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EMA workshop signals support for psychedelics

April 17, 2024
By Nuala Moran
“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health.
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Needle with drop

Alvotech-Teva biosimilar approved, impact of negotiations looms

April 17, 2024
By Mari Serebrov
Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable.
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Cloud/cybersecurity illustration

US House hearing includes calls for federal cybersecurity support

April 17, 2024
By Mark McCarty
With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.”
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Gavel and FTC logo

Member of US House blasts FTC/DOJ merger guidelines

April 17, 2024
By Mark McCarty
The new merger guidelines released by the U.S. Department of Justice and the Federal Trade Commission have proven controversial on several fronts, but now the House of Representatives is weighing in. Rep. Roger Williams (R-Texas) said the guidelines fail to account for the importance of these transactions for small businesses seeking to grow and requested that the two agencies provide data that would demonstrate whether such concerns were considered in drafting those rules.
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IQ plus

Butterfly expands ultrasound program to South Africa

April 17, 2024
By Annette Boyle
Butterfly Network Inc. expanded its collaboration with the Clinton Health Access Initiative, Global Ultrasound Institute and the Bill & Melinda Gates Foundation to increase access to maternal/fetal ultrasound technology. The program will bring 500 IQ+ systems and ultrasound training to six provinces in South Africa, following a successful introduction in late 2022 in Kenya.
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U.S. at night from space with circuit board overlay

Telehealth legislation again on tap in US House of Representatives

April 17, 2024
By Mark McCarty
Telehealth received a much-needed boost from the COVID-19 pandemic, but normal reality has settled in and a number of telehealth bills have surfaced in the U.S. House of Representatives. However, Rep. Brett Guthrie (R-Ky.) advised other members of the House that a recent extension of temporary Medicare telehealth coverage added $2 billion to Medicare spending, a fact which he said forces legislators to ensure that “whatever we move out of committee is paid for.”
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Ingenion Medical Cymactive 2

Ingenion receives CE mark for Cymactive urinary catheter

April 17, 2024
By Shani Alexander
Ingenion Medical Ltd. received a CE mark for its Cymactive 2.0R urinary catheter, a device to treat men suffering from chronic, non-neurogenic urinary retention. The technology, designed to mimic natural urination, will “transform” the lives of men currently struggling with the challenges of using Foley-type catheters, Edward Cappabianca, CEO of Ingenion Medical told BioWorld.
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China flag and vial

Biosimilars coming into their own in China, despite concerns

April 16, 2024
By Ruchita Kumar, Sudha Saryu Malhotra, and Mari Serebrov
The timing is ripe for a robust biosimilar market in China, given the rapid increase of novel biologics approved to treat cancer and inflammatory diseases in the country over the past decade and the looming patent cliffs for several established biologics. As of December, the NMPA had approved more than 20 biosimilars that were developed in China. Most of those referenced just two biologics – Roche AG’s cancer drug Avastin (bevacizumab) and Abbvie Inc.’s immunology drug Humira (adalimumab). In 2022, the oncology and immunology biosimilar market in China garnered sales of about $2 billion, according to Clarivate estimates. To reach their full potential in China though, biosimilars must win over prescribers and patients.
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Injection pens and measuring tape

China advances semaglutide biosimilars, Jiuyuan seeks NMPA nod

April 16, 2024
By Marian (YoonJee) Chu
Follow-on biologic makers in China have been working to capitalize on looming patent cliffs of blockbuster biologics. Advancing biosimilars of denosumab (Prolia/Xgeva; Amgen Inc.) and semaglutide are the latest examples.
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Neurocrine advances Nxera’s NBI-1117568 in schizophrenia

April 16, 2024
By Tamra Sami
Nxera Pharma Co. Ltd. announced that its partner, Neurocrine Biosciences Inc., is advancing NBI-1117568 to phase II trials for treatment of schizophrenia and other neuropsychiatric disorders.
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