Industry News

Data and analytics company GlobalData announced that there is a strain on the global biopharma industry’s supply chain due to the ongoing outbreak of COVID-19.

Grifols has entered into a formal collaboration with US Federal public health agencies, including the Biomedical Advanced Research Development Authority (BARDA) and the Food and Drug Administration (FDA), to produce a treatment that specifically targets COVID-19.

Prior to the global market downturn, data from the United Kingdom BioIndustry Association (BIA) and Informa Pharma Intelligence have revealed that biotech companies in the UK had raised £309 million (US$379 million).

Noting traditional clinical trials for COVID-19 convalescent plasma will take time, FDA is allowing physicians to submit requests for single-patient emergency INDs.

In light of the current COVID-19 pandemic, the agencies co-chaired the first global regulators meeting to facilitate development of vaccines against SARS-CoV-2, which causes COVID-19.

FDA officials are rolling out guidance and support for researchers striving to assess potential treatments for COVID-19 while the agency tries to object to premature optimism and regain public credibility.

FDA is offering advice and added flexibility to help sponsors adjust ongoing and planned clinical research programs during the COVID-19 outbreak.

The facility, which handles discovery chemistry services, will accelerate its operations over the next few weeks while taking precautions to guarantee the health and safety of its employees across every site.

USP technical advisors will offer assistance to drug developers to ensure material quality and testing.

The partners have initiated an observational case-control study of siltuximab in patients with COVID-19 who have developed serious respiratory complications.

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

FDA postpones routine domestic facility inspections due to the COVID-19 pandemic.

The decision comes after a state-of-emergency was declared in Washington, DC, due to the ongoing outbreak of COVID-19.

Rapid deployment kits can facilitate tech transfer and allow for communication between operators onsite and experts offsite, despite travel bans and other limitations posed by the coronavirus (COVID-19) pandemic.

The trade and packaging fair, which was originally scheduled for May 7–13, 2020 in Düsseldorf, Germany, will be rescheduled for Feb. 25–March 3, 2021 in the same location.

Now officially a worldwide pandemic, the biomedical research community is rushing to develop treatments and preventives to halt the spread and severity of the COVID-19 virus.

The CPhI event, which was originally scheduled for May 5–7, 2020 at the Pennsylvania Convention Center in Philadelphia, PA, will be rescheduled for Sept. 9–11, 2020 at the same venue.

The project, which will be titled the COVID-19 Therapeutics Accelerator, will work to pinpoint which new and repurposed drugs and biologics can treat patients immediately, and which can treat patients long-term.

The decision comes after results were received from a Phase 1, open-label study that evaluated the safety, pharmacokinetics, and preliminary efficacy of the monotherapy

New dates for the postponed event are still being determined.

The agency is postponing the inspection of most foreign facilities through April 2020.

The action involves allowing specific National Institute for Occupational Safety and Health-approved respirators not regulated by FDA to be used in healthcare settings to increase the number of respirators available in the United States.

The conference, which was originally scheduled for March 31–April 3, 2020 at the Messe München in Germany, will be rescheduled for Oct. 19–22, 2020 at the same location.

Research from data and analytics company GlobalData shows that CAR-T cell therapy innovations across APAC will make the global market for these therapies more competitive.

FDA issued a notice to drug compounders regarding the transition of licensure of biologics to the Public Health Service Act.

A guidance document answers questions regarding the transition of biologics applications from under the FD&C Act to the PHS Act.

The organization is postponing its annual meeting to July 2020 because of the developing COVID-19 outbreak.

As patent disputes within the scientific community continue, drug developers consider the intellectual property unknowns associated with this emerging technology.

With the first announced drug shortage tied to the coronavirus outbreak, FDA emphasizes urgency for monitoring drug supply chain.

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.