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Mashup Score: 22
First and only U.S. approval of a maternal vaccine to help protect infants at birth through six months of life from lower respiratory tract disease (LRTD) and severe LRTD due to RSV FDA’s decision is based on data from the pivotal Phase 3 clinical trial in more than 7,000 pregnant individuals, and including their infants a total greater than 14,000 trial participants Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved ABRYSVO™ ( Respiratory Syncytial Virus Vaccine ), the company’s bivalent RSV prefusion F (RSVpreF) vaccine, for the prevention of LRTD and severe LRTD caused by RSV in infants from birth up to six months of age by active immunization of pregnant individuals at 32 through 36 weeks gestational age. ABRYSVO is unadjuvanted and composed of two preF proteins selected to optimize protection against RSV A and B strains and was observed to be safe and effective. “ABRYSVO’s approval as the first and only maternal immunization to
Source: investors.pfizer.comCategories: Infectious Disease, Latest HeadlinesTweet
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Mashup Score: 0FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata - 10 month(s) ago
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12 Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO ™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first…
Source: investors.pfizer.comCategories: Healthcare Professionals, Latest HeadlinesTweet-
FDA has approved a 2nd JAK inhibitor for Alopecia areata - Pfizers Ritlecitinib (Litfulo) is approved for Adults and Adolescents (>12 yrs) With Severe Alopecia Areata (based on ALLEGRO trial, pub in Lancet) https://t.co/Uods58glJG https://t.co/Uods58glJG https://t.co/syCqnG6sLg
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Mashup Score: 11FDA Approves Pfizer’s LITFULO™ (Ritlecitinib) for Adults and Adolescents With Severe Alopecia Areata - 10 month(s) ago
LITFULO is the first and only treatment for severe alopecia areata approved for patients as young as 12 Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved LITFULO ™ (ritlecitinib), a once-daily oral treatment, for individuals 12 years of age and older with severe alopecia areata. The approved recommended dose for LITFULO is 50 mg. It is the first…
Source: investors.pfizer.comCategories: Healthcare Professionals, Latest HeadlinesTweet-
FDA has approved a 2nd JAK inhibitor for Alopecia areata - Pfizers Ritlecitinib (Litfulo) is approved for Adults and Adolescents (>12 yrs) With Severe Alopecia Areata (based on ALLEGRO trial, pub in Lancet) https://t.co/VmjhQOnZyS https://t.co/VmjhQOnZyS https://t.co/oUZfckt6DX
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Mashup Score: 19
Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine In the Phase 2/3 clinical trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by…
Source: investors.pfizer.comCategories: Infectious Disease, Latest HeadlinesTweet-
Pfizer and BioNTech Announce Data Demonstrating High Immune Response Following a Booster Dose of their COVID-19 Vaccine in Children 5 Through 11 Years of Age https://t.co/6jBIdpLfqv https://t.co/FvS98x2Bzt
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Mashup Score: 18
Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine In the Phase 2/3 clinical trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by…
Source: investors.pfizer.comCategories: Hematologists1, Latest HeadlinesTweet-
RT @SukunaBikona7: 401人でのデータで忍容性はよく、安全性について新規の問題はなし。 https://t.co/rRht3zUZMS 12歳以上と同様に3回目接種でオミクロンに対する有効性は高まるか。
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Mashup Score: 311
With pediatric COVID-19 cases surpassing 10 million and at the request of the FDA, the companies have submitted available data on the safety and efficacy of two 3 µg doses as part of a three-dose primary series for this age group to address the urgent public health need Companies plan to submit additional data on a third 3 µg dose in this age group in the coming months If authorization is…
Source: investors.pfizer.comCategories: Hem/Oncs, Latest HeadlinesTweet-
Wow, imagine if a Trump administration asked Pfizer to submit data for vaccine approval when 2 doses failed the very low bar of non-inferiority and 3 doses was ongoing. https://t.co/f8sHHSlpei
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Mashup Score: 2Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine - 2 year(s) ago
Third mRNA vaccine collaboration between the companies aims to accelerate development of an improved vaccine for shingles, a debilitating, disfiguring and painful disease that affects people all over the world Product candidates will be based on BioNTech’s proprietary mRNA technology and on Pfizer’s antigen technology Clinical trials are expected to start in the second half of 2022 BioNTech will…
Source: investors.pfizer.comCategories: Hem/Oncs, Latest HeadlinesTweet-
Pfizer Inc. - Pfizer and BioNTech Sign New Global Collaboration Agreement to Develop First mRNA-based Shingles Vaccine https://t.co/PjU5UL3FZf
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Mashup Score: 4Pfizer and BioNTech Provide Update on Omicron Variant - 2 year(s) ago
Preliminary laboratory studies demonstrate that three doses of the Pfizer-BioNTech COVID-19 Vaccine neutralize the Omicron variant (B.1.1.529 lineage) while two doses show significantly reduced neutralization titers Data indicate that a third dose of BNT162b2 increases the neutralizing antibody titers by 25-fold compared to two doses against the Omicron variant; titers after the booster dose are…
Source: investors.pfizer.comCategories: Hem/Oncs, Latest HeadlinesTweet-
RT @TheBcellArtist: Encouraging update from Pfizer! https://t.co/GRBJGY1tYJ https://t.co/eyYEqhGJnT
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Mashup Score: 6
PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19 In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo Pfizer plans to submit the data as part of its ongoing rolling…
Source: investors.pfizer.comCategories: Hem/Oncs, Latest HeadlinesTweet-
Pfizer press release for PF-07321332+ritonavir in patients with #COVID19 Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study https://t.co/C5cBxEL06J
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Mashup Score: 2
PAXLOVID™ (PF-07321332; ritonavir) was found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19 In the overall study population through Day 28, no deaths were reported in patients who received PAXLOVID™ as compared to 10 deaths in patients who received placebo Pfizer plans to submit the data as part of its ongoing rolling…
Source: investors.pfizer.comCategories: Hem/Oncs, Latest HeadlinesTweet-
Ritonavir press release #COVID19 Pfizer’s Novel COVID-19 Oral Antiviral Treatment Candidate Reduced Risk of Hospitalization or Death by 89% in Interim Analysis of Phase 2/3 EPIC-HR Study https://t.co/C5cBxEL06J
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Sigh @US_FDA just approved Pfizer vax ABRYSVO in pregnancy to protect infants against RSV despite a 20%! higher rate of preterm birth in vax group (5.7%) vs controls (4.7%) Most of VRBPAC shrugged off signal as "non significant" but study underpowered🧵 https://t.co/UIGtm8t3aG https://t.co/wdEHyv9Kay