Pharmaceutical Processing World Archives - Page 38 of 64

J&J COVID-19 vaccine to find use in conflict zones

Johnson & Johnson (NYSE:JNJ) has reached an agreement with the U.S. government and the public–private health partnership Gavi to distribute the Ad26.COV2.S vaccine to conflict zones or humanitarian settings.

New Brunswick, NJ–based Johnson & Johnson anticipates deliveries in such areas in the coming days.

“We believe our single-shot COVID-19 vaccine has a critical role to play in conflict zones and other humanitarian settings that can’t be reached by government vaccination campaigns, and we are proud to be part of this effort to protect the world’s most vulnerable people,” said Dr. Paul Stoffels, J&J’s vice chairman of the executive committee and chief scientific officer, in a press release.

To facilitate deliveries to such hard-to-reach areas, Gavi established the concept of a COVAX Humanitarian Buffer earlier this year. Governments and humanitarian agencies can apply for authorization for the distinction from Gavi.

The Inter-Agen…

White House says nearly one million younger children have received COVID-19 vaccines

Image courtesy of Pexels

In a White House COVID-19 Response Team press briefing today, government officials said that 900,000 children between the ages of 5 and 11 will have received their first COVID-19 vaccine dose by the end of the day.

The federal government authorized shots for that demographic last week.

Jeffrey Zients, counselor to the President, estimated that parents had made some 700,000 additional appointments at local pharmacies.

Jeff Zients at a COVID-19 briefing. Image courtesy of the White House.

At present, only the Comirnaty COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) is available to children 11 and younger.

Zients also observed that vaccinations of unvaccinated individuals had also accelerated recently. The pace is now averaging about 300,000 daily shots.

The federal government has …

Oklahoma State Supreme Court sides with J&J in opioid lawsuit

The Oklahoma State Supreme Court has overturned a 2019 opioid judgment against Johnson & Johnson (NYSE:JNJ) amounting to $465 million.

Five of the six Oklahoma Supreme Court’s justices dismissed the state’s case claiming that Johnson & Johnson breached its “public nuisance” laws in its marketing of prescription opioid drugs. “Oklahoma public nuisance law does not extend to the manufacturing, marketing and selling of prescription opioids,” the five justices wrote in their majority opinion.

Johnson & Johnson had argued that the judgment was flawed, arguing that the state did not show evidence that Johnson & Johnson caused a public nuisance in Oklahoma and that its claims violated core principles of due process.

Johnson & Johnson said in a press release that its prior sales of prescription opioids were “appropriate and responsible” but that the company has stopped selling such drugs as part of a larger effort to focus on new drug develop…

States sue to block COVID-19 vaccine mandate

Image courtesy of Unsplash

The attorneys general in 26 U.S. states are opposing the Biden administration’s plan to force many employers to require their workers to obtain vaccination against COVID-19.

While the majority of states were Republican-led, Kansas, Louisiana and Kentucky were three Democratic-leaning states that joined the litigation.

White House spokeswoman Karine Jean-Pierre said in a media briefing that the vaccine mandates have a firm legal footing.

The vaccination mandate threatens penalties of almost $14,000 per infraction.

The federal government intends to begin enforcing the rules on January 4.

The rules are more stringent for healthcare facilities receiving funding from Medicare and Medicaid. In such facilities, eligible staff must receive at least one vaccine dose before providing healthcare, treatment or other services by December 5.

U.S. cancels COVID-19 vaccine contract with Emergent BioSolutions

Emergent BioSolutions (NYSE:EBS) saw its stock plunge today after the U.S. nixed a contract to manufacture COVID-19 vaccine doses for Johnson & Johnson (NYSE:JNJ).

Earlier this year, the company disposed of tens of millions of COVID-19 vaccine doses after identifying a manufacturing error in a Baltimore plant.

FDA released a scathing inspection report related to the plant in April, while Johnson & Johnson promised to increase oversight of the facility.

Emergent noted that it would not receive $180 million worth of the $628 million it had planned on getting from the COVID-19 vaccine contract.

Emergent also produces anthrax vaccine for the U.S. government and stated in an investor’s note that it remains “ready to continue supporting the USG’s priorities to protect the American public against public health threats.”

The company had also planned on manufacturing AstraZeneca’s vaccine in the same facility, but the U.S. government asked A…

Biden’s COVID-19 vaccine mandate goes into effect

President Biden first signaled his intent to require many American workers to obtain full vaccination against COVID-19 in September.

Now, a significant number of employers must ensure their workers are either vaccinated or tested weekly for COVID-19 by January 4 as the rules become official. The requirements will apply to employers with at least 100 employees, translating to approximately 84 million workers.

At present, roughly two-thirds of Americans have received at least one dose of a COVID-19 vaccine, and just over 58% of the U.S. public is fully vaccinated, according to CDC. In addition, about one in ten people have received a booster dose.

Several other countries have substantially higher vaccination rates, including the United Arab Emirates, Portugal, Spain, Israel, Singapore, Japan and Canada.

The federal requirements also enable workers to receive paid time off to obtain vaccine doses and sick time to deal with side effects.

