AstraZeneca’s next generation, selective Bruton’s tyrosine kinase (BTK) inhibitor Calquence (acalabrutinib) has been conditionally approved in China for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. 23 March 2023
Canada’s AbCellera and British firm RQ Bio will work together to identify clinical candidates for up to three infectious disease targets, under the terms of a new research collaboration agreement. 22 March 2023
US biotech Quince Therapeutics saw its shares close up a massive 71% at $1.44 yesterday, after the company confirmed that it has received an unsolicited takeover bid from Echo Lake Capital. 22 March 2023
Psychiatric and neurologic condition specialist Karuna Therapeutics has announced a public stock offering, with the goal of raising $400 million. 21 March 2023
Clinical-stage biotech Zura Bio today announced the closing of its business combination with JATT Acquisition Corp, a special purpose acquisition company on March 20, 2023. 21 March 2023
US drugmaker Vertex Pharmaceuticals has announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved an expanded use of Orkambi (lumacaftor/ivacaftor). 20 March 2023
The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 20 March 2023
Shanghai, China-based cell/gene therapy company Gracell Biotechnologies has entered an unusual, non-exclusive global deal with US biotech Seagen to conduct pre-clinical research on Seagen’s cell therapy products and acquire non-exclusive rights to five of Seagen’s cell therapies. 18 March 2023
South Korean contract development and manufacturing organization (CDMO) Samsung Biologics says it commence the construction of a fifth plant as part of its strategic expansion in response to increased market demand 18 March 2023
Danish drugmaker Pharmacosmos has announced the launch of its intravenous iron deficiency anemia medicine MonoVer (ferric derisomaltose) in Japan. 17 March 2023
The Court of Justice of the European Union decided in favor of US biotech major Biogen, the European Medicines Agency (EMA), and the European Commission in their appeal of a General Court decision annulling the EMA’s refusal to evaluate a generic version of Tecfidera (dimethyl fumarate) because of the multiple sclerosis therapy’s regulatory data and marketing protection. 16 March 2023
UK-based Pharmanovia has expanded its endocrinology portfolio with a licensing agreement for Ghryvelin (macimorelin), a new medicine used for diagnosing adult growth hormone deficiency (AGHD) from US biopharma Aeterna Zentaris. 16 March 2023
A new gene editing company, Seamless Therapeutics, has launched in Germany with $12.5 million in seed financing from investors including Wellington Partners and Forbion. 16 March 2023
Delaware, USA-based precision oncology firm Prelude Therapeutics has entered into a clinical trial collaboration with Sino-American biotech BeiGene, for future evaluation of its investigational CDK9 inhibitor, PRT2527, in combination with BeiGene’s BTK inhibitor, zanubrutinib, in hematologic malignancies. 15 March 2023
Industry analyst Future Market Insights has forecast that the global market for psychedelic medicines, which it estimates to be currently worth $3.1 billion, will be worth over $14 billion by 2033. 14 March 2023
Japanese pharma majors Takeda and Shionogi will each receive about 130 million yen ($9.7 million) from the Japanese GHIT Fund to invest in malaria drugs development, according to a GHIT announcement issued on March 13. 14 March 2023
At a press conference last week, executives of Japanese drug major Eisai forecast $7 billion 1 trillion yen ($7.3 billion) forecast worldwide sales by 2030 for its recently US-approved Alzheimer’s treatment Leqembi (lecanemab), assuming broader coverage from the Centers for Medicare and Medicaid Services (CMS), which has so far limited the use of any amyloid-targeted Alzheimer’s drugs to clinical trials. 11 March 2023
Spanish drugmaker PharmaMar says it has received the Temporary Authorization for the commercialization of Zepzelca (lurbinectedin) by the Swiss Agency for Therapeutic Products (Swissmedic) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy without central nervous system (CNS) metastases. 10 March 2023
Kyowa Kirin has ended a decade long licensing agreement with fellow Japanese drugmaker OncoTherapy' Science’s subsidiary Immunas Pharma for the asset KHK6640, a potential Alzheimer's treatment. 10 March 2023
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