Pharmaceutical Technology Editors

The European Medicines Agency announced on Nov. 11, 2021 that its Committee for Medicinal Products for Human Use (CHMP) has recommended authorizing two monoclonal antibody (mAb) drugs to treat COVID-19 patients.

Ronapreve (casirivimab/imdevimab) (Roche Registration GmbH) is being recommended for the treatment of COVID patients who do not require supplemental oxygen but are at risk for severe disease and who are 12 years of age (weighing at least 40 kilograms) and older. It may also be used to prevent COVID-19 in people aged 12 years and older weighing at least 40 kilograms.

CHMP is recommending authorizing Regkirona (regdanvimab) (Celltrion Healthcare Hungary Kft) for treating adults with COVID-19 at risk for severe disease who do not require supplemental oxygen.

Both mAbs are the first to receive a positive CHMP opinion for treating COVID-19. The committee reached its decision after evaluating data from studies that showed the drugs significantly reduced hospitalization and death in COVID-19 patients. According to EMA, the chance of being infected by a household member with COVID-19 was reduced with Ronapreve.

Both recommendations will be sent to the European Commission for approval.

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The agency is recommending the authorization of Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab), two monoclonal antibody drugs, for treating COVID-19.

EMA Recommends Two COVID-19 Treatments

Then European Medicines Agency (EMA) announced on Nov. 10, 2021 that it has begun evaluating Moderna’s application to extend the use of its COVID-19 vaccine, Spikevax, to children ages 6–11. The agency’s Committee for Medicinal Products for Human Use (CHMP) will review vaccine data and results from an ongoing clinical study that includes children aged 6–11. EMA anticipates the evaluation to take two months, approximately. Once the CHMP reaches an outcome from the review, its opinion will be forwarded to the European Commission for a final decision.

Spikevax is currently authorized in the European Union for use in people 12 years and older.

The agency is evaluating Moderna’s application for use of Spikevax in children aged 6 to 11.

EMA Starts Evaluation of Moderna’s COVID-19 Vaccine for Children

On Nov. 10, 2021, CPhI Worldwide announced the winners of the 2021 CPhI Pharma Awards. The awards are given out to leaders in the industry who demonstrate “Excellence in Pharma” and were announced at a ceremony at Stella Polare, Fiera Milano in Milan, Italy on Nov. 9, 2021 during the CPhI Worldwide event.

The awards categories, along with the winners, are listed as follows:

Excellence in Pharma: CEO of the Year—


Excellence in Pharma: Packaging & Drug Delivery—


 for its prefilled and preloaded wearable drug delivery platform

Excellence in Pharma: Supply Chain, Logistics, and Distribution—


 for its Supplier Compliance Management Software

for its strong commitment to the community

Excellence in Pharma: Innovation in Response to COVID-19—


 for its speed of committing to 1.1 billion vaccine doses of COVAX

Excellence in Pharma: Finished Formulation—


 for the development of androgen and metabolic therapies

Excellence in Pharma: API Development—


 for their program to boost biological drug development

Excellence in Pharma: Digital Innovation—


 for its real-world evidence methodology for regulatory purposes in noncommunicable diseases, artificial intelligence, machine learning, and deep learning

Excellence in Pharma: Regulatory Procedures and Compliance—


Excellence in Pharma: Manufacturing Technology and Equipment—


 for its In-Cavity Powder Liquid 3D Printing solution.


“Despite the challenges of the past 18+ months, the pharmaceutical industry has shown both incredible resilience and a continued pursuit of innovation, something which is clearly reflected in the extremely high standard of entries for this year’s CPhI Pharma Awards,” stated Tara Dougal, Head of Content & Insights, Informa Markets, in a press release. “I’d like to thank our sponsor, Rentschler Biopharma and especially our jury, who lent their time and expertise to assessing the many entries we received. Lastly, I’d like to extend congratulations to all of the nominees for their achievements, and of course to this year’s winners!”

More information about the awards can be found at 

The winners of the 18th CPhI Pharma Awards, which are given as a recognition of ‘Excellence in Pharma’, were announced on November 9, 2021, in Milan.

CPhI Announces 2021 Pharma Awards Winners

Flagship Pioneering, the firm that founded Moderna and many other companies in the health sector, announced on Nov. 9, 2021, that it would be officially launching a transfer ribonucleic acid (tRNA) platform company, Alltrna. Founded at Flagship Labs in 2018, Alltrna has mapped tRNA biology to design tRNA medicines for various diseases driven by genetic mutations. Flagship has made an initial commitment of $50 million to Alltrna.

