Pharmaceutical Processing World Archives - Page 35 of 64

US buys 10 million additional courses of Pfizer’s COVID-19 pill Paxlovid

As COVID-19 infections in the U.S. hit new highs, President Joe Biden announced that the country would buy at least 20 million courses of Pfizer’s (NYSE:PFE) COVID-19 pill Paxlovid.

The government had planned on purchasing half as much of the drug, which won regulatory authorization in late December for certain patients with a high risk of developing severe COVID-19.

Biden also vowed that it had offered Pfizer additional resources to accelerate the manufacture of the drug.

The federal government is ready to use the Defense Production Act to spur quicker production of the drug.

Pfizer plans on providing roughly 10 million treatment courses to the government by the end of June. It plans on providing the additional 10 million courses by September 30.

Pfizer has previously announced that Paxlovid had an efficacy rate of 89% in a study focused on its potential to reduce hospitalization or death from COVID-19. The Phase 3 study involv…

The 5 most popular pharmaceutical processing stories of 2021

Image by Thomas Breher from Pixabay

With the pandemic continuing to disrupt the pharmaceutical industry, drug makers find themselves torn between the traditional domain of drug making and an emerging domain of new platforms and focuses.

This disparity was reflected in the most popular pieces of content from Pharmaceutical Processing World in 2021.

1. GSK, Pfizer and J&J among the most-fined drug companies, according to study

Some of the best-known drug companies are the most commonly hit with fines. While the pandemic has improved the pharmaceutical industry’s reputation overall, the public continues to have an ambivalent attitude towards the industry.

2. The significance of humidity control in GMP compliant production

This piece from 2018 continues to draw significant attention from readers as a result of its advice on avoiding common pitfalls associated with poor humidity control.…

WHO warns that blanket COVID-19 booster programs will draw out pandemic

WHO head Dr. Tedros Adhanom Ghebreyesus faulted wealthy nations for advocating widespread use of COVID-19 boosters while billions of people across the globe remain unvaccinated.

Ghebreyesus concluded that the situation could lead to more potentially dangerous SARS-CoV-2 mutations.

The WHO has asked wealthy countries to prioritize vaccine initiatives in countries with low vaccination rates over COVID-19 booster initiatives in areas with significant vaccination rates until at least 40% of the population across the world had received at least one dose.

The WHO recently joined leaders from the International Monetary Fund, World Bank Group, World Trade Organization, Gavi and UNICEF to accelerate COVID-19 vaccination in low-income and lower-middle-income countries.

At present, less than 5% of the population in low-income countries is fully vaccinated.

“No country can boost its way out of the pandemic,” Ghebreyesus said at a recent pre…

Vector Pharma FZCO inks deal with R-Pharm US to distribute Ixempra in the Middle East

Dubai-based Vector Pharma FZCO has signed an exclusive distribution agreement with R-Pharm US (Princeton, New Jersey) related to Ixempra (ixabepilone) in the Middle East and North Africa.

The chemotherapy agent Ixempra can be used as a monotherapy or in combination with capecitabine to treat metastatic or locally advanced breast cancer. The drug is intended to be used in patients with tumors that are resistant or refractory to anthracyclines, taxanes and capecitabine.

“Ixempra is an important therapy for patients with advanced breast cancer; the women across MENA will benefit from access to this therapy,” said Vector Pharma FZCO Managing Director Samer Semaan in a press release.

R-Pharm focuses on commercializing various drugs for oncology and chronic autoimmune therapeutic indications. R-Pharm acquired the rights to Ixempra from Bristol-Myers Squibb.

Vector Pharma specializes in distributing drugs for rare diseases and oncology.

Department of Justice accuses Xlear of deceptive advertising; Xlear responds

Last month, the Federal Trade Commission (FTC) sued nasal spray company Xlear for claiming that its xylitol-containing saline nasal spray could help fight COVID-19. Specifically, the FTC alleged that Xlear had violated the COVID-19 Consumer Protection Act.

The Department of Justice also accused the company of violating the Federal Trade Commission Act.

American Fork, Utah–based Xlear released a statement denying the charges, arguing that federal authorities have violated its First Amendment right to free speech.

“Xlear’s response [to the allegations] outlines a series of studies, including two randomized clinical trials (RCTs) and other clinical and lab data, that more than substantiate Xlear’s statements regarding COVID-19,” said Nathan Jones, Xlear’s CEO, in a press release.

Jones cited an RCT that found that the Xlear nasal spray reduced the risk of hospitalization from COVID-19 by a factor of eight.

Xlear has also asserted that its nasa…

SiO2 Materials Science announces collaboration with the South Korean conglomerate Doosan

Privately-owned materials science firm SiO2 Materials Science has entered into an agreement with Seoul-headquartered Doosan Corp. related to the distribution of its vials, syringes and blood collection tubes in Asia and Oceania.

The alliance will initially cater to the needs of pharmaceutical and diagnostics companies, with the scope of the partnership increasing over time.

As part of the partnership, Doosan will invest $100 million into Si02 and spend additional cash on building out infrastructure related to the collaboration.

