News

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.

The companies will combine combining Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen aimed at treating HIV.

Lonza will provide a manufacturing suite at its facility in Houston, TX, for the clinical and commercial production of AdCOVID, Altimmune’s single-dose intranasal vaccine candidate.

WuXi will produce SARS-CoV-2 s-proteins for BioVaxys’ COVID-19 vaccine candidate, BVX-0320, and for its Covid-T immunodiagnostic program.

Sagent Pharmaceuticals is voluntarily recalling three lots of Phenylephrine Hydrochloride Injection, USP (10 mg/mL) to the user level because of a customer complaint regarding potentially loose crimped vial overseals, which can result in a non-sterile product.

With no final nomination of FDA commissioner coming from the White House, concern has mounted among regulated industry and interested stakeholders that FDA operations and stature will suffer without a permanent commissioner able to articulate new policies and gain support for innovative programs.

Currently, supporters of the plan include the governments of Germany, Norway, and Ethiopia; Wellcome and the Bill and Melinda Gates Foundation; the World Economic Forum; and WHO, Gavi, and UNICEF.

The acquisition will expand the antimicrobial and antiviral testing capabilities of Sotera’s Nelson Labs business in the US.

I Holland, manufacturer of tablet tooling for the pharmaceutical and nutraceutical markets, has announced a number of appointments to form a new leadership team

This agreement enhances GSK’s investment in cell and gene therapy manufacturing in the UK for clinical trials.

Through the acquisition, Takeda will have access to Maverick’s T-cell engager COBRA platform, along with its development portfolio.