COVID-19 Vaccines – FDA Authorizes Pfizer Booster and ACIP Review (Day 2)

The FDA authorized booster doses of the Pfizer-BioNTech COVID-19 vaccine for certain populations. The FDA amended the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine to allow for use of a single booster dose of Comirnaty administered at least six months after completion of the primary series. The eligible population includes:

• Individuals 65 years of age and older
• Individuals 18 through 64 years of age at high risk of severe COVID-19 and
• Individuals 18 through 64 years of age whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of COVID-19 including severe COVID-19.

September 22, 2021

Byooviz™ (ranibizumab-nuna) – New biosimilar approval

The FDA announced the approval of Samsung Bioepis and Biogen’s Byooviz (ranibizumab-nuna), a biosimilar to Genentech’s Lucentis (ranibizumab). September 17, 2021

Exkivity™ (mobocertinib) – New orphan drug approval

Takeda announced the FDA approval of Exkivity (mobocertinib), for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. September 15, 2021

Tivdak™ (tisotumab vedotin-tftv) – New drug approval

Seagen and Genmab announced the FDA approval of Tivdak (tisotumab vedotin-tftv), for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. September 20, 2021

Bystolic® (nebivolol) – First-time generic

Camber/Hetero, Torrent, Ascend and ANI Pharmaceuticals launched AB-rated generic versions of Allergan’s Bystolic (nebivolol) tablets. September 17, 2021

bamlanivimab/etesevimab – Emergency use authorization expansion

The FDA announced the emergency use authorization approval (EUA) of Eli Lilly’s bamlanivimab/etesevimab. September 16, 2021

Brukinsa® (zanubrutinib) – New indication

BeiGene announced the FDA approval of Brukinsa (zanubrutinib), for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen. September 15, 2021

Cabometyx® (cabozantinib) – New indication

Exelixis announced the FDA approval of Cabometyx (cabozantinib), for the treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible. September 17, 2021

COVID-19 Vaccines – CDC’s ACIP Discusses Vaccine Boosters (Day 1)

The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) met for the first of two days of deliberation about booster doses of the mRNA COVID-19 vaccines. September 22, 2021

COVID-19 Vaccines – New Data on Booster of Janssen Vaccine

Janssen (Johnson & Johnson) announced new data on their COVID-19 vaccine showing that protection against COVID-19 increases when a booster shot of the vaccine is administered following the initial 1-dose regimen. The safety profile of the vaccine remained consistent and was generally well-tolerated when administered as a booster.September 21, 2021