…

Lessons in life or death logistics

Cell therapy image from Wikimedia Commons

The cell and gene therapy market continues to advance, thanks to its promise to treat cancers and other severe diseases. While the pandemic has had a negative impact on companies specializing in cell and gene therapies, it has also catalyzed interest in cold-chain logistics while also highlighting the promise of new therapy types.

Organizations interested in expanding their focus on cell and gene therapies can learn from best practices from organizations specializing in high-stake logistics.

Push for standards and collaboration

The initial focus on transporting mRNA vaccines at below-normal temperatures “highlighted the need for some sort of standardization,” said Ray Hornung, senior manager, logistics and emergency preparedness at Be The Match BioTherapies (Minneapolis).

Ray Hornung

While t…

Moderna takes big hit on missed Q3 projections

Moderna (NSDQ:MRNA) shares took a big hit today on third-quarter results that came up short of the consensus forecast.

MRNA shares were down 17.1% at $286.80 per share in mid-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.2%.

The Cambridge, Massachusetts-based company posted profits of $3.3 billion, or $7.70 per share, on sales of $5 billion for the three months ended Sept. 30, 2021, for a massive bottom-line gain from losses of $233 million this time last year on more than 30 times the revenues registered a year ago.

Moderna’s EPS of $7.70 came in $1.35 behind Wall Street, where analysts were looking for sales of $6.2 billion.

The company’s sales numbers were heavily influenced by its COVID-19 vaccine, which registered $4.8 billion in revenue from the sales of 208 million doses. The company has produced $10.7 billion in revenues from …

Pfizer projects $36 billion in COVID-19 vaccine revenue in 2021

Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) continue to dominate the COVID-19 vaccine market.

In 2021, Pfizer anticipates that the Comirnaty (BNT162b2) vaccine will generate $36 billion in sales.

For the sake of comparison, the company’s overall 2020 revenue was $41.9 billion.

The vaccine was the single biggest driver of revenue for the company in the third quarter, which totaled $24.1 billion overall. Compared to the same quarter last year, revenues increased 130%. Excluding Comirnaty sales, revenues grew 7% year over year.

Earlier this year, Pfizer projected that sales of the vaccine would be in the ballpark of $33.5 billion.

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

Pfizer CEO Dr. Albert Bourla stressed that the global nature of its COVID-19 vaccine sales growth. “For example, more than 75% of the revenues we have recorded up through thir…

Catalent beats The Street in Q1, raises revenue guidance

Catalent (NYSE:CTLT) shares dipped today despite first-quarter financial results that beat the consensus forecast.

The Somerset, New Jersey-based company posted profits of $93 million, or 49¢ per share, on sales of $1.025 billion for the three months ended Sept. 30, 2021, for a 13.4% bottom-line gain on sales growth of 21.2%.

Adjusted to exclude one-time items, earnings per share were 71¢, 6¢ ahead of Wall Street, where analysts were looking for sales of $1 billion.

“Catalent’s strong start to fiscal 2022 was driven by robust growth in our Biologics segment and improving dynamics in both our softgel and oral technologies and oral and specialty delivery segments,” Catalent Chair & CEO John Chiminski said in a news release. “We continued to support global efforts to address the pandemic and execute on our long-term growth strategy through disciplined acquisitions, including our recent purchase of Bettera, and continued investments in biologics drug sub…

AbbVie beats The Street in Q3, raises guidance

AbbVie (NYSE:ABBV) shares ticked up before hours today on third-quarter results that beat the consensus forecast.

The North Chicago, Illinois-based company posted profits of $3.2 billion, or $1.78 per share, on sales of $14.34 billion for the three months ended Sept. 30, 2021, for a 37.5% bottom-line gain on sales growth of 11.2%.

Adjusted to exclude one-time items, earnings per share were $3.33, 11¢ ahead of Wall Street, where analysts were looking for sales of $14.3 billion.

“We continue to deliver excellent results, with balanced performance across our portfolio driving double-digit operational sales and EPS growth,” AbbVie Chairman & CEO Richard A. Gonzalez said in a news release. “Based upon our strong momentum, we are increasing our full-year 2021 EPS guidance. We remain highly confident in AbbVie’s long-term outlook and are once again raising our dividend, which has grown over 250% since inception.”

AbbVie …

Merck rises on Street-beating Q3

Merck (NYSE:MRK) shares ticked up today on third-quarter results that beat the consensus forecast.

MRK shares were up 4.9% at $85.55 per share in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was virtually unchanged.

The Kenilworth, N.J.-based company posted profits of $4.6 billion, or $1.80 per share, on sales of $13.2 billion for the three months ended Sept. 30, 2021, for a 96.5% bottom-line gain on sales growth of 20.4%.

Adjusted to exclude one-time items, earnings per share were $1.75, 20¢ ahead of Wall Street, where analysts were looking for sales of $12.3 billion.

“Merck delivered another strong quarter with positive momentum across our business and meaningful progress across our pipeline. Our teams continued to excel as we focus on evolving our operations, while driving innovations in our labs that exemplify the best of Merck science,” Merck …