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HEOR Feature

FDA Opens Applications for PDUFA VII Real-World Evidence Programs

October 20th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

The US Food and Drug Administration (FDA) will start accepting applications for two programs that are part of the Prescription Drug User Fee Act (PDUFA VII). These programs are intended to help improve the use of real-world evidence (RWE) in approvals for new therapeutics. In addition, the program is set to promote novel clinical trial designs.

US HHS Secretary Becerra Says March-In Rights Not “Off the Table”

October 10th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

While pharma and biotech companies are still reeling from the passage of drug pricing reform in the US, their worries are still not over. Secretary Xavier Becerra of the Department of Health and Human Services (HHS) has mentioned that march-in rights are not “off the table.” The federal government has the power to take a drug’s patent and give it to other drugmakers in order to reduce the price for patients and payers, particularly those on the federal and state levels.

Researchers Put Forward New Healthcare Data Use Framework

October 3rd, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

A group of researchers from around the world have proposed a new framework for the use of healthcare data in research. The framework, published in several journals, guides researchers in several aspects of healthcare usage, such as transparency, quality assessment, and more. The team constructing the framework consisted of stakeholders from healthcare, government, research, and patient advocacy groups

EU Commission Approves Novavax COVID-19 Boosters

September 12th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

The EU Commission has approved the Novavax COVID-19 vaccine booster for adults 18 and above. The move comes only weeks after the European Medicine Agency (EMA) recommended the use of booster doses of the protein-based vaccine. The shot is currently authorized for the purpose in 3 APAC countries, Japan, New Zealand, and Japan.

Cityblock Health Raises $400 Million in Megaround

September 9th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

Cityblock Health has raised $400 million in its latest funding round. This brings the value of the startup to a whopping $5.7 billion. The company focuses on delivering care to patients in marginalized groups, aiming to provide care for 10 million patients by the end of the decade. Two key parts of the company’s strategy is integrating community support into care plans and connecting members with resources and specialized providers.

Inflation Reduction Act Maintains Expanded Health Insurance Subsidies

August 8th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

The Inflation Reduction Act, passed by the US Senate this Sunday, would preserve healthcare subsidies for 13 million people who purchase care through the marketplace. The bill, if passed by the House, would extend the subsidies through 2025. Originally, the subsidies only extended to the end of 2022.

Bristol Meyer Squibb Eyes More Major M&As

August 2nd, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

Last Wednesday, July 27th, Bristol Meyer Squibb’s CEO Giovanni Caforio signaled that the company has the resources to grow its holdings and it intends to do so. The company’s sales this Q2 were more than double the same period last year, giving the company more than enough funds to build off recent acquisitions.

Moderna Makes Deal with US Govt for Augmented COVID-19 Booster

July 29th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

Moderna has signed a contract worth up to $1.74 billion with the US government to provide an updated version of its mRNA vaccine. This version of the vaccine targets the BA.4/BA.5 Omicron strains that are currently dominant. The deal would get the US an initial 66 million doses, which could later include an additional 234 million. 

Biosimilar Boom May be on the Horizon, Potentially Saving Patients Billions

July 18th, 2022|Categories: Featured, HEOR Feature, Industry News|Tags: , |

Biosimilars, biologic generics,  hold substantial promise in expanding access to lifesaving biologics, but growth has taken a while to ramp up. With 100 biosimilars currently in the pipeline, the industry may be set up for rapid growth in the next two years. With the potential influx of new biosimilars that are significantly cheaper than their reference drugs, patients could collectively save $100 billion in the next 5 years.

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