New In Biotech: Google Maps’ COVID Tracker; Apple Watch’s Blood Oxygen Sensor
And in pharmaceutical news, "brain-boosting" supplements may contain unapproved drugs in potentially dangerous combinations and doses.
Becker's Hospital Review:
Google Maps To Show COVID-19 Outbreaks
Google Maps unveiled a new feature on Sept. 23 that displays COVID-19 cases in a user's area. The new tool is embedded with Google Maps and is labeled "COVID-19 info." When activated, it shows a seven-day average of new COVID-19 cases per 100,000 people for the area of the map being searched. (Drees, 9/23)
The Washington Post:
Apple Watch 6’s Blood Oxygen Sensor Is Unreliable And Misleading
Sometimes the new Apple Watch Series 6 reports my lungs and heart are the picture of health, pumping blood that’s 100 percent saturated with oxygen. At other times, it reports my blood oxygen is so low I might be suffering from emphysema. (I am not.) The watch can’t decide. This much is clear: Don’t buy one of these $400 devices in the hopes of monitoring your lung health. (Fowler, 9/23)
Modern Healthcare:
FDA Sets Up Center To 'Modernize' Digital Health Regulations
The Food and Drug Administration on Tuesday launched a new center tasked with coordinating and supporting the agency's efforts to "modernize" its approach to regulating digital health technologies, such as apps and wearables categorized as medical devices. The vision for the center is to provide manufacturers, FDA staff and others with resources to help speed development of digital technologies that are safe and effective, FDA officials said. The Digital Health Center of Excellence will sit within the Center for Devices and Radiological Health. (Cohen, 9/22)
In pharmaceutical news —
NBC News:
'Brain-Boosting' Supplements May Contain Unapproved Drugs, Study Says
Some “brain boosting” supplements may contain drugs not approved by the Food and Drug Administration in potentially dangerous combinations and doses, a study published Wednesday finds. Among the supplements billed as "nootropics" or "smart drugs" — which promise improvements in mental focus and memory — are some that contain not only the unapproved drugs included on the label, but also unapproved pharmaceuticals that aren’t even listed, according to the study published in Neurology Clinical Practice. (Carroll, 9/23)
Stat:
New Research Finds Unapproved Drugs In Brain-Boosting Supplements
The supplement aisle is rife with “nootropics,” “smart drugs” and “cognitive enhancers” that claim to help increase brain performance. But new research suggests some of those products also contain unapproved drugs that aren’t listed on the label. The study, published Wednesday in Neurology, found five unapproved pharmaceutical drugs — in potentially dangerous combinations and doses — in over-the-counter brain supplements. (Spinelli, 9/23)
In other pharmaceutical industry news —
Stat:
Public Funding Underwrote Most Development Of J&J Drug For TB
Amid ongoing debate over taxpayer dollars used to generate medicines, a new analysis contends that public investments contributed up to five times more than what Johnson & Johnson (JNJ) spent to develop Sirturo, its groundbreaking drug for tuberculosis. Public sector funds worth an estimated $455 million to $747 million were used to pay for clinical trials, tax credits, administration of a tax-deductible donation program, and a redeemable regulatory voucher, according to the analysis, published in PLoS One. By comparison, the health care giant was estimated to have invested anywhere from $90 million to $240 million on getting the tuberculosis drug to market. (Silverman, 9/23)
Stat:
HHS Criticizes Lilly For Seeking To Curtail Discounts For Safety-Net Hospitals
In a stern rebuke, the Department of Health and Human Services has taken Eli Lilly (LLY) to task for its recent decision to curtail the discounts offered to a federal program for safety-net hospitals and clinics. At issue is the 340B drug discount program, which was created in 1992 and requires drug makers to offer discounts that are typically estimated to be 25% to 50% — but could be much higher — on all outpatient drugs to hospitals and clinics that serve indigent populations. About 12,400 so-called covered entities, including 2,500 hospitals, participate in the program. (Silverman, 9/23)
Stat:
Novartis Sells Bonds Tied To Expanding Access To Drugs In Poor Countries
In a first-of-its-kind move by a large drug maker, Novartis (NVS) raised approximately $2.1 billion last week by selling bonds that are tied directly to its progress in making medicines accessible in certain low- and middle-income countries. Specifically, the stated goal is to expand the number of patients who receive its brand-name medicines by at least 200% by 2025, as well as programs that market medicines to combat leprosy, malaria, Chagas, and sickle cell disease by at least 50% over the same period. If the company fails to meet those expanded access goals, however, investors will receive higher interest payments. (Silverman, 9/22)
CIDRAP:
CARB-X To Fund Development Of Drug For E Coli Urinary Infections
CARB-X announced today that it will award drug maker GlaxoSmithKline (GSK) up to $7.51 million to develop a drug to treat and prevent urinary tract infections (UTIs) caused by Escherichia coli. The award will help fund development of GSK3882347, an orally bioavailable small molecule drug that targets and binds itself to a protein (FimH) found on the surface of E coli, preventing the bacteria from binding to the bladder wall and causing an infection. GSK recently began a phase 1 study to explore the drug's safety, tolerability, and pharmacokinetics. (9/22)
Stat:
Gilead To Pay $97 Million For Allegedly Using A Charity To Pay Kickbacks To Medicare Patients
Gilead Sciences (GILD) agreed to pay nearly $97 million to resolve allegations that donations it paid to a charity were actually kickbacks to Medicare patients used to cover out-of-pockets costs for its medicine used to treat a type of high blood pressure. This is only the latest instance in which federal authorities have cracked down on such arrangements between drug makers and patient assistance charities. (Silverman, 9/23)