Posts - Health Care Chief

Depression Therapy Device

Medical Devices

Sooma’s Depression Therapy Device Receives FDA Green Light

Editorial Team

March 9, 2023
3 min read

Walgreens

Hospitals & Providers

Walgreens Opts Against Selling Abortion Pills in GOP-Controlled States After Legal Pressure

Editorial Team

March 9, 2023
3 min read

Roche's Genentech filed a lawsuit against Biogen in federal court, alleging that Biogen owes extra patent royalties on sales of its wildly successful Tysabri treatment for multiple sclerosis and Crohn's disease. When Genentech created a method for producing antibodies forty years ago, several biopharma companies waited in line to license the technology. The invention, known as the "Cabilly patents" is named after scientist Shmuel Cabilly, and enabled Genentech and its parent firm Roche to construct a quasi-toll booth that produced approximately $1 billion in royalty payments per year. The validity of these patents expired in 2018, but Roche is still attempting to recover the remaining royalties it believes are still pending. According to Genentech's lawsuit, even though Tysabri was sold years after it was manufactured using Genentech's patents, Biogen is still obligated to pay royalties. Roche said that Biogen had not paid royalties on its Tysabri since the end of 2018 in a breach of contract lawsuit filed in federal court in the Northern District of California and wanted a jury trial. When Tysabri was introduced in 2004, Biogen began to pay fees. According to court records, the agreement called for Biogen to pay a mid- to low-single-digit percentage on Tysabri sales in the United States and a "reduced royalty" on sales of the medication elsewhere in the globe. Payments were made every three months. Yet according to Roche, Biogen produced Tysabri and kept stockpiles of it, according to the standard practice taking place in the industry. Notwithstanding the fact that Tysabri sales occurred after 2018, according to Roche, it is still owed royalties on the drug that was accumulated before Cabilly's expiration. Roche stated in their complaint: “Because the process for manufacturing antibodies is complex, and the consequences of a stockout potentially catastrophic, it is customary for biopharmaceutical firms that make and sell therapeutic antibodies to stockpile at least several calendar quarters worth of product, and often more than that.” Tysabri, which produced more than $2 billion in revenue each of the previous two years, is one of Biogen's most successful medications. During the four-year period from 2019 to 2022, the sales of the medication were $7.9 billion. The case raises concerns about other businesses that were in a similar licensing agreement with Roche and may have ceased paying royalties after completing sales in 2018. Genentech issued a statement in which it claimed that the company is not commenting on the case as they are confident in the enforcement of the Cabilly patents, even though the litigation is still in process. Biogen did not comment on the case. Business between Roche and Biogen has not been affected by the dispute. A late-stage bispecific antibody called glofitamab is being researched for use against blood malignancies such as B-cell non-lymphoma, and Hodgkin's. Almost three months ago, Roche and Biogen reached an agreement for royalties on its possible commercialization. Also read, The recommended price range for Eisai’s Leqembi increased by ICER

Genentech sues Biogen for royalties on blockbuster MS drug

Editorial Team

March 7, 2023
3 min read

Apotex to recall glaucoma drug after sterility concerns

Editorial Team

March 6, 2023
3 min read

Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device, Theranica Bio-Electronics' wearable gadget for alleviating migraine symptoms, approved by the FDA in 2019, might soon adopt a more aggressive strategy regarding that treatment. The FDA approved the company's request for wider use of the technology only a few months after it had filed a revised 510(k) petition with the agency. Theranica revealed this week that the Nerivio neuromodulation band, available exclusively with a doctor's prescription, may now be used to prevent migraines in addition to curing their symptoms. Those experiencing migraines (with or without aura) and who are aged minimum 12 years old now have the authorization to use the device for prevention. Acute therapy with Nerivio was first approved for use exclusively in adults, but its label was eventually expanded to include the same age bracket roughly two years later. The Nerivio gadget consists of an armband that the user wraps over their upper arm and a mobile application that controls the device's on/off status and intensity level. During each session, electrical pulses are sent from electrodes in the band to the patient's nerve fibers. These pulses aren't harmful to the wearer in any way, but they're supposed to activate the body's natural pain-control systems, which will then distribute calming sensations up the user's nerve system and into their brain. This method has been shown to be effective as an acute therapy for migraine, and new research from last year demonstrated that preventing migraines from ever manifesting by promoting pain relief across the neural system prior to their onset is also feasible. About 250 participants with either chronic or episodic migraines were included in the research. Following eight weeks of therapy, individuals given the Nerivio band reported a four-day monthly reduction in migraine days, whereas those given a placebo reported a decrease of just 1.3 days. On average, the gadget helped people with chronic migraines cut back on their headaches by 4.7 days per month, as compared to 3.2 days for those with episodic migraines. Theranica suggests 45-minute sessions on alternate days for preventative purposes, although patients have complete autonomy over their schedules. CEO Alon Ironi stated in an interview last year following the announcement of the research results and the new FDA application that permitting the Nerivio technology to be utilized in both preventative and severe treatment would render it a far more essential and effective therapy. Theranica has increased the neurostimulation capability of the gadget now that it has dual-use approval; each Nerivio unit may be used for 18 therapy sessions instead of the prior limit of 12. Units are priced at $599, but the firm claims that with insurance and its savings scheme, customers can spend as little as $10 for the initial unit and $49 for refills. Statement front the CEO: “That means, first of all, less dependency on pharmacological agents. It also means less burden, because if you only have one therapy that you have to adhere to, it’s fewer things to worry about,” Ironi remarked. “If you manage to get both significant reductions in your migraine episodes as well as to abort whatever episodes you do experience with the same therapy, that makes your life easier.” Also Read: Death toll linked to Phillips’ respiratory device recall reaches 364

Medical Devices

Theranica’s Nerivio Gains FDA 510(k) Nod For Migraine Prevention Device

Editorial Team

March 3, 2023
3 min read