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Pfizer (PFE) Inks Vaccine Deal, Faces FDA Delay on JAK Drugs
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Pfizer (PFE - Free Report) along with BioNTech (BNTX - Free Report) announced that they have entered into a collaboration with South African biopharma company Biovac to manufacture and distribute their COVID-19 vaccine within Africa.
Pfizer expects Biovac to initiate the manufacturing of finished doses in 2022, with a goal of annual production of 100 million at full operational capacity. Biovac will source the drug substance from facilities in Europe. The manufactured vaccine will exclusively be distributed in the African continent.
The collaboration with Biovac will allow the Pfizer-BioNTech COVID-19 vaccine manufacturing network to include more than 20 manufacturing facilities and the global supply chain to span across three continents.
Shares of Pfizer have risen 11.5% so far this year in comparison with the industry’s 9.5% increase.
Image Source: Zacks Investment Research
Please note that Pfizer previously partnered with Biovac in 2015 to manufacture and distribute its pneumococcal vaccine Prevnar 13.
The Pfizer-BioNTech COVID-19 vaccine is currently authorized for emergency/conditional use in several countries. Both Pfizer and BioNTech anticipate bringing new partners to expand the supply chain of their COVID-19 vaccine in Latin America.
In a separate press release, Pfizer announced that the FDA has extended the review period for regulatory applications of its Janus kinase (“JAK”) inhibitors.
The FDA stated that it will not be able to meet the PDUFA date for the new drug application (“NDA”) of Pfizer’s JAK inhibitor candidate, abrocitinib, for moderate to severe atopic dermatitis. The FDA was expected to give its decision on the NDA in third-quarter 2021. The FDA has also delayed decision of Pfizer’s sNDA seeking approval of its marketed JAK inhibitor, Xeljanz, for active ankylosing spondylitis (AS).
The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating Xeljanz in rheumatoid arthritis as the reason for delay. We remind investors that in February, the FDA issued a statement that Xeljanz may increase the risk of heart-related problems and cancer.
This is the second time that the FDA has delayed its decision on Pfizer’s NDA for abrocitinib for AD and Xeljanz’s sNDA for AS. Back in April, it delayed decisions on the same regulatory filings by three months.
We inform investors that earlier this week, Lilly (LLY - Free Report) and AbbVie (ABBV - Free Report) also announced similar decisions on FDA delays for label expansion filings for their JAK inhibitor drugs, Olumiant and Rinvoq, respectively, to treat AD indication.
The extension of review dates and other negative updates for JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs.
Image: Bigstock
Pfizer (PFE) Inks Vaccine Deal, Faces FDA Delay on JAK Drugs
Pfizer (PFE - Free Report) along with BioNTech (BNTX - Free Report) announced that they have entered into a collaboration with South African biopharma company Biovac to manufacture and distribute their COVID-19 vaccine within Africa.
Pfizer expects Biovac to initiate the manufacturing of finished doses in 2022, with a goal of annual production of 100 million at full operational capacity. Biovac will source the drug substance from facilities in Europe. The manufactured vaccine will exclusively be distributed in the African continent.
The collaboration with Biovac will allow the Pfizer-BioNTech COVID-19 vaccine manufacturing network to include more than 20 manufacturing facilities and the global supply chain to span across three continents.
Shares of Pfizer have risen 11.5% so far this year in comparison with the industry’s 9.5% increase.
Image Source: Zacks Investment Research
Please note that Pfizer previously partnered with Biovac in 2015 to manufacture and distribute its pneumococcal vaccine Prevnar 13.
The Pfizer-BioNTech COVID-19 vaccine is currently authorized for emergency/conditional use in several countries. Both Pfizer and BioNTech anticipate bringing new partners to expand the supply chain of their COVID-19 vaccine in Latin America.
In a separate press release, Pfizer announced that the FDA has extended the review period for regulatory applications of its Janus kinase (“JAK”) inhibitors.
The FDA stated that it will not be able to meet the PDUFA date for the new drug application (“NDA”) of Pfizer’s JAK inhibitor candidate, abrocitinib, for moderate to severe atopic dermatitis. The FDA was expected to give its decision on the NDA in third-quarter 2021. The FDA has also delayed decision of Pfizer’s sNDA seeking approval of its marketed JAK inhibitor, Xeljanz, for active ankylosing spondylitis (AS).
The FDA cited its ongoing review of Pfizer's post-marketing safety study, ORAL Surveillance, evaluating Xeljanz in rheumatoid arthritis as the reason for delay. We remind investors that in February, the FDA issued a statement that Xeljanz may increase the risk of heart-related problems and cancer.
This is the second time that the FDA has delayed its decision on Pfizer’s NDA for abrocitinib for AD and Xeljanz’s sNDA for AS. Back in April, it delayed decisions on the same regulatory filings by three months.
We inform investors that earlier this week, Lilly (LLY - Free Report) and AbbVie (ABBV - Free Report) also announced similar decisions on FDA delays for label expansion filings for their JAK inhibitor drugs, Olumiant and Rinvoq, respectively, to treat AD indication.
The extension of review dates and other negative updates for JAK inhibitor drugs have raised concerns regarding safety issues of this class of drugs.
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Pfizer currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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