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EMA panel probes heart inflammation with Pfizer/BioNTech COVID vaccine

pharmaphorum

A review of side effects reported with coronavirus vaccines by the EMA’s safety committee has uncovered cases of inflammation of the heart in people receiving the Pfizer/BioNTech Comirnaty shot. . It is also asking for similar data from Moderna, which manufacture a COVID-19 vaccine that like Comirnaty is based on mRNA.

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Juno Pharmaceuticals buys Omega Laboratories

Pharmaceutical Technology

The firm plans to offer more than 100 new products to the Canadian market in the next four years, with pain management, oral solutions, allergy vaccines, diabetes and weight loss as the main areas of focus. It also plans to introduce improved solutions for clients in the dental, cosmetic and animal health industries.

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COVID-19 Vaccine News: Reactions, Efficacy, Dosing and More

The Pharma Data

Rare Vaccination Side Effect in People Who Received Cosmetic Facial Fillers. Food and Drug Administration (FDA) noted that there have been a few reports of people who received cosmetic injections to smooth wrinkles or plump lips having unexpected swelling related to the COVID-19 vaccination. Here’s a look.

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FDA Announces Tentative Advisory Committee Meeting Schedule Regarding COVID- 19 Vaccines

The Pharma Data

Food and Drug Administration is announcing its plans to hold virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) in anticipation of complete submissions of emergency use authorization (EUA) requests in the coming months that have been publicly announced by COVID-19 vaccine manufacturers.

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FDA to Hold Advisory Committee Meeting on COVID-19 Vaccines to Discuss Future Boosters

The Pharma Data

Food and Drug Administration is announcing a virtual meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Wed., As we prepare for future needs to address COVID-19, prevention in the form of vaccines remains our best defense against the disease and any potentially severe consequences,” said Peter Marks, M.D.,

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FDA Limits Use of Janssen COVID-19 Vaccine to Certain Individuals

The Pharma Data

The Fact Sheet for Healthcare Providers Administering Vaccine now reflects the revision of the authorized use of the Janssen COVID-19 Vaccine and includes a warning statement at the beginning of the fact sheet for prominence which summarizes information on the risk for TTS.

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FDA Announces Advisory Committee Meeting to Discuss COVID-19 Vaccine Candidate

The Pharma Data

Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. BNT162b2 (SARS-CoV-2 vaccine) FDA Approval History. November 20, 2020 — The U.S.