Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
AI-powered protein engineering company Cradle has raised $73 million in a Series B funding. The European firm, which has now raised more than $100 million in total, calls itself the leading platform for AI-powered protein engineering. 27 November 2024
Swiss drugmaker Idorsia was trading more than 10% higher by lunchtime on Wednesday. Idorsia earlier announced that it has entered into exclusive negotiations with an undisclosed party for the global rights to aprocitentan. 27 November 2024
Samsung Bioepis has appointed Kyung-Ah Kim as its new president and chief executive, succeeding Christopher Hansung Ko, who will lead the Samsung Future Business Division. 27 November 2024
US clinical stage biotech Alector saw its shares tumble 35% to $2.57 by close of trading yesterday, as it announced disappointing results from the INVOKE-2 Phase II clinical trial evaluating the safety and efficacy of AL002 in slowing disease progression in individuals with early Alzheimer’s disease (AD). 27 November 2024
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
PTC Therapeutics has announced that its Phase II trial for utreloxastat, aimed at treating amyotrophic lateral sclerosis (ALS), failed to meet its primary endpoint. 27 November 2024
The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) today announced that Dr Thomas Schinecker, chief executive (CEO) of Swiss pharma giant Roche (ROG: SIX), will take up the post as president of the trade association effective January 1, 2025. 26 November 2024
US central nervous system (CNS) disorders specialist Axsome Therapeutics today released encouraging late-stage results for its narcolepsy candidate AXS-12 (reboxetine), sending its shares edging up 2.6% to $100.00 in pre-market activity. 26 November 2024
Clinical-stage US CAR-T therapies developer Poseida Therapeutics saw its shares skyrocket 227% to $9.36 pre-market today, on the news of a proposed takeover by Swiss pharma giant Roche. 26 November 2024
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Taiwan generics drugmaker Lotus Pharmaceuticals has received approval in Vietnam for its cancer drug vinorelbine soft gel in two varieties - 20mg and 80mg- to compete with the branded version Navelbine, originated by French drugmaker Pierre Fabre. 3 March 2023
A judge in the USA has dismissed litigation against Bristol Myers Squibb, alleging the New York-based company defrauded former Celgene shareholders out of $6.4 billion. 3 March 2023
Despite strong protest from the UK pharmaceutical sector, including several companies quitting the scheme, the government has confirmed plans to raise the revenue clawback rate paid by firms subject to the Statutory Scheme for branded medicines from 24.4% to 27.5%. 3 March 2023
Swedish rare disease specialist Hansa Biopharma today announced today that Matthew Shaulis will join the company effective March 16 as chief commercial officer and president of its US affiliate 3 March 2023
Belgian biotech Galapagos’ suffered a disappoint earlier this month, when its already commercialized JAK inhibitor Jyseleca (filgotinib) fell short in the induction cohorts of a Phase III Crohn's disease (CD) trial. 3 March 2023
G-protein coupled receptor (GPCR) company Confo Therapeutics has announced a worldwide licensing agreement with US pharma major Eli Lilly for the Belgian firm’s clinical stage CFTX-1554 and back-up compounds. 2 March 2023
USA-based Ambrx Biopharma and partner NovoCodex Biopharmaceuticals have announced an update on ACE-Breast-02, a Phase III breast cancer trial. 2 March 2023
Dutch autoimmune diseases specialist argenx said today that Karen Massey will join the company as chief operating officer COO, effective March 13, 2023. 2 March 2023
Markets were not hugely worried by predictions for a tough 2023 for Merck KGaA, with the German company’s share price only marginally down late Thursday. 2 March 2023
Florida, USA-based Avenue Therapeutics, which was founded by Fortress Biotech, today announced that it has entered into an exclusive license agreement with AnnJi Pharmaceutical, a Taiwanese clinical-stage drug company. 2 March 2023
Following in the steps of other big insulin producers, US pharma major Eli Lilly yesterday announced price reductions of 70% for its most commonly prescribed insulins and an expansion of its Insulin Value Program that caps patient out-of-pocket costs at $35 0or less per month. 2 March 2023
Results from the Phase III VANGUARD study evaluating garadacimab (CSL312) as a once-monthly, prophylactic treatment for attacks due to hereditary angioedema (HAE) met its primary and secondary endpoints, demonstrating that monthly subcutaneous injections of garadacimab significantly reduced the attack rate compared to placebo. 2 March 2023
The US Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted that the available data support the safety and effectiveness of UK pharma major GSK’s respiratory syncytial virus (RSV) older adult vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. 2 March 2023
Research from industry analyst GlobalData finds that while generics currently dominate the market for lupus treatments, a change is on the way led by new biologics. 2 March 2023
If January offered excitement, promise and hope for a busy year of pharma M&A ahead, then February has more than tempered those expectations. 2 March 2023
The developers of the newly-approved hemophilia A therapy Altuviiio (efanesoctocog alfa) have announced positive results from the Phase III XTEND-Kids trial. 2 March 2023
In 2022, generic drugs remained a significant public health priority for the US Food and Drug Administration (FDA), the agency announced yesterday, along with publishing its 2022 Office of Generic Drugs (OGD) Annual Report. 2 March 2023
The influential Institute for Clinical and Economic Review (ICER), a Boston, USA-based pricing watchdog, has released a report into the cost-effectiveness of Leqembi (lecanemab). 1 March 2023