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
Pfizer has achieved another regulatory breakthrough, a couple of years on from jointly launching the first mRNA vaccine to reach the market. 10 March 2023
Despite being presenting with briefing documents expressing some concerns about efficacy and safety, the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) has voted 11 to 2 in favor of Polivy (polatuzumab vedotin-piiq) for the treatment of people with previously untreated diffuse large B-cell lymphoma (DLBCL). 10 March 2023
US biotech Gilead Sciences has now been awarded damages totalling nearly a quarter of a billion dollars in a case that the drugmaker filed against several healthcare clinics, pharmacies, prescribers, and lab testing facilities. 10 March 2023
Some $230 million has now been raised by Ring Therapeutics, a life sciences company founded by Flagship Pioneering with the aim of revolutionizing gene therapy with its commensal virome platform. 10 March 2023
New clinical data from US pharma giant Merck & Co for MK-0616, an investigational oral cholesterol-lowering drug, revealed that it significantly reduced low-density lipoprotein (LDL) cholesterol in adults. 10 March 2023
The Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer (la/mUC). 10 March 2023
Zeta Pharma is a fast-growing branded generic pharmaceutical company in the Egyptian market that was established in 2010 and started its production and marketing activities in 2015 on the hepatitis C virus products products Sofocivir, Zetaciver and Sofocivir Plus. 10 March 2023
Effective March 11, Gustavo Pesquin will become the next chief executive (CEO) of Asklepios BioPharmaceutical (AskBio), which was acquired in 2020 by Germany’s Bayer. 9 March 2023
ModeX Therapeutics, an OPKO Health company, has entered into an exclusive worldwide license and collaboration agreement with Merck & Co for the development of MDX-2201, ModeX’ pre-clinical nanoparticle vaccine candidate targeting Epstein-Barr virus (EBV). 9 March 2023
Privately-held Swiss drugmaker Ferring was responsible for two out of the eight biological medicines approved by the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research in 2022. 9 March 2023
Shares of MacroGenics were up 10.9% at $6.10 in early trading today, after the biopharmaceutical company revealed that it has entered into an agreement to sell its royalty interest on future global net sales of Tzield (teplizumab-mzwv) to a wholly-owned subsidiary of DRI Healthcare Trust for up to $200 million. 9 March 2023
Staff at the US Food and Drug Administration (FDA) have prepared a report on the use of Roche’s Polivy (polatuzumab vedotin) alongside Rituxan (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in previously untreated large B-cell lymphoma. 9 March 2023
Latest trail results show that solanezumab did not slow the progression of cognitive decline due to Alzheimer's disease (AD) pathology when initiated in individuals with amyloid plaque but no clinical symptoms of the disease, known as the pre-clinical stage of admitted US pharma major Eli Lilly. 9 March 2023
The US subsidiary of Japanese drug major Astellas Pharma today announced disappointing top-line results from the Phase III MORPHO clinical trial evaluating gilteritinib as a maintenance therapy following allogeneic hematopoietic stem cell transplantation (HSCT) for patients with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) mutated acute myeloid leukemia (AML). 9 March 2023
Cambridge, USA-based clinical-stage biotech QurAlis Corporation has closed an oversubscribed $88 million Series B financing, bringing the total funds raised by the company0 to $143.5 million. 9 March 2023
Biotech companies in the Asia-Pacific (APAC) region are trailing Western rivals in terms of venture capital financing, according to a report from GlobalData. 9 March 2023
UK pharma major AstraZeneca this morning released new Phase III data on two of its oncology drugs, showing positive results in lung cancer survival. 9 March 2023
UK biotech Redx Pharma added to its woes, announcing that top-line results of its Phase II program were not sufficient enough to support the development of its RXC004 treatment as a monotherapy. 8 March 2023