Fresenius Kabi launches gadoterate meglumine injection

Fresenius Kabi has begun selling gadoterate meglumine injection, USP, a bioequivalent and therapeutic equivalent substitute for Guerbet’s contrast agent Dotarem.

The product launch is the second contrast agent Fresenius Kabi has introduced in the U.S. this year. The Kale Zurich, Illinois–based company launched iodixanol injection, USP, in July during a nationwide shortage.

Radiologists use contrast agents to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.

“Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of gadoterate meglumine injection, USP,” said John Ducker, president and CEO of Fresenius Kabi USA, in a news release. “Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi gadoterate meglumine will provi…

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Fujifilm establishing cell culture subsidiary in Korea

Fujifilm announced today that it is establishing a Seoul, South Korea–based subsidiary to accelerate its business growth in the cell culture media space.

With paid-in capital of ₩300 million (roughly $250,000), the new subsidiary opens tomorrow.

It will import cell culture media for bioproduction and advanced cell and gene therapies. Its goal through its direct sales and marketing will be to meet local customers’ needs for custom media. The market for cell culture media in South Korea has been growing at an annual rate of 15%, according to Fujifilm.

“The establishment of a new subsidiary is an important step toward further business expansion in the rapidly-growing market in South Korea,” said Yutaka Yamaguchi, corporate VP and GM of the Life Sciences Business Division at the Tokyo-based company.

“Fujifilm will, as a partner for customers in the bio-industry, continue to strongly support their research, development, and manufacturing, thereby…

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Roche names new CEO of Roche Diagnostics

Roche (SIX:RO, ROG; OTCQX:RHHBY) has named Matt Sause (45), head of Roche Diagnostics’ North America Region, to become the CEO of Roche Diagnostics on January 1, 2023.

Sause is a Roche veteran, working for the company from 2002 to 2018. He was a senior molecular account manager in his first role working for the company. He was eventually promoted to various senior positions in general management and global product leadership in the company’s diagnostics and pharmaceutical divisions. From July 2018 to July 2019, he worked as an executive at Roche’s Genentech division. In that role, he was involved in developing Tecentriq (atezolizumab) for head and neck cancers.

Matt Sause

From July 2019 to October, he worked as an executive at Gilead Sciences but rejoined Roche in November 2019.

“Matt Sause’s career at Roche has spanned twenty years in multiple countries across Asi…

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Gilead gains ground in HIV drug counterfeit litigation

A New York federal judge has frozen the assets of several individuals and entities for their alleged role in distributing counterfeit versions of Gilead Science’s (Nasdaq:GILD) HIV medications.

Presiding over the U.S. District Court for the Eastern District of New York, Judge Ann M. Donnelly also denied the defendants’ motion to dismiss the case for lack of personal jurisdiction and improper venue and permitted the case to proceed.

The defendants in the case are suppliers, distributors and pharmacies accused of operating an HIV drug counterfeiting ring. The lawsuit accuses three companies of involvement in the counterfeit ring, including Synergy Group Wholesalers, Cesar Castillo Wholesalers and DNS Distributor. It also states that Julio Martin Gonzalez assisted in the scheme.

According to recently unsealed court documents, Lazaro Roberto Hernandez and Armando Herrera were cited as the two kingpins involved in the scheme to market counterfeit …

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Johnson & Johnson names proposed consumer health spinoff ‘Kenvue’ 

Johnson & Johnson (NYSE:JNJ) has announced that it will name its consumer health division ‘Kenvue.’

Earlier this year, GSK (NYSE:GSK) made a similar move by naming its consumer healthcare segment ‘Haleon.’ That moniker fuses the old English word ‘hale’ with the name ‘Leon.’ The first word means ‘healthy’ while the second refers to ‘strength.’

Haleon became a separate unit in July 2022.

Similarly, Kenvue brings together the words ‘ken,’ meaning ‘knowledge,’ and ‘vue,’ meaning ‘sight.’

Johnson & Johnson has signaled its intent to spin off Kenvue by November 2023.

The remaining company, headquartered in New Brunswick, New Jersey, would continue to focus on its drug and device businesses.

“Unveiling the Kenvue brand is a defining moment for our stakeholders and an important part of the planned separation,” said Thibaut Mongon, CEO Designate, Kenvue, in a news release. “We breathe life into some of the world’s most iconic and belo…

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Pfizer and Moderna seek FDA nod for omicron-adapted COVID boosters in children

[Image courtesy of Pixabay.]

Pfizer/BioNTech (NYSE:/PFE, Nasdaq BNTX) and Moderna (Nasdaq:MRNA) have both won emergency use authorizations in the U.S. for bivalent vaccine boosters based on BA.4/BA.5.

Pfizer is aiming to win authorization to use its updated COVID-19 vaccine in children aged 5 through 11 years. Moderna has requested that FDA greenlight the use of its omicron booster in individuals 6 to 17.

Pfizer’s shot is currently authorized for individuals at least 12 years old, while Moderna’s is authorized for individuals 18 and up.

Pfizer noted in a news release that it had submitted safety and immunogenicity data for the bivalent BA.1-adapted vaccine to FDA. The company also included preclinical and manufacturing data related to the bivalent omicron BA.4/BA.5-adapted vaccine.

