A risk of rare but potentially life-threatening blood clots in combination with low platelet levels after a jab of Johnson & Johnson's Janssen COVID-19 vaccine has convinced the U.S. FDA to limit its use. The vaccine is now authorized in the U.S. only for adults who wouldn't otherwise be vaccinated and those who can't or shouldn't, for medical reasons, get another approved vaccine. Through March 18, 2022, the FDA and CDC have identified 60 confirmed cases, including nine fatal cases of the condition, called thrombosis with thrombocytopenia syndrome – a rate of 3.23 cases per million doses of vaccine administered. Read More
IPOs continue to be sluggish but two companies, Pepgen Inc. and Bausch & Lomb Corp., that began trading May 6 managed to sidestep the turbulence despite having to lower their expectations before the market opened. Pepgen stock (NASDAQ:PEPG) closed at $12.89 per share May 6, up 7.4% on the day. Bausch & Lomb also had a solid IPO launch May 6 as shares (NYSE:BLCO) closed 11.1% upward at $20 each. Read More
There are 40 years of history behind the development of phosphoinositide 3-kinase (PI3K) inhibitors, Rebecca Dent told her audience at ESMO Breast Cancer 2022. And there have been success stories. There are five FDA-approved PI3K inhibitors in several cancer types, and in April, the FDA approved Vijoice (alpelisib; Novartis AG) for PIK3CA-related overgrowth spectrum, a rare disorder resulting from germline mutations of PIK3CA. Read More
As the American Society of Clinical Oncology meeting nears, presenters are talking up their prospects, including Biomea Fusion Inc. with early data from experiments testing BMF-219, an oral, irreversible covalent menin inhibitor – one in an intriguing class that has sparked efforts by various developers. Read More
Tumor infiltrating lymphocyte (TIL) therapy is a promising approach to cancer cell therapy that could provide a new option for people whose cancers have not responded to previous lines of treatment – and Denmark’s Cbio A/S is heading to the clinic with a new contender in the field. Delegates at the Anglonordic Life Science Conference in London, held on May 5, heard from CEO Ulrik Cordes, who explained the company aims to outperform rivals from Iovance Biotherapeutics Inc. and Instil Bio Inc. with its proprietary approach to TIL. Read More
Juniper Biologics Pte. Ltd. has added another candidate to its pipeline in the space of less than a month. In the latest deal, the Singapore-based company inked an exclusive licensing agreement with Switzerland’s Helsinn Healthcare SA, gaining rights to develop and commercialize oncology drug infigratinib in Australia, New Zealand, Southeast Asia and certain markets in the Middle East and Africa. Read More
Could investments in biopharmaceutical companies in 2022 be as aggressive as 2021, which saw a record 1,968 biopharma deals worth about $213.5 billion? So far, 2022 may be the lowest financing year since 2017 overall. But, drilling down to venture capital, private companies raised $5.7 billion in Q1 through 129 transactions, making it the second-best first quarter in history with 2021 at the top. BioWorld Senior Analyst Karen Carey explores the data with staff writer Lee Landenberger, explaining what happened in Q1 and where Q2 is headed. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Acousia, Alzamend, Arcturus, Argenx, Astrazeneca, Aulos, Bavarian, Belite, Compass, Elpiscience, Immunic, Karuna, Marinus, Telix, Paradigm, Valneva. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Agile, Arca, Avalo, Biomarin, CSL, Novartis. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Bio Products, Daiichi, Incyte, Jiangsu Recbio, Kempharm, Moleculin, Newsoara, Palisade, Vistagen, Xortx.
