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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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Conceptual image for brain cancer treatment

Radiopharma glioma imaging agent fast-tracked as Telix preps NDA

April 16, 2024
By Tamra Sami
The U.S. FDA granted fast track designation to Telix Pharmaceutical Ltd.’s TLX101-CDx for glioma imaging as the firm prepares to file its NDA in the first half of 2024, a Telix spokesperson told BioWorld.
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Euvichol

Eubiologics wins WHO prequalification for oral cholera vaccine

April 16, 2024
By Marian (YoonJee) Chu
South Korea’s Eubiologics Co. Ltd. said it gained the World Health Organization’s (WHO) prequalification designation on April 16 for its simplified oral cholera vaccine, approved as Euvichol-S.
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1-10-abbott-heartmate3.png

Long-term use of Heartmate devices associated with obstruction

April 16, 2024
By Mark McCarty
The long-term use of ventricular assist devices is becoming a problem for at least some of these devices, as demonstrated by the recall of the Heartmate II and Heartmate 3 devices by Abbott Laboratories’ Abbott Vascular division due to obstruction of the outflow graft used to attach the device to the human heart.
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Cloud/cybersecurity illustration

US House hearing includes calls for federal cybersecurity support

April 16, 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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Illustration of cryoblation procedure in breast

Icecure seeks FDA authorization to market cryoablation system for breast cancer

April 16, 2024
By Shani Alexander
Icecure Medical Ltd. submitted data to the U.S. FDA seeking de novo marketing authorization for its Prosense system to treat patients with early stage T1 invasive breast cancer in combination with adjuvant hormone therapy. Prosense is a minimally invasive cryoablation technology that freezes and destroys tumors, both malignant and benign.
Read More
Marburg virus
Infection

US orphan drug designation awarded to Soligenix’s Marvax for Marburg marburgvirus infection

April 16, 2024
The FDA has granted orphan drug designation to the active ingredient in Soligenix Inc.’s Marvax, a heat stable subunit protein vaccine of recombinantly expressed Marburg marburgvirus (MARV) glycoprotein, for the prevention and post-exposure prophylaxis against MARV infection.
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Rx trial innovation center opens at US FDA

April 15, 2024
By Mari Serebrov
To take clinical trial innovation to the next level, the U.S. FDA’s Center for Drug Evaluation and Research (CDER) is opening the CDER Center for Clinical Trial Innovation. The center, known as C3TI, “will be a central hub within CDER to support the implementation of innovative approaches to clinical trial design and conduct,” said Kevin Bugin, CDER’s lead for C3TI and deputy director of operations in the Office of New Drugs.
Read More
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