Regulatory affairs

AstraZeneca joins with Care Access Research on COVID-19 antibody trial

23-Feb-2021 By Jenni Spinner

The pharma firm is partnering with the decentralized research organization on a Phase III trial testing a long-acting antibody combination treatment.

Developing vaccines and therapeutics for virus variants: FDA releases new guidance

23-Feb-2021 By Rachel Arthur

The US Food and Drug Administration (FDA) has issued guidance for companies developing vaccines, diagnostics and therapeutics against new variants of SARS-CoV-2.

COVID-19 accelerating RWE use in clinical settings: ConcertAI

16-Feb-2021 By Jenni Spinner

A leader from the clinical data solutions firm explains how the challenges created by the pandemic have helped fuel creativity and innovation in studies.

AHA training aids researchers with heart-to-heart talks

14-Feb-2021 By Jenni Spinner

The American Heart Association’s Heart of Communicating Science modules are designed to help experts break complex talk into easy-to-understand language.

Latest FDA COVID-19 updates and activity

09-Feb-2021 By Jenni Spinner

The federal agency continues to keep researchers, pharma firms and citizens apprised of current happenings and research related to the virus and pandemic.

World Cancer Day

Lung cancer community severely impacted by COVID: report

04-Feb-2021 By Jenni Spinner

A report from the World Economic Forum and Lung Ambition Alliance outlines the impacts the pandemic is having on lung cancer diagnoses and treatment.

Designated ‘Breakthrough Therapies’ draw support from Calyx

28-Jan-2021 By Jenni Spinner

The company’s medical imaging technology and other eClinical solutions reportedly played a part in half of the treatments to receive the FDA designation.

FDA COVID-19 responses and recommendations this week

28-Jan-2021 By Jenni Spinner

As the COVID-19 vaccines continue the early stages of circulation in the US, the agency keeps an eye on industry actions and offers advice to key players.

FDA approves injectable treatment for HIV patients

25-Jan-2021 By Jenni Spinner

The agency has given the thumbs up to ViiV’s once-a-month Cabenuva, the first FDA-approved injectable, complete regimen for adults diagnosed with HIV.

Continuus lands $69.3m US drug manufacturing contract

21-Jan-2021 By Jenni Spinner

The small-molecule pharmaceuticals manufacturer secured a DoD/HHS government contract to manufacture critical medicines for a range of conditions.

COVID-19 a ‘catalyst’ for innovation in 2020: Oracle

18-Jan-2021 By Jenni Spinner

A leader from Oracle Health Sciences examines the dynamic, challenging year and highlights creativity and ingenuity displayed by research professionals.

Widening access to COVID-19 data

18-Jan-2021 By Rachel Arthur

California information technology and services company Syntegra and the National Institutes of Health (NIH) have signed a partnership to 'democratize access to the largest set of COVID-19 patient records': with the use of Syntegra's synthetic...

Fight against pharma counterfeiting must go deeper: TruTag

13-Jan-2021 By Jenni Spinner

A leader from the anti-counterfeit solutions firm says that while packaging-level efforts may have an effect, on-dose technology is worth a closer look.

LA customs agents seize $19m in counterfeit Viagra pills

13-Jan-2021 By Jenni Spinner

Authorities discovered the fake Pfizer erectile-dysfunction tablets in one of three cargo containers full of fraudulent goods, recently arrived from China.

Counterfeit Janssen HIV drug discovered in US pharmacies

13-Jan-2021 By Jenni Spinner

The pharmaceutical firm reports a counterfeit version of its Symtuza HIV treatment has been found and pulled from shelves at three American pharmacies.