Pharmaceutical Technology Editors

Huma announced on March 23, 2022 that it has partnered with AstraZeneca to scale and accelerate innovation for digital health. The companies will launch Software as a Medical Device (SaMD) companion apps targeted at several therapeutic areas and will partner to help accelerate the adoption of decentralized clinical trials.

Huma already possesses technology that powers digital-first care, serving more than 1.8 million active patient users across more than 3000 hospitals and clinics. The technologies are designed to provide more efficient care delivery by connecting with clinical workflows.

AstraZeneca has invested in the development of its digital health platform AMAZE to improve the care and management of patients. The collaboration with Huma will combine with the strong foundation of AMAZE to accelerate digital-first care across therapeutic areas and launch SaMDs.

"This collaboration marks an important moment as it is a first for AstraZeneca in the digital health space as well as in the industry for chronic diseases and SaMDs in support of different treatments,” said Karan Arora, chief commercial digital officer of AstraZeneca, in a press release. “With Huma, we are accelerating AstraZeneca’s ambition to achieve earlier diagnosis and treatment for patients with chronic diseases so they can lead better, more fulfilling lives.”

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Huma has acquired AstraZeneca’s digital health platform, and AstraZeneca has become a shareholder of Huma in a partnership to accelerate digital-first patient care.

Huma and AstraZeneca Partner to Accelerate Innovation for Digital-First Patient Care

Pfizer announced on March 24, 2022 that its respiratory syncytial virus (RSV) vaccine candidate, RSVpreF, received Breakthrough Therapy Designation from FDA for the prevention of lower respiratory tract disease caused by RSV in individuals 60 years of age or older.

FDA’s Breakthrough Therapy Designation is designed to accelerate the development and review of drugs and vaccines that are intended to treat or prevent serious conditions and demonstrate substantial improvement over available therapies.

RSV is a contagious virus that can affect the lungs and breathing passages and can be potentially life-threatening for infants, children with chronic medical conditions, and older adults. According to Pfizer, RSV infections in older adults account for approximately 177,000 hospitalizations and 14,000 deaths each year in the US alone. There are currently no prophylactic, therapeutic, or vaccine options for older adults with RSV.

“Today’s decision is a significant step forward in our efforts to help protect vulnerable populations, particularly older adults, against certain potentially serious respiratory illnesses, including RSV,” said Kathrin U. Jansen, senior vice-president and head of vaccine research & development at Pfizer, in a press release. “The clinical and economic burden of RSV represents a critical need, and we look forward to our ongoing dialogue with the FDA to accelerate the development of our RSV vaccine candidate.”

Pfizer’s respiratory syncytial virus vaccine candidate has received Breakthrough Therapy Designation from FDA for the prevention of RS in older adults. 

FDA Grants Breakthrough Therapy Designation for Pfizer Respiratory Syncytial Virus Vaccine Candidate 

EMA has recommended a conditional marketing authorization in the EU for Carvykti (ciltacabtagene autoleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three prior therapies and whose cancer has worsened since they received their last treatment.

Multiple myeloma is a rare cancer that affects the plasma cells, a type of white blood cell found in bone marrow that produces antibodies. Plasma cells uncontrollably increase in numbers, resulting in abnormal, immature plasma cells multiplying and filling up the bone marrow. Cancerous plasma cells no longer protect the body from infections and instead produce abnormal proteins that can cause problems in the kidneys, bones, or blood.

There are currently limited therapeutic options for patients whose disease has returned or no longer responds to existing medicines, which is why new medicines are needed for these patients.

Ciltacabtagene autoleucel is a chimeric antigen receptor (CAR)-T cell medicine that collects and modifies a patient’s own immune T-cells to create a personalized treatment that is then infused back into the patient. The recommendation will now be sent to the European Commission for a decision on the adoption of an EU-wide marketing authorization.

EMA has recommended a conditional marketing authorization for a new gene therapy to treat adult patients with multiple myeloma.

