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Malaria booster vaccine shows durable high efficacy in African children, meeting WHO-specified 75% efficacy goal

World Pharma News - Thu, 09/08/2022 - 10:00
Researchers from the University of Oxford and their partners have today reported new findings from their Phase 2b trial following the administration of a booster dose of the candidate malaria vaccine, R21/Matrix-M™ - which previously demonstrated high-level efficacy of 77% over the following 12 months in young west African children in 2021.

FDA grants Breakthrough Therapy Designation to Pfizer's Group B Streptococcus vaccine candidate

World Pharma News - Wed, 09/07/2022 - 10:00
Pfizer Inc. (NYSE:PFE) today announced that its investigational Group B Streptococcus (GBS) vaccine candidate, GBS6 or PF-06760805, received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the prevention of invasive GBS disease due to the vaccine serotypes in newborns and young infants by active immunization of their mothers during pregnancy.

Strict COVID lockdowns in France improved cardiovascular health

World Pharma News - Tue, 09/06/2022 - 10:00
A new paper in European Heart Journal - Digital Health, published by Oxford University Press, indicates that social-distancing measures like total lockdown have a measurable impact on vascular health. The study compared the impact on the health of people living in a partial vs. a total lockdown during the beginning of COVID-19.

Stem cell-gene therapy shows promise in ALS safety trial

World Pharma News - Mon, 09/05/2022 - 10:00
Cedars-Sinai investigators have developed an investigational therapy using support cells and a protective protein that can be delivered past the blood-brain barrier. This combined stem cell and gene therapy can potentially protect diseased motor neurons in the spinal cord of patients with amyotrophic lateral sclerosis, a fatal neurological disorder known as ALS or Lou Gehrig's disease.

Research reveals widespread use of ineffective COVID-19 treatments after FDA deauthorized their use

World Pharma News - Fri, 09/02/2022 - 10:00
Monoclonal antibodies are laboratory-designed treatments tailor-made to fight specific infections. In early 2021, the U.S. Food & Drug Administration issued emergency use authorization for two monoclonal antibodies (bamlanivimab/etesevimab and casirivimab/imdevimab) for the treatment of mild to moderate COVID-19 in high-risk, non-hospitalized patients.

Xenpozyme™ (olipudase alfa-rpcp) approved by FDA as first disease-specific treatment for ASMD (non-CNS manifestations)

World Pharma News - Thu, 09/01/2022 - 10:00
The U.S. Food and Drug Administration (FDA) has approved Xenpozyme™ (olipudase alfa-rpcp) for the treatment of non-central nervous system (non-CNS) manifestations of acid sphingomyelinase deficiency (ASMD) in adult and pediatric patients. Xenpozyme is the first therapy indicated specifically for the treatment of ASMD, and is currently the only approved treatment for this disease.

FDA approves first treatment for Acid Sphingomyelinase Deficiency, a rare genetic disease

World Pharma News - Wed, 08/31/2022 - 10:00
Today, the U.S. Food and Drug Administration approved Xenpozyme (Olipudase alfa) for intravenous infusion in pediatric and adult patients with Acid Sphingomyelinase Deficiency (ASMD), a rare genetic disease that causes premature death. Xenpozyme is the first approved medication to treat symptoms that are not related to the central nervous system in patients with ASMD.

Efficacy, cash and more will increase booster shot acceptance

World Pharma News - Tue, 08/30/2022 - 10:00
The more effective the COVID-19 booster, the more likely people are to get it, according to new Cornell research. And they are more likely to accept the booster shot with cash incentives and if it is made by Moderna or Pfizer.

As the Omicron variant of COVID-19 emerged, Cornell researchers conducted the public opinion survey - thought to be one of the first to assess the factors that affect people's willingness to receive a vaccine booster.

BioNTech's statement on patent infringement lawsuit filed by Moderna

World Pharma News - Mon, 08/29/2022 - 10:00
BioNTech SE (Nasdaq: BNTX, "BioNTech") published an official statment: "BioNTech is aware of reports that Moderna has sued Pfizer and BioNTech, alleging that COMIRNATY® infringes certain Moderna patents. BioNTech's work is original, and we will vigorously defend against all allegations of patent infringement.

