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Regulation

Novavax preps for Q2 COVID vaccine EUA submission; plus Fibrogen, Inovio, J&J, Aslan, Merck, Oncopeptides and Athenex

Mar 2, 2021 | 2:36 AM GMT

Novavax Inc. (NASDAQ:NVAX) said in its 4Q20 earnings report that it is discussing COVID-19 vaccine NVX-CoV2373 with FDA and may submit a request for emergency use authorization of candidate next quarter. The biotech announced on Feb. 22 that it completed enrollment in the 30,000-subject U.S. and Mexican Phase III PREVENT-19 trial of the adjuvanted, protein-based COVID-19 vaccine.

Novavax also revealed it’s testing a six-month booster shot, on top of the initial prime-boost vaccinations, in its U.S. and Australian Phase I/II trial; and that it plans to begin human studies of variant-specific candidates, as stand-alone or bivalent products, midyear. Other COVID-19 vaccine developers are taking similar steps to address SARS-CoV-2 variants.

EUA for J&J’s one-shot COVID vaccine
COVID-19 Vaccine Janssen became on Saturday the first  authorized one-shot COVID-19 vaccine and the first authorized adenoviral vector COVID-19 vaccine in the U.S. The EUA followed Friday’s unanimous vote by FDA’s Vaccines and Related Biologic Products Advisory Committee (VRBPAC) in favor of the product from Johnson & Johnson (NYSE:JNJ). On Sunday, CDC’s Advisory Committee on Immunization Practices followed the EUA by recommending the vaccine in individuals ages 18 and up. 

FDA sets panel for roxadustat ahead of March 20 PDUFA 
FibroGen Inc. (NASDAQ:FGEN) and AstraZeneca plc (LSE:AZN; NASDAQ:AZN) said FDA’s Cardiovascular and Renal Drugs Advisory Committee will meet to discuss an NDA for roxadustat to treat anemia of chronic kidney disease. The companies have not received a confirmed meeting date. The PDUFA date for the therapy, which is approved in China, Chile and Japan, is March 20.

Inovio meets in Phase III
Inovio Pharmaceuticals Inc. (NASDAQ:INO) said VGX-3100 met the primary and secondary endpoints of the Phase III REVEAL 1 trial to treat HPV-16/18-associated cervical high-grade squamous intraepithelial lesions.

Oncopeptides’ Pepaxto approved for MM
FDA approved Pepaxto melphalan flufenamide from Oncopeptides AB (SSE:ONCO) to treat relapsed or refractory multiple myeloma patients who have received at least four prior lines of therapy. It’s the first peptide-drug conjugate approved for multiple myeloma, according to the company.

Merck pulls SCLC indication from Keytruda label
Merck & Co. Inc. (NYSE:MRK) said it is withdrawing from Keytruda pembrolizumab’s U.S. label treatment of small cell lung cancer indication in patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy. The change follows the checkpoint inhibitor’s failure to improve overall survival in the confirmatory Phase III KEYNOTE-604 study.

Setback for Athenex in breast cancer
Shares of Athenex Inc. (NASDAQ:ATNX) lost 55% to $5.46 after FDA issued a complete response to an NDA for oral paclitaxel plus encequidar to treat metastatic breast cancer. According to the company, the agency wants a “new adequate and well-conducted” study as well as additional risk mitigation strategies to reduce toxicity

Aslan’s dermatitis candidate lowers symptoms in Phase I
Shares of Aslan Pharmaceuticals Ltd. (NASDAQ:ASLN) rose 19% to $5.25 after interim Phase I data showed nine atopic dermatitis patients given the middle or high ASLAN004 dose had a 74% average reduction at week eight from baseline in Eczema Area Severity Index (EASI) score vs. 42% in five placebo-treated patients. The Singapore-based company said it is planning a $60 million follow-on.

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