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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…

Former SCWorx CEO indicted over alleged COVID-19 rapid tests scheme

The U.S. Dept. of Justice announced that Marc Schessel of SCWorx was indicted for charges related to an alleged COVID-19 test scheme.

Schessel, the former CEO of the New York-based company, was charged with two counts of securities fraud for his alleged participation in a scheme to mislead investors about SCWorx’s procurement of COVID-19 rapid test kits in the early stages of the COVID-19 pandemic.

Court documents alleged that Schessel caused SCWorx to issue multiple public statements claiming the company was buying and reselling at least 48 million COVID-19 test kits, despite knowing that such statements were false and misleading. In April 2020 — just a month after the COVID-19 pandemic took hold of the world — Schessel executed a supply agreement with an unnamed Australian company to obtain 2 million COVID-19 test kits per week for six months, starting on April 24, 2020.

The agreement was made based on an understanding that SCWorx had FDA’s…

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.

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…

FDA authorizes Labcorp’s non-prescription COVID-19 test that also detects flu, RSV

The FDA authorized Labcorp’s seasonal respiratory virus RT-PCR DTC test for use without a prescription.

Individuals with symptoms of respiratory viral infection consistent with COVID-19 can use the seasonal respiratory virus test that can identify and differentiate multiple respiratory viruses at the same time, which marks the first direct-to-consumer, multi-analyte COVID-19 test authorized by FDA.

Users can self-collect a nasal swab sample at home and send it to Labcorp for testing. It can identify and differentiate influenza A and B (the flu), respiratory syncytial virus (RSV) and SARS-CoV-2, the virus causing COVID-19. Results are delivered through an online portal, with healthcare provider follow-up for positive or invalid test results.

Samples can be self-collected by individuals 18 years and older on their own, by those 14 and older with adult supervision, or with adult assistance for individuals aged two years and older.

“While the FD…

AstraZeneca paying up to $157M for broad-spectrum monoclonal antibodies against COVID

RQ Biotechnology (London) emerged from stealth mode today, saying that AstraZeneca will pay it up to $157 million plus royalties for its existing mAbs against SARS-CoV-2.

“Our vision is to build on our successful debut with neutralizing antibody therapy for SARS-CoV-2 and develop innovative medicines to address current and evolving unmet needs in other viral infectious diseases,” said Hugo Fry, a former Sanofi executive who is CEO of RQ Bio.

“By combining our expertise and innovative excellence in core areas, we have created a smarter approach to antibody generation, making us uniquely positioned to deliver fast patient impact,” Fry said in a news release.

The agreement gives AstraZeneca an exclusive worldwide license to develop, manufacture and commercialize mAbs against SARS-CoV-2.

“The COVID-19 pandemic has changed the landscape for immune therapies, including the use of monoclonal antibodies to protect vulnerable patien…

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…

SK Bioscience and GSK seek regulatory nod for COVID-19 vaccine in South Korea

SK Bioscience (KRX:302440) and GSK (NYSE:GSK) have filed a biologics license application with the Korean Ministry of Food and Drug Safety for their SKYCovione, a recombinant protein-based COVID-19 vaccine candidate.

The self-assembled nanoparticle vaccine candidate is adjuvanted with GSK’s pandemic adjuvant.

SKYCovione fared well in a Phase 3 study involving more than 4,000 adults in Thailand, Vietnam, New Zealand, Ukraine, the Philippines and South Korea.

In the study, the vaccine candidate performed better in terms of neutralizing antibody levels than AstraZeneca’s Vaxzevria COVID-19 vaccine. SKYCovione also had a good safety profile in the study. In particular, it generated neutralizing antibody titers almost three times more than the control vaccine two weeks after administering the second dose.

“At this point in time, when countries around the world are developing strategies to respond to the endemic phase of the COVID-19 gl…

Intuitive shares dip as first-quarter profits fall short

Intuitive (Nasdaq: ISRG) posted first-quarter financial results that fell short of the consensus forecast on Wall Street for earnings, but exceeded analysts’ expectations for sales.

The Sunnyvale, California–based robotic surgery technology developer reported profits of $366 million, or $1.02 per diluted share, on sales of $1.49 billion for the three months ended March 31, 2022. Compared with Q1 2021, that was a 14% decrease in the bottom line and 15% growth in sales.

Adjusted earnings per share were $1.00, 8¢ short of Wall Street, where analysts were looking for EPS of $1.08 on sales of $1.43 billion. Intuitive noted that it retroactively adjusted prior year EPS information to reflect a three-for-one stock split.

Worldwide procedures performed with Intuitive’s da Vinci surgical robot increased approximately 19% compared to the first quarter of 2021. The COVID-19 pandemic continued to hold back procedures and supply chain disruptions continued, the…

Johnson & Johnson rises on mixed bag Q1, increased 2022 guidance

Johnson & Johnson (NYSE:JNJ) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast.

The New Brunswick, New Jersey-based company posted profits of $5.1 billion, or $1.93 per share, on sales of $23.4 billion in the first quarter for a 16.9% bottom-line slide on sales growth of nearly 5%.

Get the full story at our sister site, MassDevice.

Moderna says bivalent COVID-19 boosters could offer more robust protection against variants

Moderna (Nasdaq:MRNA) announced that its first bivalent booster vaccine candidate, mRNA-1273.211, offered superior protection against SARS-CoV-2 variants of concern compared with its first-gen mRNA-1273 vaccine.

A 50-µg booster of the mRNA-1273.211 vaccine offered protection against the beta, delta and omicron variants for six months and appeared to provide similar tolerability to the FDA-approved mRNA-1273 vaccine.

The company continues to develop a vaccine known as mRNA-1273.214 with more omicron-specific mutations. That vaccine candidate is now in a Phase 2/3 clinical trial. The company expects data from that trial to be available in the second quarter.

Moderna has published data related to the mRNA-1273.211 candidate as a preprint study in Research Square.

The company continues to bet that its bivalent booster candidate, mRNA-1273.214, will find use as a booster in autumn 2022 in the Northern Hemisphere.

In any event, the mRNA-1273.211 …