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Home » Newsletters » BioWorld

BioWorld

Nov. 5, 2019

View Archived Issues
Gastrointestinal-stomach-h-pylori

Path of least resistance: Talicia wins in H. pylori, Redhill launch next year

Redhill Biopharma Ltd. CEO Dror Ben-Asher told BioWorld that the 2 million patients targeted by just-approved, delayed-release Talicia, previously known as RHB-105, for adult infection by Helicobacter pylori represents "the baseline where we start our promotion," and there's an opportunity to help many more patients. "When you combine the high prevalence of roughly 100 million Americans infected and more than half of the world's population with the association with gastric cancer, it's a major public health concern," he said. About 800,000 people worldwide die every year from gastric cancer, and about 90% of cases are caused by H. pylori. Read More

FDA tells Aveo to wait on tivozanib NDA filing

Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said. Read More

FDA under temporary new leadership as Senate considers nominee

How much Senate Democrats oppose President Donald Trump's new nominee to take over the reins of the FDA could depend on whom they dislike or distrust more – Stephen Hahn, the nominee, or Brett Giroir, who just became the new acting FDA commissioner. Read More

China grants conditional nod to Green Valley's GV-971 for Alzheimer's disease

BEIJING – Chinese drug regulators granted conditional approval to Shanghai Green Valley (Group) Co. Ltd.'s marine-derived oligosaccharide, GV-971, to treat Alzheimer's disease (AD), but required further trials to prove the drug's efficacy after marketing. Read More

Pascal, Y-biologics to collaborate in bispecific antibodies for leukemia

HONG KONG – Canadian company Pascal Biosciences Inc., headquartered in Vancouver, and South Korean biotech Y-biologics Inc., based in Daejeon, have signed a research collaboration agreement for the discovery and development of bispecific antibodies for the treatment of leukemia. Read More

Court says PTAB appointment process is unconstitutional

The U.S. Court of Appeals for the Federal Circuit has decreed that the regulations governing appointment of judges to the Patent Trial and Appeal Board (PTAB) violate the U.S. Constitution – a decision that gives a medical device maker a new bite at patent litigation, but which also raises the question of whether a large number of PTAB decisions will have to be relitigated. Read More

Amgen says it wants the Revolution for its phase Ib

Amgen Inc. and Revolution Medicines Inc. will collaborate on a clinical trial evaluating the combination of RMC-4630, Revolution's SHP2 inhibitor, and Amgen's AMG-510, a KRAS-G12C inhibitor. Amgen will conduct the phase Ib trial to treat patients with advanced solid tumors harboring the KRAS G12C mutation and Revolution will provide Amgen with RMC-4630. Read More

Earnings for Nov. 5, 2019

Quarterly snapshots from biopharma companies with marketed products. Read More

Financings for Nov. 5, 2019

Biopharmas raising money in public or private financings. Read More

In the clinic for Nov. 5, 2019

Clinical updates, including trial initiations, enrollment status and data readouts and publications. Read More

Other news to note for Nov. 5, 2019

Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief. Read More

Regulatory actions for Nov. 5, 2019

Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations. Read More

Regulatory front for Nov. 5, 2019

The latest global regulatory news, changes and updates affecting biopharma. Read More

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