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Intellia and Regeneron's CRISPR ATTR Therapy Durable at 1-Year

Fri, 06/24/2022 - 02:00
Intellia Therapeutics and Regeneron Pharmaceuticals presented positive interim data from an ongoing Phase I trial of NTLA-2001 for transthyretin (ATTR) amyloidosis.

Serious Safety Signal Slows Sarepta’s MOMENTUM in DMD Trial

Fri, 06/24/2022 - 02:00
Sarepta announced that the FDA has put the Phase II trial for its SRP-5051 (vesleteplirsen) for the treatment of patients with DMD on clinical hold following a serious safety signal.

Xenotransplant Patient’s New Heart Doubled in Size, Autopsy Shows

Fri, 06/24/2022 - 02:00
The genetically-modified heart of a man who died two months after his heart was replaced with that of a pig had nearly doubled in size, autopsy results show.

Sanofi-GSK COVID-19 Vaccine Candidate Effective Against Omicron

Fri, 06/24/2022 - 02:00
​​​​​​​Positive news continues for COVID-19 vaccine development and distribution, with Sanofi and GSK announcing the success of their candidate against the Omicron variant.

FDA Strengthens Ability to Pull Breakthrough Designation, Releases Neurodegenerative Action Plan

Fri, 06/24/2022 - 02:00
FDA releases new draft guidance that addresses Breakthrough Therapy designation and action plan for rare, neurodegenerative diseases.

Roche Accelerator in Shanghai Helps Biotechs Expand Collaborations & Networks

Fri, 06/24/2022 - 02:00
The Roche Accelerator is designed to help companies bridge the gap between idea and proof-of-concept. It is one of several incubators recently founded by Western companies.

Amryt Pushes Back Against FDA Decision on Rare Skin Disease Treatment

Fri, 06/24/2022 - 02:00
Amryt Pharma is filing a formal dispute resolution request (FDRR) with the FDA after receiving a CRL that delays the production of its drug for a rare skin disorder.

PwC Projects 'Flurry of Deals' Across Life Science Industry

Fri, 06/24/2022 - 02:00
A new report by PwC projects that the second half of this year will see a “flurry of deals activity across all areas of the sector.”

Research Roundup: Single Scan Diagnoses Alzheimer's, Women Underrepresented in Trials

Fri, 06/24/2022 - 02:00
Researchers have been able to use machine learning to evaluate MRI scans and diagnose Alzheimer's in a single scan. For that and more research news, continue reading.

Emergent, Astellas & More Submit New Applications to FDA

Fri, 06/24/2022 - 02:00
With the submission of NDAs and BLAs, multiple companies are bidding for regulatory approval of drug candidates. BioSpace takes a look at several of the latest requests.

BUSM Researchers Gain Insight into Key Genetic Driver of Alzheimer’s

Fri, 06/24/2022 - 02:00
The Boston University School of Medicine has unraveled details about a known genetic component for the development of Alzheimer’s disease (AD): the APOE4 gene.

Biogen Abandons Aduhelm Study Following Low Patient Enrollment

Fri, 06/24/2022 - 02:00
Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm after only 29 people signed up for an expected enrollment of 6,000 patients.

AbbVie Redeems Priority Review Voucher for Rinvoq Approval

Fri, 06/24/2022 - 02:00
AbbVie has redeemed a Rare Pediatric Disease Priority Review Voucher for Rinvoq (upadactinib), following its FDA approval for adults with moderately to severely active ulcerative colitis in March.

RedHill Axes 1/3 of US Workforce in 18-Month Frugality Plan

Fri, 06/24/2022 - 02:00
RedHill announced that it will lay off a third of its U.S. workforce in an effort to save money over the next year and a half.

BioSpace Movers & Shakers: Acer, Viridian, BioPorto, atai & More

Fri, 06/24/2022 - 02:00
There were multiple leadership changes in the biopharma industry, with several new chief executive officers tapped to guide companies through their next growth phases.

Breaking Ground & Leaving Town: June Brings Job Creations, Layoffs for Life Sciences

Fri, 06/24/2022 - 02:00
The life science industry is growing rapidly, and many companies have announced expansions and job creation. Still, others have been forced to cut costs and slash jobs. For that and more, continue reading.

AstraZeneca Looks to Add to Small Group of Wilson Disease Drugs

Thu, 06/23/2022 - 02:00
An experimental AstraZeneca drug for Wilson disease hit the mark in a Phase III study in which the drug, ALXN1840, was able to mobilize copper three times greater than standard-of-care.

WHO Mulls Emergency Declaration on Monkeypox, Poliovirus Detected in UK Water Supply

Thu, 06/23/2022 - 02:00
The WHO will decide whether to declare a public health emergency following the recent outbreaks of monkeypox, and poliovirus has been detected in London water samples.

Novartis Tops Busy Week with Solid Tumor Combo Drug Approval

Thu, 06/23/2022 - 02:00
In addition to patent cases, partnerships and pledging money to global tropical disease efforts, Novartis scored a win on a combo-treatment for solid tumors.

New Variants Escape Antibody Responses of Vaccinated, Long COVID Affects 1 in 5

Thu, 06/23/2022 - 02:00
Although COVID-19 appears to be on the run in the U.S., there is still a threat of resurgence. Here’s a look at some of the most recent COVID-19 stories and research.