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EMA Releases Report on Real-World Evidence

June 26th, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , |

The European Medicines Agency published a report last week discussing the use of real-world evidence (RWE) in clinical trials and regulatory decisionmaking, the benefits it can provide, and the challenges in doing so. RWE, according to the report, is widely used in pharmacovigilance studies, but its use in early drug development still faces uncertainties.

FDA Grants Roche Accelerated Approval for Lymphoma Therapeutics

June 23rd, 2023|Categories: Featured, Industry News|Tags: , , , , |

The US Food and Drug Administration (FDA) has granted Roche accelerated approval for Columvi, its antibody-based therapeutics for two aggressive forms of lymphoma. Results from a phase 1/2 study found the drug provided durable remission for over half of patients and a complete response for 43%, with 66% continuing to respond for 9 months or longer.

FDA Grants Full Approval of Amgen’s Supplemental Biologics License Application for Leukemia Treatment

June 23rd, 2023|Categories: Featured, Industry News|Tags: , , , , |

Amgen’s supplemental biologics license application (sBLA) for its leukemia treatment Blincyto has received full approval by the US Food and Drug Administration (FDA). The move comes based on new data from two phase 3 trials, upgrading the treatment’s accelerated approval to a full approval in the treatment of CD19-positive B-cell precursor acute lymphoblastic leukaemia (B-ALL).

Verana Launches Real-World Evidence-Driven Clinical Trial Site Selection Platform

June 23rd, 2023|Categories: Featured, Industry News|Tags: , , |

Verana Health has launched VeraSite, a new platform that uses real-world evidence (RWE) to help clinical trial sponsors select clinical trial sites. The tool uses electronic health records (EHR) to identify locations with large eligible patient populations. With this platform, Verana hopes to address one of the biggest challenges facing clinical trials – recruitment.

Biden Administration Meets with Drugmakers to Discuss Naloxone Prices

June 23rd, 2023|Categories: Featured, Industry News|Tags: , , , |

Officials from the Biden Administration met with drugmakers this week to discuss prices of naloxone, a drug used to immediately reverse opioid overdoses. Emergent Biosolutions, the manufacturer of brand name Narcan, took heat for setting its price for 2 doses at $50. Concerns were also raised about the high cost of other formulations, which can reach $100 for uninsured people.

Sarepta’s New Duchenne Gene Therapy to Cost $3.2 Million

June 23rd, 2023|Categories: Featured, Industry News|Tags: , |

Hot on the heels of approval by the US Food and Drug Administration (FDA), Sarepta has announced the price of its Elevidys, its new gene therapy for Duchenne muscular dystrophy, at $3.2 million. This makes it one of the most expensive therapeutics in history. However, Sarepta claims this price is far below it’s initial cost-effectiveness estimates.

FDA Approves First Gene Therapy for Duchenne Muscular Dystrophy

June 22nd, 2023|Categories: Featured, Industry News|Tags: , |

In a first for the rare disease, the FDA has approved Sarepta’s gene therapy for Duchenne Muscular Dystrophy, a genetic condition that causes progressive muscle wasting in childhood, primarily affecting boys. The approval covers children between the ages of 4 and 5, contrary to the request from advocacy groups to open up the treatment to all children with the disorder who can still walk.

From Analysis to Action: Exploring Health Equity with Aletha Maybank

June 22nd, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , , |

In a new interview with Nature, senior vice president and chief health equity officer at the American Medical Association (AMA) Aletha Maybank, MD, MPH, speaks about her work analyzing the processes underlying health disparities and how they can be targeted to promote better outcomes in marginalized populations.

CDC Adcomm Hesitantly Recommends RSV Vaccines for Older Adults

June 22nd, 2023|Categories: Featured, Industry News|Tags: , , , , , |

GSK’s Arexy and Pfizer’s Abrysvo vaccines for respiratory syncytial virus (RSV) have received recommendations from the US Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP). While the committee voted almost unanimously in support of the vaccines for adults aged 60-64, the recommendation for adults over 65 was far more contentious, sitting at 9-5 for and against, respectively.

FDA Grants Priority Review for Sickle Cell Gene Therapy by Bluebird Bio

June 22nd, 2023|Categories: Featured, Industry News|Tags: , , |

The US Food and Drug Administration (FDA) has accepted bluebird bio’s application for priority review for its sickle cell gene therapy lovotibeglogene autotemcel (lovo-cel). The decision was made based on efficacy data from 36 patients and safety results from 50. Sickle cell disease (SCD) is an inherited blood disorder caused by a mutation in the gene encoding for hemoglobin that sticks together inside red blood cells.

PhRMA Enters the Legal Fight against US Medicare Drug Pricing Negotiations

June 22nd, 2023|Categories: Featured, Industry News|Tags: , , , , |

The pharmaceutical trade group PhRMA has entered the fray, joining BMS and Merck in filing legal challenges against the upcoming US Medicare drug pricing negotiations. Unlike the arguments raised by the two pharma giants’ complaints, which centered on the First Amendment, PhRMA’s argument hinges on fines imposed on manufacturers who do not work with the negotiation process violates the Eighth Amendment. In addition to pharma, the Global Colon Cancer Association and the National Infusion Center Association have filed their own suits.

Pharma is Eyeing Supreme Court Case on Upcoming Medicare Drug Pricing Negotiations

June 21st, 2023|Categories: Featured, Industry News|Tags: , , , , |

With lawsuits recently filed by the pharma giants Merck and BMS, pharma seems set on bringing litigation over upcoming Medicare drug pricing negotiations to the US Supreme Court. Some analysts think that the companies are eyeing the highest court in the land due to some justices’ relationships with the companies.

