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BioNTech Unveils the BioNTainer, a Modular mRNA Vaccine Factory to Help Production in Africa

XTalks

BioNTech announced its new vaccine manufacturing approach in Africa where the company will ship modular factories, called the BioNTainer, to the continent to enable domestic production of the vaccines to help increase supplies. Related: BioNTech to Build First mRNA Vaccine Production Plant in Africa. Photo source: BioNTech.

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STAT+: Pharmalittle: Moderna must face patent claims over its Covid-19 vaccine; Pfizer and BioNTech testing combo Covid and flu shot

STAT News

… A Delaware federal court refused to throw out patent infringement claims brought by Arbutus Biopharma and Genevant Sciences against Moderna over its sale of Covid-19 vaccine doses to the U.S.  Genevant and Arbutus sued Moderna in February, seeking royalties from Moderna’s sale of its Covid-19 vaccine.

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Biologic Therapeutics Development, Part 1: Definition and Distinct Characteristics

Camargo

Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product. Essentially, a biologic is a product that is produced from living organisms or that contains components of living organisms.

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Quality by design with a focus on biosimilars

Pharmaceutical Technology

For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve. Even minor amounts of biological contaminants in your sample could cause unwanted biological effects,” Dr Amiji says.

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Black Women’s Group Launches Lawsuit Against Johnson & Johnson Over Targeted Baby Powder Ads

XTalks

Johnson and Johnson has faced thousands of lawsuits over its iconic baby powder, which people claim the company knew for decades contained asbestos. Talc and asbestos are often found together in nature, which is why mined talc can contain the carcinogen. Related: AstraZeneca Prevails in EU COVID-19 Vaccine Lawsuit. “We

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Health Highlights: Dec. 30, 2020

The Pharma Data

Becomes First Country to Approve Covid-19 Vaccine From Oxford-AstraZeneca. Britain became the first country to give authorization to the coronavirus vaccine developed by AstraZeneca and the University of Oxford, The New York Times reported Wednesday. More Dangerous Mouthwashes and Hand Sanitizers Recalled. Shane Erickson Inc.

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Monkeypox Case Reported in the US as Virus Spreads Across Europe and North America

XTalks

Britain recently announced it will be offering the smallpox vaccine, which is 85 percent effective against monkeypox according to the World Health Organization (WHO) , to healthcare workers in the country due to the handfuls of cases being reported across Europe. Related: Malaria Vaccine a Breakthrough Success with 77 Percent Efficacy.

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