27 November 2024 The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA.
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm BeOne Medicines, formerly BeiGene. 27 November 2024
After trading closed yesterday, Exelixis revealed that the US Food and Drug Administration (FDA) has notified the company that the supplemental New Drug Application (sNDA) for cabozantinib (Cabometyx) for the treatment of adults with previously treated advanced pancreatic neuroendocrine tumors (pNET) and advanced extra-pancreatic NET (epNET) will be discussed at an Oncologic Drugs Advisory Committee (ODAC) meeting in March 2025. 27 November 2024
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 November 2024
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
The strain of opioid use disorder (OUD), a chronic neurological disorder characterized by the compulsive, repeated use of opioid drugs, has weighed heavily on many countries in recent years, especially the USA. 27 November 2024
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
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
Germany’s Merck KGaA has provided new longer-term findings from its research into evobrutinib, an oral Bruton’s tyrosine kinase (BTK) inhibitor. 26 October 2022
According to the Russian pharma trade body the ARPM, the 2nd Annual “Right to Health” Congress was held in Moscow, aimed to highlight the prospects of the domestic healthcare industry, which have become more acute in modern geopolitical conditions, in a wide format. 26 October 2022
HIV specialist ViiV Healthcare has announced positive findings from the Phase IIa BANNER proof-of-concept study, looking at its antibody N6LS. 26 October 2022
The US Food and Drug Administration yesterday granted accelerated approval to Tecvayli (teclistamab-cqyv), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for adult patients with relapsed or refractory multiple myeloma. 26 October 2022
Anglo-Swedish pharma major AstraZeneca’s shares were up as much as 3% this morning, after it announced new clinical data indicating that its capivasertib, a potential first-in-class AKT inhibitor, could become a new option for patients in early and 1L metastatic HR+/ET-sensitive breast cancer, regardless of biomarker status. 26 October 2022
Boston, USA-based start-up Normunity, which is working on drugs based on a potentially breakthrough biotechnology, yesterday launched out of stealth with a $65 million Series A funding round. 26 October 2022
The market for spinal muscular atrophy (SMA), a progressive neuromuscular disease that can be fatal, has attracted many of biopharma’s biggest names. 25 October 2022
Following USA-based JSR Life Sciences’ launch of Similis Bio in May this year as a biosimilar partner, the new unit has signed its first development and license agreement, which is with Brazilian drugmaker Blau Farmacêutica. 25 October 2022
US biotech major Biogen today reported third quarter 2022 financial results that were better than investors expected, but the stock fell 2.3% to $267.84 in early trading. 25 October 2022
Sales and income were both down at Swiss pharma giant Novartis for the third quarter of 2022, with the company missing analyst estimates on both measures. 25 October 2022
Japanese pharma major Astellas Pharma has announced a strategic investment to support the advancement of Texas, USA-based Taysha Gene Therapies’ adeno-associated virus (AAV) gene therapy development programs for the treatment of Rett syndrome and giant axonal neuropathy (GAN). 25 October 2022
UK-based oncology specialist Scancell Holdings today announced a licensing agreement with Danish biotech Genmab to develop and commercialize a Scancell investigational anti-glycan monoclonal antibody into novel therapeutic products. 25 October 2022
Pharma trade body Medicines Australia has welcomed the Anthony Albanese’s government Budget announced by Treasurer Jim Chalmers today, which takes steps towards addressing economic pressures and introduces new funding for Prescription Benefit Scheme (PBS) listings. 25 October 2022
In a note filed with the US Securities and Exchange Commission (SEC), California’s Lyell Immunopharma sought to reassure investors that the termination of its deal with GSK would have “minimal impact” on cash and operations. 25 October 2022
Seattle, USA-based immunotherapy company Alpine Immune Sciences dipped 5% on Monday, after saying it has voluntarily stopped enrollment in two studies – NEON-1 and NEON-2 - of its davoceticept drug candidate following the death of a second patient in one of the trials. 25 October 2022
US biotech Mirum Pharmaceuticals edged up 2.6% to $20.02 yesterday, as it released positive top-line data from its Phase III MARCH-PFIC trial evaluating Livmarli (maralixibat) in rare pediatric disease progressive familial intrahepatic cholestasis (PFIC). 25 October 2022
Talking the talk alone is no longer enough for pharma companies where their digital strategies are concerned—now they need to walk the walk, too. 24 October 2022
Following its previous rejection of Sumitomo Pharma’s full acquisition proposal, endocrinology specialist Myovant Sciences has now accepted an increased offer from the Japanese major, with the news pushing its shares up 9% to $26.72 this morning. 24 October 2022