Congress Asks Stakeholders for their Thoughts on the 340B Program

June 21st, 2023|Categories: Featured, Industry News|Tags: , , , , |

US senators from both sides of the aisle have issued a letter calling for input on the 340B Drug Pricing Program from stakeholders. The program provides eligible care centers with reduced prices on certain prescription drugs. Some stakeholders have complained about a lack of clarity and transparency from the program.

Catching Up with the Latest from CMS

June 21st, 2023|Categories: Featured, Industry News|Tags: , , , |

The US Centers for Medicaid and Medicare Services (CMS) has been busy over the past few months. In a new Becker’s Payer Issues article, learn about the 13 latest moves by the agency that you should know. The first is a new projection by the agency, which expects to see a 7.7% increase in payer spending this year, as well as a 2.1 drop in Medicare spending.

Wells Fargo Sees Opportunities in Managed Care Stock Sell-Off

June 21st, 2023|Categories: Featured, Industry News|Tags: , , , , |

A wave of stock sell-offs in the managed care industry represent a buying opportunity, according to analysts at Wells Fargo. The sell-offs were sparked by comments from UnitedHealth and Humana that noted an uptick in procedures covered by Medicare Advantage plans that were likely postponed during the pandemic.

New Real-World Evidence from AstraZeneca Finds Medication Discontinuation Worsens Hyperkalemia

June 21st, 2023|Categories: Featured, HEOR Feature, Industry News|Tags: , , , |

New real-world evidence (RWE) presented at this year’s European Renal Association Congress explored hypokalemia care, finding that reduction or discontinuation of renin-angiotensin-aldosterone system inhibitor (RAASi) worsens outcomes of patients admitted for hyperkalemia (HK), high calcium levels in blood. RWE from the ZORA study shows that few patients have their RAASi medications reinitiated after a hyperkalemia event, which is associated with a two times increase in mortality.

FDA Approves Millenia’s Old Gout Therapy from Agepha Pharma for Heart Disease

June 20th, 2023|Categories: Featured, Industry News|Tags: , , , |

Colchicine, an ancient treatment for gout, has been approved by the US Food and Drug Administration (FDA) for treating vascular inflammation present in patients with heart disease. The therapy, now produced by Agepha Pharma, is combined with a statin and reduces risk of serious cardiovascular events like stroke or heart attack.

Using Knowledge Graphs to Understand Real-World Data and Identify Stakeholders

June 20th, 2023|Categories: Featured, Industry News|Tags: , , |

As more companies are utilizing real-world data (RWD) and real-world evidence (RWE) for drug development and market access, new strategies are needed to sift through massive data pools to identify actionable insights. In a new IQVIA blog post, learn about how a research team used artificial intelligence and knowledge graphs to identify key stakeholders in digital health policy data.

Flatiron Health Teams Up with UK Hospital Trust

June 20th, 2023|Categories: Featured, Industry News|Tags: , , |

Flatiron Health has announced it has formed a partnership with a key hospital trust in Europe, the Leeds Teaching Hospitals NHS Trust (LTHT). In the partnership, Flatiron will help researchers and clinicians turn unstructured cancer information into high-quality real-world data (RWD) and real-world evidence to help drive decision-making and research efforts.

BMS Joins the Legal Fray Over Medicare Drug Pricing Negotiations

June 20th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Bristol Myers Squibb (BMS) has thrown its legal hat in the ring, filing a lawsuit against the Biden Administration over upcoming Medicare drug pricing negotiations set up by the Inflation Reduction Act. In doing so, they join Merck as legal challengers to the process, which will set the prices drug companies can charge for a select set of high-price prescription therapeutics.

Dr. Mandy Cohen Selected for Next CDC Director

June 20th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Mandy Cohen, MD, has been selected by the Biden Administration to lead the Centers for Disease Control and Prevention (CDC) as its next director. Cohen, who lead North Carolina’s response to COVID-19, will take the helm in early July, according to the White House. She is succeeding the current director, Rochelle Walensky.

Pharma is Scrambling to Respond to Upcoming Medicare Drug Pricing Negotiations

June 16th, 2023|Categories: Featured, Industry News|Tags: , , , , |

With Medicare drug price negotiations, pharma is looking for a move to either delay or block the process and prepare for it in the meantime. Merck and the US Chamber of Commerce filed suit against the Centers for Medicare and Medicaid Services (CMS) earlier this month. Others, including the industry group PhRMA, have spelled out potential consequences of the negotiations.

PBMs in the Hot Seat: Scrutinizing and Regulating the Industry

June 16th, 2023|Categories: Featured, Industry News|Tags: , , , , |

Pharmacy benefit managers (PBM), which act as middlemen that help set formularies and drug prices, have faced a wave of US congressional scrutiny in recent months. This includes hearings, committees, and even legislation. In a new Mintz article, catch up on all the latest updates on federal activities targeting the industry and its practices.

Real-World Evidence and Reimbursement Decision-Making in China

June 16th, 2023|Categories: Featured, Industry News|Tags: , , |

As prescription drug spending is on the rise in China, coverage decisions are becoming increasingly important and more complex with the advent of new of high-cost, high-reward therapeutics. In a new article in The BMJ, learn more about the role that real-world evidence (RWE) is playing in the reimbursement decision-making process.

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