more: e.lilly/3GWZ6g9

Bayer announced that asundexian, a novel factor XIa inhibitor being evaluated for secondary prevention of #stroke, has received fast track designation from the #FDA @US_FDA @healioneurology #Cardiotwitter healio.com/news/cardiolog…

#FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. This summary presents FDA's analysis of data from the monarchE trial, the basis for the abemaciclib+endocrine therapy approval in the adjuvant setting. #bcsm ascopubs.org/doi/abs/10.120…

CROs embracing tech to decentralize trials and speed enrollment as regulators show support 'with their feet' fiercebiotech.com/cro/cros-embra…

Targeting rare diseases: Inside Durham biotech startup's latest deal #WRALTechWire wraltechwire.com/2022/01/13/tar…

The government price-fixing scheme moving through Congress poses a grave danger to innovation, and in particular, the scientific breakthroughs for @POTUS Biden's key cancer moonshot project. #savecures mercurynews.com/2021/12/07/opi…

Mind blowing margins: #Hospitals markup CAR-T by 300%+ over WAC Even at lowest #340B discounts, #hospitals absorb ~2/3 of $$ that comm'l plans @UHC & @BCBSAssociation spend on CAR-T (and also get medical payments on top of these spreads) Fantastic work by @rgalBernstein

FDA Approves Merck’s KEYTRUDA® (pembrolizumab) as Adjuvant Treatment for Adult and Pediatric (≥12 Years of Age) Patients With Stage IIB or IIC Melanoma Following Complete Resection shorturl.at/ghotD

Today, in partnership with @SageBiotech, we announced interim data from the open-label Phase 3 SHORELINE Study designed to follow patients with #MDD over the course of one year. Learn more here:

Rounding out #PancreaticCancer awareness month with a look at advances in treatment and detection of this disease cc @clearyonc @DanaFarber_Hale

Congrats to @Arrevus, a @NCCommerce #OneNCSmallBiz grantee, on their recent acquisition. This acquisition by @aceragen builds their portfolio of therapies for #cysticfibrosis, Farber disease, and other infectious diseases. Great article by @ncbiotech! wraltechwire.com/2021/11/15/sta…

We are pleased to share 18 month topline results from our HELIOS-A Phase 3 study of vutrisiran, an investigational #RNAi therapeutic in development for the treatment of hATTR #amyloidosis with polyneuropathy. #RNAitherapeutics #siRNA

In a new @NatureComms paper we found where #Cardiomyocytes – the cells that make our hearts contract – proliferate, and showed that they can regenerate after a heart attack. This could potentially lead to new therapeutic targets for #HeartFailure. go.nature.com/3FhgH2S

We are sharing the excitement! Huma and @Bayer will use #machinelearning in this research project to accelerate diagnosis for certain types of lung cancer through more precise readings of CT (computed tomography) scans. #collaboratetocure #TeamBayer #AI

FDA approves Exelixis’ Cabometyx for differentiated thyroid cancer feedproxy.google.com/~r/Pharmatimes… #lifesciences #pharma

Vertex announces publication in @NEJM of a #Phase3 study evaluating one of our #cysticfibrosis medicines. Read more in today's press release on news.vrtx.com.

The recent FDA approval for our minimally invasive Amplatzer Amulet provides new options for a common heart condition known as atrial fibrillation (or AFib): abbo.tt/3mxNtWv Important safety information: abbo.tt/AmuletISI

#Breaking: Today we announced Phase III topline results from a trial evaluating our regimen against the standard of care for patients with previously untreated diffuse large B-cell lymphoma, or #DLBCL. Learn more: gene.com/media/press-re…