Industry News

With Democrats controlling Congress and the White House, expectations are high that policy makers will revise certain coverage and payment policies.

The vaccine met the primary endpoint with a vaccine efficacy of 89.3% in its Phase III trial in the United Kingdom and a vaccine efficacy of 49% in HIV-positive participants and 60% in HIV-negative participants in a South African Phase IIb trial.

FDA published guidance that includes risk-based recommendations for minimizing the potential transmission of COVID-19.

The vaccine is 66% effective overall in preventing moderate to severe COVID-19 28 days after vaccination.

The European Medicines Agency has recommended granting conditional marketing authorization for AstraZeneca’s COVID-19 vaccine.

BIA has welcomed the announcement from the UK government that genomics expertise and capacity will be offered globally to help identify new variants of the virus that cause COVID-19.

The dispute between the European Commission (EC) of the European Union and pharmaceutical company AstraZeneca continues.

The European Medicines Agency (EMA) has issued the first safety update on a COVID-19 vaccine—Comirnaty (Pfizer/BioNTech vaccine).

The project is aimed at discovering novel transport mechanisms in the human intestinal tract that could be used for oral delivery of diverse therapeutic modalities.

The company is discontinuing the development of its SARS-CoV-2/COVID-19 vaccine candidates, V590 and V591, to focus on advancing its two SARS-CoV-2/COVID-19 therapeutic candidates, MK-4482 and MK-7110.

The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.

Woodcock will serve as acting commissioner of FDA, taking over for Stephen Hahn, FDA’s previous acting commissioner.

The drug offers immediate post-exposure protection against the virus and will serve as a counterpart to the vaccine during its early phases.

The approval was based on positive results from a single-arm Phase II trial where the treatment demonstrated significant antitumor activities in patients with the disease.

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far.

The CPhI event, which was originally scheduled for Aug. 31–Sept. 2, 2021 at the Fiera Milano in Milan, Italy, will be rescheduled for Nov. 9–11, 2021 at the same venue.

This new agreement covers 1.25 million additional doses of the antibody cocktail containing casirivimab and imdevimab for the treatment of COVID-19.

A report on the FDA PREPP initiative’s work in 2020 aims to strengthen the Agency’s response to future public health emergencies.

The Altrui Foundation is a non-profit organization that serves as a center point between manufacturers of unused medications and the charitable organizations that seek them.

As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA.

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

WuXi STA served as the marketing authorization holder (MAH) and offered end-to-end support, including drug substance, amorphous solid dispersion, tablet, and packaging for the product.

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

The European Commission has granted a conditional marketing authorization to Moderna for its COVID-19 vaccine.

Intravacc and Cristal Therapeutics have entered into a strategic collaboration for the development of novel vaccine programs against human diseases.

Part of Operation Warp Speed, the trial will enroll 30,000 people ages 18 to 64 and 65 and older at 115 sites.

President Trump signed the COVID-19 package, which appropriates $2.3 trillion to finance the federal government through September 2021 and provides support for individuals and entities suffering from the economic crisis wrought by the pandemic.

The agency is organizing a second public meeting on January 8, 2021 to discuss the assessment, approval, and roll-out of new COVID-19 vaccines.

The guidance provides information on review timelines during the COVID-19 pandemic.

The new guidance provides information on how sponsors should interact with the agency regarding complex innovative trial design proposals.