Data Dispute Threatened Disruption To The Organ Transplant System

The Washington Post: UNOS, Buckeye Dispute Threatens Flow Of Organs To Transplant Hospitals
The flow of lifesaving organs to 63 U.S. transplant centers could be disrupted as soon as Wednesday by a dispute over the use of data, another potential blow to the troubled transplant system the government has promised to overhaul. (Bernstein, 7/3)

The Washington Post: Transplant Group Extends Deadline That Threatened Flow Of Crucial Organs 
The United Network for Organ Sharing has given Buckeye Transplant Services until July 19 to comply with its demands on use of transplant data. The extension offers a reprieve to the 63 hospitals and transplant centers that rely on Buckeye to evaluate the suitability of organs for potential recipients. Nathan Kottkamp, an attorney for UNOS, wrote to lawyers for Buckeye this week to notify the company of the extension, according to a copy of an email shared with The Washington Post. (Miroff and Bernstein, 7/4)

In other developments across the health industry —

Reuters: US FDA Declines To Approve Amneal's Parkinson's Drug Over Safety Concerns 
The U.S. Food and Drug Administration (FDA) has declined to approve Amneal Pharmaceuticals' (AMRX.N) drug designed to help control symptoms in Parkinson's disease patients for a longer duration, citing inadequate safety data. ... .The health regulator, in a complete response letter, has requested additional data as it was not convinced beyond doubt about the safety of one of the ingredient, carbidopa, used in the drug, even though some studies have demonstrated the safety of the other component, levodopa, the company said. (7/3)

Reuters: Fresenius Launches Biosimilar Version Of AbbVie's Humira At 5% Discount 
The generic drug unit of Germany's Fresenius (FREG.DE) said on Monday the price for Idacio, its copycat version of Abbvie's (ABBV.N) top-selling rheumatoid arthritis drug, will be at a 5% discount to Humira's list price. Fresenius joins drugmakers Boehringer Ingelheim, Sandoz and Organon, which launched Humira biosimilars, or copies of biologic drugs, this week. (7/3)

Reuters: Samsung Biologics Unveils $897 Mln Manufacturing Deals For Pfizer
South Korea's Samsung Biologics (207940.KS) announced on Tuesday two deals with Pfizer (PFE.N) worth a combined $897 million to manufacture products for the U.S. pharmaceutical giant. The latest deals will see the biotech division of the Samsung Group produce biosimilar products ranging from oncology and inflammation to immunotherapy in the period to 2029 at its new Plant 4 in South Korea. (7/4)

Reuters: Evotec Wins Orthopoxvirus Antibody Contract From U.S. Government 
Evotec's (EVTG.DE) Seattle-based subsidiary has won a $74 million contract with the U.S. Department of Defence to develop monoclonal antibody-based drugs targeting orthopoxviruses, the German biotech firm said on Wednesday. The contract includes existing antibody development, antibody discovery, and artificial intelligence driven de novo antibody design of therapeutic candidates, Evotec said in a statement. (7/5)

Stat: Ozempic's Maker Bought Prescribers Over 450,000 Meals Last Year
Novo Nordisk spent $11 million on meals and travel for thousands of doctors last year, federal records show, as part of its push to promote Ozempic and other weight loss-inducing diabetes drugs. The pharmaceutical company bought more than 457,000 meals to educate doctors and other prescribers about its portfolio of drugs known as GLP-1 agonists, according to the newly released data from the Centers for Medicare and Medicaid Services. (Florko, 7/5)

Modern Healthcare: Y Combinator Leads Funding For Startup Alfie Health
Y Combinator, the startup accelerator that helped produce Airbnb and Instacart, led a pre-seed funding round of $2.1 million for Alfie Health, a virtual obesity clinic. Alfie uses an artificial intelligence system to produce treatment recommendations and behavioral changes for patients. The recomendations are reviewed by clinicians, with the company relying on telehealth visits to track a patient's progress. Treatment prescribed by Alfie's clinicians may include popular glucagon-like peptide agnostics, or GLP-1 medications. (Turner, 6/30)

Minnesota Public Radio: Hennepin Healthcare Makes Its Case For More Equity, Inclusion Training
Between taking care of patients, filling out medical charts and teaching students, doctors and nurses at Hennepin Healthcare in Minneapolis are taking the time to do their own education. For about three hours each month, staff from across the system sit together in small groups to discuss racism in the broader world and inside the walls of their own institution. Using documentaries, podcasts and instructor-led conversations, staff from across the health care system spend time discussing, learning and, ideally, implementing the training in a clinical setting. While diversity, equity and inclusion programs are common in health care, having this kind of intensive requirement is an atypical move. (Wiley, 7/5)