Moderna sues Pfizer and BioNTech for infringing patents central to Modernas innovative mRNA technology platform

World Pharma News - Fri, 08/26/2022 - 10:00
Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today is filing patent infringement lawsuits against Pfizer and BioNTech in the United States District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany.

Novartis announces intention to separate Sandoz business to create a standalone company by way of a 100% spin-off

World Pharma News - Thu, 08/25/2022 - 10:00
Novartis today announced its intention to separate Sandoz, its generics and biosimilars division into a new publicly traded standalone company, by way of a 100% spin-off.

The spin-off aims to maximize shareholder value by creating the #1 European generics company(1) and a global leader in biosimilars, allowing Novartis shareholders to participate fully in the potential future upside for both Sandoz and Novartis Innovative Medicines.

New generation of corona vaccine shows promising results

World Pharma News - Wed, 08/24/2022 - 10:00
Researchers at Karolinska Institutet in Sweden are developing a coronavirus vaccine designed to be less sensitive to mutations and equipped for future strains. The vaccine showed promising results in mice in a newly published study in EMBO Molecular Medicine, and the researchers now hope to be able to take it to safety studies on humans.

Study first to link weed killer Roundup® to convulsions in animals

World Pharma News - Tue, 08/23/2022 - 10:00
A recent report by the United States Centers for Disease Control and Prevention found more than 80 percent of urine samples from children and adults in the U.S. contained the herbicide glyphosate. A study by Florida Atlantic University and Nova Southeastern University takes this research one step further and is the first to link the use of the herbicide Roundup®, a widely used weed killer, to convulsions in animals.

Pfizer and BioNTech submit application to U.S. FDA for Emergency Use Authorization of Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

World Pharma News - Mon, 08/22/2022 - 10:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced they have completed a submission to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) of a booster dose of an Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine for individuals 12 years of age and older.

Metformin drastically reduces COVID hospitalization

World Pharma News - Fri, 08/19/2022 - 10:00
The widely available diabetes drug metformin reduced serious outcomes by more than half if started within 4 days of COVID symptoms in a large, randomized, double blind controlled trial, the University of Minnesota announced today. The results were published Aug. 18 in the New England Journal of Medicine.

Bayer supports demining in Ukraine with donation to non-profit "Fondation suisse de déminage"

World Pharma News - Thu, 08/18/2022 - 10:00
Bayer supports the humanitarian non-profit organization "Fondation suisse de déminage" (FSD) in their mission to demine land that was contaminated by mines and unexploded devices since the onset of the war in Ukraine. A donation of 825,000 euros will be dedicated to purchasing a large-size mechanical mine clearance machine.

Powerful new antibody neutralizes all known SARS-CoV-2 variants

World Pharma News - Wed, 08/17/2022 - 10:00
As SARS-CoV-2 has evolved and mutated, therapeutic antibodies that worked early in the pandemic have become less effective, and newer variants, especially Omicron, have developed ways to evade the antibodies we make in response to vaccines. A new, broadly neutralizing antibody developed at Boston Children's Hospital could potentially improve our ability to defend against future variants.

Scientists develop gel made from spider silk proteins for biomedical applications

World Pharma News - Tue, 08/16/2022 - 10:00
Researchers at Karolinska Institutet in Sweden and the Swedish University of Agricultural Sciences have discovered that spider silk proteins can be fused to biologically active proteins and be converted into a gel at body temperature. One of the goals is to develop an injectable protein solution that forms a gel inside the body, which could be used in tissue engineering and for drug release, but also make gels that can streamline chemical processes where enzymes are used.

Pfizer announces positive top-line results from Phase 3 study of 20-valent pneumococcal conjugate vaccine in infants

World Pharma News - Mon, 08/15/2022 - 09:00
Pfizer Inc. (NYSE:PFE) announced positive top-line results from its pivotal U.S. Phase 3 study (NCT04382326) in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.

Roche announces U.S. FDA approval of Xofluza to treat influenza in children aged five years and older

World Pharma News - Fri, 08/12/2022 - 10:00
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of acute uncomplicated influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours.