Pharmaceutical Technology Editors

ProBioGen, a contract manufacturing and development organization, announced on Feb. 11, 2022, that it had come to an agreement with AstraZeneca to license out its GlymaxX technology. According to a company press release, GlymaxX improves target cell killing orchestrated by natural killer cells, enhancing antibody-dependent cell-mediated cytotoxicity (ADCC).

According to the release, GlymaxX prevents the addition of the sugar fucose in the N-linked antibody carbohydrate part by introducing an enzyme which deflects the cellular pathway of fucose biosynthesis. The absence of fucose enhances ADCC activity for antibodies directed against cancer and infectious diseases, making it ideal for drug discovery purposes. Additionally, one unique advantage of GlymaxX is that it can use the same modified cell line to produce antibodies of varying levels of fucosylation.

"We are delighted that AstraZeneca decided to implement our technology, which has shown great potential in making molecules more potent and efficient." said Gabriele Schneider, chief business officer, ProBioGen, in the press release.

Articles

The deal between ProBioGen and AstraZeneca will allow AstraZeneca to use ProBioGen’s GlymaxX technology.

ProBioGen Inks License Agreement Deal with AstraZeneca

The European Medicines Agency’s (EMA’s) Pharmacovigilance Risk Assessment Committee (PRAC) announced on Feb. 11, 2022 the adoption of updated guidance on core requirements for risk management plans of COVID-19 vaccines. Guidance published during the pandemic has been updated to include content requirements for summary safety reports to be submitted to the agency and details on safety topics where monitoring with periodic safety update reports is more appropriate. The updated guidance also includes considerations for frequency changes for summary safety reports and when it is appropriate to no longer submit safety reports.

The updates were made after discussion at PRAC and experience gathered during the pandemic. The 

Guidance published during the pandemic has been updated to include content requirements for summary safety reports. 

EMA Updates Guidance on Risk Management Plans for COVID-19 Vaccines

The European Medicines Agency (EMA) announced on Feb. 11, 2022 that its Pharmacovigilance Risk Assessment Committee (PRAC) is assessing reports of heavy menstrual bleeding and lack of menstruation associated with COVID-19 vaccines Comirnaty and Spikevax. Previous reports of period disorders were analyzed in the safety summary reports for COVID-19 vaccines approved in the European Union. It was concluded that evidence at the time did not support a causal link between the vaccines and menstrual disorders.

PRAC has requested an in-depth evaluation of available data from spontaneous reporting systems, clinical trials, and published literature after spontaneous reports of menstrual disorders with both vaccines. “At this stage, it is not yet clear whether there is a causal link between the COVID-19 vaccines and the reports of heavy periods or amenorrhea. There is also no evidence to suggest that COVID-19 vaccines affect fertility,” the agency stated in a press release.

The agency’s safety committee is assessing reported cases of period irregularities associated with Comirnaty and Spikevax mRNA vaccines.

EMA Investigating Reports of Menstrual Irregularities with COVID-19 Vaccines

The European Medicines Agency (EMA) announced on Feb. 11, 2022 that its Pharmacovigilance Risk Assessment Committee (PRAC) has started a safety review of Janus kinase (JAK) inhibitors used to treat chronic inflammatory disorders, such as rheumatoid arthritis, psoriatic arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, ulcerative colitis, and atopic dermatitis. Final results from a clinical trial of the JAK inhibitor Xeljanz (tofacitinib), which showed that patients taking Xeljanz who were at risk for heart disease were more likely to experience cardiovascular problems, prompted the review.

The trial results also showed there was a higher risk of patients developing cancer when using Xeljanz than in those patients treated with TNF-alpha inhibitors. “The study also showed that compared with TNF-alpha inhibitors, Xeljanz was associated with a higher risk of death due to any cause, serious infections, and blood clots in the lungs and in deep veins (venous thromboembolism VTE),” the agency stated in a press release.

Preliminary findings in another study involving Oluminat (baricitinib), a JAK inhibitor, suggest an increased risk in cardiovascular problems in VTE patients treated with the drug, compared with those treated with TNF-alpha inhibitors.

“In the treatment of inflammatory disorders, Olumiant and other JAK inhibitors work in a similar way to Xeljanz. PRAC will therefore carry out a review to determine whether these risks are associated with all JAK inhibitors authorized in the EU for the treatment of inflammatory disorders and whether the marketing authorizations for these medicines should be amended,” the agency stated.

The agency’s safety committee is reviewing the use of Janus kinase inhibitors to treat inflammatory disorders because of the potential for major cardiovascular problems.

EMA Reviews Safety of Janus Kinase Inhibitors to Treat Inflammatory Disorders

On Feb. 15, 2022, the European Medicines Agency (EMA) released its overview of key recommendations made in 2021. There were 92 medicines recommended for marketing authorization in 2022, with 53 being active substances not previously authorized in the European Union. New active substance recommendations were up 35% over 2020. Five negative opinions were given out, and seven applications were withdrawn during the year.

There were four COVID-19 vaccines recommended in 2021, as well as five treatments. EMA also approved 33 new COVID-vaccine manufacturing sites in 2021, which increased vaccine manufacturing capacity and supply. 

The majority of drugs (20) were recommended to treat cancer, and more than 12 medicines were recommended for the treatment of neurological conditions. Other conditions that received treatment recommendations included immunology/rheumatology, endocrinology, cardiovascular, dermatology, ophthalmology, pneumology, among others.

Orphan drugs approved by EMA in 2021 included Pemazyre for the second-line treatment of advanced or metastatic bile duct cancer, Imcivree to treat obesity, Voxzogo to treat achondroplasia, Bylvay to treat progressive familial intrahepatic cholestasis, and Koselugo to treat pediatric patients with neurofibromatosis type 1 plexiform neurofibromas.

The agency recommended 53 new active substances in 2021, up 35% from 2020.

New Medicines Recommendations Up in 2021, EMA States

Cell and gene therapy (CGT) companies can now use new integrated commercial packaging and distribution services from Thermo Fisher Scientific, the company announced on Feb. 15, 2022. The services are designed to facilitate the transition of cell and gene therapies from clinic to commercial launch for patients across the United States and Europe.

Patheon, a Thermo Fisher Scientific company, is offering commercial packaging services for CGT as an end-to-end solution that combines the good manufacturing practice (GMP) storage, serialization, ultracold and cryogenic packaging, and global distribution that developers need to support their logistics plans.

Some priorities surrounding the new services include:

: support for the Drug Supply Chain and Security Act (DSCSA) and Falsified Medicines Directive (FMD) designed to ensure that product identity required for allogeneic products is maintained throughout the entire supply chain.

: packaging and distribution services available at cryocenters in Frederick, MD, and Weil-am-Rhein, Germany, support commercial launches in the US and European Union.

: experienced project teams with expertise in clinical trials designed to enable commercial success.

“There is a large number of cell and gene therapies reaching commercialization in the next few years that will make a significant impact in patients’ lives,” said Chris Armstrong, president, clinical trial services, Thermo Fisher Scientific, in a company press release. “Our integrated services are specifically designed to meet specialized needs for cell and gene therapies to ensure supply chain integrity from manufacturing through packaging, labeling, and distribution. This will help accelerate the introduction of these important life-saving medicines.”

Thermo Fisher Scientific's solution for cell and gene therapies involves a combination of cold chain logistics, serialization compliance, and distribution 