Pharmaceutical Technology Editors

 on Sept. 17, 2021 that the US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibitingFlorida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions, including drugs intended to be sterile. Under the consent decree, Premier Pharmacy is required to not engage in compounding operations or distribution until corrective actions are completed and the company and its facility are in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). It must also establish and implement a comprehensive quality control system and receive authorization from FDA before it can resume operations.

“Premier Pharmacy and its owner placed patients at significant risk. Outsourcing facilities must follow good manufacturing practice to ensure patients are not exposed to poor quality, potentially harmful drugs,” said Donald D. Ashley, J.D., director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a press release. “We will continue to take appropriate enforcement actions to ensure that companies follow important safety requirements to avoid putting patients’ health at risk.”

FDA previously inspected the company’s facility in 2014, which resulted in a warning letter. A follow up inspection in 2016 led to a regulatory meeting with the company in 2018. Premier Pharmacy recalled affected sterile injectable products in April 2018, and another follow-up inspection was conducted by FDA in April 2019, which resulted in additional products recalled by the company in June 2019. The company deregistered as an outsourcing facility for compounded drugs in 2019.

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US District Court for the Middle District of Florida entered a consent decree of permanent injunction prohibiting Florida-based Premier Pharmacy Labs from producing or distributing drugs because of insanitary conditions.

Federal Court Enters Consent Decree Against Florida Compounder

FDA announced on Sept. 17, 2021, that it has approved the first biosimilar to Lucentis (ranibizumab injection). Byooviz (ranibizumab-nuna), a monthly intravitreal injection, has been approved to treat eye diseases such as neovascular age-related macular degeneration (nAMD), macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The agency based the approval on evidence that included structural and functional characterization, comparative clinical efficacy, and safety evaluations.

“Today’s approval provides another treatment option for millions of people whose vision is impaired and is another step forward in our commitment to provide access to safe, effective and high-quality biological products,” said Sarah Yim, M.D., director of FDA’s Office of Therapeutic Biologics and Biosimilars, in a 

. “Continuing to grow the number of biosimilar approvals is a key part of our efforts to provide greater access to treatment options for patients, increase competition and potentially lower costs.”

The agency approved Byooviz (ranibizumab-nuna), a biosimilar to Lucentis (ranibizumab injection), for the treatment of several eye diseases.

FDA Approves Biosimilar for Treatment of Eye Disease

AstraZeneca announced on Sept. 21, 2021 that they will be investing $360 million into a new manufacturing facility that will produce small molecule APIs in Ireland. The new plant is planned to support both late-stage development and early commercial supply.

According to a company press release, the facility will be capable of manufacturing various medicines, including new modalities such as antibody drug conjugates and oligonucleotides. The company also expects the facility to significantly reduce commercialization costs and lead times, as well as introduce more sustainable manufacturing processes. This would contribute to the company’s Ambition Zero Carbon program, which aims to have zero carbon emissions by 2025.

The planned investment is at Alexion Campus in College Park, Dublin. The project, which was developed in collaboration with IDA Ireland—Ireland’s investment agency—is expected to create approximately 100 highly skilled direct jobs, such as scientists and engineers, as well as additional indirect jobs.

“I warmly welcome today’s announcement from AstraZeneca that it is to establish its first ever manufacturing facility in Ireland.” said Micheál Martin, Taoiseach [prime minister of the Republic of Ireland], in the press release. “In choosing Ireland as the location for its new next-generation active pharmaceutical ingredient manufacturing facility, AstraZeneca joins the very strong and successful network of global life sciences companies we have in Ireland. I wish them every success with their operations here.”

“This is a tremendously proud moment for us all at AstraZeneca, and I am delighted that we are bringing this very significant investment to Dublin which, with the support of the IDA, will create highly skilled jobs, nurture the country’s dynamic life sciences sector and allow for the development of high value-added medicines.” said Pascal Soriat, CEO of AstraZeneca, in the press release.

AstraZeneca will establish an API manufacturing facility near Dublin, Ireland.

AstraZeneca to Invest $360 Million in Advanced Manufacturing Facility in Ireland

Pfizer and BioNTech announced on Sept. 20, 2021 that topline data from their Phase II/III COVID-19 vaccine in children aged 5 to 11 demonstrated positive results. According to a Pfizer press release, the results demonstrated that the vaccine was safe, well-tolerated, and showed robust neutralizing antibody responses.

