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FDA is limiting the use of Janssen’s COVID-19 vaccine to certain individuals.

Issues related to mifepristone prescribing and dispensing are emerging in the debate over legislation to reauthorize FDA user fees for drugs and medical products.

Purolite has received the Queen’s Award for Enterprise in the International Trade category.

Members of Congress asked FDA about multiple contentious issues, including expedited approvals, vaccines for young children, orphan drug exclusivity, access to medical abortions, conflicts of interest, and hiring initiatives.

Moderna has filed for emergency use authorization of its COVID-19 vaccine for use in young children six months to under six years of age.

Pfizer and BioNTech have submitted an application for Emergency Use Authorization for a COVID-19 vaccine booster dose in young children.

FDA has approved Veklury to treat COVID-19 in pediatric patients under 12 years of age.

Catalent will invest $350 million into integrated biologics drug substance and drug product manufacturing at Bloomington, Indiana facility.

Moderna, Pfizer, and BioNTech are seeking FDA approval for a fourth dose of their respective COVID-19 vaccines.

Novartis will pay Voyager up to $1.75 billion for access to Voyager’s novel Tracer AAV capsids for potential use with three CNS targets.

Hovione has announced that Jean-Luc Herbeaux will take over for Guy Villax as CEO on April 1, 2022.

Califf will face challenges that include COVID-19, opioids, and user fees.

Medicago and GSK have announced that Health Canada has approved COVIFENZ, an adjuvanted plant-based COVID-19 vaccine.

Novavax announces the first doses of Nuvaxovid COVID-19 vaccine have begun shipping to European Union member states.

The turnkey facilities will promote scalable vaccine production for an end-to-end manufacturing network for mRNA-based vaccines in Africa.

ImmunoGen and Eli Lilly and Company have entered into an agreement that gives Lilly exclusive rights to research, develop, and commercialize ADCs designed for targets selected by Lilly from ImmunoGen’s camptothecin technology.

Eli Lilly and Company is investing $1 billion to establish a new manufacturing stie in Concord, N.C., to manufacture parenteral products and devices.

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

UCB and Zogenix have agreed to an acquisition deal totaling nearly $2 billion.

FUJIFILM Diosynth Biotechnologies plans to invest £400 million (US$528 million) to expand its Billingham, Teeside facility in the United Kingdom.

Pfizer’s $6.7 billion acquisition of Arena will give them access to a portfolio of immuno-inflammatory therapies.

Pfizer found that two-dose recipients exhibited a more than 25-fold reduction in neutralization titers against Omicron relative to wild-type.

AstraZeneca struck a deal worth up to more than $3.5 billion with Ionis Pharmaceuticals for the rights to develop and commercialize their transthyretin (TTR) amyloidosis treatment.

Recordati’s blockbuster acquisition of EUSA Pharma gives them access to a portfolio of four drugs that treat rare cancers.

The Comirnaty vaccine received a positive opinion from the EMA’s CHMP for children five to under 12 years of age.

Novo Nordisk’s 3.3 billion acquisition of Dicerna gives them access to their RNAi technology.

FDA has amended its EUA for Pfizer-BioNTech’s and Moderna’s COVID-19 booster to include all individuals aged 18 or older.

The White House has nominated Robert Califf to head FDA, ending months of uncertainty about the future path for the high-profile agency.

The Pfizer-BioNTech COVID-19 vaccine is the first to receive FDA Emergency Use Authorization for use in children ages five to 11.

Moderna’s KidCOVE study showed a robust neutralizing antibody response in children aged six to under 12.