Pharmaceutical Technology Editors

On July 16, 2021, Nexus Pharmaceuticals celebrated the opening of the company’s new manufacturing facility in Pleasant Prairie, Wis.

Facility construction began in August 2019 and was completed in 2021. The Phase I investment of $100 million supports a new, three-story manufacturing facility with an advanced isolator system and multiple lyophilization machines. Commercial production is expected to commence in 2022. The full, multi-phase project is expected to be completed in ten years, which is approximately a $250-million investment.

 its support to increase vaccine manufacturing because of the COVID-19 pandemic. With the new manufacturing capacity at the Wisconsin facility, Nexus can maintain the production of existing products and begin manufacturing vaccines without having to sacrifice the production of one drug for another.

The company hopes to bring more than 77 new high-tech manufacturing and science jobs by 2022, creating 400+ new local jobs long-term. According to a company press release, Nexus also intends to partner with local institutions to provide job training and career and research opportunities.

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Nexus Pharmaceuticals celebrated a new manufacturing facility in Pleasant Prairie, Wis.

Nexus Opens New Wisconsin Manufacturing Facility

Amneal Pharmaceuticals announced on July 19, 2021 that it received abbreviated new drug application approval from FDA for the generic version of TobraDex.

Dexamethasone and tobramycin ophthalmic suspension 0.3%/0.1% is the generic version of TobraDex and is indicated for steroid-responsive inflammatory ocular conditions. Specifically, when a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

“Today’s announcement of an additional ophthalmic product approval in our generic portfolio is important,” said Chirag and Chintu Patel, co-CEOs, Amneal Pharmaceuticals, in the press release. “It is another proof point of the continued execution of our strategy to develop and commercialize complex generics.”

Amneal Pharmaceuticals received ANDA approval from FDA for the generic version of TobraDex.

FDA Approves Amneal’s Generic Version of TobraDex

In a July 19, 2021 press release, Meissa Vaccines announced that a single adjuvant-free dose of the company’s intranasal recombinant live attenuated COVID-19 vaccine, MV-014-212, was equally effective against SARS-CoV-2 (compared to the efficacy of currently authorized vaccines), according to preclinical data in nonhuman primates (NHPs). The data also showed that MV-014-212 stimulated mucosal (nasal immunoglobulin A [IgA]) antibodies in the upper respiratory tract and systemic (serum neutralizing and binding IgG) antibodies.

A conventional live attenuated coronavirus vaccine strategy is not recommended for SARS-CoV-2 because coronaviruses are genetically unstable, according to the company press release. MV-014-212 was built using the company’s AttenuBlock platform, which produces a vaccine backbone that provides appropriate attenuation, genetic stability, and optimized immunity. Moreover, live attenuated vaccines are effective at lower dosages and scalable.

According to the press release, injected vaccines may reduce but not contain transmission of COVID-19. The live attenuated intranasal vaccine, on the other hand, has the potential to block transmission, prevent infections, and provide broad and long-lasting immunity, the company claims.

Meissa’s intranasal COVID-19 vaccine generated both mucosal and systemic antibodies in NHPs and was protective against wild-type SARS-CoV-2 challenge. The company also enrolled and dosed SARS-CoV-2 seronegative and seropositive adult participants in all dosage groups of a Phase I clinical trial of MV-014-212. Interim analysis of the trial data is expected later this year.

Meissa Vaccines’s MV-014-212, an intranasal recombinant live attenuated COVID-19 vaccine, induced mucosal and systemic antibodies against SARS-CoV-2 and two variants of concern.

Meissa’s Intranasal COVID-19 Vaccine Yields Promising Preclinical Data

PerkinElmer has entered into an agreement on July 26, 2021 to acquire BioLegend, a global developer and manufacturer of antibodies and reagents used in biomedical research (cytometry, proteogenomics, multiplex assays, recombinant proteins, magnetic cell separation, and bioprocessing). The transaction is expected to close by the end of 2021 and is valued at $5.25 billion.

With this acquisition, PerkinElmer will offer solutions in areas such as cell and gene therapy discovery. The company will also move into new spaces like proteogenomics. BioLegend’s new headquarters in San Diego, Calif. will serve as PerkinElmer’s center for research reagent content development.

PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.

PerkinElmer to Acquire BioLegend in $5.25-Billion Deal

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine, Spikevax, to include adolescents 12 years of age and older, Moderna announced in a 

Moderna announced data from the ongoing Phase II/III study on June 10, 2021, which enrolled more than 3,500 participants ages 12–18 years in the United States. After two doses of the Moderna COVID-19 vaccine, no cases of COVID-19 were observed in the vaccine group, and the study met its primary endpoint. The vaccine was generally well tolerated with a safety and tolerability profile consistent with the previous Phase III study in adults.

Most of the adverse events were mild or moderate in severity. Injection site pain was the most common local adverse event, while the most common systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia, and chills.

The European Commission will consider authorizing the use of the Moderna COVID-19 vaccine in adolescents younger than 12 years of age.

Moderna is also conducting the KidCOVE study, a Phase II/III study, of mRNA-1273 in children ages six months to 12 years.

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

EMA’s CHMP Adopts Positive Opinion for Moderna COVID-19 Vaccine Use in Adolescents 

 the selection of Onco360, an independent Oncology Pharmacy, to be a specialty pharmacy partner for Rezurock (belumosudil). Rezurock is a new oral treatment for the treatment of chronic graft-versus-host disease (chronic GVHD) after failure of at least two prior lines of systemic therapy for adult and pediatric patients 12 years and older.

, which is distributed and marketed by Kadmon Pharmaceuticals, following the Phase II KD025-213 clinical trial (NCT03640481).

Chronic GVHD is the leading cause of non-relapse mortality following allogeneic HCT and often develops within the first year after allogeneic HCT, according to the National Comprehensive Cancer Network (NCCN) Guidelines for Hematopoietic Cell Transplantation (HCT). It also can affect multiple organ systems, including skin, gastrointestinal tract, liver, lungs, and more.

First-line treatment for chronic GVHD involves systemic corticosteroids. But according to the NCCN guidelines, patients may develop steroid-refractory disease and require additional/alternative treatment.

Kadmon Pharmaceuticals selects Onco360 to be a specialty pharmacy partner for Rezurock (belumosudil).