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Approvals in the Crazy Year of 2020

Eye on FDA

During 2020, FDA was able to approve 53 – not surpassing the 2018 all time record of 59, but certainly an admirable second place. Notably, the 2020 NME approvals included 22 related to oncology, with 2 new GIST treatments, 3 in breast cancer and 2 approvals in prostate cancer. That, however, was not really the case.

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Monthly News Roundup – December 2020

The Pharma Data

Monthly News Roundup – December 2020. Moderna and Pfizer’s COVID-19 Vaccines Roll Out in Early Phase. Food and Drug Administration (FDA) issued Emergency Use Authorization for two COVID-19 vaccines: Pfizer-BioNTech’s BNT162b2 and Moderna’s mRNA-1273. The duration of protection from the vaccines are not known yet.

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Keeping tabs on Covid-19: FDA approves Veklury as first treatment for Covid-19 and Takeda and Moderna bring 50 million vaccines to Japan

The Pharma Data

More recently, the FDA announced regulatory approval for the first treatment for Covid-19. FDA approves first treatment for Covid-19. On October 22, the FDA approved the antiviral drug Veklury for use in adult and pediatric patients for the treatment of Covid-19 requiring hospitalization.

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AstraZeneca Release “Pooled Analysis” Phase 3 Data on COVID-19 Vaccine | 2020-12-08

The Pharma Data

AstraZeneca (AZ) and the University of Oxford have presented new data from a “pooled analysis” of phase 3 trials evaluating COVID-19 vaccine AZD1222 at two different dose regimens, demonstrating an average efficacy of 70.4 The University of Oxford claims no vaccinated participants were hospitalized or suffered serious forms of the disease.

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OBI Pharma Announces Presentations at ESMO Asia 2020 Virtual Annual Meeting for OBI-833, a Novel Anti-Globo H Targeted Therapeutic Cancer Vaccine

The Pharma Data

19, 2020 /PRNewswire/ — OBI Pharma, Inc. These results will be presented by the lead investigators of OBI Pharma’s novel anti-Globo H therapeutic cancer vaccine, OBI-833. Session Date and Time: Friday, November 20, 2020. Session Date and Time: Friday, November 20, 2020. TAIPEI, Taiwan , Nov. About OBI Pharma.

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Big Decisions – Reviewing FDA Advisory Committee Outcomes Since 2020

Eye on FDA

Note these numbers cover meetings about drug applications only, not including vaccines or cellular therapies. That said, beginning in 2020 meetings began skewing to more negative outcomes and 2022 was the first year where the number of negative outcomes outweighed the number of positive outcomes.

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Allergists’ Group Updates Guidelines on COVID-19 Vaccines

The Pharma Data

22, 2020 — In very rare cases, some people have had severe allergic reactions after receiving the new COVID-19 vaccines, leading the American College of Allergy , Asthma, and Immunology (ACAAI) to issue updated guidance for Americans with allergies. © 2020 HealthDay. TUESDAY, Dec.

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