HONG KONG – New approaches to trials, digitalization and the effective use of advance technologies like artificial intelligence are reshaping how clinical trials are conducted, drugs are discovered, and new devices are developed, said participants at the Asia-focused Phar-East 2020 conference on Dec. 8.
TOKYO – Steadily over a decade and a half, Japan’s drugs and devices regulator has all but eliminated a huge drug lag that put the second largest drug market in the world well behind most others in terms of the time it took for approvals and patient access to innovative drugs.
As expected, the FDA cleared Biocryst Pharmaceuticals Inc.’s oral, once-daily Orladeyo (berotralstat, formerly known as BCX-7353) for the prevention of hereditary angioedema (HAE) attacks. Last month, Biocryst, as part of its earnings report, said approvals of the compound, a kallikrein inhibitor evaluated by U.S. regulators without an advisory committee meeting, could come in Japan this month and in the EU by the first half of next year.
PERTH, Australia – Melbourne-based Telix Pharmaceuticals Ltd. is acquiring Scintec Diagnostics GmbH subsidiary Therapharm GmbH in a deal worth AU$33 million (US$24.24 million) plus royalties.
Zug, Switzerland-based Therapharm has developed a portfolio of radiolabeled diagnostic and therapeutic products, and the deal brings Telix a new targeting asset in hematology, Telix CEO Chris Behrenbruch told analysts during a Dec. 1 conference call.
Personalized medicine, also referred to as precision or targeted medicine, continues to have a significant impact on the treatment of diseases, particularly cancer. Over the past decade or so there has been a dramatic surge in research and development investments in this field. According to the Washington-based Personalized Medicine Coalition, there are about 286 such medicines on the market currently, a number that has more than doubled from the 132 that were available in 2016, representing the largest four-year increase since the PMC began tracking personalized therapies back in 2008.
LONDON – The 10 weeks of laboratory time lost during the first U.K. COVID-19 lockdown will translate to a 17-month delay in oncology drug discovery and development projects, according to the Institute of Cancer Research (ICR) in London.
Although Eiger Biopharmaceuticals Inc. sees more would-be opportunities with ultra-rare disease-targeting Zokinvy (lonafarnib), the company’s vice president of clinical and development operations, Colin Hislop, said that “at the moment, we’re very clearly focused on the population identified in the label, because it fits most closely with the mechanism of action.”
Citing a lack of evidence that it improves survival, the need for ventilation or time to clinical improvement, the World Health Organization (WHO) has advised doctors against using Gilead Sciences Inc.’s antiviral Veklury (remdesivir) to treat COVID-19.
PERTH, Australia – Mesoblast Ltd. inked an exclusive global licensing deal with Novartis AG for the development, manufacture and commercialization of Mesoblast’s mesenchymal stromal cell product remestemcel-L, with an initial focus on the acute respiratory distress syndrome, including that associated with COVID-19, just six weeks after the FDA issued a complete response letter for the therapy as a treatment for steroid-refractory acute graft-versus-host disease.
HONG KONG – Shanghai and New Jersey-based Lianbio has landed a commitment of up to $70 million in non-dilutive capital from a new collaboration with Pfizer Inc., just weeks raising $310 million in an oversubscribed crossover financing round. The collaboration is aimed at developing and commercializing new pharmaceutical products in Greater China.