Pharmaceutical Technology Editors

FDA approved Jardiance (empagliflozin) on Feb. 24, 2022 to reduce the risk of cardiovascular death and hospitalization for heart failure in adults.

According to FDA, heart failure affects more than 650,000 people in the United States each year and is the leading cause of hospitalization in people over 65 years of age. Symptoms commonly include shortness of breath, fatigue, and swelling in the legs.

Empagliflozin is meant to reduce the risk of cardiovascular death and hospitalization for patients with heart failure. The drug was originally approved by FDA in 2014 as a diet and exercise supplement to improve glucose control in adults with type 2 diabetes. Empagliflozin is also approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

“Today’s approval will provide a treatment option for a wider range of patients with heart failure,” said Norman Stockbridge, M.D., PhD, director of the Division of Cardiology and Nephrology in FDA’s Center for Drug Evaluation and Research, in a press release. “While Jardiance may not be effective in all patients with heart failure, this approval is a significant step forward for patients and our understanding of heart failure. Coinciding with February’s annual observance of American Heart Month—a reminder for individuals to focus on cardiovascular health—this action will provide physicians another tool to address heart disease.”

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FDA approves Jardiance (empagliflozin) for wider range of patients with heart failure.

FDA Approves Treatment for Wider Range of Patients with Heart Failure

Certara, a global leader in biosimulation, announced on Feb. 23, 2022 that FDA has licensed Certara’s Immunogenicity (IG) Simulator to research and evaluate immunogenicity in protein-based therapeutics. Certara’s IG Simulator can predict the immune response of therapeutics in development.

Immunogenicity is the tendency of a molecule to trigger an immune response. According to the press release, it is a major problem with protein-based therapeutics such as antibody-based drugs or biological medicines. Immunogenicity can be challenging to predict and can negatively impact drug development projects late in the process.

Certara’s IG Simulator is used to better understand and study immunogenicity of a wide range of biologics. Researchers will be able to utilize the Simulator in innovative ways, creating virtual patients and conducting computer-based trials. The IG Simulator has been validated in 20 clinical case studies, including mono and combination therapies.

“The FDA’s decision to license our IG Simulator affirms the importance of biosimulation for addressing the most important challenges in drug development,” said Piet van der Graaf, PharmD, PhD, senior vice president of Quantitative Systems Pharmacology (QSP) at Certara, in the press release. “For the past five years, we have invested, developed, and validated our IG Simulator with a high level of rigor. We are excited by this opportunity to expand the impact of our Simulator to quickly assess immunogenicity risk, addressing pressing questions and guiding study design for better clinical outcomes.”

FDA licenses Certara’s Immunogenicity Simulator to research and evaluate immunogenicity in protein-based therapeutics. 

FDA Licenses Certara’s Immunogenicity Simulator 

AstraZeneca and Honeywell will partner to develop next-generation respiratory inhalers using the propellant HFO-1234ze, which has up to 99.9% less Global Warming Potential (GWP) than currently used respiratory medicine propellants, AstraZeneca announced on Feb. 22, 2022.

Patients with asthma and chronic obstructive pulmonary disease (COPD) often need inhaled medicines, many of which are pressurized metered dose inhalers (pMDIs). In many of these medicines a propellant, which contains small amounts of a type of greenhouse gas (GHG), is used to deliver the medicine into the lungs. According to the press release, respiratory diseases affect hundreds of millions of people around the world, creating a significant clinical need for pMDIs, which are important device options for patients.

AstraZeneca’s integration of their near-zero GWP propellant HFO-1234ze is intended to reduce respiratory healthcare carbon emissions without restricting patient choice or risking improvement in health outcomes.

This development of next-generation respiratory inhalers is part of AstraZeneca’s flagship sustainability program, Ambition Zero Carbon. The company also announced that the entirety of its imported electricity now comes from renewable sources, and that the company has achieved a 59% reduction in it5s Scope 1 and 2 greenhouse gas (GHG) emissions since 2015.

"We are making great progress on our ambition to be zero carbon across our global operations by the end of 2025 and carbon negative across our entire value chain by 2030,” said Pascal Soriot, CEO of AstraZeneca, in the press release. “Our collaboration with Honeywell demonstrates AstraZeneca’s commitment to advancing sustainable healthcare innovation, with the aim of improving outcomes for patients while reducing our environmental footprint.”

AstraZeneca and Honeywell will partner to develop next-generation respiratory inhalers as part of AstraZeneca’s Ambition Zero Carbon program. 

AstraZeneca Progresses Ambition Zero Carbon Program with Honeywell Partnership to Develop Next-Generation Respiratory Inhalers

A new collection of caps, vials, inserts, kits, well plates, and mats from Thermo Fisher Scientific is intended to improve analytical performance and sample security for chromatography and mass spectrometry users in routine and research laboratories. The new consumables are applicable in both the pharma and biopharma sectors as well as across the clinical, food, environmental, and academia sectors.

