News

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.

CRB decided to integrate the groups to further focus on end-to-end design and construction organization in order to expand project execution and improve its client and employee experience.

The investments are expected to double Thermo Fisher’s manufacturing capacity while creating more than 1500 jobs at 11 manufacturing sites in the Americas, Europe, and Asia.

The expansion plans to increase Vectura’s DPI dosage form development, specifically its unit dose and multi-dose inhalers, and integrated device design and manufacturing for customer programs.

Through the acquisition, Amgen will have access to Five Prime’s oncology portfolio, which includes bemarituzumab, Five Prime’s Phase-III ready anti-FGFR2b antibody.

Rokote Laboratories Finland, an academic spin-out located in Finland, is working to develop a nasal spray vaccine against COVID-19 based on research from the University of Helsinki and the University of Eastern Finland.

The expansion will allow Ashland to focus on clinical study projects and commercialization activities.

USP is collaborating with Phlow to build a new lab that will develop test methods and standards to facilitate broader adoption of continuous manufacturing.

Heather N. Sugrue will serve as the company’s vice-president of Business Development.

Manufacturing of the vaccine will take place at Baxter’s fill/finish sterile manufacturing facilities located in Bloomington, IN.

Validation for SaaS LIMS, advance analytics, and cybersecurity features announced during Pittcon virtual press conference.

The European Medicines Agency has begun a rolling review based on laboratory and clinical studies of the Sputnik V (Gam-COVID-Vac).

The European Medicines Agency and Health Canada have published clinical data used to support the authorization of Moderna’s COVID-19 vaccine.

The agency is working to identify and obstruct scammers looking to profit from the pandemic.

The guidance document provides recommendations for reporting and implementing changes to container closure system components consisting of glass vials and stoppers for sterile drug products.

With funding from the federal government, Merck will expand capacity to produce J&J’s COVID-19 vaccine.

In a pandemic, genetic vaccines offer several advantages over traditional approaches.

AstraZeneca has announced that the mass rollout of its COVID-19 vaccine has begun via the COVAX initiative.

Oxular has raised US $37 million in a financing round led by specialist life sciences investor, Forbion.

Arcline Investment Management has acquired ChargePoint Technology, strengthening its global presence.

A recent survey by SwedenBIO has demonstrated a major upswing in the Swedish life science industry.

EMA has recommended that Evrysdi be granted marketing authorization in the EU for the treatment of patients with certain types of SMA.

RDIF has announced that the Sputnik V vaccine for COVID-19 has been approved in Slovakia under the emergency use authorization procedure.

The EC has launched a structured dialogue aimed at gaining a better understanding of global medicines supply chains and to identify potential causes and drivers of vulnerabilities.

Pharmaceutical laboratories must work to maintain lab data integrity practices as the pandemic surges on and cybersecurity risks increase.