FDA Approves First Biosimilar Alternative To Arthritis Drug Humira
Stat reports that although the Food and Drug Administration has approved the interchangeable biosimilar drug, questions remain over whether it will really impact health systems. In other news, the FDA rejected the Omeros drug narsoplimab, aimed at aiding bone marrow transplant complications.
Stat:
FDA Approves Interchangeable Humira Biosimilar, But Savings Are Dubious
For the first time, U.S. regulators have approved an interchangeable, biosimilar version of Humira, a hugely popular medicine used to treat rheumatoid arthritis, among other ailments. But the extent to which the approval might make a real difference to the U.S. health care system is uncertain, because availability is a long way off and the dosing regimen may not be competitive. (Silverman, 10/18)
Stat:
An FDA Rejection Derails Omeros, Exposing The Empty Promises Of Its CEO
It’s remarkable to watch Omeros CEO Greg Demopulos and his executive team dissolve into a pool of obfuscation and incompetence when the truth finally arrives. The company said Monday that the Food and Drug Administration rejected its drug called narsoplimab meant to treat patients with a rare but often-deadly complication of bone marrow transplants. The denial finally revealed what many Omeros critics — myself, included — have known for years. The clinical development of narsoplimab was built on shaky, often nonsensical clinical data and a mountain of misleading statements about FDA agreements. (Feuerstein, 10/18)
Axios:
This Arthritis Drug Cost $198 In 2008. Now It's More Than $10,000
In 2008, a box of 30 anti-inflammatory rectal suppositories that treats arthritis, called Indocin, had a price tag of $198. As of Oct. 1, the price of that same box was 52 times higher, totaling $10,350. As federal lawmakers continue to waver on drug price reforms, Indocin is another example of how nothing prevents drug companies from hiking prices at will and selling them within a broken supply chain. (Herman, 10/18)
In other pharmaceutical and biotech news —
Bloomberg:
Covid Led To Closer Work Between FDA, Pharma, Genentech CEO Says
Close collaboration between U.S. drugmakers and regulators in the pandemic is speeding the way for new therapies in other areas including Alzheimer’s disease, the head of Roche Holding AG’s Genentech unit said. The Food and Drug Administration’s flexibility in terms of data submission and clinical trials endpoints “offers so much possibility to bring treatments, meaningful treatments, to patients sooner,” Genentech Chief Executive Officer Alexander Hardy said Monday in an interview with Bloomberg Television from the HLTH conference in Boston. (Tozzi, 10/18)
Axios:
The System Of Recalling Flawed Medical Devices Is Broken
Recalling ineffective or even potentially lethal medical devices is a slow process that jeopardizes patient care, a new report from MedTech Dive explains. "Unless you're hands-on dealing with recalls — even at a hospital — a lot of people don't realize just how broken the process is," the founder of a company that works with providers to process recalls told MedTech Dive. (Herman, 10/19)
Stat:
‘I Don't Know Anybody Who Wants Their Health Disrupted’: Ken Frazier Steps Out In New Venture Capital Role
Former Merck CEO Ken Frazier, famous for building the drugmaker into one of the world’s biggest cancer companies, shed his pharma garb in his first public appearance since starting a new role with the venture capital giant General Catalyst. In July, General Catalyst appointed Frazier, who remains the executive chairman of Merck, as head of the firm’s “health assurance initiatives,” which seek to create equitable and affordable health care through consumer-centric offerings. The splashy hire of Frazier, who is leading the firm’s newly created $600 million Health Assurance Fund, rocketed General Catalyst to prominence in the health care space. (Aguilar and Herper, 10/18)
Bloomberg:
Theranos Elizabeth Holmes Trial: Claims Of Military Use Haunts Fraud Case
Of the numerous lies Elizabeth Holmes is accused of telling, her claim that Theranos Inc. blood analyzers were used by the military, in helicopters and on the battlefield, is one of the most outlandish -- and it’s now rebounding at her criminal fraud trial. A former Theranos employee who worked closely with the startup founder is expected to testify Tuesday that her attempt to win military contracts morphed into bluster to attract investors and partners, including Safeway Inc. and Walgreens. (Rosenblatt, 10/19)
Also —
Houston Chronicle:
Houston Doctor Who Prescribed More Than 1.3 Million Doses Of Opioids Faces Lengthy Prison Term
A federal jury found a Houston physician guilty on Monday of prescribing more than 1.3 million doses of opioids through a strip mall clinic on Gessner in Spring Branch, according to a Justice Department news release. On a busy day, the doctor sometime doled out more than 90 unlawful prescriptions to “patients,” prosecutors said. Dr. Parvez Anjum Qureshi, 56, a geriatric and family medicine specialist from Houston, was convicted of unlawfully prescribing controlled substances between 2014 and 2016 to patients at Spring Shadows Medical Clinic of Houston. A fellow clinic employee, Rubeena Ayesha, 52, of Houston, previously pleaded guilty to aiding in the pill mill scheme. (Banks, 10/18)