In the trial, participants were given a two-dose regimen of 10 µg administered 21 days apart. This is a smaller dose than the 30 µg dose used for people 12 and older, but was selected for this demographic because of concerns surrounding safety, tolerability, and immunogenicity.

The antibody responses were comparable to those in a previous study in people aged 16-25 who were immunized with 30 µg doses. The SARS-CoV-2–neutralizing antibody geometric mean titer (GMT) in this trial was 1197.6 one month after the second dose. This was non-inferior to the GMT of 1146.5 from participants ages 16 to 25 years old, used as the control group for this analysis. Additionally, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the US–underscoring the public health need for vaccination,” said Albert Bourla, chairman and CEO, Pfizer, in the press release. “These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

The topline data from Pfizer and BioNTech’s trial suggests that a 10 µg vaccine is safe and effective among the 5 to 11 age group.

 Pfizer and BioNTech Announce Positive Results In COVID-19 Vaccine Trial for Children Ages 5 to 11

The University of California Riverside (UCR) announced in a Sept. 16, 2021, press release that their scientists are researching whether a plant-based messenger RNA (mRNA) vaccine can be created. This vaccine would not have restrictions that require refrigeration during transport and storage, such as those used for the COVID-19 vaccines. 

The goal for this project is to show that DNA containing the mRNA vaccines can be successfully delivered into the part of plant cells where it can replicate. This would demonstrate the plants can produce enough mRNA to rival a traditional vaccine or injection. They also hope to determine the proper dosage.

The key to making this work are chloroplasts, which are small organs in plant cells that convert sunlight into energy the plant can use. These chloroplasts produce sugar and other molecules that allow the plant to grow. In the past, Juan Pablo Giraldo, an associate professor in UCR’s Department of Botany and Plant Sciences and research lead, found it is possible for chloroplasts to express genes that aren’t naturally part of the plant after conducting prior research where he sent foreign genetic material into plant cells inside a protective casing.

“Ideally, a single plant would produce enough mRNA to vaccinate a single person,” said Giraldo in UCR’s press release. “We are testing this approach with spinach and lettuce and have long-term goals of people growing it in their own gardens. Farmers could also eventually grow entire fields of it.”

The National Science Foundation contributed a $500,000 grant toward their research, which is being performed in collaboration with scientists from UC San Diego and Carnegie Mellon University.

UCR scientists are researching whether a plant-based messenger RNA vaccine can be created and aim to eliminate the need for the refrigeration of mRNA vaccines during transport and storage.

Researchers from the University of California Riverside Investigate Plant-Based mRNA Vaccines

Statins, a commonly prescribed cholesterol-lowering drug, may be an effective treatment for ulcerative colitis, according to a new Stanford Medicine study—the results of which were published in a Sept. 16, 2021, press release. Researchers found that people with ulcerative colitis who were taking statins, regardless of their age, had a 50% decrease in colectomy rates and were less likely to be hospitalized.

Purvesh Khatri, PhD, associate professor of medicine and of biomedical data science, and his team analyzed publicly available genomic data from hundreds of patients with ulcerative colitis who had a colon biopsy. They looked for certain genomic signatures (patterns of gene activity) that seemed to persist in most patients with the condition and found a disease signature that was robust across all the datasets, regardless of whether the patient was experiencing a flare in disease. They then worked to identify how certain drugs affected the gene activity associated with ulcerative colitis. After cross-referencing the data, the team identified three drugs that reversed the gene signature of ulcerative colitis: two chemotherapy drugs and a statin. 

Rather than pursuing a clinical trial, the researchers turned to data from electronic health records to see if patients who had ulcerative colitis and were on statins needed a colectomy. They found that people with ulcerative colitis who were taking statins, regardless of their age, had about a 50% decrease in colectomy rates and were less likely to be hospitalized. In addition, they found that patients who were taking statins were prescribed other anti-inflammatory medications at a lower rate. While it’s not known how statins can impact ulcerative colitis, Khatri said they are known to have some sort of general anti-inflammatory capacity.

A paper describing the study was published on Sept. 16, 2021, in the 

Journal of the American Medical Informatics Association

. The research was supported by the National Institutes of Health, the Stanford University Medical Scientist Training Program, the Bill and Melinda Gates Foundation, the Department of Defense, and the Ralph & Marian Falk Medical Research Trust.

People with ulcerative colitis who are taking statins were found to have a 50% decreased risk of colectomies and hospitalization, according to a Stanford Medicine study.