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Pharmaceutical
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.
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Biotechnology
US biotech star-up Capsida Biotherapeutics has entered a multi-year strategic collaboration with pharma major Eli Lilly’s subsidiary Prevail to develop transformative genetic medicines for serious diseases. 5 January 2023
Pharmaceutical
Merck & Co’s Lagevrio (molnupiravir) has been granted emergency approval by China’s National Medical Products Administration. 5 January 2023
Biotechnology
It has been a long road for Geron’s telomerase blocker, but the company is now finally planning a commercial launch for imetelstat in 2024. 5 January 2023
Biotechnology
A report from industry commentator GlobalData highlights the potential for cell therapies to transform the treatment of multiple sclerosis (MS). 5 January 2023
Biotechnology
UK pharma major AstraZeneca said today that its Biologics License Application (BLA) for nirsevimab has been accepted for review by the US Food and Drug Administration (FDA) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease in newborns and infants. 5 January 2023
Generics
Finnish drugmaker Orion Corporation says it has signed a long-term license agreement with US drugmaker Amneal Pharmaceuticals, to commercialize Amneal’s generic products in Orion territories. 5 January 2023
Pharmaceutical
US cancer specialist Spectrum Pharmaceuticals has lost more than 50% of its stock market value in the past six months, and it has now lost a member of its beleaguered management team, too. 4 January 2023
Biotechnology
Taking advantage of the vast cash pile generated by the success of its COVID-19 vaccine Spikevax, US mRNA therapeutics and vaccines specialist Moderna (Nasdaq: MRNA) today announced its first out-right acquisition since its launch in 2020. 4 January 2023
Pharmaceutical
UK-based ADVANZ PHARMA has acquired exclusive rights to register and commercialize AT-007, a Phase III development compound for the treatment of several rare neurological diseases, including galactosemia and SORD deficiency, in the European Economic Area, the UK, and Switzerland. 4 January 2023
Biotechnology
Shares of US biotech firm Vera Therapeutics nose-dived in after-hours trading on Tuesday, after it announced what it described as “positive” the Phase IIb ORIGIN clinical trial of atacicept in patients with immunoglobulin A nephropathy (IgAN), which met its primary endpoint. 4 January 2023
Biotechnology
A planned merger between US biotech Sesen Bio and privately-held firm Carisma Therapeutics has run into headwinds. 4 January 2023
Biotechnology
Israeli biotech Chemomab Therapeutics has presented promising results on CM-101, its CCL24-neutralizing monoclonal antibody, in non-alcoholic steatohepatitis (NASH). 4 January 2023
Pharmaceutical
Canadian firm Aurinia Pharmaceuticals and India’s Sun Pharmaceutical have moved quickly to settle a patent dispute in the US market. 4 January 2023
Biotechnology
Switzerland-based biotech ADC Therapeutics today announced the appointment of Dr Mohamed Zaki as chief medical officer, bringing over 20 years of experience in hematology and oncology drug development to his role. 4 January 2023
Biotechnology
USA-based tumor drug resistance specialist Deciphera Pharmaceuticals saw its shares close down 2.7% at $15.94 yesterday, after it announced findings of a planned exploratory analysis of data from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) using circulating tumor DNA (ctDNA) from a subgroup of patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib who harbor mutations in KIT exon 11 and 17/18 only. 4 January 2023
Biotechnology
Polish clinical-stage biotech Molecure has announced that Dr Samson Fung, currently chief medical officer, has been appointed to the company’s management board. 4 January 2023
Biotechnology
CAR-T therapy company Allogene Therapeutics has swiftly named its replacement for executive vice president of research and development Rafael Amado, who has resigned to join Sino-American firm Zai Lab. 3 January 2023
Generics
In November 2022, the US Food and Drug Administration (FDA) hosted a webinar on the topic Understanding Generic Narrow Therapeutic Index (NTI) Drugs. The aim of the webinar was to educate healthcare professionals on NTI drugs and the FDA’s efforts to ensure therapeutic equivalence of generic NTI drugs.1 3 January 2023
article
Adding to its deal with Jounce Therapeutics last week for its anti-CCR8 antibody in a $67 million accord, US biotech Gilead Sciences today announced a collaboration and licensing agreement with EVOQ Therapeutics, to advance its proprietary technology for the treatment of rheumatoid arthritis (RA) and lupus. 3 January 2023
Biotechnology
A new development and licensing deal with Germany’s Merck KGaA will augment the pipeline of immunotherapy specialist PDS Biotechnology. 3 January 2023
All news
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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