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
Italian drugmaker Chiesi and Swedish biotech Affibody have agreed a collaboration and licensing agreement to develop and commercialize innovative treatments for respiratory diseases using the latter company’s technology. 8 March 2023
The Indian government is seeking to overhaul the patent rules in the country to spur innovation and research and development (R&D). Minister for Commerce and Industry Piyush Goyal said the commitment to quality will transform manufacturing in the country. 8 March 2023
The strategic venture capital unit of US healthcare giant Johnson & Johnson (NYSE: JNJ) has put its weight behind a $100 million boost for a new precision medicine company. 8 March 2023
Stalicla, a Swiss company specializing in the identification of specific phenotypes of autism spectrum disorder (ASD) has entered into a Cooperative Research and Development Agreement (CRADA) with the US National Institute on Drug Abuse (NIDA), part of the US National Institutes of Health (NIH). 8 March 2023
Protagonist Therapeutics’ shares closed up a massive 52% at $23.09 yesterday, after it announced positive top-line results from the FRONTIER 1 Phase IIb clinical trial evaluating the oral Interleukin-23 receptor (IL-23R) antagonist peptide JNJ-2113 in patients with moderate-to-severe plaque psoriasis. 8 March 2023
Japanese biotech Carna Biosciences has terminated a licensing deal with its Chinese partner BioNova Pharmaceuticals and regained all China rights of the asset AS1763, a BTK inhibitor treating chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and B-cell non-Hodgkin lymphoma (B-cell NHL). 8 March 2023
There will be changes impacting drugmakers doing business in Northern Ireland as a result of February’s Windsor Framework agreement between the UK and European Union (EU). 7 March 2023
An analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) met the prespecified target for objective response rate (ORR) and demonstrated durable response across multiple HER2-expressing advanced solid tumours in heavily pre-treated patients. 7 March 2023
US clinical-stage cancer biotech Volastra Therapeutics, which is focused on exploiting chromosomal instability (CIN), today announced completion of the in-licensing of Amgen’s sovilnesib (AMG650), an oral, first-in-class small molecule inhibitor of KIF18A. 7 March 2023
Paris-headquartered Noema Pharma, a biopharma company targeting debilitating central nervous system (CNS) disorders, has raised around $112 million in a Series B financing round. 7 March 2023
Shorla Oncology, a privately-held, female founded US-Ireland pharmaceutical company, today announced that the US Food and Drug Administration (FDA) has approved the company’s oncology drug, Nelarabine Injection, for the treatment of T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma. 7 March 2023
The Russian drugmaker R-Pharm is accelerating its expansion in the domestic market this year with the planned investments of 4 billion roubles ($100 million) in the building a new production facility in St Petersburg and the establishment of a large-scale production in the capital city of Moscow. 7 March 2023
Original drugs have begun to be massively replaced by generics in the Russian pharmaceutical market, which is mainly due to falling real incomes of local customers and the overall negative situation in the country’s economy, reports The Pharma Letter’s local correspondent. 7 March 2023
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
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