Pfizer Archives - Page 5 of 33 - Medical Design Sourcing

Pfizer CEO tests positive for COVID-19

Pfizer’s (NYSE:PFE) CEO Dr. Albert Bourla acknowledged in a statement that he has COVID-19.

Bourla, who is 60, has received four doses of the Pfizer-BioNTech Comirnaty vaccine. He also has begun taking a course of the company’s antiviral Paxlovid.

The Pfizer CEO notes that symptoms to date have been very mild.

Pfizer’s revenue has soared during the pandemic, largely thanks to the Comirnaty COVID-19 vaccine. Last year, the vaccine almost doubled Pfizer’s revenue to roughly $81 billion in 2021, making it the largest pharma company.

Last week, Bourla noted in an earnings call that the company continues to be well-positioned in the pandemic.

“In the second quarter, we recorded the largest amount of quarterly sales in our history,” Bourla noted in a news release.

The company continues to develop updated COVID-19 vaccine boosters, which the company expects to be commercially available in the early fall.

In July, Pfizer and …

Pfizer shares positive top-line data from Phase 3 Study of pneumococcal vaccine

Pfizer (NYSE:PFE) said it is planning on filing a supplemental Biologics License Applications (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate in infants by the end of the year.

After announcing positive data from a pivotal U.S. Phase 3 study (NCT04382326), the company said the 20vPnC vaccine candidate, if approved, would offer the broadest serotype coverage of any pneumococcal vaccine in infants.

PFE shares ticked up 3.69% to $50.08 in afternoon trading.

The 20vPnC vaccine candidate would protect against pneumococcal disease (IPD) resulting from 20 Streptococcus pneumoniae (pneumococcus) serotypes.

FDA approved the 20-valent conjugate vaccine for adults 18 and older last year. The vaccine for that demographic is known as Prevnar 20.

Earlier this year, FDA approved Merck’s (NYSE:MRK) Vaxneuvance pneumococcal 15-valent conjugate vaccine for infants and children.

In Pfizer’s Phase 3 study, the 20vPnC yielded stro…

Pfizer to scoop up Global Blood Therapeutics for $5.4 billion

After a banner year in 2021, Pfizer (NYSE:PFE) is on a spending spree. The company plans to acquire Global Blood Therapeutics (GBT) (Nasdaq:GBT) for $68.50 per share. The total sale price of acquisition, if it moves forward, would be roughly $5.4 billion.

Global Blood Therapeutics’s therapeutic focus is primarily on sickle cell disease.

In March, Pfizer finalized the $6.7 billion acquisition of Arena Pharmaceuticals. The company announced in May that it planned to acquire migraine drugmaker Biohaven Pharmaceuticals for $11.6 billion.

Pfizer completed the acquisition of privately-held ReViral in June.

The centerpiece of the acquisition

GBT has developed Oxbryta (voxelotor), a novel sickle hemoglobin inhibitor that won FDA approval in November 2019. In addition, the drug has scored approval in the European Union, United Arab Emirates, Oman and Great Britain.

Voxelotor binds to hemoglobin and stabilizes red-blood cells in an oxygenated state.<…

Fall 2022 COVID-19 vaccine candidate tracker

[Photo from Pexels]

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.

But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.

A variety of companies are developing next-generation COVID-19 vaccines that could potentially optimize the strength and durability of immune protection compared to the first crop of vaccines.

Here, we round up notable COVID-19 vaccine candidates that, at least, could help pave the way for the fall 2022 booster drive.

BNT162b5

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) are developing a bivalent COVID-19 vaccine candidate known as BNT162b5 based on the ancestral strain and a BA.1 Omicron variant. The vaccine has a modified spike protein design to optimize the immune response …

Pfizer and BioNTech tease next-gen COVID-19 vaccine strategy

As federal officials wax poetic about the prospect of intranasal COVID-19 vaccines and other novel vaccine platforms, Pfizer Inc. (NYSE:PFE) and its partner BioNTech (Nasdaq:BNTX) have announced that a randomized Phase 2 study will study an incrementally improved COVID-19 vaccine known as BNT162b5.

The updated vaccine candidate includes a modified spike protein designed to bolster immunogenicity over the first-generation COVID-19 vaccine.

Pfizer notes that it plans on testing multiple vaccine candidates with the novel spike protein design to offer a more durable and broader immune response against SARS-CoV-2 infections and associated COVID-19.

The companies’ original BNT162b2 vaccine remains one of the most widely used worldwide. In 2021, the vaccine was the best-selling pharmaceutical product, generating $51.1 billion between Pfizer and BioNTech.

The bivalent BNT162b5 vaccine blends RNAs targeting the ancestral strain coronavirus and the omicron …

White House holds next-gen COVID-19 vaccine summit

Image courtesy of Wikipedia

The federal government continues to work closely with notable COVID-19 manufacturers, including Moderna and Pfizer, hosting a summit today focused on the future COVID-19 vaccines.

“We need a vaccine that can stand up to multiple variants,” said White House Covid-19 Response Coordinator Ashish Jha.

While White House officials called for developing inexpensive novel vaccines that could be delivered nasally or via a skin patch, they did not specify where the funding for such efforts would come from.

As the omicron BA.5 lineage has gained momentum, some pundits have called for the government to spur the development of novel vaccines.

The Biden administration hopes to stymie future SARS-CoV-2 variants, curb infection and transmission of the virus and ensure that future vaccines offer longer-lasting protection.

Moderna and Pfizer are both developing bivalent …

Pfizer and BioNTech seek EMA authorization for COVID-19 vaccination in young children

Pfizer Inc. (NYSE:PFE) and BioNTech SE (Nasdaq: BNTX) have filed paperwork with the European Medicines Agency (EMA) requesting permission to use the Comirnaty COVID-19 vaccine in children aged 6 months to 5 years old.

As in the U.S., the companies are attempting to win authorization for a 3-µg dose vaccine administered as a three-dose series.

On June 17, FDA authorized the use of the Pfizer-BioNTech and Moderna vaccines in children as young as six months in the U.S. Before that, an FDA advisory committee unanimously supported the authorization of the Pfizer and Moderna vaccines in young children.

The EMA request included data from a Phase 2/3 randomized, controlled study based on data from 4,526 children 6 months to less than 5 years of age.

The study found that three doses of the vaccine resulted in a robust immune response with a safety profile similar to a placebo. In addition, the companies noted that adverse events were less common in young c…

Touchlight inks patent license deal with Pfizer related to the use of dbDNA in mRNA products

Touchlight, a British biotech focused on enzymatic DNA production, has announced signing a non-exclusive patent license agreement with Pfizer.

The worldwide deal will give Pfizer rights to Touchlight’s enzymatic doggybone DNA (dbDNA) patent portfolio for use in manufacture and commercialization of mRNA-based vaccines, therapeutics and gene therapies.

dbDNA is a synthetic DNA vector and enzymatic DNA manufacturing process.

Under the terms of this agreement, Touchlight will get an upfront payment in addition to clinical and commercial milestone payments and royalties after commercialization.

Touchlight notes that ddBNA can support the manufacture of rapid, synthetic and scalable manufacture of GMP DNA with a footprint.

The process can support the manufacture of genes >20kb.

Touchlight claims the dbDNA technique can accelerate the manufacture of DNA-based therapies.

“We are delighted to establish this agreement with Pfizer to …

July 2022 Issue: Pulsed-field ablation, DeviceTalks Boston and the Pharma 50

What is pulsed-field ablation? Here’s what you need to know

Dexcom CEO expects ‘science boom’ with CGM, automated insulin delivery

Tips for vetting contract manufacturers

They said it at DeviceTalks Boston

FDA can’t explain drop in device recalls, but experts point to COVID disruption

2022 Pharma 50: The 50 largest pharmaceutical companies

Innovators shake up the Pharma 50

As a father raising a toddler and an infant, I was relieved by the latest milestone in the COVID-19 pandemic: the authorization of vaccines for children between 6 months and 5 years.

The good news came as Pharma Editor Brian Buntz and the rest of our team were putting the final touches on this edition’s Pharma 50 project. It’s our annual ranking of the biggest pharmaceutical companies by global revenue, featured on our affiliated Drug Discovery & Development site. (Our Big 100 report on largest medic…

FDA backs COVID-19 boosters with BA.4/5 spike proteins for fall

Photo from Pexels

The first-generation COVID-19 vaccines remain potent tools in protecting against severe COVID-19, but their effectiveness in protecting against infections from the SARS-CoV-2 has slipped as the virus evolves. While boosters improve protection, their effectiveness wanes over time.

FDA followed the lead of its independent Vaccines and Related Biological Products Advisory Committee (VRBPAC) in backing the inclusion of an omicron component in future COVID-19 vaccines.

In particular, the agency recommends that vaccine makers develop bivalent COVID-19 vaccines with an omicron BA.4/5 spike protein component combined with the current vaccine composition.

FDA expects the updated vaccines to be used as a booster in “early to mid-fall 2022,” but the current formulation of vaccines for use as a primary series will remain unchanged.

Moderna and Pfizer have already shared data from c…

Pfizer seeks to comply with voluntary Net-Zero Standard by 2040

The voluntary Net-Zero Standard asks organizations to reduce emissions to near-zero levels by 2050 and neutralize any residual emissions.

Pfizer (NYSE:PFE) has announced its intent to meet that benchmark by 2040.

Pfizer intends to reduce its Greenhouse Gas (GHG) emissions by 95% and its value chain emissions by 90% from 2019 levels by 2040. To reach that goal, the company plans to reduce its reliance on fossil fuels and work with similarly-minded suppliers. It also plans to invest in a fleet of hybrid and electric vehicles.

The Net-Zero Standard was first announced by the Science-Based Targets initiative (SBTi).

Other pharma companies that have vowed to comply with the standard include AstraZeneca (LON:AZN), Bayer (OTCMKTS:BAYRY), Biogen (Nasdaq:BIIB), GSK (NYSE:GSK), Johnson & Johnson (NYSE:JNJ), Novartis (NYSE:NVS) and Sanofi (EPA:SAN).

Pfizer notes that its work to comply with the standard is part of its Environmental, Social and Gov…

Pfizer and BioNTech forge new COVID-19 vaccine deal with U.S. government

Pfizer Inc. (NYSE:PFE) and its partner BioNTech SE (Nasdaq:BNTX) profited handsomely from COVID-19 vaccine sales in 2021. The firms raked in more than $59 billion in combined sales of the Comirnaty vaccine.

The two companies have now announced a new vaccine supply agreement with the U.S. government worth $3.2 billion. Under the terms of the agreement, the government will receive 105 million additional doses of the vaccine at the 30 µg, 10 µg and 3 µg dose levels.

The deal could include an omicron-adapted COVID-19 vaccine, assuming FDA authorizes an updated booster.

Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to back the use of omicron-containing boosters.

Pfizer announced that it could begin shipping doses for the deal as soon as the late summer and continue into the fourth quarter of 2022.

The U.S. government also has the option to buy up to 195 million additional doses for a total of 300…