News

EFPIA and Vaccines Europe urge the avoidance of any reactionary measures that could disrupt the production and delivery of COVID-19 vaccines.

AstraZeneca has released the results of its primary analysis of the Phase III trial data evaluating its COVID-19 vaccine.

Stelis Biopharma has closed its Series B and Series C fundraise for US $195 million, which will be used to progress the company’s growth initiatives and help scale its business.

ABPI has responded to the publication of the UK government’s plans for the future of clinical research.

Nordic Capital has invested in medical dermatology company, Leo Pharma, becoming an active minority owner and partner to the Leo Foundation.

Roche has revealed the positive topline results from it Phase III trial assessing the investigational antibody cocktail of casirivimab and imdevimab in high-risk non-hospitalized COVID-19 patients.

After releasing US Phase III trial data for AZD1222, more questions have been raised with AstraZeneca concerning potentially outdated information that could provide an incomplete view of efficacy.

Is FDA approving too many new drugs and added indications too quickly based on surrogate endpoints that fail to pan out?

The agency says that data do not support the use of ivermectin to prevent or treat COVID-19 outside of clinical trials.

FDA has issued warning letters to two US-based manufacturers, Honest Globe and Biolyte Laboratories, for selling products labeled as containing cannabidiol in ways that violate the Federal Food, Drug, and Cosmetic Act.

CPhI’s post-pandemic report predicts strong progression in pharma innovation, with breakthroughs in multi-modal disease therapies, a transformative effect of mRNA platforms, and significant growth in contract services.

Mecart has achieved FM-4880 and FM-4882 certification of its cleanroom wall and ceiling panels from the FM Approvals certification organization.

Cybin will use Catalent’s Zydis orally disintegrating tablet technology for the delivery of its novel deuterated tryptamine, CYB003, a potential therapy for treatment-resistant psychiatric disorders.

To maintain business continuity and employee safety during the pandemic, many companies have begun tracking and maintaining records of employee health information.

The companies will work to discover and develop RNA-targeting small-molecule therapeutics for difficult-to-address indications.

The new facility, which is expected to be operational by spring 2025, will feature 8 x 20,000-L bioreactors with the potential to add further 24 x 20,000-L bioreactors based on market demand.

MHRA and EMA have confirmed that the benefits of the AstraZeneca COVID-19 vaccine continue to outweigh the risk of side effects.

Hovione has successfully completed the Phase II clinical trial of its ophthalmic formulation of minocycline, Meizuvo.

Romaco, supplier of processing and packaging equipment, has acquired STE Tecpharm, S. L., a Spanish manufacturer of processing technology.

BIA has released comments urging the UK government to take a science-based approach to the regulatory framework for gene editing and GMOs.

Patrick D. Walsh will take over the role from Walter J. Kaczmarek III, who is stepping down as CEO.

Using the capabilities of Pharma Waldhof, one of Aceto’s facilities in Düsseldorf, Germany, the company plans to provide customers with access to raw materials, tested products for pharmaceutical cell culture applications, and cell culture media ingredients.

Under an expanded agreement with J&J, Catalent Biologics will increase manufacturing capacity at its Anagni, Italy, site to accommodate the large-scale commercial supply of Janssen’s COVID-19 vaccine.

Provider of iPSC-derived cells, media, and characterization services, Axol Bioscience, has signed a merger agreement with Censo Biotechnologies, a cell biology CRO.

The Testa Center in Sweden provides access to equipment and expertise to help bridge the gap between biopharmaceutical discovery and industrialization.

The Federal Trade Commission is launching a broad review of drug-company mergers, with an eye to examining how such actions can harm competition in the biopharmaceutical industry.

The companies will collaborate at BioCentriq’s GMP facilities to produce Tevogen’s proprietary COVID-19 targeted T cells.

Sana will be authorized to use the iPSC cell lines from FUJIFILM Cellular Dynamics for the research and development, clinical and commercial manufacture, and commercialization, of the cell therapies derived from the lines.

The transaction is set to close during the first half of 2021 and is expected to enhance drug substance and drug product capabilities for WuXi.

The companies will use capacity at IDT previously reserved for Takeda’s dengue vaccine candidate, TAK-003, to manufacture Janssen Pharmaceutical’s single-shot COVID-19 vaccine.