Latest Pharma and Biotech News
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
All news
Biotechnology
The UK’s health technology assessor has approved the first chimeric antigen receptor (CAR) T-cell therapy for use on the National Health Service (NHS) in England. 26 January 2023
Biotechnology
KSQ Therapeutics, a privately-held US biotech developing therapies to treat cancer and autoimmune diseases using its CRISPRomics platform, has announced a deal with Ono Pharmaceutical. 25 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) Antimicrobial Drugs Advisory Committee has voted favorably, by 14 to 1, that Cidara Therapeutics, as part of its New Drug Application (NDA), provided sufficient evidence supporting a favorable benefit-risk assessment for a limited use indication for rezafungin. 25 January 2023
Pharmaceutical
US drugmaker Eli Lilly is to invest an additional $450 million and create at least 100 new jobs to expand its manufacturing capacity at the company's Research Triangle Park facility in North Carolina. 25 January 2023
Biotechnology
Histiocytic neoplasms, also known as histiocytosis, are rare disorders in which specialized immune cells (histiocytes) accumulate and form tumors in tissues such as skin, bones, liver, lungs, lymph nodes and spleen.1,2 25 January 2023
Pharmaceutical
The Chinese Center for Disease Control and Prevention has recorded that Omicron lineages BA.5.2 and BF.7 account for 97.5% of all local infections in the country. 25 January 2023
Biotechnology
The European Medicines Agency is to review a regulatory submission from Swiss gene editing specialist CRISPR Therapeutics and partner Vertex Pharmaceutical. 25 January 2023
Pharmaceutical
The US Department of Health and Human Services (HHS) yesterday issued a new report showing the major savings coming to people with Medicare thanks to the $35 cap on a month’s supply of insulin. 25 January 2023
Biotechnology
Deciphera Pharmaceuticals’ shares rose 4.4% to $18.85 in after-hours trading yesterday, when the US biopharma company presented additional data from the planned exploratory analysis from the INTRIGUE Phase III clinical study of Qinlock (ripretinib) using circulating tumor DNA (ctDNA) from patients with gastrointestinal stromal tumor (GIST) previously treated with imatinib. 25 January 2023
Biotechnology
More gloomy news from Finch Therapeutics, as the microbiome company announced it would scrap the Phase III PRISM4 trial of its recurrent C. difficile infection (CDI) candidate CP101. 25 January 2023
Generics
US tech giant Amazon has announced RxPass, a new Prime membership benefit from Amazon Pharmacy that offers patients affordable access to commonly prescribed generic medications that treat more than 80 common health conditions. 25 January 2023
Pharmaceutical
Revenues in the fourth quarter came in below expectations for Johnson & Johnson, with the company reporting sales of $23.7 billion, a decline of 4.4%. 24 January 2023
Pharmaceutical
A new chief executive is to take over from Jeff Hatfield at Vividion Therapeutics, Bayer’s wholly-owned subsidiary that is using discovery technologies to unlock high value, traditionally undruggable targets with precision therapeutics for devastating cancers and immune disorders. 24 January 2023
Pharmaceutical
The European Commission Decision Reliance Procedure (ECDRP) has been extended to December 31, 2023, when a new international recognition framework will be in place, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) announced today. 24 January 2023
Biotechnology
Boston, USA-based biotech Blueprint Medicines Corporation has announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental new drug application (sNDA) for Ayvakit (avapritinib) to treat indolent systemic mastocytosis (SM). 24 January 2023
Biotechnology
French therapeutic peptides for rare endocrine and metabolic diseases company Amolyt Pharma today announced it has entered into a research agreement and licensing option with XOMA Corp. 24 January 2023
Generics
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis, has signed an agreement to acquire worldwide product rights for leading systemic antifungal agent Mycamine (micafungin sodium, Funguard in Japan) from Astellas Pharma. 24 January 2023
Biotechnology
Pliant Therapeutics, a Californian biopharma focused on discovering and developing fibrosis drugs, closed up by more than a third on Monday. 24 January 2023
Pharmaceutical
In a sudden turn of events, Novartis' Entresto (sacubitril/valsartan) patent has been reinstated in India, after a two-judge bench stayed a previous order that invalidated it. 24 January 2023
Pharmaceutical
Shares of US clinical-stage biotech Axcella Therapeutics were up nearly 70% at $0.72 pre-market this morning, after it announced a regulatory path to registration of AXA1125 in the treatment of long COVID fatigue. 24 January 2023
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