Formulation and Drug Delivery

The companies will combine Intravacc’s OMV delivery platform with S-proteins with Celonic’s CHOvolution mammalian cell expression system to produce B and T-cell responses against SARS-CoV-2.

Patient advocates, research experts, and industry are calling for more user fee revenues to support CBER programs to advance innovative therapies.

The UK government is committing a further £100 million (US $127 million) to ensure that there is capability to manufacture a successful COVID-19 vaccine at scale in the UK.

The European Medicines Agency has set up an infrastructure to support real-world monitoring of the efficacy and safety of COVID-19 vaccines and treatments.

Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.

Pending approval of the Pfizer and BioNTech mRNA-based vaccine candidate against SARS-COV-2, the companies will supply the US government with an initial 100 million doses.

Should therapies and vaccines be cheap or free in a pandemic and would that really dry up innovation?

The project will focus on providing a faster route to clinical studies for AstraZeneca’s potential COVID-19 vaccine, AZD1222.

The UK government has secured early access to 90 million COVID-19 vaccine doses from the BioNTech/Pfizer alliance and Valneva.

Study reports immune and T-cell response from CanSino COVID-19 vaccine candidate.

Preliminary data from a German Phase I/II trial shows Pfizer/BioNTech COVID-19 vaccine candidate produces immune response.

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

Global regulatory authorities have published a report describing the aligned positions on COVID-19 vaccine development, which were agreed upon by meeting participants of the second workshop on COVID-19 vaccine development.

FDA officials are moving to clarify standards and requirements for vetting and approving viable preventives.

VAR2 Pharmaceuticals has been selected for its development of a drug-conjugated malaria protein that potentially selectively binds to most human tumor types.

BARDA and DOD have awarded a $450-million contract to Regeneron Pharmaceuticals to manufacture and supply an investigational double antibody cocktail in development for treating COVID-19.

The European Commission has approved Lynparza (olaparib) for use in patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer within the European Union.

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

The new site will offer initial design and development, low-volume manufacturing, and scalable high-quality production of wearable drug delivery devices.

The agreement will fund the late-stage clinical development, a Phase III clinical trial, large-scale manufacturing, and the delivery of 100 million doses of Novavax’s COVID-19 vaccine candidate, NVX‑CoV2373.

Emergent is entering into a five-year agreement with Janssen Pharmaceuticals for the large-scale drug substance manufacturing of Johnson & Johnson’s investigational COVID-19 vaccine, Ad26.COV2-S.

Lonza is making additional investments in its global particle engineering network for expanded capacity and specialized capabilities.

The new facility in Grand Rapids, MI, is part of the CDMO’s aggressive expansion plan.

Intravacc will license CimCure’s iBoost technology, and the companies will jointly develop a COVID-19 vaccine candidate.

Demand for custom drug delivery solutions is increasing and bringing forth an exciting period of valuable, innovative development opportunities.

Controlled-release formulations offer numerous advantages for developers and patients, and this market is expected to continue to experience growth in the near future.

RNA is easier to manipulate than DNA but challenging to deliver to the right cells.

Phesgo is a fixed-dose-combination subcutaneous injection of Perjeta (pertuzumab) and Herceptin (trastuzumab) for treating HER2-positive breast cancer.

The complete response letter was issued for a biologics license application for Abicipar pegol, an investigational treatment for wet age-related macular degeneration, based on FDA’s determination of an unfavorable benefit–risk ratio.

Appropriate analytical assays are needed to determine and ensure that biosimilar critical quality parameters are on track.