According to a company press release, various diseases stem from the same nonsense mutation, where the code for an amino acid has mutated into a “stop” codon. This results in a truncated or shortened protein product that is at the root of many genetic diseases. To combat this, Alltrna has designed a tRNA that can read these stop codons and deliver the desired amino acid, restoring production of the correct, full-length protein. If successful, a single tRNA medicine could treat various diseases with the same underlying genetic mutation.

"Alltrna builds on the more than decade long exploration, conducted at Flagship Labs, focusing on the RNA world as a source of programmable therapeutic modalities," said Noubar Afeyan, co-founder and chairman of Alltrna and CEO of Flagship Pioneering, in the press release. "With Alltrna's platform we are leveraging tRNAs as the critical gatekeepers of protein production to target our central translation code for unprecedented therapeutic effect."

According to the press release, Alltrna's tRNA platform harnesses the combinatorial potential of the hundred-plus different modifications possible at each nucleotide position. The stable structure, small size, and diversity of tRNAs make them ideal candidates for therapeutic treatments.

"We have built the world's first tRNA therapeutic platform by combining the extensive learnings at Flagship in RNA design and delivery with a reinforced learning framework that unlocks the relationship of tRNA modality to biological output, disease application, and drug design," said Lovisa Afzelius, origination partner at Flagship Pioneering and founding CEO of Alltrna, in the press release. "Since the company's founding, we have established a deep understanding of tRNA biology and its diverse combinatorial modifications to systematically design, program, and deliver tRNAs to correct disease."

Flagship Pioneering has officially launched Alltrna, a company planning to combat genetic diseases with transfer ribonucleic acid (tRNA) medicine.

Flagship Pioneering Launches Transfer RNA Company, Alltrna

Birmingham Biotech, a biotechnology company specializing in diagnostic tests, protective nasal sprays, and mobile medical facilities, announced on Nov. 9, 2021, that it had reached a licensing agreement with the University of Birmingham to commercialize their antiviral nasal spray. Designed by Professor Liam Grover, a member of the university’s Healthcare Technologies Institute, the nasal spray is designed to protect against COVID-19.

“As COVID-19 restrictions around the world are gradually lifting, there is a real need for effective methods of viral protection,” said Grover in a Birmingham Biotech press release. “While existing measures like wearing masks and handwashing remain essential, this nasal spray provides an additional protective measure with the potential to reduce transmission. We are thrilled to be working with Birmingham Biotech to bring the [antiviral] nasal spray to individuals around the world.”

According to the press release, the spray is designed to work by encapsulating and deactivating the virus while it is still in the nose, preventing wider uptake by the body. It is formulated with two compounds: a polysaccharide gel that coats and retains the virus, so it does not travel further down the respiratory tract, and carrageenan, an antiviral agent. According to the Birmingham researchers, carrageenan completely inhibited SARS-CoV-2 activity.

“We are delighted to enter into a partnership with the University of Birmingham and to be able to work together with its world-leading academic researchers, to advance medical innovations,” said Michael Hsu, managing director of Birmingham Biotech, in the press release. “We have a shared commitment to bring our proprietary anti-COVID-19 nasal spray to as many people as possible at an affordable price, focusing on developing markets with the greatest need.”

The licensing agreement covers the entire duration of the patent and gives Birmingham Biotech exclusive marketing and sale rights outside of India. According to the press release, the nasal spray is expected to be available in the United Kingdom and Asia in early 2022.

The agreement will allow Birmingham Biotech to commercialize the University of Birmingham’s antiviral COVID-19 nasal spray.

Birmingham Biotech and the University of Birmingham Sign Licensing Agreement for Antiviral Nasal Spray Against COVID-19

On Nov. 8, 2021, Azurity Pharmaceuticals announced FDA has approved EPRONTIA (topiramate) oral solution, 25 mg/mL to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older. According to the company, it is the first liquid formulation of topiramate to be approved by FDA as a monotherapy for treating partial-onset or primary generalized tonic-clonic seizures and for use as an adjunctive therapy for treatment of partial-onset seizures, primary generalized tonic-clonic seizures or seizures associated with Lennox-Gastaut syndrome.

“I am pleased that there will now be an FDA-approved liquid formulation of topiramate for patients who may require or prefer a liquid formulation,” said Michael C. Smith, MD, Director, Rush Epilepsy Center, and Professor, Department of Neurological Sciences, Rush University Medical Center, in a 

. “Clinical challenges have existed for years for clinicians looking for a high quality, predictable formulation option of topiramate to effectively meet the varied needs of patients and caregivers.”

EPRONTIA (topiramate) oral solution, 25 mg/mL has been approved to treat certain seizures in patients two years of age or older and for use to prevent migraine in patients 12 years of age and older.