Incorrect dosing cups prompt recall of 2 GSK cough syrups

CDC, industry brace for high flu vaccine demand | Incorrect dosing cups prompt recall of 2 GSK cough syrups | DOJ sues Regeneron over charity-funded cost sharing

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June 25, 2020

US health authorities and vaccine makers are working to boost supplies of flu vaccine doses amid fears that a spike in COVID-19 infections will coincide with the flu season. Manufacturers plan to produce 189 million doses this year, up 10% from last year's volume, while the CDC is purchasing 7 million doses to be used in state adult vaccination programs, 14 times the total the agency normally buys for adults.

Full Story: The Washington Post (tiered subscription model) (6/24)

Liability and Safety

Incorrect dosing cups prompt recall of 2 GSK cough syrups

GlaxoSmithKline is pulling a single lot of Dimetapp cough syrup and two lots of Children's Robitussin cough syrup due to incorrect dosing cups. The affected products were distributed across the US from February to June.

Full Story: Becker's Hospital Review (6/19)

DOJ sues Regeneron over charity-funded cost sharing

The Department of Justice filed a lawsuit against Renegeron Pharmaceuticals accusing the company of funneling kickbacks through a patient assistance foundation to cover cost sharing for Medicare patients taking its macular degeneration drug Eylea. According to the lawsuit, the scheme helped boost sales of Eylea, which normally costs more than $10,000 per year, and allowed Regeneron to receive $1.9 billion from Medicare.

Full Story: Reuters (6/24)

Group calls for boxed warning on diabetes drug label
Becker's Hospital Review (6/24)

Business and Market Trends

Utilization, not drug costs, increased 2019 drug spending

Spending reports by the largest pharmacy benefit managers, CVS Health, Express Scripts, and Prime Therapeutics, show that higher utilization, not increasing drug costs, drove specialty drug spending in 2019, according to an analysis by Drug Channels Institute. Annual specialty drug spending by these PBMs rose by less than 3%, according to the spending reports.

Full Story: Drug Channels (6/22)

FDA: About 150 drugs in short supply
Managed Healthcare Executive (6/24)

Government and Regulatory

Health Care and Policy

FDA program to share patient-reported outcomes in cancer drug trials

The FDA has announced a pilot program called Project Patient Voice that will allow drug companies to share information on patient-reported symptoms during clinical trials for cancer drugs. The program will feature a public website, which will contain information on patient symptoms from before the start of treatment and during the first six months of the trial, offering side effect insights not currently available in the FDA safety tables.

Full Story: Bloomberg Law (free content) (6/24)

Hahn: FDA on target to meet user fee goals this year
Regulatory Focus (6/23)

Company and Financial News

Moderna taps Catalent for COVID-19 vaccine contract

Moderna tapped Catalent to handle commercial fill-finish manufacturing for its mRNA-based COVID-19 vaccine candidate. Catalent will provide vial filling and packaging capacity for an initial 100 million doses for the US market.

Full Story: FiercePharma (6/25)

CSL Behring to buy uniQure's hemophilia B gene therapy
FierceBiotech (6/25)

News from Aon

Aon assembles broad coalition to move the economy forward

The coalition will focus on how organizations work, travel and convene in wake of the COVID-19 pandemic. Learn more.

Aon's COVID-19 Insights & Resources

The global outbreak of the novel coronavirus (COVID-19) has created unprecedented challenges. Aon has developed a resource site to help business leaders implement effective responses to the impact of the pandemic on businesses, employees and communities. These insights can help readers make better decisions in these complex and volatile times. Learn more and view the COVID-19 Response Site.

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Aon plc (NYSE:AON) is a leading global professional services firm providing a broad range of risk, retirement and health solutions. Our 50,000 colleagues in 120 countries empower results for clients by using proprietary data and analytics to deliver insights that reduce volatility and improve performance.

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