Launched under the Thermo Scientific SureSTART portfolio in February 2022, the new consumables are compatible with all add-on and chromatography autosamplers, allowing analysts to use the new portfolio regardless of instrument vendor, according to a Feb. 21, 2022, company press release. The new collection provides sample security and low compound adsorption, even for challenging, low-level analytes, which provides laboratories with confidence in results and reduces the time needed for reviewing background peaks or identifying analytes that have shifted retention times.

The SureSTART product line draws from existing products that have been historically successful in the market. The collection aims to provide precise and consistent measurements between different vials and different lots.

“As a trusted provider of vials, closures, and well plates, we continue to innovate to offer laboratories the improved flexibility and assurance needed to meet analytical requirements,” said Detlev Lennartz, product manager, sample handling, chromatography and mass spectrometry, Thermo Fisher, in the press release. “SureSTART consumables are built from high-quality materials that meet both the performance and price requirements of our customers, providing the confidence they need to analyze challenging analytes. Additionally, the new collection is fully compatible with GC [gas chromatography], GC–MS [gas chromatography mass spectrometry], LC [liquid chromatography] and LC–MS [liquid chromatography mass spectrometry] analytical instruments and includes three performance levels to help laboratories choose the right product for their experimental needs.”

A new portfolio of chromatography and mass spectrometry consumables launched by Thermo Fisher Scientific is designed to meet higher performance requirements while remaining economical.

Thermo Fisher Scientific Introduces New Portfolio of Chromatography and Mass Spectrometry Consumables

TFF Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on developing and commercializing innovative drug products based on its patented Thin Film Freezing (TFF) technology platform, announced on Feb. 24, 2022 that its inhaled niclosamide product completely inhibits viral replication of both the Delta and Omicron variants of SARS-CoV-2. This discovery came from the results of the company’s 

The results demonstrate that inhaled niclosamide appears to be the most potent inhibitor of SARS-CoV-2 replication, including the Omicron variant. The results also confirm previous findings that validated the potent antiviral efficacy of niclosamide in a human airway model.

Niclosamide was originally approved for use as an oral anthelmintic drug by FDA in 1982. The drug has limited water solubility and low absorption and bioavailability when administered orally. TFF Pharmaceuticals intends to utilize its Thin Film Freezing technology to produce an inhaled formulation of niclosamide to directly target the lungs, where SARS-CoV-2 infection occurs. This approach would avoid gastrointestinal side effects and overcome the bioavailability limitations of systemic administration.

“These supportive data increase our confidence that inhaled niclosamide could become an important new therapeutic to combat COVID-19 infection,” said Glenn Mattes, CEO of TFF Pharmaceuticals, in the press release. “Inhaled niclosamide’s demonstrable potency at such low concentrations should enable us to deliver reduced doses of the drug directly to the lung without compromising antirviral activity, thereby conferring a major potential advantage with respect to safety and tolerability. As more pathogenic variants of the SARS-CoV-2 virus emerge, it is essential that potent antiviral therapies are available to help significantly reduce the morbidity and mortality associated with this infection, particularly in the most vulnerable populations who suffer from cardiopulmonary deficiencies.”

TFF Pharmaceuticals announces findings that inhaled niclosamide significantly inhibits viral replication of the Omicron variant of SARS-CoV-2.

Inhaled Niclosamide Inhibits Viral Replication of the Omicron Variant of SARS-CoV-2

Medicago and GlaxoSmithKline (GSK) announced on Feb. 24, 2022 that Health Canada has approved COVIFENZ, a plant-based, recombinant, adjuvanted COVID-19 vaccine. The vaccine is indicated for the prevention of COVID-19 in individuals 18 to 64 years of age.

COVIFENZ uses Coronavirus-Like Particle (CoVLP) technology with the vaccine composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs) co-administered with GSK’s pandemic adjuvant. Vaccination will consist of two doses administered intramuscularly 21 days apart.

The Government of Canada has a Marketing Authorization Holder contract with Medicago to supply the COVID-19 vaccine. Medicago is planning on fulfilling this order as soon as possible. Health Canada based its decision to approve the vaccine on scientific data shared by Medicago as part of their rolling submission that began in April 2021 under an Interim Order, and concluded with the filing of a New Drug Submission-CV.

“The approval of our COVID-19 vaccine is a significant milestone for Canada in the fight against the pandemic. We appreciate Health Canada’s timely review,” said Takashi Nagao, president and CEO at Medicago, in the press release. “We’re also grateful for the Government of Canada’s support in the development of this new vaccine, and we are manufacturing doses to start fulfilling its order.”

“This first approval is an important milestone in our approach of pairing GSK’s well-established pandemic adjuvant with promising antigens to develop protein-based, refrigerator-stable COVID-19 vaccines to help protect people against COVID-19 disease,” added Roger Connor, president of GSK Vaccines, in the press release.“We look forward to working with Medicago to make the vaccine available in Canada and to progress further regulatory submissions.”

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.