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Developers of Pfizer/BioNTech COVID-19 vaccine to establish Asia-Pacific mRNA R&D center

mRNA Victoria announced today that the developers of the Pfizer/BioNTech COVID-19 vaccine will establish a clinical R&D center in the Asia-Pacific region.

The center enables Victorian and Australian researchers to advance the next generation of mRNA vaccines and therapies. The R&D center aims to facilitate partnerships on scientific mentoring, business development advice and drug design.

Once operational, the facility will manufacture next-generation mRNA treatments and vaccines for research and clinical trials. This includes potential infectious diseases, cancer medicines and personalized cancer treatments. It will form part of BioNTech’s global network to attract demand for Melbourne’s clinical trial expertise, according to a news release.

Establishing its first Asia-Pacific R&D center in Melbourne helps BioNTech provide state-of-the-art drug development and research capabilities to the local ecosystem, the company said. A partn…

Pfizer and Moderna seek FDA nod for omicron-adapted COVID boosters in children

[Image courtesy of Pixabay.]

Pfizer/BioNTech (NYSE:/PFE, Nasdaq BNTX) and Moderna (Nasdaq:MRNA) have both won emergency use authorizations in the U.S. for bivalent vaccine boosters based on BA.4/BA.5.

Pfizer is aiming to win authorization to use its updated COVID-19 vaccine in children aged 5 through 11 years. Moderna has requested that FDA greenlight the use of its omicron booster in individuals 6 to 17.

Pfizer’s shot is currently authorized for individuals at least 12 years old, while Moderna’s is authorized for individuals 18 and up.

Pfizer noted in a news release that it had submitted safety and immunogenicity data for the bivalent BA.1-adapted vaccine to FDA. The company also included preclinical and manufacturing data related to the bivalent omicron BA.4/BA.5-adapted vaccine.

Moderna’s updated booster for adults includes a 50-µg dose of mRNA, while the Pfizer-BioNT…

Pfizer to provide up to 6 million Paxlovid courses to developing countries

Pfizer (NYSE:PFE) has reached an agreement to supply as many as six million courses of its oral COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) to the Global Fund, which seeks to help more than 100 low-to-middle income countries fight diseases such as COVID-19, HIV, tuberculosis and malaria.

Pfizer notes that the agreement with the Global Fund is part of a broader strategy to ensure equitable global access to Paxlovid.

The Global Fund’s COVID-19 Response Mechanism offers grant support to developing countries to procure COVID-19 tests, treatments and personal protective gear.

The Global Fund determined which 132 countries were eligible after reviewing data related to income classification and disease burden.

Pfizer will use a tiered pricing scheme for Paxlovid for the 132 countries. According to that plan, low- and lower-middle-income countries will pay a not-for-profit price for the drug, while upper-middle-income countries will pay a rat…

Pfizer and AI firm CytoReason extend alliance

The computational disease model developer CytoReason has announced that it has entered into a multi-year partnership with Pfizer (NYSE:PFE) that is potentially worth $110 million over the next five years.

In the recent partnership, Pfizer will make a $20 million equity investment in CytoReason. The company will also obtain options to license platform and disease models from Tel Aviv–based CytoReason.

The new collaboration will center around Pfizer’s focus on developing a variety of disease models and high-resolution models for several therapeutic areas.

The two companies began working together in 2019.

Pfizer has used CytoReason’s biological models of the immune system for drug development efforts related to immune-mediated and immuno-oncology diseases.

CytoReason reports that Pfizer has used its platform for R&D programs related to more than 20 diseases.

“CytoReason’s biological data allows us to gai…

Pfizer launches Phase 3 mRNA flu vaccine study

This computer-generated image shows influenza virus hemagglutinin epitopes arrayed on a nanoparticle. [Image courtesy of NIAID]

Big Pharma behemoth Pfizer (NYSE: PFE) has dosed the first participants in a pivotal Phase 3 clinical trial to test its quadrivalent modified RNA (modRNA) influenza vaccine candidate.

The mRNA flu vaccine study will enroll roughly 25,000 healthy U.S. adults.

Pfizer is not the only company to develop an mRNA flu vaccine. In December, Moderna (Nasdaq:MRNA) announced positive interim data from a Phase 1 study of its quadrivalent seasonal flu vaccine candidate, mRNA-1010. That data, however, disappointed investors, as mRNA-1010 had a similar performance to Sanofi’s (NSDQ:SNY) Fluzone HD flu vaccine.

Moderna’s (Nasdaq:MRNA) mRNA-1010 flu vaccine is now in a Phase 3 study. That study is fully enrolled with approximately 6,000 participants. Moderna anticipates the va…

Pfizer’s plan to acquire GBT for $5.4B hits legal road bump

In early August, Pfizer (NYSE: PFE) announced its intent to acquire Global Blood Therapeutics (Nasdaq:GBT) for $68.50 per share, or approximately $5.4 billion.

Now, however, investors are pushing back, alleging that GBT executives made incomplete and misleading statements to win shareholder approval for the prospective deal.

In a complaint filed in the Southern District of New York, plaintiff and shareholder Richard Lawrence requested that the court temporarily block an investor vote on the proposed merger scheduled for September 30.

Lawrence claims in the complaint that GBT shared a “materially incomplete and misleading” Schedule 14A definitive proxy statement with the SEC pertaining to the company’s financial projections and financial analyses.

The plaintiff is asking for a jury trial.