EMA Grants Recommendation for New Gene Therapy to Treat Adult Patients with Multiple Myeloma

Excipients solution provider DFE Pharma, equipment supplier Harro Höfliger, and API manufacturer Sterling announced on March 24, 2022 a unique partnership with the establishment of Inhalation Together (INTO) in the field of dry powder inhalation (DPI).

This initiative will provide R&D services to pharmaceutical companies in the respiratory field, improving formulation development to be simpler, faster, and easier to manage. The combination of INTO’s suite of services and each of the companies’ field of expertise allows for a stronger and more focused progression for development.

Developing a DPI formulation requires a strong interdependency between process, powder, device, and patient. To address this complexity, INTO provides consultancy services, such as solid-state characterization and sono-crystallization of APIs and studies to optimize formulation, blending, and filling.

I am very excited about the INTO initiative because it increases speed to market and reduces the complexity of formulation and process development,” said Martti Hedman, CEO of DFE Pharma, in the press release. “The three companies have a very good understanding of the critical aspects of development and manufacture of DPI products, therefore, adding significant value to our customers.”

DFE Pharma, Harro Höfliger, and Sterling have announced a partnership called Inhalation Together to provide formulation services for respiratory products.

DFE Pharma, Harro Höfliger, and Sterling Partner to Provide Formulation Services for Respiratory Products

Gamma Biosciences announced on March 22, 2022 an initiative through its subsidiary Mirus Bio, a specialist in nucleic acid delivery technology, to develop novel, highly active lipid-polymer nanocomplexes for therapeutic mRNA delivery 

This initiative will help to develop improved mRNA delivery solutions using Mirus’ proprietary formulations of membrane active polymers and lipids.

“mRNA vaccines and gene therapies require efficient delivery of RNA or DNA cargo. Both RNA and DNA are large, hydrophilic macromolecules and require an ‘active nanoparticle’ to assist delivery into cells,” said Laura Juckem, PhD, vice-president of scientific operations at Mirus Bio, in the press release. “Our extensive work with viruses and viral infection processes for more than two decades has allowed us to create ‘active non-viral nanoparticles,’ which incorporate membrane-active molecules and mimic the natural behavior of viruses to carry out this process.”

“Leveraging our rationally designed polymer and lipid libraries, which are the foundation of our current range of 

 transfection products, we are identifying novel formulations for further development and optimization,” said Dale Gordon, CEO at Mirus Bio, in the press release. “We believe newly identified polymer or lipid/polymer nanocomplex compounds will be applicable for both next-generation mRNA vaccine development and targeted mRNA-based therapeutics.”

Gamma Biosciences has announced an initiative through its subsidiary, Mirus Bio, to develop lipid-polymer nanocomplexes for improve mRNA delivery solutions.

Gamma Biosciences and Mirus Bio to Develop Lipid-Polymer Nanocomplexes 

Roquette, a company focused on providing plant-based ingredients, plant proteins, and pharmaceutical excipients, announced on March 22, 2022 an investment plan for €25 million (approximately USD $27.5 million) for liquid and powder polyols between 2022 and 2024 at its site in Lestrem, France. The investment will establish a strong, reliable supply for the future and strengthen the company’s position as a leader in the polyols market.

Polyols are key pharmaceutical excipients in oral dosage forms. They are directly compressible and aid in the formulation of swallowable, chewable, or dispersible tablets. The higher purity grades of polyols are also APIs and are widely used in injectable solutions. They are also used in oral care applications because of their functionalities as non-crystallizing humectant, non-cariogenic, or shelf-life enhancer.

The investment will improve equipment efficiency, increase safety standards, standardize industrial operations, and improve overall production performance. The investment will also ensure a sustainable supply of polyols in the market and meet customers’ increasing expectations for greater flexibility.

Roquette is investing €25 million at its site in Lestrem, France to strengthen its position in the polyols market.