Pfizer Archives - Page 7 of 33 - Medical Design Sourcing

Pfizer to spend $120M to make COVID-19 oral treatment in U.S.

Pfizer (NYSE: PFE) announced today that it will invest $120 million into its Kalamazoo, Michigan facility to support U.S.-based production of its COVID-19 antiviral Paxlovid (nirmatrelvir/ritonavir).

The investment is expected to create more than 250 additional, high-skilled jobs at the Kalamazoo site.

The money will expand the production of active pharmaceutical ingredient (API) and registered starting materials (RSMs) used in the manufacture of nirmatrelvir. Pfizer noted in a news release that results from its EPIC-HR (Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients) study showed an 88% reduction in COVID-19-related hospitalization or death among adults treated with Paxlovid compared to placebo within five days of noticing symptoms.

“Pfizer Global Supply has made the impossible possible, making billions of vaccine doses and now millions of treatment courses to help battle the deadly COVID-19 pandemic,” said Prizer CEO Dr. Albert Bo…

Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

[Photo by Eugene Chystiakov]Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data supports a third dose of their COVID-19 vaccine in young children.

Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and a favorable safety profile similar to placebo in children aged six months to under five years old.

Get the full story at our sister site, Pharmaceutical Processing World.

Pfizer, BioNTech moving forward on seeking COVID-19 vaccine EUA for youngest children

Pfizer-BioNTech COVID-19 vaccine. [Image courtesy of Wikimedia Commons]

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) announced today that data supports a third dose of their COVID-19 vaccine in young children.

Topline safety, immunogenicity and vaccine efficacy data from a Phase 2/3 trial evaluating a third 3-µg dose of the vaccine — marketed in the U.S. as Comirnaty — showed a strong immune response and a favorable safety profile similar to placebo in children aged six months to under five years old.

In the trial, 1,678 children received a third dose of the vaccine at least two months after second dose, while omicron was the predominant variant. Non-inferiority was met for both the 6-24 month-old population and the 2-under 5-year-old population for both primary endpoints, with the vaccine well tolerated, leading to no new safety signals.

Vaccine efficacy (a secondary endpoint) registered at 80.…

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

Pfizer-BioNTech

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

Get the full story from our sister site, Drug Discovery & Development.

FDA allows booster dose Pfizer-BioNTech COVID-19 vaccine in children 5 to 11

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine.

The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said FDA Commissioner Robert M. Califf in a news release.

While “COVID-19 tends to be less severe in children than adults,” Califf noted that the omicron wave has resulted in more children getting infected and hospitalized with COVID-19 infections. “Children may also experience longer-term effects, even following initially mild disease,” he added.

The FDA has determined that vaccine effectiveness in all authorized populations wanes in the weeks and months following administration of a second dose.

“The FDA has determined that the known and potential benefits of a single booster dose of the Pfizer-BioNTech COVID…

Pfizer to shell out $11.6B for migraine drugmaker Biohaven

Pfizer (NYSE:PFE) today announced that it has entered into an agreement to acquire Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), which is best known for Nurtec ODT (rimegepant), a dual-acting migraine therapy.

Pfizer will pay $148.50 per share in cash to acquire Biohaven, totaling approximately $11.6 billion.

Get the full story from our sister site, Pharmaceutical Processing World.

Pfizer to shell out $11.6B for migraine drugmaker Biohaven

Pfizer (NYSE:PFE) today announced that it has entered into an agreement to acquire Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN), which is best known for Nurtec ODT (rimegepant), a dual-acting migraine therapy.

Pfizer will pay $148.50 per share in cash to acquire Biohaven, totaling approximately $11.6 billion.

Nurtec generated $462 million in revenue in 2021. Pfizer anticipates that the acquisition will fuel continued growth through the remainder of the decade and beyond.

Evaluate Pharma projects that Nurtec could generate $2 billion in international sales by 2026.

Nurtec image courtesy of Biohaven

Nurtec is a calcitonin gene-related peptide (CGRP) agonist that has emerged as a popular preventive treatment for migraines with or without aura.

Notable competitors in the class include Qulipta (atogepant) from AbbVie (NYSE:ABBV and Ubrelvy (ubrogepant) from AbbVie subsidiar…

Pfizer ticks up on Street-beating Q1, lessens full-year guidance

Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast.

The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%.

Adjusted to exclude one-time items, earnings per share were $1.62, 15¢ ahead of Wall Street, where analysts were looking for sales of $23.9 billion.

Get the full story at our sister site, Drug Discovery & Development.

Pfizer ticks up on Street-beating Q1, lessens full-year guidance

Pfizer (NYSE:PFE) shares rose today on first-quarter financial results that came in ahead of the consensus forecast.

The New York-based pharmaceutical company posted profits of $7.9 billion, or $1.37 per share, on sales of $25.7 billion for the three months ended April 3, 2022, for a 61.2% bottom-line gain on sales growth of 76.8%.

Adjusted to exclude one-time items, earnings per share were $1.62, 15¢ ahead of Wall Street, where analysts were looking for sales of $23.9 billion.

Pfizer reported 82% operational growth overall, while the company registered operational growth of 2% when excluding its Comirnaty COVID-19 vaccine and Paxlovid oral COVID-19 treatment. Comirnaty sales grew by $10.2 billion to $13.2 billion in the quarter, while Paxlovid contributed $1.5 billion to global sales, driven by the U.S. launch of the treatment in December 2021 and following international launches.

“I am very proud of our performance this quarter, both from a fina…

Pfizer’s COVID-19 antiviral disappoints as post-exposure prophylactic

Pfizer (NYSE:PFE) announced that its COVID-19 antiviral Paxlovid failed to reach statistical significance in reducing risk after patients were exposed to the SARS-CoV-2 virus.

The primary endpoint of the Phase 2/3 EPIC-PEP (Evaluation of Protease Inhibition for COVID-19 in Post-Exposure Prophylaxis) study was to reduce the risk of confirmed and symptomatic COVID-19 in adults after exposure to a household contact.

Paxlovid (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) led to risk reductions of 32% at day five of therapy. That figure climbed to 37% at day ten of treatment.

The study was completed during the omicron wave.

The emergency use authorization for the drug calls for the drug to be administered twice daily for five days.

Paxlovid appeared to be well tolerated across the EPIC-PEP study and the related EPIC-HR and EPIC-SR trials. In addition, Pfizer noted that the post-market safety data were also encouraging.

The st…

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

Get the full story from our sister site, Drug Discovery & Development.

FDA signals careful approach in authorizing COVID-19 vaccines in young children

FDA is planning a series of virtual meetings of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) throughout June.

In the meetings, the advisory committee will discuss authorizing the COVID-19 vaccine from Novavax (Nasdaq:NVAX) and authorizing the use of the vaccines from Moderna (Nasdaq: MRNA) and Pfizer-BioNTech (NYSE:PFE; Nasdaq:BNTX) in children aged 6 months to 5 years old.

The agency has tentatively scheduled three VRBPAC meetings for June 8, 21 and 22 to discuss offering the Moderna and Pfizer-BioNTech vaccines to younger children.

In addition, the FDA will meet to discuss the possibility of recommending modifying the strain composition of COVID-19 vaccines for the fall.

The VRBPAC is scheduled to meet on June 7 to discuss authorization of the Novavax vaccine in adults 18 and older.

The Novavax NVX‑CoV2373 vaccine has received conditional authorization from several regulatory authorities internationally. Its pr…