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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 RNA company Avidity Biosciences closed 55% higher following Wednesday’s trading. 15 December 2022
Biotechnology
Adding to a string of approved indications for the interleukin (IL) and IL-4 blocking antibody, the European Commission (EC) has expanded the marketing authorization for Dupixent (dupilumab) in the European Union to treat adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. 15 December 2022
Biotechnology
A Danish company developing a vaccine against group B streptococcus (GBS) - an infection often known as Strep B - has 72 million ($77 million) euros more to spend. 15 December 2022
Pharmaceutical
Nucleic acid therapy specialist Exicure has been dealt a blow by the termination of collaborations with AbbVie and Ipsen. 15 December 2022
Pharmaceutical
A novel targeted protein degradation (TPD) candidate from Kymera Therapeutics is to be advanced by its research and development partner, Sanofi. 15 December 2022
Pharmaceutical
US eyecare pharma company Harrow Health’s shares jumped 15% to $12.77 after it announced a binding agreement for the acquisition of the exclusive US commercial rights to five Food and Drug Administration (FDA) approved ophthalmic products from Swiss pharma giant Novartis 15 December 2022
Pharmaceutical
Prices for a wide range of drugs in the Russian pharmaceutical retail sector are steadily growing due to a significant reduction of their supplies and disappearance from retail shelves. 15 December 2022
Generics
The Russian government together with some leading domestic financial corporations will provide support to domestic producers of active pharmaceutical ingredients (APIs) that will primarily be in the form of provision of preferential loans and other benefits for them, reports The Pharma Letter’s local correspondent. 15 December 2022
Biotechnology
As the year draws to a close, this article presents some of the wins of the orphan drug community in terms of US FDA approvals, while highlighting challenges faced by the sector and looking ahead to the expectations of the next year. 15 December 2022
Pharmaceutical
India’s Torrent Pharmaceuticals has inked a strategic alliance with Germany’s Boehringer Ingelheim to co-market diabetes drugs and fixed-dose combinations in India. The Indian company will co-market empagliflozin, empagliflozin+ metformin and empagliflozin+ linagliptin in India. 15 December 2022
Biotechnology
As anticipated, following a positive decision from its scientific committee, the European Medicines Agency has granted marketing authorization for Pluvicto (vipivotide tetraxetan). 14 December 2022
Biotechnology
Sanofi and Regeneron’s interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab) is already an enormously successful drug, even though safety issues have been identified. 14 December 2022
Biotechnology
Replay, a genome writing company reprogramming biology by writing and delivering big DNA, has announced the launch of Kaleibe, a herpes simplex virus (HSV) gene therapy company targeting genetic brain disorders. 14 December 2022
Pharmaceutical
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF) in adults with a forced vital capacity (FVC) above 80% predicted. 14 December 2022
Pharmaceutical
As the 64th annual meeting of the American Society of Hematology (ASH) drew to a close in New Orleans on Tuesday, more clinical updates provided a window into the development prospects for two important programs in this therapy area. 14 December 2022
Biotechnology
French drug resistance specialist Ribonexus has appointed Steven Powell as chief executive, as the company prepares to seek more financing for its small molecule programs. 14 December 2022
Pharmaceutical
The US Food and Drug Administration’s (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted eight to three that the benefits of omecamtiv mecarbil do not outweigh its risks for the treatment of heart failure with reduced ejection fraction (HFrEF). 14 December 2022
Pharmaceutical
Eli Lilly saw its shares close down 2.3% at $358.66, after the US major announced financial guidance for 2023, which was viewed as slightly disappointing. 14 December 2022
Biotechnology
US clinical stage biotech Praxis Precision Medicines’ shares closed up nearly 5% yesterday and rose a further 2.3% to $2.25 pre-market, on the news of a strategic collaboration with Belgium’s UCB, based on Praxis’ PRAX-020 program, for the discovery of small molecule therapeutics as potential treatments of KCNT1 related epilepsies. 14 December 2022
Pharmaceutical
USA-based drug developers Tellus Therapeutics, a neonatal care company developing treatments for new-borns in the neonatal intensive care unit (NICU), and Peroxitech, emerging biopharma developing a novel peptide for treating acute lung injury (ALI), have announced the closing of Series A financings led by the Perceptive Xontogeny Venture Fund. 14 December 2022
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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