Pharmaceutical Technology Editors

The European Centre for Disease Prevention and Control (ECDC) and the European Medicine Agency’s (EMA’s) COVID-19 task force (ETC) have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population. The vaccines being referred to are Pfizer’s Comirnaty and Moderna’s Spikevax.

ECDC and EMA concluded that there is currently no clear evidence in the European Union that adults with normal immune systems will benefit from a fourth dose. However, in adults aged 80 years and older, the agencies agreed that a fourth dose may be administered for the protection against COVID-19.

There may be a reevaluation of recommending a fourth dose for adults aged 60 to 79 years depending on the epidemiological situation changes and new data. As of now, there is no clear evidence that the current three-dose vaccination system is decreasing in effectiveness for this age group.
ECDC and EMA will continue to review available evidence on the effectiveness of COVID-19 vaccines and update their recommendations accordingly. National authorities in the EU make the final decisions on the administration of vaccines, including booster doses.

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ECDC and EMA have concluded that it is too early to consider using a fourth dose of mRNA COVID-19 vaccines in the general population.

ECDC and EMA Issue Advice on Fourth Doses of mRNA COVID-19 Vaccines

Teva Pharmaceuticals has initiated a voluntary nationwide recall of lot 31329657B of IDArubicin Hydrochloride Injection USP 5 mg/5 mL vial to the user level in the United States.

The recall was initiated due to an internal inspection that found particulate matter, identified to be silica and iron oxide, in one vial of the product. No other vials have been observed to contain the particulate matter. Teva has not received any complaints regarding product quality or adverse events.

According to the company, if an injectable product containing particulate matter is administered, local irritation or swelling may occur in response to the foreign material. If this particulate matter reaches the blood vessels, it could cause blockages in various organs such as the heart, lungs or brain which can cause stroke and even lead to death. Though the health hazard risk could be severe if particulate matter is administered, Teva’s internal health assessment determined that the likelihood of patient harm is remote or unlikely.

IDArubicin Hydrochloride Injection USP is indicated for the treatment of acute myeloid leukemia (AML) in adults in combination with other approved anti-leukemic drugs. Teva notified its customers of the recall on March 28, 2022 and requested the return of impacted product. The company will continue to regularly update all relevant stakeholders and regulatory authorities to resolve the situation.

Teva has initiated a voluntary nationwide recall of one lot of IDArubicin Hydrochloride Injection USP 5mg/5 mL due to the presence of particulate matter.

Teva Issues Voluntary Nationwide Recall of IDArubicin Hydrochloride Injection USP 5 mg/5 mL

The WeylChem Group of Companies announced on April 6, 2022 that its new multi-purpose custom manufacturing plant has been put into operation. The plant is located at the company’s French site in Lamotte in the Hauts-de-France region. The company invested approximately €7 million (approximately US$7.5 million) into enhancing the site’s flexibility and capacity in synthesizing modern, complex, and corrosive molecules.

The project includes a high level of automation, including the use of robotic elements to allow for greater efficiency. The existing production line went through a comprehensive overhaul, adding an acid-proof Hastelloy filter dryer, a thin-film evaporator, and a stainless steel reactor. The result of these additions allows for temperatures of up to 200 °C and a service pressure of up to 8 bars to be reached.

“Further upgrading our custom manufacturing capacity and capabilities enables us to serve our customers even better—particularly those in the pharmaceutical industry—by providing efficient, digitally-driven high-quality processes within a demanding business environment,” said Alix Deschamps, managing director of WeylChem Lamotte, in a press release.

“This large investment forms part of a global initiative to enhance our multi-purpose set-up that also includes the new Halex and ring chlorination plants in Germany,” added Uwe Brunk, president of the WeylChem Group of Companies. “I’m extremely happy with how smoothly the project has been managed, despite the challenges posed by the Covid situation. This new asset strengthens our position as a versatile, high-quality partner with reliable European supply chains.”
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WeylChem has put a new multi-purpose custom manufacturing plant at its French site in Lamotte into operation.

WeylChem Inaugurates New Multi-Purpose Plant in Lamotte, France

The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced on April 6, 2022 the funding for the establishment of Tuberculosis Research Advancement Centers (TRACs). The funding will be through four grant awards spanning over five years, with the total funding in the first year alone totaling approximately $4.3 million.

