Californian company IncellDx will study Pfizer's maraviroc – a CCR5 antagonist that is approved for the treatment of HIV – in a COVID-19 Phase II trial. 20 October 2020
Hikma Pharmaceuticals has deepened ties with Arecor, with a new exclusive agreement to co-develop a ready-to-administer injectable medicine in the USA. 20 October 2020
Gene specialist Praxis Precision Medicines has priced an upsized initial public offering (IPO) at $19 per share, with proceeds of around $190 million expected. 20 October 2020
The Food and Drug Administration has granted full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. 17 October 2020
Swiss clinical-stage biotech VectivBio has closed a $110 million crossover financing from new investors, with the aim of advancing its medicines for rare diseases. 15 October 2020
Privately-held Blue Oak Pharmaceuticals and and Exscientia, a clinical-stage artificial intelligence (AI) drug-discovery company, have announced a drug-discovery collaboration to treat brain disorders. 15 October 2020
US biotech Scynexis has submitted a New Drug Application to the US Food and Drug Administration for oral ibrexafungerp for the treatment of vulvovaginal candidiasis, also known as vaginal yeast infection. 14 October 2020
Age-related macular degeneration (AMD) is the leading cause of blindness in older adults across western countries. It damages the retina but its exact causes are not fully understood, according to a new report from Edison Investment Research. 14 October 2020
Japanese drugmaker Shionogi has announced the back-to-back publication of two studies in The Lancet Infectious Diseases highlighting the efficacy and safety of cefiderocol against some of the most difficult-to-treat Gram-negative bacterial infections. 13 October 2020
US pharma giant Pfizer and partner Germany’s BioNTech have entered into an agreement with the New Zealand government to supply 1.5 million doses of their potential COVID-19 vaccine, according to local media reports. 13 October 2020
Privately-held UK-based company Oxular has announced that it has received both Rare Pediatric Disease and Orphan Drug designations from the US Food and Drug Administration (FDA) for OXU-003, the firm’s proprietary drug in development for the treatment of retinoblastoma. 12 October 2020
From October 19, 2020, developers of human or veterinary medicines should use the European Medicines Agency’s IRIS Regulatory & Scientific Information Management Platform to request scientific advice. 12 October 2020
The Canadian subsidiary Pfizer and Germany BioNTech have announced the initiation of a rolling submission to Health Canada for BNT162b2, their lead candidate from the companies' vaccine development program against COVID-19. 10 October 2020
Indian drugmaker Glenmark Pharmaceuticals today announced results of its “FAITH” combination trial with antivirals umifenovir and favipiravir for the treatment of moderate hospitalized COVID-19 patients. 9 October 2020
Bristol Myers Squibb today announced that Health Canada has approved Zeposia (ozanimod) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS) to decrease the frequency of clinical exacerbations. 7 October 2020
Zejula (niraparib) is now approved in Canada for the monotherapy maintenance treatment of women with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. 6 October 2020
The UK’s Health Secretary, Matt Hancock, announced on Monday at Conservative Party conference that the Medicines and Healthcare products Regulatory Agency (MHRA) will join Project Orbis, an initiative led by the USA’s Food and Drug Administration Oncology Center of Excellence. 6 October 2020
Trevi Therapeutics has announced significant milestones in its clinical programs for Haduvio (nalbuphine), an investigational therapy aimed at treating chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). 4 October 2024
Italian pharma major Recordati saw its shares rise more than 5% to 52.00 euros in early trading, as it announced a deal to expand its portfolio of marketed rare disease medicines. 4 October 2024
Paris-based asset manager Kurma Partners has raised 140 million euros ($154 million), successfully completing the first closing of Biofund IV 4 October 2024
The European Medicines Agency’s pharmacovigilance committee, PRAC, has started a review of medicines containing finasteride and dutasteride following concerns regarding suicidal ideation (suicidal thoughts) and behaviors. 4 October 2024
Opioid Use Disorder (OUD) is a chronic neurological disorder that is described as the consequences associated with repeated, compulsive use of opioid drugs and prolonged self-administration of opioid drugs. 4 October 2024
Proposals from the National Health Service (NHS) England have been set out for a phased launch of Eli Lilly’s obesity injection Mounjaro/Zepbound (tirzepatide) at the start of a consultation. 4 October 2024
Aspire Pharma, a UK-based niche generics business, has announced the acquisition of all assets from Canute Pharma, further expanding its product range. 4 October 2024
Bristol Myers Squibb has received a new approval from the US Food and Drug Administration for its blockbuster checkpoint blocker, Opdivo (nivolumab). 4 October 2024
Singapore’s Agency for Science, Technology and Research (A*STAR) and US biotech incubator Flagship Pioneering have agree to collaborate on advancing health and sustainability outcomes in Singapore and the broader Asia Pacific region. 4 October 2024
The US Food and Drug Administration (FDA) has removed the partial clinical hold on delpacibart etedesiran (del-desiran/AOC 1001), an investigational treatment designed to address the root cause of myotonic dystrophy type 1 (DM1), under development by US biotech Avidity Biosciences . 4 October 2024
F2G’s September $100m funding round provides the company with crucial funds to
renavigate approval of its lead drug, olorofim. The substantial financing also
highlights the paucity of novel antifungal products in the clinic. 3 October 2024
The US Food and Drug Administration (FDA) has granted the Gilead Sciences subsidiary Kite a Regenerative Medicine Advanced Therapy Designation (RMAT) for Yescarta (axicabtagene ciloleucel) for adults with newly-diagnosed, high-risk large B-cell lymphoma (LBCL). 3 October 2024
The US Food and Drug Administration (FDA) has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. 3 October 2024
Israel’s Teva Pharmaceutical Industries and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, have announced a global licensing deal for the development of an anti PD-1 oncology biosimilar candidate. 3 October 2024
Caliway Biopharmaceuticals has successfully completed its initial public offering, raising NT$6.4 billion ($206 million), the largest IPO in Taiwan's biotech industry to date. 3 October 2024
Kedrion Biopharma has finalized an agreement with Germany-based Biotest for the long-term commercialization and distribution of Yimmugo (immune globulin) in the USA. 3 October 2024
US clinical-stage biotech Arcus Biosciences has entered into a clinical trial collaboration with AstraZeneca on renal cancer treatments. 3 October 2024
PeptiDream says that its wholly-owned PDRadiopharma subsidiary has entered into a strategic partnership with French nuclear medicines firm Curium. 3 October 2024