US biotech Seagen’s shares were down 5.6% at $116.67 in early trading, as the firm’s board of directors announced its president, chief executive and chairman, Clay Siegall, is on a leave of absence. 9 May 2022
A Delaware, US, federal jury on Friday declared that Illumina willfully infringed two of Complete Genomics' DNA sequencing patents and should pay $334 million in damages, while also invalidating three Illumina patents that CGI was accused of infringing. 7 May 2022
The US Food and Drug Administration has released two draft guidances for industry focused on the development of drugs to treat Crohn’s disease (CD) and ulcerative colitis (UC). 30 April 2022
Sino-American biotechnology company BeiGene has announced the ground-breaking of its flagship US manufacturing and clinical R&D center at the Princeton West Innovation Campus in Hopewell, New Jersey, USA. 29 April 2022
Oxford, UK-based biotech OMass Therapeutics has raised £75 million ($100 million) in a series B financing round led by new investors, GV, Northpond Ventures and Sanofi Ventures. 28 April 2022
The European Commission has granted marketing authorization to Kapruvia (difelikefalin) for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD) in adult hemodialysis patients from Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics. 28 April 2022
In India, an emergency authorization has been granted for a two-dose regimen of the COVID-19 vaccine developed by local drugmaker Zydus Lifesciences. 26 April 2022
Along with its first-quarter financials results on Monday, Swiss pharma giant Roche revealed that the Phase II acelERA trial on giredstrant did not meet its primary endpoint of progression-free survival in people with a certain form of advanced breast cancer. 26 April 2022
Glenmark Pharmaceuticals has launched a novel diabetes med in India, a fixed-dose combination of the widely-used DPP4 inhibitor teneligliptin, together with pioglitazone. 25 April 2022
Health Canada has granted Marketing Authorization for the expanded use of Vertex Pharmaceuticals’ Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children with cystic fibrosis (CF) ages six through 11 years who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. 21 April 2022
US biotech Dragonfly Therapeutics has announced an expansion of its research collaboration with AbbVie to discover and develop Dragonfly's novel immunotherapies for new targets in autoimmune and fibrotic diseases. 21 April 2022
Regeneron Pharmaceuticals revealed on Friday that the US Food and Drug Administration has extended by three months its review of the Biologics License Application (BLA) for REGEN-COV (casirivimab and imdevimab) to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals. 15 April 2022
Nagoya, Japan-based RaQualia Pharma has received approval of its new drug application (NDA) in China for its acid-related gastrointestinal disease treatment tegoprazan, a potassium competitive acid blocker (P-CAB). 14 April 2022
Mitsubishi Tanabe Pharma Corporation and The Research Foundation for Microbial Diseases of Osaka University have announced the submission of an application for marketing authorization in Japan. 13 April 2022
Switzerland-based Myovant Sciences and US pharma giant Pfizer have announced an update on the Supplemental New Drug Application (sNDA) for Myfembree (relugolix 40mg, estradiol 1mg and norethindrone acetate 0.5mg) for the management of moderate to severe pain associated with endometriosis. 13 April 2022
Privately-owned pharma company Galen has acquired the rights to Provocholine 100mg Powder for nebuliser solution (methacholine chloride) - manufactured by Methapharm Specialty Pharmaceuticals of Canada - to exclusively distribute and commercialize in the UK. 12 April 2022
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
Abivax ABVX) today announced the results of an interim efficacy and safety analysis of an open-label maintenance (OLM) study that enrolled patients with ulcerative colitis (UC). 3 October 2024