Latest Pharma and Biotech News
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
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
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
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Chief executive Paul Hudson presented an upbeat results statement for Sanofi Friday morning, highlighting strong performance in the third quarter and a range of clinical developments under way. 28 October 2022
Biotechnology
The latest in a series of Industry Leader pieces from biological reagent supplier and service provider Sino Biological. 28 October 2022
Pharmaceutical
The pharmaceutical industry in Europe has questioned measures aimed at improving the way wastewater is treated by countries within the European Union. 28 October 2022
Biotechnology
Gilead Sciences announced its financial results for the third quarter of 2022 after markets closed yesterday, but the US biotech major’s shares were up 4.8% at $73.58 pre-market today. 28 October 2022
Biotechnology
Markets seemed unfazed, as GSK’s (LSE: AZN) shares barely moved on the news yesterday that it was discontinuing a development program for otilimab, as a result of mediocre performance of the drug in rheumatoid arthritis. 28 October 2022
Biotechnology
The European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for lebrikizumab for the treatment of moderate to severe atopic dermatitis submitted by Almirall. 28 October 2022
Pharmaceutical
Shares in Merck & Co were nearly 2% higher at lunchtime Thursday after the US pharma giant presented its third quarter 2022 financial results. 27 October 2022
Pharmaceutical
Ipsen has reported a 16% rise in its revenue for the third quarter of 2022. 27 October 2022
Biotechnology
US immuno-oncology cell therapy company 2seventy bio’s shares gained 3.5% to $16.00 this morning, as it announced a strategic alliance with Chinese biotech JW Therapeutics. 27 October 2022
Biotechnology
Positive top-line results from two global Phase III studies, BALATON and COMINO, evaluating the first and only bispecific antibody for the eye, Vabysmo (faricimab), in macular edema due to branch and central retinal vein occlusion (BRVO and CRVO) were released today by Swiss pharma giant Roche. 27 October 2022
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical’s shares edged 1.8% higher to $12.97 in early US trading, after it reported financial results for the first half of its fiscal year ended September 2022. 27 October 2022
Biotechnology
Anglo-Swedish pharma major AstraZeneca has presented new results on Ultomiris (ravulizumab) in neuromyelitis optica spectrum disorder (NMOSD). 27 October 2022
Pharmaceutical
A fairly positive outcome from a meeting of the US regulator’s scientific panel raises the prospect that pharma major GSK may be able to succeed where its British counterpart AstraZeneca has failed. 27 October 2022
Pharmaceutical
Rare diseases specialist Swedish Orphan Biovitrum saw its shares fall more than 3% to 204.40 kronor this morning after releasing third-quarter 2022 financial result. 27 October 2022
Generics
The US Food and Drug Administration (FDA) yesterday released its fiscal year (FY) 2023 Generic Drug User Fee Amendments (GDUFA) Science and Research Priority Initiatives. 27 October 2022
Pharmaceutical
In the USA, the Biden-Harris Administration has made expanding access to health insurance and lowering health care costs for America’s families a top priority, and, starting now, consumers can preview their health care coverage options and see the savings available to them in the most competitive Marketplace in history. 27 October 2022
Biotechnology
The questions that were posed to the biopharmaceutical industry in 2020 were more urgent than ever before, as the COVID-19 pandemic brought much of the world to a standstill. 27 October 2022
Biotechnology
A US regulatory submission from microbiome company Seres Therapeutics has been accepted, with an expected decision date of April 26, 2023. 26 October 2022
Biotechnology
Australia’s largest biotech CSL Limited today revealed it has entered into a strategic option and license agreement with Arizona, USA-based Translational Sciences for rights to its enhanced thrombus (blood clot) dissolving drug candidate, TS23. 26 October 2022
Biotechnology
German-born UK resident Volker Hirsch has joined the Medicines Discovery Catapult (MDC) as chief commercial officer. 26 October 2022
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