| | | |   | Howdy, it's Meghana today, and for every day this week. On tap today: why payers are reticent to cover the fancy new wave of precision medicine tests, how Dupixent should become even more of a blockbuster, and more. | | | Who’s going to pay for the new, fancy diagnostics? It seems like the number of highfalutin diagnostic tools is increasing exponentially. While they sure are promising for precision medicine, for most patients, they’re fairly unattainable. That’s because it’s hard to get insurers to reimburse for these new tests. There hasn’t yet been much validation showing that these diagnostics lead to improved patient outcomes, or cost savings — which means payers have been reticent to pay up. “The question isn’t, ‘Does the test work? Does it measure what you say it’s going to?’ Generally that’s true,” one insurance exec said at a discussion the other day at the 16th annual Personalized Medicine Conference. “The bigger question is clinical utility. What’s going to happen as a result of that information? And frequently, that is lacking or limited.” Read more. | Dupixent approved for its first GI indication We have yet another approved use for Sanofi and Regeneron’s blockbuster Dupixent. The FDA just green-lighted the monoclonal antibody for a new indication — eosinophilic esophagitis. This is the first and only medication that’s been approved for the disease, which affects more than 160,000 Americans. This is the first time Dupixent has been approved for a gastrointestinal condition. EoE, as it’s called, is a progressive and chronic inflammatory disease that causes the esophagus to narrow, making swallowing extremely difficult and painful. This makes patients avoid solid food entirely: “Every meal becomes a worry,” one Sanofi R&D lead told FiercePharma. In a Phase 3 trial, about 60% of patients taking Dupixent saw a significant reduction in eosinophils, which are the inflammation-triggering white blood cells, compared with about 5% of the placebo group. Dupixent is currently approved to treat atopic dermatitis, asthma, and chronic rhinosinusitis. Last year, it netted nearly $6 billion in sales. | How to navigate the requirements and pressure of disclosing clinical trial data When releasing clinical trial data, finding the right balance between the “duty to disclose” vs. “pressure to disclose” conundrum is not easy. Handled correctly, for both private and public companies, these milestones are a great way to raise visibility within the investment, clinical, and scientific communities. If done incorrectly, the consequences can be severe. Best practices are discussed in this article. | European regulator suspends dozens of generics The European Medicines Agency said that the marketing authorization for dozens of generics drugs should be suspended, after finding “serious concerns” in bioequivalence studies from a CRO called Synchron Research Services meant to demonstrate their efficacy compared to branded drugs. The generic makers evaluated have to show new data from an alternate evaluation company that prove the drugs’ safety and efficacy. The EMA said that some of the drugs in question are critically important in some EU countries, and national regulators can postpone the suspension. Notably, the FDA notified a number of generics makers last fall that there were serious data problems and “significant” misconduct with tests run by Synchron and Panexcell, another CRO. Read more. | Pfizer refunding consumers for misleading coupons Pfizer has been tasked with refunding $290,000 to settle claims from about 5,000 people who say they spent more than they expected using coupons doled out by the drugmaker. Pfizer will also pay $120,000 to the states of Colorado, Kansas, Vermont, and Arizona, where these particular consumers live. This isn’t the first time Pfizer’s has been faced with such allegations. Three years ago, Pfizer paid nearly $1 million to settle charges of misleading consumers in Oregon, and in 2018, it paid $700,000 in a settlement with New York state. In every situation, the consumers were told they’d have to “pay no more than” a small amount of money — about $15 to $25 — but then had to pay much more. Read more. | More reads - Big Pharma lobbies for slice of G20 fund to prepare for next pandemic. (Financial Times)
- Bipartisan trio of senators ask FTC to look at PBMs and tactics to keep insulin prices high (Endpoints News)
- Controversial plan brings Ph.D. students to biotech for training. (Science)
- Tracking coronavirus in animals takes on new urgency (Washington Post)
| Thanks for reading! Until tomorrow,  | | | |
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