The centers will support the development of the next generation of tuberculosis researchers, providing mentoring, funding support, opportunities for multidisciplinary and collaborative research, and training in laboratory and clinical settings. The continuing improvement of tuberculosis research will allow for the discovery or improvement of diagnostics, therapeutics, and vaccines for the disease.

Tuberculosis is a bacterial disease that is currently the second leading cause of death from a single infectious agent worldwide, after COVID-19. According to NIH, approximately 10 million new tuberculosis cases were diagnosed in 2020 and approximately 1.5 million lives were lost to the disease.

The grant awards were made to Texas Biomedical Research Institute, San Antonio; Johns Hopkins University, Baltimore; Emory University, Atlanta; and University of Washington School of Medicine, Seattle.

NIH has announced four new grant awards to fund new tuberculosis research advancement centers. 

NIH Funds New Tuberculosis Research Advancement Centers

Advanced Accelerator Applications (AAA), a Novartis company, announced on April 6, 2022 that the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued a positive scientific opinion for lutetium vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC). The therapy was approved through the Early Access to Medicines Scheme (EAMS) and applies to PSMA-positive mCRPC patients who have been treated with androgen receptor (AR) Pathway inhibition and taxane-based chemotherapy or who are not medically suitable for taxanes.

This positive opinion allows eligible patients in the UK early access to lutetium vipivotide tetraxetan while the MHRA completes its full marketing authorization application (MAA) review. The EAMS is meant to enable patients with life-threatening or seriously debilitating conditions to access medicines that have not yet been granted marketing authorization. These medicines are often filling a clear unmet medical need or providing an alternative treatment option.

Novartis received promising innovative medicine (PIM) designation for lutetium vipivotide tetraxetan in September 2021. Medicines must have received a PIM designation in order for the MHRA to provide a positive scientific opinion through EAMS.

“The positive scientific opinion for an Early Access to Medicines Scheme for lutetium vipivotide tetraxetan in this group of patients with a life-threatening disease shows the clear unmet medical need recognized by the MHRA,” said Dr. Gerhard Compion, medical lead at AAA, in a press release. “Patients who have metastatic prostate cancer classified as CRPC may have already had many lines of treatment before, including chemotherapy and hormone therapy. Their life expectancy is limited, and they may have run out of other treatment options. I am very relieved that eligible patients will now be able to access this radioligand therapy in England while the MHRA completes the Marketing Authorization Application review.”

UK’s MHRA has issued a positive opinion for the Early Access to Medicines Scheme for radioligand therapy in patients with advanced prostate cancer.

Early Access Issued for Eligible Patients in the UK for Radioligand Therapy in Advanced Prostate Cancer

INCOG Biopharma, a contract development and manufacturing organization (CDMO), has successfully completed the construction of a new cleanroom production area within its new 90,000-sq.-ft.biopharma manufacturing site. The completion of this construction marks a milestone in the company’s $100 million investment in a new facility and goals to ready current good manufacturing practice (CGMP) manufacturing capabilities for injectable drug product capacity.

The new cleanroom production area will feature a multi-use aseptic filling line with integrated isolator technology, capable of processing both bulk vials and ready-to-use vials, syringes, and cartridges. The cleanroom space will also be used for formulation activities, inspection, labeling, and packaging services. The cleanroom project, completed in collaboration with AES Clean Technology, will enable INCOG to greatly increase its drug product manufacturing and handling capacity as well as provide flexibility and customization for growth.

“I’m thankful for our partners at AES, Shiel Sexton, Javan Engineering, OPTIMA Pharma, and extended teams. INCOG is now even closer to opening our doors to advance therapies into the hands of patients and providers,” said Alex Haig, INCOG’s vice president of operations, in a press release. “The completion of the cleanroom space means we are ready to install our OPTIMA filling line and maintain our target to be CGMP ready by Q3 2022. With growing demand for injectables, our team is well positioned and ready to help alleviate capacity constraints in the global markets.”

INCOG Biopharma has completed the construction of its cleanroom production area, marking a milestone in the completion of an overall $100 million investment in a new facility. 