Morning Briefing
Summaries of health policy coverage from major news organizations
Trial Of RSV Vaccine Shows Safe, Positive Results
Bloomberg: Respiratory Syncytial Virus: GSK RSV Vaccine Delivers Positive Trial Results
GSK Plc said its vaccine targeting a respiratory virus that causes hundreds of thousands of hospitalizations in older adults each year delivered positive results in a trial, a boost for the drugmaker after falling behind in the quest to develop a Covid shot. The vaccine against respiratory syncytial virus, or RSV, surpassed its primary goal in the study without safety concerns, becoming the first to show significant efficacy in adults over 60, the company said in a statement Friday. The UK pharmaceutical giant said it expects to file with regulators in the second half of the year. GSK shares rose as much as 2.7% in London. (Paton, 6/10)
Reuters: GSK Closer To Cracking Elusive Vaccine For Common Respiratory Virus
GSK aims to get its respiratory syncytial virus (RSV) vaccine to regulators for review later this year, after interim data showed the vaccine was effective in a keenly-watched late-stage study involving older adults. RSV is a leading cause of pneumonia in toddlers and the elderly, but the complex molecular structure of the virus and safety concerns have stymied efforts to develop a vaccine since the virus was first discovered in 1956. (Grover, 6/10)
In other pharmaceutical news —
Stat: FDA Advisers Endorse Bluebird Bio’s Gene Therapy For Rare Disorder
Advisers to the Food and Drug Administration voted unanimously in favor of approving an investigational gene therapy from Bluebird Bio on Thursday, concluding that its benefits for children with a rare and deadly disorder outweigh a demonstrable risk of causing cancer. The FDA’s independent advisers voted 15-0 to recommend Bluebird’s eli-cel, a one-time treatment for cerebral adrenoleukodystrophy, a genetic neurological disorder that affects young boys. The agency, which has promised to make a final decision on eli-cel by Sept. 16, is not required to follow the advice of its advisory committees. (Garde, 6/9)
Fox News: Heart Attack Risk Can Be Found Through Non-Invasive Calcium Score Screening Scan
A screen for heart disease is available that may determine your risk of heart disease even before you show signs or symptoms, health experts told Fox News. According to the American heart association, (AHA), this test, also known as a coronary artery calcium (CAC) test, takes CAT scan images of the blood vessels that support the heart muscle. The test looks for buildup of calcified plaque that can affect the flow of blood to the heart. The calcium is composed of cholesterol, fats, calcium and other substances in the blood and is different from the calcium in bones, according to the AHA. The test involves a CT-scan of the chest that takes about ten minutes to perform and then a score representing the amount of plaque present is assigned to the patient. A higher CAC test score suggests you may be at a higher risk for future heart attack and have a higher chance of significant narrowing in the coronary arteries, according to health experts at the Cleveland Clinic. Depending on your score, your physician will determine the appropriate treatment for you that may include medication or a procedure. (McGorry, 6/9)
The New York Times: Blood Tests That Detect Cancers Create Risks For Those Who Use Them
Jim Ford considers himself a lucky man: An experimental blood test found his pancreatic cancer when it was at an early stage. It is among the deadliest of all common cancers and is too often found too late. After scans, a biopsy and surgery, then chemotherapy and radiation, Mr. Ford, 77, who lives in Sacramento, has no detectable cancer. “As my doctor said, I hit the lottery,” he said. Tests like the one that diagnosed him have won praise from President Biden, who made them a priority of his Cancer Moonshot program. A bill in Congress with 254 cosponsors would authorize Medicaid and Medicare to pay for the tests as soon as the Food and Drug Administration approved them. (Kolata, 6/10)
Columbus Dispatch: Cardinal Health Grove City Distribution Center To Open By End Of 2022
Grove City is the solution Cardinal Health has found to help the company accommodate its expanding at-Home Solutions business. The Dublin-based company on June 2 announced plans to build its 10th distribution center at 6335 Seeds Road in Grove City to support at-Home Solutions, which provides medical supplies and care in the home for people with chronic and serious health conditions. The new distribution center is expected to be up and running by the end of 2022 and primarily serve the central Ohio region, said Rob Schlissberg, Cardinal Health at-Home Solutions president. (Froman, 6/9)
Indianapolis Star: Fishers Bio-Sciences Corridor Starts To Come Alive
A third bio-sciences firm began construction Tuesday in Fishers of a large manufacturing plant and office in a planned corridor for advanced light industry. List Bio's new $125 million building is expected be completed by the end of 2023 and have 210 employees. The facility is on 15 acres at 126th Street and Cumberland Road. The company, a subsidiary of South Korea-based Genome & Company, makes drugs for the last stages of clinical trials and commercial use.Fishers donated 15 acres for the plant and gave the company a 15 year, 50% property tax abatement of $3.7 million. The city has purchased 70 acres in the district for $16 million to set aside for companies. (Tuohy, 6/10)
In updates on the Theranos trial —
The Wall Street Journal: Former Theranos President’s Defense Rests In Criminal-Fraud Trial
Lawyers for Ramesh “Sunny” Balwani called their second and final witness and rested their brief defense of the onetime Theranos Inc. executive charged with a dozen counts of criminal fraud. Mr. Balwani didn’t testify in his own defense. Thursday’s testimony from technical consultant Richard Sonnier brings the trial, which follows the conviction of Theranos founder and Chief Executive Elizabeth Holmes in January, nearer to completion. Mr. Sonnier’s technical testimony about a database followed testimony from an Arizona physician, who backtracked some of her support for Theranos on the stand. (Somerville, 6/9)
