BioBiz: Merck to aid in COVID-19 vax production; Novavax eyes FDA filing for COVID-19 vax

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Pharma giant, Merck is supporting efforts to expand the manufacturing capacity and supply of COVID-19 medicines and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), will provide Merck with funding, up to $268.8 million to adapt and make available a number of existing manufacturing facilities for the production of COVID-19 vaccines and medicines.

Merck has also entered into agreements with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, to support the manufacturing and supply of Johnson & Johnson’s SARS-CoV-2/COVID-19 vaccine. Merck will use its facilities in the United States to produce drug substance, formulate and fill vials of Johnson & Johnson’s vaccine.

Novavax is eyeing a second-quarter FDA filing for emergency use of its COVID-19 vaccine. The goal suggests the U.S. could join the U.K. on the list of countries to authorize the vaccine in the first half of the year.

The success of the vaccine in a 15,000-subject U.K. phase 3 clinical trial gives Novavax a clear path to a positive decision by the Medicines and Healthcare products Regulatory Agency (MHRA). However, the lack of data from another phase 3 trial that only recently completed enrolling 30,000 subjects in the U.S. and Mexico makes the route to an FDA OK less clear.

The FDA also announced today that has authorized marketing for Memic Innovative Surgery’s Hominis system for transvaginal hysterectomy. Hominis is the first FDA-approved robotically-assisted surgical device for performing transvaginal hysterectomy, with an indication for performing benign hysterectomy with salpingo-oophorectomy, according to an FDA news release.

Using minimally invasive surgical instruments inserted through the vagina and a video camera inserted laparoscopically through a small incision on the abdomen, the Hominis surgical system is designed to remove the uterus. The transvaginal approach requires fewer incisions on the abdomen compared to the traditional laparoscopic hysterectomy, the FDA said.

NYC-based biotech, Q BioMed has signed a 5-year agreement effective this month, to commercially to serve the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD). The company will be supplying its bone cancer pain drug, Strontium89 to over 9 million beneficiaries and other patients in the federal system. The agreement provides U.S. veterans and other federal government agencies access to Strontium89 for eligible patients. The final FSS contract is effective March 1, 2021, and has a five-year term. The FSS contract will extend access to Strontium89 to over nine million VA beneficiaries and others within the federal system.

The Company is preparing commercially to serve the U.S. Department of Veterans Affairs (VA) and Department of Defense (DoD) with activities that include a VA sales force, formulary and market access, medical education, and marketing. Efforts will begin in March 2021 and build throughout the year as the FSS agreement is translated to clinical use. 

“Q BioMed is very encouraged by this important milestone. This agreement further extends the commercial reach of Strontium89 to eligible adult patients suffering pain from metastatic bone cancer in the VA and other federal agencies,” said Q BioMed CEO Denis Corin in a statement.