Industry News

Emergent BioSolutions has been granted approval from FDA to ship certain lots of their AstraZeneca vaccine.

FDA has approved the intravenous medication Nexviazyme for treatment of Pompe Disease.

The guidance aids in the development, validation, and use of near infrared-based analytical procedures.

A global safety database analysis has demonstrated no increased incidence of thrombosis with TTS after the second dose of Vaxzevria.

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

The University of Sheffield has launched an innovative gene therapy program that could pave the way for novel treatments for neurodegenerative diseases.

FDA has approved AstraZeneca’s Saphnelo, a type I interferon receptor antibody for treating systemic lupus erythematosus.

FDA is launching a new crowdsourcing challenge to solicit ideas for pediatric research.

The expanded authorization from FDA enables the use of Regeneron Pharmaceuticals’ REGEN-COV antibody cocktail therapy for post-exposure prophylaxis in certain people exposed to SARS-CoV-2.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Entries are now open for the 18th Annual CPhI Pharma Awards in Milan.

In the first half of 2021, the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research approved 29 novel therapies.

Kineret (anakinra) is under evaluation by EMA's CHMP as a treatment for adult COVID-19 patients who are at an increased risk of severe respiratory failure.

EMA's CHMP has taken the decision to start a rolling review of Vidprevtyn—Sanofi Pasteur’s COVID-19 vaccine.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

PerkinElmer has entered into an agreement to acquire BioLegend, a global developer and manufacturer, in a deal valued at $5.25 billion.

The EMA’s CHMP has adopted a positive opinion recommending marketing authorization for Moderna’s COVID-19 vaccine (Spikevax) to include adolescents 12 years of age and older.

The European Commission has granted marketing authorization to bluebird bio for its gene therapy SKYSONA for the treatment of early CALD.

The US federal government awarded new funding to the National Institute for Innovation in Manufacturing Biopharmaceuticals, including funding under the American Rescue Plan that will be used to advance vaccine manufacturing.

EMA's safety committee, PRAC, has concluded that there is no evidence linking the viral vector in Zynteglo to a blood cancer known as acute myeloid leukemia (AML).

After a review of three cases, EMA's PRAC has advised against the use of Janssen’s COVID-19 vaccine in people who have a history of capillary leak syndrome.

EMA's PRAC has found a possible link to very rare cases of myocarditis and pericarditis after vaccination with Comirnaty and Spikevax COVID-19 vaccines.

A new report by Radnor Capital Partners and commissioned by the BIA has shown that international investors are being drawn toward the biotech sector of the UK.

White House proposal includes measure to make drugs more affordable.

FDA’s review and approval of Aduhelm triggers controversy and a call for review from within the Agency.

The recently published Life Sciences Sector Vision, from the UK government, has been welcomed by the UK BioIndustry Association (BIA).

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.