Amicus Therapeutics Inc.’s results from the phase III trial called Propel with AT-GAA (cipaglucosidase alfa and miglustat) for late-onset Pompe disease (LOPD) met with split opinions, though Wall Street took a decidedly dim view and left shares (NASDAQ:FOLD) to close at $12.57, down $6.16, or 33%. Read More
Immunogen Inc. leads a busy earnings season with numbers that pushed the stock (NASDAQ:IMGN) 30.3% higher on Feb. 12. The antibody-drug conjugates developer posted revenues of $132.3 million for 2020 compared to its $82.3 million in revenues for 2019, a 62.2% increase. Read More
Sagimet Biosciences Inc., a company developing an oral fatty acid synthase (FASN) inhibitor for the potential treatment of nonalcoholic steatohepatitis, has raised $80 million in a crossover financing led by an undisclosed public equity health care investment fund. Read More
PERTH, Australia – Australia’s Therapeutic Goods Administration is proposing changes to its fees and charges and is asking stakeholders for feedback on three different proposed fee structures for the 2021-2022 financial year. Read More
Recently published findings in JAMA Psychiatry related to the sharply increased risk of death from COVID-19 in people with schizophrenia put the spotlight on drug development in the space, which has been steadily heating up the past few years. Read More
The U.S. House Energy and Commerce Committee needed two days of hearings to get through a spending measure that provided the FDA with $500 million for its part in the government response. The CDC would receive $7.5 billion for vaccine distribution and tracking, all developments that ran parallel to an announcement that another 200 million doses of vaccine will be delivered by the end of July at a cost of $3.7 billion. Read More
BioWorld tracked a total of 295 phase I, II and III clinical news items in January, a rise of 39% compared with the number recorded during the pre-pandemic month of January 2020. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Allovir, Amicus, Basilea, Denali, Dicerna, Jasper, Modra, Regeneron, Roche, Sanofi, Takeda. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Amgen, Apollomics, Aqualung, Biontech, Généthon, Moderna, Pfizer, Regeneron, Sanofi, Tyg, Whitelab. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Curevac, Immunitybio, Lysogene, Nantkwest, Regeneron, Seagen, Xeris. Read More
