Industry News

FDA advisors agreed unanimously on a more limited booster plan after rejecting Pfizer’s original request to authorize its third shot for everyone over age 16.

Democrats failed to gain sufficient support to advance long-debated legislation to permit Medicare drug price negotiations.

The new FDA office will reorganize IT, data, and cybersecurity functions to an agency level.

FDA and EMA will provide scientific advice to applicants concerning complex generic and hybrid products.

Both Marion Gruber and Phillip Krause, FDA officials, co-authored a document disputing the need for COVID-19 boosters for most people.

Ardena acquires Idifarma, adding spray drying technology and high potency capabilities.

The White House announced a nearly $3 billion program to ramp up production of vaccines and their components.

Immutep was granted a Chinese patent for LAG525, a LAG-3 antagonist antibody, under evaluation for cancer treatment.

Two of FDA’s vaccine regulators will be leaving in the fall of 2021, which has the potential to impact COVID-19 vaccine recommendations for both children under the age of 12 and booster shots.

Insilico Biotechnology has joined the Inno4vac project—an innovative European public-private partnership aimed at accelerating vaccine R&D timelines.

The University of Southern California and Amgen have teamed up to provide researchers access to two of Thermo Fisher Scientific’s cryo-EM instruments.

BioMed X has partnered with Janssen to start two new research programs for autoimmune diseases and drug delivery.

Promega will demonstrate applications of bioluminescence tools at Discover Glo 2021.

FDA’s full approval of the Pfizer-BioNTech COVID-19 vaccine raises hopes that this action will help overcome vaccine hesitancy.

Director-General Tedros Adhanom Ghebreyesus is concerned booster shots could limit supply for countries struggling to get first and second vaccine doses.

MHRA has approved Moderna’s COVID-19 vaccine for use in 12–17-year-olds.

ICMRA has published a report setting out recommendations on how regulators should address the issues that the use of AI poses to global medicines regulation.

EMA has started evaluating RoActemra (tocilizumab), an anti-inflammatory medicine, as a potential treatment for hospitalized adult patients with severe COVID-19.

The user fees set for fiscal year 2022 are noteworthy, as their announcement comes as FDA and industry are finalizing agreements for new five-year user fee programs.

UK's ABPI responds to the latest revisions being made to NICE methods for assessment of drugs and devices.

WHO’s solidarity plus trial will enroll hospitalized patients to test artesunate, imatinib, and infliximab in hospitalized COVID-19 patients.

BlackBerry’s QNX real-time operating system may create cybersecurity vulnerabilities, according to FDA.

BlueAllele has been granted a US patent for its advanced gene-editing technology, PALIDON, which is compatible with existing gene editing nucleases and delivery systems.

Thermo Fisher’s manufacturing site in Greenville, NC was recognized for manufacturing excellence.

FDA has granted its first approval for an idiopathic hypersomnia treatment.

FDA has opened a public docket soliciting feedback on the regulation process surrounding PANDAs.

The agency has amended the emergency use authorizations for the Pfizer-BioNTech and Moderna vaccines to allow certain immunocompromised people to receive an additional dose of the vaccine.

The President calls for granting Medicare authority to negotiate drug prices and penalties for pharma companies that raise prices faster than inflation.