Following years of testing against a lengthy roster of viral foes, Chimerix Inc.'s Tembexa (brincidofovir) has finally won FDA approval as a medical countermeasure against smallpox. Read More
A day before its June 5 PDUFA date and three months after its original PDUFA, Ryplazim (plasminogen, human-tvmh), from Liminal Biosciences Inc., won FDA approval for treating plasminogen deficiency type 1 hypoplasminogenemia, becoming the first approved therapy for the rare genetic disorder. Read More
Although 2020 is the highest money-making year on record for the biopharma industry, a direct comparison of the first five months indicates that the amount raised so far in 2021 is 22% ahead of last year, while the number of financings climbed 26%. Read More
Stemirna Therapeutics Co. Ltd., which specializes in mRNA technology, said it raised nearly $200 million to speed up the clinical study of its COVID-19 vaccine candidate, SW-0123. It is in phase I study in China and preclinical data have been published in Nature. Read More
LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10. Read More
Updated interim data from the ongoing dose-escalation portion of Harpoon Therapeutics Inc.’s phase I/IIa study of HPN-424 showed the metastatic castration-resistant prostate cancer therapy may move on to a dose expansion. Read More
Shares of Cullinan Oncology Inc. (NASDAQ:CGEM) rose 11.3% to close at $33.11 on June 4 as an update on its EGFR inhibitor, CLN-081, suggested it may prove competitive with Johnson & Johnson's recently approved treatment, Rybrevant (amivantamab), for adults with non-small-cell lung cancer (NSCLC) whose tumors bear EGFR exon 20 insertion mutations. Read More
DUBLIN – The latest update from Merus NV’s phase I/II trial of zenocutuzumab (MCLA-128) – and its early access program – in patients with solid tumors harboring an NRG1-fusion offered a slight improvement on the data disclosed in an abstract released last month, in the run-up to the 2021 American Society of Clinical Oncology meeting. Read More
Sanofi SA is hoping an oral successor to Astrazeneca plc’s Faslodex (fulvestrant) could be a significant moneyspinner as it seeks to re-establish itself as a major player in oncology – and is pushing ahead with clinical trials to get it to market ahead of rivals. The Paris-based pharma has announced it is to start a new phase III trial of its second-generation oral selective estrogen receptor degrader (SERD) drug, amcenestrant, targeting high-risk patients with early breast cancer who need adjuvant drugs to suppress formation of secondary tumors after surgery. Read More
In February 2020, when Redhill Biopharma Ltd. acquired the peripherally acting mu-opioid receptor antagonist (PAMORA) Movantik (naloxegol) from Astrazeneca plc, new prescriptions were dropping. But that picture has turned around after about nine months of promotion, with strong reimbursement trends for the product, and Redhill may have positioned itself to become a leader in the gastrointestinal (GI) space. Read More
New and updated preclinical and clinical data presented by biopharma firms at the American Society of Clinical Oncology's annual meeting, including: Alligator, Amgen, Antengene, Beigene, Deciphera, Eli Lilly, Exelixis, Gilead, Magenta, Novartis, Phio, Puma, Spectrum, Tarveda, Yingli. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D, Acadia, Advaccine, Albireo, Alzheon, Beyondspring, Galapagos, Gilead, Mirum, Point, Precision, Valbiotis, Valneva, Vincerx, Virios, Zynerba. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Akebia, Akoya, Auransa, Bioasis, BMS, Catalyst, Celgene, , Cyclerion, CNS, IGM, Innovent, Kye, Medunik, Pharvaris, Polarisqb, Roche, Surface. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Ortho Regenerative Technologies, Pharmaessentia USA, Pharming Group, Regeneron, Visen. Read More
