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Home » Newsletters » BioWorld

BioWorld

Nov. 29, 2023

View Archived Issues
Stock chart with falling red arrow

‘Ridiculous’ site-based hitches mar Biovie phase III in Alzheimer’s

For the second time this week, a contract research organization has come under fire for trial-conduct issues – criticism leveled most recently by Biovie Inc., which saw its shares (NASDAQ:BIVI) tumble $3.03, or 60%, to end Nov. 29 at $1.96 on missed-endpoint data from the phase III trial testing Alzheimer’s disease prospect NE-3107. The data fell short of statistical significance due to site exclusions caused by what Biovie said were “significant good clinical practice violations and protocol deviations.” Read More

Phenomic signs $509M deal with Boehringer for cancer targets

Companies have invested billions for decades to crack the problem of treating the deep complexities involving stromal cancers, Phenomic AI CEO Girish Aakalu told BioWorld. Now he and his company are on the receiving end as they enter a new collaboration with Boehringer Ingelheim GmbH. Read More
Brain and encephalography

US warns of safety issues from seizure medications; UK restricts valproate

The U.S. FDA put out a safety warning Nov. 28 that antiseizure drugs levetiracetam and clobazam can cause a rare but serious hypersensitivity drug reaction that may start as a rash but can progress to injure internal organs. In addition, U.K. health care providers are being told to get a plan in place now to implement the first phase of the Medicines and Healthcare products Regulatory Agency’s new regulatory measures  to reduce the risks of valproate, a treatment for epilepsy and bipolar disorder. Read More

Redhill shares climb eightfold on Talicia exclusivity

Redhill Biopharma Ltd.’s stock (NASDAQ:RDHL) has soared in recent days following news that the U.S. FDA granted five years of market exclusivity for Talicia, a first-line therapy for eradication of Helicobacter pylori infection, which affects about 35% of the U.S. adult population. Read More
COVID-19 mRNA vaccine vials, syringe

Japan approves first self-amplifying mRNA COVID-19 vaccine from CSL, Arcturus

In a global first, Japan's Ministry of Health, Labor and Welfare has approved CSL Ltd.’s and Arcturus Therapeutics Inc.’s self-amplifying messenger RNA (sa-mRNA) vaccine (ARCT-154) for COVID-19 in adults. The approval marks the first milestone for a November 2022 licensing deal under which CSL subsidiary CSL Seqirus in-licensed Arcturus’ late-stage sa-mRNA vaccine platform technology. Read More

Appointments and advancements for Nov. 29, 2023

New hires and promotions in the biopharma industry, including: 20med, Agomab, Belhaven, Eagle, Engene, Gossamer. Read More

Financings for Nov. 29, 2023

Biopharmas raising money in public or private financings, including: Arrivo, Biolexis, Seelos. Read More

In the clinic for Nov. 29, 2023

Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alpha Tau, Ambrx, Argenx, Erasca, Escient, Exonate, Geneuro, Immunovant, Index, Merck, Nanoviricides, Rallybio, Remegen, Roivant, Skye, Tectonic, Tolremo. Read More

Other news to note for Nov. 29, 2023

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abellera, Adaptimmune, Arecor, Ascendis, Eli Lilly, Generation, GSK, Kazia, Moderna, Orlance, Prism, Teijin, Timber. Read More

Regulatory actions for Nov. 29, 2023

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aldeyra, Arcturus, Arrowhead, Carisma, CSL, Effector, Ethris, Novavax, Orexo, Sernova, Springworks. Read More

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