Early Phase Development

BioMed X Institute and Janssen Research & Development to start two new research programs in the field of autoimmune diseases and drug delivery.

Samsung Biologics has adopted Solentim’s cell seeding and cell metric platforms at its new R&D center in San Francisco, CA.

Strong immune response by patients receiving two doses of vaccine suggests a possible treatment strategy.

SGS has announced the receipt of approval from Belgium’s Federal Agency for Medicines and Health Products (FAMHP) to begin a new clinical trial of a potential treatment for patients with COVID-19 related respiratory failure.

GlaxoSmithKline (GSK) and Medicago have announced a collaboration for the development and evaluation of a COVID-19 vaccine candidate.

The European Directorate for the Quality of Medicines and Healthcare (EDQM) has published a new general chapter (2.6.32) in the European Pharmacopoeia (Ph. Eur.) supplement 10.3.

Full results from the Phase III ETHOS trial have demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations in patients with moderate to very severe COPD after treatment with triple-combination therapy Breztri Aerosphere.

Biotechnology company, ILC Therapeutics, has revealed that it has entered into a research partnership with the University of St Andrews aimed at progressing a therapeutic drug that can treat COVID-19 to clinical trials.

Biopharmaceutical company, Atriva Therapeutics, has announced, in a May 28, 2020 press release, that it will develop ATR-002, an oral small molecule, for treatment of patients with moderate-to-severe COVID-19 that require hospitalization in a Phase II study.

Merck will acquire Themis Bioscience and collaborate with IAVI and Ridgeback Bio on COVID-19 vaccines and therapies.

A new strategic plan from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, details the institute’s plan for accelerating research to diagnose, prevent and treat COVID-19.

US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.

Biopharma companies responding to the COVID-19 outbreak think accelerating the development of vaccines is safe.

Pre-clinical immunization studies of iBio’s SARS-CoV-2 VLP candidates are being performed by Texas A&M.

Synairgen, a respiratory drug discovery and development company, has announced that it has received expedited approvals to conduct a trial of its inhaled formulation of interferon-beta-1a, SNG001, in COVID-19 patients.

An NIH study of a COVID-19 vaccine is enrolling Seattle-based healthy adult volunteers.

Thermo Fisher Scientific launched the ALPS 5000 Plate Sealer to simplify the plate sealing process and provide enhanced dependability and productivity for stand-alone and integrated robotic projects.

Can investing in early formulation studies drive a new therapy successfully across the commercialization finish line?

Quick approval pathways challenge teams to balance compliance with the need for speed.

Synthetic biology can help researchers circumvent the challenges of traditional methods of antibody generation.

Mereo BioPharma Group and Oncologie have entered a global licensing agreement for the development and commercialization of navicixizumab.

PhoreMost, a biopharma company based in the United Kingdom, and Boehringer Ingelheim have entered into a multi-project drug discovery collaboration agreement, it was revealed.

Swiss-based specialist pharma R&D company, MetP Pharma, has been granted a Notice of Allowance from the Unites States Patent and Trademark Office (USPTO) for its patent titled, “Treatment of Demyelineating Diseases.”

A simulation-based drug discovery company, Turbine, has announced the closing of an institutional funding round worth EUR 3 million (US $3.3 million), which will be used to redesign the oncology drug discovery process.

Takeda Pharmaceutical Company has acquired an exclusive global license from COUR Pharmaceuticals for the development and commercialization of an investigational celiac disease therapy.

Antimicrobial resistance is now the third leading cause of death in the US. As developers continue to leave an unprofitable market, legislation and new reimbursement models propose to stimulate development of new antibiotics.

Limited guidance and numerous challenges create confusion about the scope and timing of stability testing for drugs in development.

Lipid-based formulations provide a versatile solution to bioavailability issues, but a multi-disciplinary approach is needed to overcome limitations with poorly soluble compounds.

The new facility will handle clinical supply management, primary and secondary packaging, complex labeling services, clinical storage, distribution, and drug returns and destruction and will include stability chambers.

Novartis revealed results from two new clinical trials indicating that Entresto (sacubitril/valsartan) significantly improves measures of cardiac structure and function in heart failure with reduced ejection fraction.