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The FDA and industry groups have laid out their initial proposals in several negotiation meetings ahead of the third authorization of the Biosimilar User Fee Act (BsUFA) that will cover fiscal 2023 through 2027. Read More
The FDA has issued a complete response letter (CRL) to LEO Pharma, requesting additional information regarding a device component for the Danish drugmaker’s moderate-to-severe atopic dermatitis candidate tralokinumab. Read More
Worldwide drug spending — excluding spending on COVID-19 vaccines — is projected to increase by 3 percent to 6 percent at a compounded annual growth rate through 2025, climbing to $1.6 trillion, fueled primarily by oncology and immunology development, says a new report from IQVIA. Read More
The FDA has withdrawn a Trump era policy aimed at improving transparency by requiring the agency to publish more information on drug review timelines. Read More
The chief executive officer of troubled Emergent BioSolutions has promised to deliver “within days” the company’s response to a scathing Form 483 issued in April following a serious mix-up of vaccine materials that ruined millions of doses of Johnson & Johnson’s (J&J) COVID-19 vaccine. Read More
The FDA’s Oncologic Drugs Advisory Committee assembled yesterday for its third and final meeting this week to discuss accelerated approvals for cancer drugs that didn’t verify their benefit in confirmatory trials, advising the agency to withdraw indications for Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) and Merck’s Keytruda (pembrolizumab) while defending another Keytruda indication. Read More
AstraZeneca (AZ) reportedly may not file for FDA Emergency Use Authorization (EUA) of its COVID-19 vaccine until mid-May as it needs more time to gather supporting data. Read More
Moderna said it plans to produce up to 3 billion doses of its messenger RNA-based COVID-19 vaccine globally in 2022, including booster shots against viral variants and pediatric vaccines. Read More
The latest round of GDUFA III reauthorization discussions between the FDA and industry focused on facility inspections, drug master files (DMFs) and annual reporting commitments. Read More
The European Medicines Agency (EMA) is reviewing Eli Lilly’s arthritis drug Olumiant (baricitinib) as a possible treatment for hospitalized COVID-19 patients age 10 years and older who require supplemental oxygen. Read More