Pharmaceutical Processing World Archives - Page 46 of 64

FDA signs of on extended shelf life for J&J vaccine

FDA has agreed to extend the shelf life of the Johnson & Johnson COVID-19 to six months. The previous shelf life was four and a half months.

The regulatory agency based its decision on data from ongoing studies involving vaccine doses stored at the previously indicated storage temperature of 2–8°C (35.6–46.4°F).

There is currently a stockpile of J&J viral-vector vaccine across the U.S. Vaccination rates in the U.S. have slumped in recent months. The rare possibility of blood clots stemming from the vaccine has contributed to diminished demand. And the mRNA vaccines from Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) continue to be the most popular options. More than 150 million Americans have received two doses of the mRNA vaccines from Pfizer and Moderna, while some 13 million have received the single-dose J&J vaccine.

Pfizer shares surge on strong Q2

Pfizer (NYSE: PFE) posted second-quarter results today that beat the consensus forecast. In addition, thanks to solid vaccine sales, the company boosted its outlook for the remainder of the year. The company expects annual sales of the two-dose vaccine it jointly developed with BioNTech to hit $3.5 billion.

The New York City–based company reported profits of $5.563 billion, or $0.98 per share, on sales of $19.0 billion for the three months ended June 30, for a bottom-line gain of 59% and operational growth of 86% compared with Q2 2020.

Adjusted diluted earnings per share were $1.07, eight cents ahead of The Street, where analysts were looking for EPS of $0.99 on sales of $9.9 million.

“I couldn’t be prouder of the way Pfizer has started 2021,” said Pfizer CEO Dr. Albert Bourla in the earnings call.

While COVID-19 vaccine sales drove the majority of its growth in the second quarter, Bourla said the company is “equally proud of the second-quarter pe…

COVID-19 vaccine mandates pick up steam

Photo by Frank Meriño from Pexels

The Department of Justice recently decided that federal law doesn’t block public or private organizations from requiring COVID-19 vaccines.

Following that decision, a growing number of organizations are beginning to mandate COVID-19 vaccines. The Department of Veteran Affairs became the first federal agency to do so. That decision will require full vaccination for some 115,000 workers. The Department is allowing employees eight weeks to comply. The government agency reported in a press release that four of its employees had died from COVID-19. All of them were unvaccinated.

New York City has issued a similar mandate for its 340,000 municipal workers. The order doesn’t go into effect until Labor Day, which is Sept. 6.

California will also require that state employees either receive a COVID-19 vaccine or face weekly tests and in-door mask requirements. California…

Alphabet’s Calico renews AbbVie partnership

Calico Life Sciences, an R&D biotech founded in 2013 as a Google subsidiary, is reaffirming its partnership with AbbVie (NYSE: ABBV) it initially formed in 2014. The latest agreement extends the collaboration from 2022 to 2025 while allotting $500 million in additional funding from both companies.

The two companies are collaborating on three clinical stage programs related to immuno-oncology and neurodegeneration. They also have 20 early-stage programs in development.

Calico became part of Alphabet in 2015, when Google decided to restructure as Alphabet as a holding company.

Calico made waves upon launch when it vowed to “cure death.”

At present, Calico and AbbVie currently have two PTPN2 inhibitors in Phase I studies.

The companies plan to continue its work to advance their pipeline of preclinical and clinical drug candidates, which have “first-in-class potential,” according to Gerry Fox, vice president, discovery at …

Big pharma resists international corporate tax proposal

Image from https://torange.biz/medications-big-money-19928

Pharma companies are resisting a tentative agreement between 130 countries to create a minimum corporate tax of 15%. The plan intends to combat tax inversion and other forms of tax avoidance.

Some U.S. industries, including Big Tech, have backed the plan given its potential to simplify accounting — even if it increases their tax rate.

But the pharma industry is highlighting its role in developing COVID-19 vaccines and other therapies in their opposition to the plan. Arguing that higher taxes would curb their ability to innovate, drug companies are worried about the proposal’s threat to their bottom line. Large pharma companies could see their tax bill increase by hundreds of millions of dollars annually if the plan is finalized. Moreover, pharmaceutical companies could see a larger tax hike than some other industries given their global presenc…

Exploring pharma applications of Xilinx’s adaptive system-on-modules

Image courtesy of Xilinx

Earlier this year, Xilinx (San Jose, Calif.) launched its Kria line of adaptive system-on-modules (SOMs) for a host of AI applications, including in factory and healthcare environments. In terms of the former, the SOMs target digital twin, predictive maintenance and defect detection applications.

SOMs, which are small embedded boards about the size of a credit card, enable the abstraction of hardware functionality. As a result, developers can design at the board level rather than the chip level. For hardware designers, SOMs promise to avoid rudimentary design work. SOMs also enable software developers to begin work in parallel with a hardware team.

Smart factory applications related to vision AI are a core focus area for the first product in the Xilinx SOM portfolio, the Kria K26 SOM.

