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.
Today's issue
Refine Search
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
Pharmaceutical
Needing to keep pace with the pace of innovation set by drugmakers, the European Medicines Agency (EMA) has responded by setting up a new group. 22 November 2022
Biotechnology
Munich, Germany-based clinical-stage biotech CatalYm said today it has successfully closed a 50 million-euro ($49 million) Series C financing round. 22 November 2022
Biotechnology
Privately-held Swiss ophthalmology company Oculis has released positive results of the licaminlimab active-controlled, multicenter, randomized, parallel-group Phase II clinical trial assessing the effect of topical licaminlimab (OCS-02) on anterior chamber (AC) cell grade in patients with acute anterior uveitis (AAU). 22 November 2022
Biotechnology
Franco-American biopharma Erytech Pharma revealed Monday that the company will no longer be developing its lead candidate Graspa (eryaspase), an l-asparaginase encapsulated inside donor-derived red blood cells (RBCs). 22 November 2022
Pharmaceutical
German family-owned drugmaker Grünenthal today announced that Janneke van der Kamp will join the company as the new chief commercial officer (CCO), effective March 1, 2023. 22 November 2022
Biotechnology
A decade on from the founding of The Cell and Gene Therapy Catapult (CGT Catapult), the UK-based industry accelerator is celebrating its successes. 22 November 2022
Pharmaceutical
Italy-based privately-owned Angelini Industries has appointed Jacopo Andreose as chief executive (CEO) of its subsidiary Angelini Pharma. 22 November 2022
Biotechnology
Adding to an Emergency Use Authorization (EUA) in the USA for the vaccine last month, US biotech Novavax says that Health Canada has granted expanded authorization for Nuvaxovid (COVID-19 vaccine (Recombinant protein, adjuvanted)) (NVX-CoV2373). 22 November 2022
Pharmaceutical
Pharma observers of today might sometimes see Merck KGaA as somewhat smaller than its American namesake and as having been left behind by more recent arrivals on the European pharma scene. 21 November 2022
Biotechnology
Denmark’s Genmab (Nasdaq: GMAB) edged up 1.3% after it announced that the US Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application for epcoritamab (DuoBody-CD3xCD20). 21 November 2022
Biotechnology
New Jersey, USA’s Merck & Co is targeting bone marrow disorders with the $1.35 billion all-cash acquisition of Imago BioScience. 21 November 2022
Pharmaceutical
During World Antimicrobial Awareness Week, demands for action are being made at European level as well nationally. 21 November 2022
Biotechnology
Investing in early-stage multicenter trials is imperative to achieve global commercialization for Chinese biotechs, but a US site may not be necessary, said speakers at the Chinatrials meeting held in Shanghai earlier this month. 21 November 2022
Pharmaceutical
Building on the antimicrobial resistance (AMR) joint statement published in 2019, the International Coalition of Medicines Regulatory Authorities (ICMRA) today issued a report that highlights successful regulatory and non-regulatory interventions used in different countries to address the growing public health problem of antimicrobial resistance (AMR). 21 November 2022
Generics
A couple of months ago, Teva Pharmaceutical Industries’ chief executive Kåre Schultz indicated that he will not renew his contract as chief executive come November 2023, as the Israeli generics giant revealed plans to finalize its $4.35 billion national opioid settlement by the end of the year and start paying up in 2023, as well as reporting a loss in three out of the last four quarters. 21 November 2022
Biotechnology
As with rival Moderna, COVID-19 vaccine partners Pfizer and BioNTech are keen to show that their adapted booster works better than their original jab against currently-circulating strains. 21 November 2022
Pharmaceutical
British charity Cancer Research UK has extended a strategic alliance with Astex Pharmaceuticals, dedicated to the discovery and development of novel small molecule therapeutics. 21 November 2022
Biotechnology
US pharma giant Merck & Co has recently presented positive top-line results from the Phase III STELLAR trial evaluating the safety and efficacy of sotatercept, an investigational activin receptor type IIA-Fc fusion protein being evaluated as an add-on to stable background therapy for pulmonary arterial hypertension (PAH). 21 November 2022
Pharmaceutical
Ireland-headquartered Avadel Pharmaceuticals saw its shares gain more than 12% to $8.03 on Friday, after it announced a positive patent dispute ruling. 21 November 2022
Biotechnology
Over the past two decades, numerous complex cancer therapies called antibody drug conjugates (ADCs) have been tested in clinical trials and approved for use in patients. 21 November 2022
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze