Mark Wilcox, professor of medical microbiology at the University of Leeds, said Seres Therapeutics Inc.’s top-line phase III data with oral microbiome therapeutic SER-109 against recurrent Clostridium difficile infection (CDI) are “about as good as it gets” in the tough-to-treat patient population.
Bayer AG’s Lampit (nifurtimox) to treat Chagas disease in pediatric patients, approved by the FDA on Friday, is an oral, antiprotozoal medication for newborns to patients under 18, who weigh at least 2.5 kg and are diagnosed with Chagas disease caused by Trypanosoma cruzi.
HONG KONG – The recent approval of all-oral hepatitis C virus (HCV) drug RDV/DNV, a combination of Asclevir (ravidasvir) and Ganovo (danoprevir), helped boost shares of Ascletis Pharma Inc. (HK:1672), which ended July with a 10% jump to HK$3.36 (US43 cents), as the Hangzhou, China-based company continues to push its pipeline of treatments forward and improve its outlook.
The two-year standstill provision in Assembly Biosciences Inc.’s potential $540 million pact with Beigene Ltd. to advance hepatitis B virus (HBV) therapies was “highly negotiated,” said Jason Okazaki, Assembly’s chief legal and business officer.
Armata Pharmaceuticals Inc.’s recent $15 million award for a three-year program from the U.S. Department of Defense to partially fund a phase Ib/II study added to the already growing resurgence of notice for phage-based therapeutics, with even big pharma starting to take heed.
HONG KONG – Osaka, Japan-based Shionogi & Co Ltd. continues to make global inroads with its influenza treatment, Xofluza (baloxavir marboxil), submitting supplemental new drug applications in Japan and Taiwan for a post-exposure prophylaxis indication on the back of positive results from its phase III trials.
PERTH, Australia – The University of Queensland’s Centre for Superbug Solutions has discovered a new class of antibiotics that has garnered an award from Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).
While biopharmaceutical research is currently concentrating on the threat posed by the COVID-19 pandemic, the disease has provided a sharp reminder that our focus should not be lost on infectious diseases as a whole, along with the growing global problem of antibiotic resistance (AMR), which has the potential to dwarf COVID-19 in terms of deaths and economic costs, according to the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).
Two weeks after receiving a letter from the FDA citing deficiencies in the NDA seeking approval for VP-102 (cantharidin 0.7% topical solution) in molluscum contagiosum, Verrica Pharmaceuticals Inc. disclosed an unsurprising complete response letter.
LONDON – Twenty-three pharma companies are joining forces in the AMR Action Fund and have raised $1 billion in new money for the clinical development of antibiotic drugs addressing the most resistant bacteria. Working with philanthropic backers, the fund aims to bring two to four new antibiotics through to approval by 2030.