The Wall Street Journal: Tyson Foods To Drop ‘No Antibiotics Ever’ Label On Some Chicken Products 
Tyson Foods is reintroducing certain antibiotics to its chicken supply chain, and will drop its “no antibiotics ever” tagline from Tyson-branded chicken products. (Thomas, 7/2)

USA Today: Eli Lilly Weight Loss Drug Retatrutide: What You Need To Know
Retatrutide is one of Lilly’s latest wonder drug developments, another potential treatment among the many the company has invested in to help reduce obesity. The phase 2 results translated to an average weight loss reduction of up to 24% of body weight over 11 months, and Lilly scientists say longer studies could show that number to be higher. The company plans to extend the study period in the phase 3 trial to examine the drug’s full potential. Other improvements noticed during the trial included lowered blood sugar levels and improved cholesterol levels. (Napier, 7/2)

Stat: Gilead And Teva Defeat Antitrust Lawsuit Over HIV Medicines
In a setback to AIDS activists, a federal court jury on Friday cleared Gilead Sciences and Teva Pharmaceuticals of allegations that the companies struck an illegal deal that inflated prices for HIV medicines. A lawsuit filed four years ago accused Gilead of using a range of controversial business tactics that led the U.S. health care system to overspend for HIV medicines. These included so-called pay-to-delay settlements of patent litigation and moves that purportedly stalled development of safer versions of medicines that had years left of patent protection. (Silverman, 6/30)

Stat: Dexcom's Push To Bring CGM To Type 2 Diabetes Patients
For years, diabetes tech company Dexcom has been striving to get its continuous glucose monitors into the hands of type 2 diabetes patients. Last week at the American Diabetes Association’s conference, the company unveiled plans for software built entirely for these patients, including ones who don’t take insulin. (Lawrence, 7/3)

Bloomberg: Daiichi, AstraZeneca Drop On Concern Over Lung-Cancer Drug
While the drug significantly slowed progression of the most common form of lung cancer more than standard chemotherapy, it hasn’t yet improved overall survival rates, Daiichi and AstraZeneca said in a statement late Monday. There were also some adverse reactions that led to patient deaths, the companies said, using the technical term of Grade 5 events. No further details were given. (Mulier and Matsuyama, 7/3)

Stat: AstraZeneca Lung Cancer Study Comes In Below Expectations
AstraZeneca said on Monday that a new lung cancer treatment outperformed standard-of-care chemotherapy in a trial, but investors found the results less impressive than anticipated, sending company shares down in early trading. (Joseph, 7/3)

Stat: Psychedelics Near Approval, But How Do They Work? 
The founder of Field Trip, a chain of shuttered ketamine clinics currently facing insolvency, put forward an unexpected theory of how psychedelics work to treat depression last month. “The truth is, almost all of the effect of psychedelic-assisted therapy could be placebo,” said Ronan Levy, speaking at a five-day conference on the emerging field of psychedelic medicine. “Personally I don’t have a problem with that. The outcomes are the outcomes, and that’s really what matters in my view.” While there’s evidence to support the idea (which, if correct, would make Field Trip’s $5,250 price for six ketamine sessions an unusually expensive placebo effect), attendees at Psychedelic Science 2023 heard an array of explanations for the potential benefits of psychedelic drugs for people with various mental illnesses. (Goldhill, 7/3)

Axios: Most Hepatitis C Patients Encounter Barriers To Treatment: CDC
Only a third of Americans infected with hepatitis C from 2013 to 2022 were treated and cured, according to a new report from the Centers for Disease Control that pointed to barriers to diagnoses, drugs and preventive services. Overcoming those barriers will require comprehensive screening and treatments for all persons regardless of insurance status, the report said. (Dreher, 7/30)

Also —

KFF Health News: Patients Squeezed In Fight Over Who Gets To Bill For Pricey Infusion Drugs
Health insurers and medical providers are battling over who should supply high-cost infusion drugs for patients, with the tussle over profits now spilling into statehouses across the country. The issue is that some insurers are bypassing hospital pharmacies and physician offices and instead sending more complex drugs through third-party pharmacies. Those pharmacies then send the medications directly to the medical provider or facility for outpatient infusing, which is called “white bagging,” or, more rarely, to patients, in what is called “brown bagging.” That shifts who gets to buy and bill for these complex medications, including pricey chemotherapy drugs. (Liss, 7/5)