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2021 COVID-19 News: Pfizer to File for Full Approval of Its Vaccine and More

Biospace news - Tue, 05/04/2021 - 02:00
Please check out the biopharma industry's COVID-19 stories that are trending for May 4, 2021.

AbCellera-Eli Lilly Antibody Shows Potency Against All Current COVID-19 Variants

Biospace news - Tue, 05/04/2021 - 02:00
Should this antibody continue to prove to be safe and effective in clinical studies, it will replace the previously authorized bamlanivimab, which has since been sidelined due to the rise of viral variants that diminished its effectiveness.

Speeding new treatments

World Pharma News - Mon, 05/03/2021 - 12:00
A year into the COVID-19 pandemic, mass vaccinations have begun to raise the tantalizing prospect of herd immunity that eventually curtails or halts the spread of SARS-CoV-2. But what if herd immunity is never fully achieved - or if the mutating virus gives rise to hyper-virulent variants that diminish the benefits of vaccination?

Moderna announces emergency use listing granted by the World Health Organization for its COVID-19 vaccine

World Pharma News - Mon, 05/03/2021 - 10:00
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announced that the World Health Organization (WHO) has issued Emergency Use Listing (EUL) for its COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

The Seven Stages of Alzheimer's Disease Explained

Biospace news - Mon, 05/03/2021 - 02:00
There are seven stages of Alzheimer’s disease, and understanding each stage is a useful aid in setting your expectations whether you might have the disease or you’re caring for someone with the illness.

AstraZeneca Celebrates a First as FDA Approves Farxiga for Chronic Kidney Disease

Biospace news - Mon, 05/03/2021 - 02:00
The regulatory nod marks the first time the FDA approved an SGLT2 inhibitor for the treatment of CKD regardless of diabetes status.

Already on Fast Track, Aceragen Launches with $35 Million and Farber Disease Drug

Biospace news - Mon, 05/03/2021 - 02:00
Grabbing a fast-tracked novel enzyme replacement therapy for a rare pediatric disease, new biopharma Aceragen launched with $35 million in hand for product financing.

Astellas Pulls the Plug on R&D Partnership with Cytokinetics

Biospace news - Mon, 05/03/2021 - 02:00
One year after Astellas and California-based Cytokinetics extended an agreement to develop Skeletal Sarcomere Activators, the Japanese pharma company is walking away from the deal.

Q1 2021: A Look at Biopharma’s Top 25 Companies by Market Cap

Biospace news - Mon, 05/03/2021 - 02:00
BioSpace takes an in-depth look at the Top 25 of Q1.

Relay Therapeutics Appoints Key Leadership Members Following Acquisition

Biospace news - Mon, 05/03/2021 - 02:00
​Clinical-stage precision medicine company Relay Therapeutics has brought two new senior level management team members into the fold, including Tara O’Meara and Charles Ferté.

New Hope for Sickle Cell Disease Patients as FDA Approves Chiesi's Ferriprox

Biospace news - Mon, 05/03/2021 - 02:00
The U.S. FDA approved Chiesi Global Rare Diseases’ Ferriprox for treatment of transfusional iron overload caused by sickle cell disease (SCD) or other anemias in adults and children ages three years and older. This approval expands the use of the drug for patients with SCD or other anemias.

Clinical Rockstar Pamela Tenaerts Advancing Patient-Centric Trials at Medable

Biospace news - Mon, 05/03/2021 - 02:00
As Tenaerts takes the scientific helm at Medable, she will leverage the company’s proprietary platform to advance decentralized research methodologies with evidence-based best practices for patient-centric clinical trials.

Clinical Catch-Up: April 26-30

Biospace news - Mon, 05/03/2021 - 02:00
Although clinical trial news related to COVID-19 was slow last week, there’s quite a bit of news on studies for other indications.

Six Dementia Patients Received Controversial Gene Therapy Injection in Mexico, BioVia Says

Biospace news - Mon, 05/03/2021 - 02:00
If actually administered to these patients, this could represent the first recorded attempt to manage dementia that uses an injectable gene therapy technique.

Large collaboration creates cell atlas of COVID-19 pathology

World Pharma News - Fri, 04/30/2021 - 10:00
Scientists from several hospitals and research centers have shown what happens in individual cells of patients who died of COVID-19. In a study published in Nature, the researchers describe how infected cells from multiple organs exhibited a range of molecular and genomic changes. They also saw signs of multiple, unsuccessful attempts by the lungs to repair themselves in response to respiratory failure, which is the leading cause of death in COVID-19 patients.

DEMO: Nanome Triggers Deep Drug Development Insights Via Virtual Molecule Design

Biospace news - Fri, 04/30/2021 - 02:00
If you equate virtual reality (VR) to games or pain relief applications, you’re missing one of science’s most amazing tools.

FDA CRL Hurdle for LEO Pharma on Tralokinumab

Biospace news - Fri, 04/30/2021 - 02:00
The U.S. FDA has released a Complete Response Letter (CRL) following its review of LEO Pharma’s tralokinumab. Further data on a device component is the issue brought to light by the recently completed Biologics License Application (BLA) review.

Bristol Myers' Opdivo Fails to Maintain Accelerated Approval in Liver Cancer

Biospace news - Fri, 04/30/2021 - 02:00
The U.S. FDA's Oncologic Drugs Advisory Committee did not agree in a recent meeting to maintain the accelerated approval of Bristol Myers Squibb’s Opdivo (nivolumab) as a second-line treatment of hepatocellular carcinoma.

COVID-19 Vaccine Manufacturing Mishap Spurs C-Suite Shakeup at Emergent

Biospace news - Fri, 04/30/2021 - 02:00
Battered by vaccine manufacturing mishaps that led to the contamination of 15 million doses of the Johnson & Johnson vaccine, Emergent BioSolutions is shaking up its leadership to ensure such errors do not occur again.

AstraZeneca Hits Another Bump in the Road to COVID-19 Vaccine Approval in the US

Biospace news - Fri, 04/30/2021 - 02:00
AstraZeneca’s COVID-19 vaccine road to approval has been anything but smooth.