Moderna’s updated booster for adults includes a 50-µg dose of mRNA, while the Pfizer-BioNT…

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Actylis launches with focus on raw materials and performance ingredients for life sciences and specialty chemicals 

The company Actylis made its debut today, integrating specialty ingredient specialist Aceto with 10 specialty ingredient manufacturing and sourcing companies.

Port Washington, New York–based company will serve customers in various industries, including pharmaceutical and biopharmaceutical companies. It will also offer materials to companies specializing in nutrition, cosmetics, agriculture and specialty chemicals markets.

Among the specialty ingredient manufacturing and sourcing companies integrated in the merger are A&C, A&C Bio Buffer, Biotron Laboratories, Cascade Chemistry, Finar, Inter-Actifs, IsleChem, Pharma Waldhof, Syntor Fine Chemicals and Talus.

Actylis bio buffer facility. [Picture: Keith Wiseman]

The consolidation of those companies plus Aceto “enables us to offer customers across diverse locations and industries highly flexible, customized solutions addressing their s…
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U.S. government earmarks $1.6 billion to battle opioid crisis and overdose epidemic

[Photo by Karolina Grabowska from Pexels]

The U.S. Department of Health and Human Services (HHS) has awarded more than $1.6 billion as a part of an initiative to battle the drug overdose epidemic.

SAMHSA’s State Opioid Response (SOR), Tribal Opioid Response (TOR) grant programs and Health Resources and Services Administration (HRSA)’s rural communities opioid response programs will lead the new initiative.

The government plan will expand access to the opioid mu receptor antagonist naloxone, and improve access to opioid treatment programs. It also includes provisions to reduce abuse of stimulants such as cocaine and methamphetamine that contribute to the overdose epidemic.

The government initiative will also provide funding for law enforcement in high-intensity drug trafficking areas.

Drug-involved overdose deaths have surged in recent years, according to federal statistics.

In 2020…

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Lonza bolsters HPAPI multipurpose suite for payload linkers in Switzerland

Contract development and manufacturing organization Lonza has completed the expansion of its highly potent API (HPAPI) multipurpose suite in Visp, Switzerland. The expansion gives Lonza additional development and manufacturing capacity for antibody-drug conjugates (ADC) payloads. The site includes a range of equipment for manufacturing payload linkers.

Divided into cleavable and non-cleavable types, linkers are a vital component of ADCs as they connect an antibody with a drug (payload) through a chemical bond.

Lonza anticipates that the ADC market will grow swiftly, given the demand for novel targeted cancer therapeutics.

The company has announced a series of expansions in recent years, including investing in upgraded drug manufacturing services last year.

To learn more about the most recent expansion, we reached out to Lonza’s Giovanna Libralon, senior director, commercial development, small molecules and Iwan Bertholjotti, senior director, comme…

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Pfizer to provide up to 6 million Paxlovid courses to developing countries

Pfizer (NYSE:PFE) has reached an agreement to supply as many as six million courses of its oral COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) to the Global Fund, which seeks to help more than 100 low-to-middle income countries fight diseases such as COVID-19, HIV, tuberculosis and malaria.

Pfizer notes that the agreement with the Global Fund is part of a broader strategy to ensure equitable global access to Paxlovid.

The Global Fund’s COVID-19 Response Mechanism offers grant support to developing countries to procure COVID-19 tests, treatments and personal protective gear.

The Global Fund determined which 132 countries were eligible after reviewing data related to income classification and disease burden.

Pfizer will use a tiered pricing scheme for Paxlovid for the 132 countries. According to that plan, low- and lower-middle-income countries will pay a not-for-profit price for the drug, while upper-middle-income countries will pay a rat…

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FDA updates ad comm meeting date for sabizabulin in hospitalized COVID-19 patients  

The oncology biopharma Veru (Nasdaq: VERU) has announced that the FDA has moved the date for its Pulmonary-Allergy Drugs Advisory Committee to discuss the potential emergency use authorization (EUA) of sabizabulin for hospitalized COVID-19 patients.

The meeting is now slated for November 9, 2022.

It was originally scheduled for October 6, 2022.

VERU shares skidded almost 15% to $12.15 in early afternoon trading.

In particular, the Miami-based company aims to obtain EUA or COVID-19 patients with an elevated risk of developing acute respiratory distress syndrome (ARDS).

In April, the company shared positive efficacy and safety data from an interim analysis of a Phase 3 study evaluating oral sabizabulin 9 mg against a placebo.

The company halted the study after an independent data monitoring committee unanimously recommended doing so.

The primary endpoint for the drug was reducing the proportion of deaths by Day 60.

The co…

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EU approves AstraZeneca’s Evusheld COVID-19 antibody cocktail

AstraZeneca (LON:AZN) has announced that its long-acting antibody combination Evusheld (tixagevimab and cilgavimab) has received marketing authorization in the European Union. 

Formerly known as AZD7442, Evusheld is indicated for treating individuals 12 and older infected with SARS-CoV-2 who are at risk for severe COVID-19. The indication is limited to those weighing at least 40 kg who do not need supplemental oxygen. 

European regulators based their recommendations on data from the placebo-controlled Phase 3 TACKLE COVID-19 study that demonstrated a single intramuscular (IM) dose of Evusheld. 

Evusheld thus differs from other COVID-19 antibodies that require an infusion. 

The placebo-controlled TACKLE study found that Evusheld provided clinically and statistically significant protection against severe COVID-19 or death from any cause compared. 

Outcomes were best for individuals who received Evusheld therapy at an early stage of disease pr…

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