As Wall Street awaits data from VBL Therapeutics Inc.’s phase III trial with ofranergene obadenovec (ofra-vec, also known as VB-111) in platinum-resistant ovarian cancer (PROC), the company hosted a key opinion leader conference call on the gene therapy’s likely market reception along with assorted details regarding the upcoming results from the 409-patient experiment known as Oval.
The potential €100 million (US$114 million) deal disclosed Feb. 10 between infectious disease specialist Aicuris Anti-infective Cures AG and Hybridize Therapeutics for a BK virus therapy stimulated interest in the space, where a number of players are seeking a treatment. None exists today.
The FDA has given thumbs up to two clinical studies for a transcatheter aortic valve replacement (TAVR) system developed by HLT Inc. to treat aortic stenosis among high-risk patients. Those studies will include aortic regurgitation which also occurs when an aortic valve doesn't open and close tightly enough but for which there are few suitable, noninvasive treatments.
Impel Neuropharma Inc. presented multiple abstracts affirming the effectiveness of Trudhesa (dihydroergotamine mesylate) nasal spray in treating migraine attacks. The data – all subsets from the phase III, open-label, pivotal STOP-301 trial – show that acute use of Trudhesa delivered via Impel’s Precision Olfactory Delivery (POD) technology may enhance patients’ quality of life by reducing migraine-associated disability, prolonging headache-free periods and limiting the number of migraine attacks over time.
Results from a new peer-reviewed study show people develop emotional bonds with artificial intelligence (AI) therapy chatbots in a similar way to in-person therapists. The study evaluated 1,205 people using a mental health app developed by Wysa Ltd. to assist symptoms of anxiety or depression. The chatbot guides users through therapy exercises including cognitive-behavioral techniques (CBT), dialectical behavior therapy, meditation, breathing and yoga to build mental resilience skills.
China’s Ministry of Science and Technology issued a draft rule on regulations governing sharing of human genetic resources that provides clarity on parts of the regulation that were previously ambiguous, Katherine Wang, partner at Ropes & Gray in Shanghai, told BioWorld.
Results from a phase III study comparing Celltrion Inc.’s biosimilar VEGF ligand inhibitor CT-P16 to Roche Holding AG’s Avastin (bevacizumab) in patients with metastatic or recurrent non-squamous non-small-cell lung cancer (NSCLC) found it to be similarly effective and as safe compared to the reference drug. Incheon, South Korea-based Celltrion presented the results at the 2022 annual meeting of the American Association for Cancer Research. The company now plans “to speed up the approval process through consultation with regulatory authorities in each country,” a Celltrion official said.
Akili Interactive Labs Inc. has made grabbing and holding attention a distinguishing feature of its digital therapeutics and overall company strategy. Last month, it made news with its hire of gaming industry veteran Jon David as its chief product officer. Now, a study indicates a new product in development may help people with depression extend their attention span and possibly improve cognition, two common symptoms associated with the mood disorder that are not treated by most medications.
As part of a series of guidances addressing clinical trial diversity, the U.S. FDA issued a draft guidance April 13 focused on improving enrollment of participants from underrepresented racial and ethnic populations.
Beigene Ltd.’s BTK inhibitor Brukinsa (zanubrutinib) has met the primary endpoints in a phase III trial to treat patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma.
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