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Industry, Vaccines

Gates Foundation supports HIV and malaria research

January 14, 2022

Via: Pharma Times

The new commitment from the Bill & Melinda Gates Foundation supports the development of Vir Biotech’s ‘vaccinal antibody’ technology, a significant tool in combatting global infectious diseases. Vir’s antibody research initiative aims for a functional cure for HIV and for […]


FDA, Regulations

Senate Committee Backs Califf Nomination to Head FDA

January 14, 2022

Via: Drugs.com

The nomination of former U.S. Food and Drug Administration head Dr. Robert Califf to again lead the agency now heads to the full Senate for a vote, after a Senate committee on Thursday voted 13-8 for approval. Among those who […]


Clinical Trials, Research and Development

Accelerating Clinical Trials in the EU (ACT EU) initiative launch

January 14, 2022

Via: European Pharmaceutical Review

The European Commission (EC), the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA) have launched an initiative to transform clinical trials within the European Union (EU). The Aim of Accelerating Clinical Trials in the EU (ACT EU) […]


Industry, Vaccines

As Omicron Surges, Effort to Vaccinate Young Children Stalls

January 14, 2022

Via: Kaiser Health News

Two months after Pfizer’s covid vaccine was authorized for children ages 5 to 11, just 27% have received at least one shot, according to Jan. 12 data from the Centers for Disease Control and Prevention. Only 18%, or 5 million […]


Clinical Trials, Research and Development

Medicare Limits Aduhelm Coverage to Patients in Clinical Trials

January 12, 2022

Via: Biopharm International

In a highly unusual decision for a therapy approved by FDA, the Centers for Medicare and Medicaid Services (CMS) took action to limit prescribing and use of Biogen’s new and controversial Alzheimer’s treatment Aduhelm (aducanumab). The CMS National Coverage Determination […]


Clinical Trials, Research and Development

Medicare limits Aduhelm coverage to clinical trial participants

January 12, 2022

Via: Pharmaphorum

Biogen and partner Eisai had been hoping for good news from the review of Aduhelm (aducanumab) by the Centre for Medicare and Medicaid Services (CMS), but the draft decision means broad coverage of the drug will have to wait for […]


Biotech, Industry

COVID Pandemic Prompts Renewed Interest in Biotech Startups

January 12, 2022

Via: Biopharm International

The momentum of biotech and biopharma companies is on the rise in anticipation of a new wave of emerging therapies moving through the industry’s development pipeline. In addition, the COVID-19 pandemic highlighted the importance of companies that can react quickly […]


Mergers and Acquisitions

Pfizer and Acuitas Therapeutics Collaborate on Lipid Nanoparticle Delivery System

January 11, 2022

Via: Biopharm International

Pfizer and Acuitas Therapeutics, a company focused on developing lipid nanoparticle (LNP) delivery systems to enable messenger RNA (mRNA)-based therapeutics, have entered into a development and option agreement under which Pfizer will have the option to license, on a non-exclusive […]


Clinical Trials, Research and Development

Leveraging print and digital communications for patient-centric clinical trials

January 10, 2022

Via: Biopharma Dive

One of the strongest trends in clinical trials is patient centricity, which is to say, making the patient experience as easy and accessible as possible. During the height of the COVID-19 pandemic, this became even more of a focus because […]


Cell and Gene Therapy, Industry

Pfizer expands into gene editing with Beam research deal

January 10, 2022

Via: Biopharma Dive

Last summer, Mikael Dolsten, head of research and development at Pfizer and the company’s top scientist, was thinking of new uses for the messenger RNA technology the pharmaceutical giant had developed so effectively for its coronavirus vaccine. The drugmaker already […]


News

Bayer trumpets $1bn CRISPR deal with Mammoth Bio

January 10, 2022

Via: Pharmaphorum

The German group is paying $40 million upfront to kick off the alliance, which is focusing on the development of up to five CRISPR drugs that can be delivered in vivo for liver-targeted diseases. There is another $1 billion in […]


Industry, Vaccines

FDA Shortens Time to Booster After Moderna Vaccine to 5 Months

January 7, 2022

Via: Drugs.com

Citing the rapid spread of the Omicron variant and the need for protection against it, U.S. federal health officials are shortening the recommended time between the second dose of the Moderna vaccine and a booster shot from six months down […]