As a result, factory owners deploying SOMs can get smart factory projects up and runni…

Miki Pulley touts new magnetic couplings

Miki Pulley magnetic couplings isolate shafts and motor for clean system operation, performing without system vibration. [Image courtesy of Miki Pulley]

Miki Pulley (Plymouth, Minn.) has new magnetic couplings that “mechanically isolate” the shafts and motor to provide clean operation in mixing systems, including in pharmaceutical and laboratory operations.

The mechanically isolated magnetic coupling transmits torque through the air through both input and output hubs of the coupling. The couplings contain rare-earth neodymium magnets, which create a magnetic field that transmits torque through plastic, glass, aluminum and other minimally ferrous materials without physical engagement.

The couplings’ non-contact design is particularly important when a mixing system requires cleanliness and motor isolation. Think no dust, debris or mechanical wear

The new couplings also have a “so…

An inside look at Northern California’s growing biomanufacturing hub

Vacaville shown on Google Maps

Vacaville, Calif. is home to a burgeoning biotech hub.

And there’s more to Vacaville’s biomanufacturing industry than Genentech’s presence there. “Genentech is just one of the biotech companies to open in Vacaville,” said Don Burrus, the city’s director of economic development services. “We’ve had biomanufacturers here for almost 30 years.”

Genentech set up shop in the city, located 35 miles southeast of Sacramento, in the late 1990s. The company acquired land in the city in 1994.

More recently, Lexington, Mass.–based Agenus purchased 120 acres in the city.

When Burrus began working for the city in June 2020, he collaborated with economists and other economic development experts to analyze the city’s economic drivers.

“We were able to determine that biomanufacturing and advanced manufacturing were big economic drivers,” Burrus said.

Afte…

Pfizer-BioNTech to provide U.S. with another 200M shots for kids, boosters

Pfizer-BioNTech vaccine [Image courtesy of Wikipedia]

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) announced today that the U.S. government has purchased another 200 million doses of their COVID-19 vaccine.

Media outlets including CNN and the Financial Times cited a Biden administration official saying the additional doses are needed to vaccinate children under 12, pending FDA authorization, plus the potential need for additional booster shots against variants. In a recent CNN interview, President Joe Biden predicted that the government will OK vaccines for young children in the next few months; Dr. Anthony Fauci of the National Institute of Allergy and Infectious Diseases told a Senate panel that it could be by early winter.

Pfizer and BioNTech expect to deliver the additional doses from October 2021 through April 2022, bringing the total doses purchased by the U.S. government for the American public to…

Takeda and Capsida announce manufacturing plant investments in California

Takeda Pharmaceuticals (NYSE:TAK) has announced that it is investing $126 million to expand a production facility in Thousand Oaks, one of the largest cities in Ventura County, California. The money will support constructing a new 15,000-ft2 manufacturing facility and the renovation of an existing 14,000–ft2 plant.

The mayor of the city, Claudia Bill-de la Peña, joined Takeda officials in a groundbreaking ceremony yesterday.

In a YouTube video, Stephen Hatke, site head of Takeda, says the investment will help it grow its portfolio of treatments while bolstering production capacity for rare disease therapies.

The news coincided with a separate announcement from Capsida Biotherapeutics, Inc. to open a manufacturing plant in the same city. Capsida specializes in developing targeted gene therapies with a next-generation adeno-associated virus engineering platform.

Capsida Biotherapeutics is a relatively new entity, having launched from stealth m…

China rebuffs WHO’s plan to continue investigating origins of COVID-19

The possibility that SARS-CoV-2 resulted from a laboratory accident has gained a degree of plausibility among several world leaders.

But China has rejected calls for further investigation into the matter, saying such allegations disregard “common sense,” as Zeng Yixin, vice-minister of the National Health Commission (NHC), said at a press briefing.

White House press secretary Jen Psaki criticized China’s stance, adding in a press briefing that “their position is irresponsible and, frankly, dangerous.”

China has also entertained a theory that Fort Detrick, an Army base in Maryland, is the source of the pandemic.

While the Fort Detrick lab researches infectious viruses, there is no evidence it is the outbreak’s source.

After initially discounting the possibility of the lab-leak scenario, the WHO has recommended further studies in China. Recently, the organization sought to audit laboratories and markets in Wuhan.

The investigation into…

Johnson & Johnson, other companies to pay $26B over opioid crisis

California Attorney General Rob Bonta announced a $26 billion settlement with Johnson & Johnson, among other companies, over opioids.

The settlement includes Johnson & Johnson, who manufactured and marketed opioids, along with pharmaceutical distributors Cardinal, McKesson and AmerisourceBergen.

According to a news release, the settlement resolves investigations and litigation over the companies’ roles in creating and fueling the opioid epidemic while requiring significant industry changes to prevent such a crisis from repeating itself.

“Nothing can undo the devastating loss of life caused by the opioid epidemic, or stop the grief it has caused for its victims and their families, but this proposed settlement represents one step in the process of healing our communities,” Bonta said in the release. “Along with our coalition partners, our office has worked to hold accountable bad actors who fueled this public health crisis …