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National CDC-funded study confirms that mRNA vaccines protect against serious COVID-19 during pregnancy

World Pharma News - Mon, 09/26/2022 - 10:00
The first large, real-world study of the effectiveness of mRNA COVID-19 vaccines during pregnancy found these vaccines, especially two initial doses followed by a booster, are effective in protecting against serious disease in expectant mothers whether the shots are administered before or during pregnancy.

2nd Annual Next Generation Pharmaceutical Cleanrooms Conference

World Pharma News - Fri, 09/23/2022 - 10:00
5 - 6 October 2022, London, United Kingdom.
SAE Media Group are pleased to announce the 2nd Annual Next Generation Pharmaceutical Cleanroom Conference. An event that focuses on cleanroom technology in the pharmaceutical industry, the conference will serve to bridge that gap between the two areas while simultaneously providing a unique selling point.

Pfizer to supply Global Fund up to 6 million PAXLOVID™ treatment courses for low-and-middle-income countries

World Pharma News - Thu, 09/22/2022 - 10:00
Pfizer Inc. (NYSE: PFE) announced today an agreement to supply up to six million treatment courses of its COVID-19 oral treatment, PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) to Global Fund as part of its COVID-19 Response Mechanism (C19RM). The C19RM has been the primary channel for providing grant support to low- and middle-income countries to purchase COVID-19 tests, treatments, personal protective equipment and critical elements of health systems strengthening.

Shutting down backup genes leads to cancer remission in mice

World Pharma News - Wed, 09/21/2022 - 10:00
The way that tumor cells enable their uncontrolled growth is also a weakness that can be harnessed to treat cancer, researchers at the University of Michigan and Indiana University have shown.

Their machine-learning algorithm can identify backup genes that only tumor cells are using so that drugs can target cancer precisely.

Bird's enzyme points toward novel therapies

World Pharma News - Tue, 09/20/2022 - 10:00
Thank the rare crested ibis for a clue that could someday help our bodies make better drugs.

The species of bird is the only one known to naturally produce an enzyme able to generate a noncanonical amino acid; that is, one not among the 20 necessary to encode most proteins.

WHO grants prequalification to GSK's Mosquirix - the first and only approved malaria vaccine

World Pharma News - Mon, 09/19/2022 - 10:00
GSK plc (LSE/NYSE: GSK) announced that the World Health Organization (WHO) has awarded prequalification to Mosquirix (also known as RTS,S/AS01), GSK's groundbreaking malaria vaccine. This is the first prequalification for a malaria vaccine and is an important step in rolling out the vaccine in countries with moderate to high P. falciparum malaria transmission.

WHO strongly advises against antibody treatments for COVID-19 patients

World Pharma News - Fri, 09/16/2022 - 10:00
The antibody drugs sotrovimab and casirivimab-imdevimab are not recommended for patients with COVID-19, says a WHO Guideline Development Group of international experts in The BMJ.

These drugs work by binding to the SARS-CoV-2 spike protein, neutralising the virus's ability to infect cells.

Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine booster in European Union

World Pharma News - Thu, 09/15/2022 - 10:00
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced a 30-µg booster dose of their Omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine (COMIRNATY® Original/Omicron BA.4/BA.5 15/15 µg) has been recommended for conditional marketing authorization (cMA) by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) for individuals ages 12 years and older.

Mucosal antibodies in the airways protect against omicron infection

World Pharma News - Wed, 09/14/2022 - 10:00
High levels of mucosal antibodies in the airways reduce the risk of being infected by omicron, but many do not receive detectable antibodies in the airways despite three doses of the SARS-CoV-2 vaccine. These are the findings of a study published today in The New England Journal of Medicine, led by researchers at Karolinska Institutet and Danderyd Hospital in Sweden.

Drug turns cancer gene into "eat me" flag for immune system

World Pharma News - Tue, 09/13/2022 - 10:00
Tumor cells are notoriously good at evading the human immune system; they put up physical walls, wear disguises and handcuff the immune system with molecular tricks. Now, UC San Francisco researchers have developed a drug that overcomes some of these barriers, marking cancer cells for destruction by the immune system.

Novartis invests in early technical development capabilities for next-generation biotherapeutics

World Pharma News - Mon, 09/12/2022 - 10:00
Novartis today announced it is investing in next-generation biotherapeutics with the creation of a fully integrated, dedicated USD 300m scientific environment that will bolster its capacity and capabilities for early technical development of biologics. Spanning both drug substance and drug product development, the multi-year investment will be implemented across existing Novartis locations in Switzerland, Slovenia and Austria,

U.S. clinical trial evaluating antiviral for monkeypox begins

World Pharma News - Fri, 09/09/2022 - 10:00
A Phase 3 clinical trial evaluating the antiviral tecovirimat, also known as TPOXX, is now enrolling adults and children with monkeypox infection in the United States. Study investigators aim to enroll more than 500 people from clinical research sites nationwide. Interested volunteers can visit the ACTG website (clinical trial A5418) for more information.

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.