“The Asia and Oceania region represents a significant market opportunity for vials and syringes specifically designed for biologic drugs and vaccines,” said Lawrence Ganti, President of SiO2 Materials Sciences, in a statement.

SiO2 Materials Science reports that its products have been used in the packaging of hundreds of millions of COVID-19 vaccine doses internationally. In addition, it has more than 100 active projects wi…

Israel plans to authorize fourth COVID-19 vaccine dose for high-risk populations

Photo by Frank Meriño from Pexels

Mere months ago, health experts were divided on whether COVID-19 boosters were necessary for the broader public.

Then came delta and then came omicron.

Now Israel is moving to become one of the first countries to offer a fourth dose of COVID-19 vaccine to people at least 60 years old and those at high risk of severe disease. Countries such as Switzerland and the U.K. have reduced the window of time for booster eligibility from six months down to four and three months, respectively.

As a result, COVID-19 vaccines from companies such as Pfizer and its partner BioNTech, Moderna and others continue to be a hot commodity.

A number of companies, including Pfizer and Moderna, are also developing omicron-specific versions of their vaccines. Both of those companies are gearing up for clinical trials in early 2022.

Earlier this month, Pfizer CEO Dr. Al…

Nordson Medical – Biopharmaceutical Components Cryogenic Compatibility

As we have seen with certain vaccines over the last 18 months, cryogenic transport and storage is becoming a significant issue for biopharmaceutical manufacturers as more products and components must be stored at very low temperatures to be kept functional. The repercussions of these new requirements are being felt throughout the biopharmaceutical production industry as there had never been such a surge in demand for cold storage and transport. As such, our biopharmaceutical family of products needed to be shown to be compatible with the extreme cold they may need to be transported and stored in.

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Novo Nordisk faces Wegovy supply challenges in US

Novo Nordisk (NYSE:NVO) announced that one of its contract manufacturers filling syringes for its Wegovy (semaglutide) pens in the U.S. market has temporarily ceased manufacturing following Good Manufacturing Practices problems.

The company projects it will be unable to meet U.S. demand for the drug in the first half of 2022 and that use of the drug will likely be constrained to a limited number of patients.

NVO shares dipped 8.21% to $107.45 today.

Novo Nordisk anticipates a resolution of the supply shortage by the second half of 2022.

The obesity drug Wegovy is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated for patients with a body mass index of 30 kg/m2 or greater or 27 kg/m2 or greater (overweight) with at least one weight-related comorbidity.

Federal judge throws out Purdue Pharma’s opioid settlement that protected Sackler family

Colleen McMahon of the U.S. District Court for the Southern District of New York overturned a sweeping settlement against Purdue Pharma over its role in the opioid crisis.

Purdue’s Oxycontin (oxycodone) is among the most widely used opioids.

In September, Judge Robert Drain of the U.S. Bankruptcy Court in White Plains, New York, authorized a Chapter 11 bankruptcy settlement against the company. However, several states involved in the suit vowed to appeal the decision.

McMahon argued that the agreement should not have shielded the Sackler family that owned Purdue Pharma from civil liability for opioid-related lawsuits.

The Sacklers had sought immunity from opioid claims as part of the $4.5 billion agreement.

In a 2007 plea agreement with the U.S., Purdue Pharma acknowledged that it had marketed OxyContin inappropriately and submitted false claims to the federal government related to the drug.

McMahon’s ruling will likely mean that the…

FDA authorizes abortion drug distribution by mail

The FDA has decided to allow dispensing of mifepristone from Danco Laboratories by mail using certified prescribers of pharmacies. The move also allows dispensing of the drug via telemedicine.

The agency had previously required that individuals obtain the abortion drug mifepristone (Mifeprex) in person.

FDA notes that the mail-order distribution model became popular during the pandemic, leading the agency to cease enforcing the in-person dispensing rule.

Some states, however, have moved to block the distribution of the drug, which is also known as RU486.

FDA indicates that the progestin antagonist mifepristone be used together with the drug misoprostol in the first 70 days of gestation. Misoprostol is a widely available prescription drug indicated as an ulcer treatment. FDA recommends that patients take mifepristone first and then misoprostol two days later.

Nearly half of U.S. states have either banned or limited the use of the mifepriston…

Distributed control system supports CMO’s surge in drug production during the pandemic

In the early days of the COVID-19 pandemic, Thermo Fisher Scientific quickly expanded its manufacturing capacity at its Greenville, North Carolina plant to meet demand. The expansion involved adding a new production suite, safeguarding quality, and enabling sufficient production flexibility.

During the expansion, the plant upgraded its existing Distributed Control System (DCS) to support the production of two vital pharmaceuticals during the pandemic. The first was for the antiviral drug Veklury (remdesivir) from Gilead Sciences. FDA approved Veklury to treat patients with COVID-19 needing hospitalization. Thermo Fisher Scientific retooled the plant to manufacture the EUA-authorized Moderna COVID-19 vaccine.

When retooling their plant, Thermofisher upgraded their DCS, which supports the production, conveying and handling of pharmaceuticals.

In late 2020, boosting the manufacturing of antivirals for those hospitalized with COVID-19 was critical, according…