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Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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Biotechnology
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Pharmaceutical
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
Biosimilars
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
Biotechnology
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
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Pharmaceutical
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
Pharmaceutical
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
Biotechnology
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
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Pharmaceutical
US rare diseases specialist Soligenix closed 19% lower after Tuesday’s trading following news of a setback with its lead drug candidate. 15 February 2023
Biotechnology
Canadian precision meds company Fusion Pharmaceuticals has announced the acquisition from Texas, USA-based RadioMedix, of the investigational new drug application (IND) for an ongoing Phase II clinical trial. 15 February 2023
Biotechnology
Shares of US biotech Gritstone bio were up 2.23% t $2.67 pre-marker as the company, announced that it has entered into a clinical trial agreement with the National Cancer Institute (NCI), an institute of the USA’s National Institutes of Health. 15 February 2023
Pharmaceutical
Florida, USA-based Axogen, which is developing and marketing innovative solutions for peripheral nerve injuries, has announced the appointment of Jens Schroeder Kemp to the newly created role of chief marketing officer. 15 February 2023
Biotechnology
Chinese biotech Clover Biopharmaceuticals has launched its COVID-19 vaccine in China. 14 February 2023
Biotechnology
UK pharma major GSK is discontinuing its collaboration with Vir Biotechnology on vaccines against COVID-19, with Vir continuing to discover, develop and advance next-generation solutions for COVID-19 and other potential coronavirus outbreaks, independently or with other partners. 14 February 2023
Biotechnology
German life sciences and technology company Merck KGaA has announced findings of a new analysis of long-term follow-up data from the Phase III JAVELIN Bladder 100 trial. 14 February 2023
Pharmaceutical
The range medicines available in Russian pharmacies is steadily declining, which is mainly due to tough economic environment in the country, caused by Western sanctions and the existing problems with logistics, reports The Pharma Letter’s local correspondent. 14 February 2023
Biotechnology
Last week’s US Food and Drug Administration (FDA) clinical hold on genetic medicines company 4D Molecular Therapeutics Fabry disease (FD) gene therapy program (4D-310) could benefit fellow US drugmaker Sangamo Therapeutics. 14 February 2023
Pharmaceutical
Sorrento Therapeutics, a US company focused on acquiring, developing and commercializing non-opioid pain management products, has issued a statement alongside its majority-owned subsidiary Scilex Holding Company. 14 February 2023
Pharmaceutical
Shares of US regenerative medicines firm Frequency Therapeutics plummeted more than 80% to $0.75 yesterday, after it announced it is terminating programs in sensorineural hearing loss (SNHL) because FX-322 failed to meet the goal of a study in people with acquired SNHL, and is slashing its workforce. 14 February 2023
Pharmaceutical
Following the announcement that Sanofi’s global head of R&D John Reed is leaving the French drugmaker, his destination has been revealed as the US healthcare giant Johnson & Johnson. 14 February 2023
Biotechnology
China and USA-based Harbour BioMed saw its shares rise more than 7% to HK$3.17, after it announced an exclusive license agreement with US firm Cullinan Oncology for the development and commercial rights on HBM7008 (CLN-418) in the USA. 14 February 2023
Biosimilars
The advent of biologics has opened doors for the treatment of several acute and chronic medical conditions.1 Unlike conventional medicines, biologics are derived from living organisms using complex biomedical processes. As a result, development of biologics is more complicated as compared to conventional drugs.2 14 February 2023
Biotechnology
French drugmaker Ipsen has announced three-year minimum, 44-month median, follow-up results from the Phase III CheckMate -9ER trial showing that Cabometyx (cabozantinib) and Opdivo (nivolumab) improve survival and response rate after three-years in the first-line treatment of advanced renal cell carcinoma, compared to sunitinib. 14 February 2023
Biotechnology
Australian biotech company CSL Limited , the world's No 2 influenza vaccine provider in sales, today released financial results for the fist half of fiscal year 2022/23, showing that total revenues were up 19% to US$7.184 billion, US$889 million of which is attributable to CSL Vifor. 14 February 2023
Pharmaceutical
Leaked proposals for the European Commission’s (EC) Pharmaceutical Review package have angered an industry group. 13 February 2023
Pharmaceutical
Shares of US ophthalmic drug developer Ocuphire Pharma were lifted 7.6% to $3.53 this morning, as the company updated on the development of its lead product candidate. 13 February 2023
Pharmaceutical
French drugmaker Sanofi is searching for a new global head of R&D after the role’s current incumbent John Reed announced he was off to pursue an undisclosed opportunity outside the company. 13 February 2023
Biotechnology
G1 Therapeutics’ shares fell 51.8% to $3.43 pre-market today, as the US oncology drug developer said it would terminate a study of its lead drug, trilaciclib, as it was unlikely to be effective in extending survival in patients with a type of colorectal cancer. 13 February 2023
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