GBT is the developer of Oxbryta (voxelotor), a sickle hemoglobin inhibitor that won FDA approval in November 2019. GBT’s lead produ…

Pfizer and BioNTech get positive CHMP opinion for updated bivalent BA.4/BA.5-adapted COVID-19 vaccine booster

Pfizer (NYSE: PFE) and its partner BioNTech (Nasdaq:BNTX) could potentially win authorization to market a 30-µg booster dose of their omicron BA.4/BA.5 bivalent-adapted COVID-19 vaccine after the Committee for Medicinal Products for Human Use (CHMP) backed the vaccine for individuals 12 and older.

The European Commission will likely make a final decision on the updated vaccine soon.

The updated vaccine has won emergency use authorization in the U.S. for use as a booster.

The new vaccine contains 15-µg of mRNA encoding the spike protein of the original form of SARS-CoV-2 and 15-µg of mRNA encoding the spike protein of the omicron BA.4/BA.5 sublineages.

Earlier this month, Pfizer and BioNatech announced they received a positive CHMP opinion for an omicron BA.1-adapted bivalent COVID-19 vaccine booster.

“Due to our multifaceted approach helping to address emerging variants and subvariants of concern, public health authorities in the EU will ha…

FDA greenlights bivalent COVID-19 boosters from Pfizer and Moderna

FDA has authorized bivalent COVID-19 boosters from Moderna (Nasdaq:MRNA) and Pfizer/BioNTech (NYSE:PFE/Nasdaq:BNTX).

The FDA has authorized the updated Moderna vaccine as a single booster dose in individuals at least 18 years old. In addition, the agency authorized the Pfizer/BioNTech vaccine for those at least 12 years old.

Individuals in those age groups who have waited at least two months after receiving a second or third dose of a monovalent COVID-19 vaccine are eligible for the bivalent COVID-19 boosters.

The updated Moderna mRNA-1273.222 and Pfizer/BioNTech BNT162b5 vaccines could be available at U.S. vaccination sites in the coming days.

The updated COVID-19 vaccines encode the spike protein from the original SARS-CoV-2 strain and the BA.4 and BA.5 lineages of the omicron variant.

According to data from Walgreens, the omicron variant is responsible for nearly 100% of COVID-19 infections in the U.S.

Clinical trial data suggeste…

How Pfizer’s alliance with Morgan State University prioritizes diversity in vaccine development

Pfizer (NYSE:PFE) and Morgan State University have unveiled a novel program known as the Doctor of Public Health (DrPH) Fellowship in Vaccines Medical Development. A central aim of the program is to foster diversity in vaccine development.

In particular, the two-year DrPH program aims to increase the number of minority scholar-practitioners involved in vaccine development. In addition, the initiative will offer fellows training and networking opportunities to pave the way for leadership roles in the biopharma industry.

The program officially launched today.

Ronika Alexander-Parrish

Ronika Alexander-Parrish, a clinical scientist at Pfizer and founding director of the DrPH Fellowship, said the idea came out of brainstorming that began in the early days of the COVID-19 pandemic, which highlighted healthcare inequity.

Alexander-Parrish said the company’s leadership embraced her vis…

Moderna says Pfizer-BioNTech COVID vaccine infringed its patents

Moderna (Nasdaq:MRNA) announced today that it is suing Pfizer and its COVID-19 vaccine partner BioNTech over patent infringement in U.S. and German courts.

Cambridge, Massachusetts–based Moderna said it is in the process of filing the complaints in U.S. District Court in Massachusetts and the Regional Court of Düsseldorf in Germany.

The suits could pit three of the most significant COVID-19 vaccine makers against each other in an IP battle with billions of dollars potentially at stake. COVID-19 vaccine revenue boosted Pfizer to the top of the list among the Pharma 50 largest pharmaceutical companies on Drug Discovery & Development. Moderna and BioNTech also joined the Pharma 50 for the first time in the most recent edition.

“We are filing these lawsuits to protect the innovative mRNA technology platform that we pioneered, invested billions of dollars in creating, and patented during the decade preceding the COVID-19 pandemic,” Moderna CEO…

Pfizer and BioNTech seek U.S. authorization for omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine

[Image courtesy of Wikimedia Commons]

Pfizer (NYSE:PFE) and BioNTech (Nasdaq:BNTX) have filed paperwork with the FDA requesting Emergency Use Authorization (EUA) for an updated COVID-19 vaccine booster.

Specifically, the request relates to an omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine.

In late June, FDA recommended including an omicron BA.4/5 component for COVID-19 vaccine boosters.

Last week, the UK approved Moderna’s bivalent COVID-19 vaccine based on the original omicron lineage BA.1.

Pfizer and BioNTech are seeking authorization for a booster vaccine targeting the more recent sublineages omicron BA.4/BA.5.

If granted, the booster would be available for individuals at least 12 years old.

Pfizer and BioNTech note that the vaccine, if authorized, is available for immediate shipment.

The companies note that they plan on beginning a clinical trial focused o…

Next-gen Pfizer-BioNTech vaccine candidates fare well in Phase 2/3 study

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates.

One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant.

A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led to a significantly higher immune response against omicron BA.1 than the companies’ original vaccine.

Booster doses of 30 µg and 60 µg generated a robust immune response in the Phase 2/3 study.

In the U.S., the BA.1 variant is responsible for a single-digit percentage of COVID-19 infections.

The company plans on sharing the data with the scientific community and health authorities to accelerate the potential introduction of an omicron-adapted booster “as soon as possible if authorized by regulators,” said Pfizer CEO Dr. Albert Bourla.

“Omicron has ne…