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
Biotechnology
US biotech major Amgen reported its quarterly financial results late Thursday. 4 November 2022
Pharmaceutical
Shares of Swiss biopharma Kinarus Therapeutics Holding ( were down 13% by midday after it confirmed plans to focus on clinical trials of its lead candidate KIN001 in ophthalmic and pulmonary fibrosis indications, and to refocus its capital resources and financing efforts to drive these programs. 4 November 2022
Biotechnology
Struggling in the wake of the discontinuation of ziritaxestat, Belgian biotech Galapagos is to undertake a radical restructuring aimed at jump-starting the business. 4 November 2022
Biotechnology
Shares of US gene and cell therapy company Abeona Therapeutics hit a high of $4.80 yesterday but closed 13% lower at $3.87, after it announced positive top-line data from its pivotal Phase III VIITAL study assessing the safety and efficacy of EB-101 for the treatment of patients with recessive dystrophic epidermolysis bullosa (RDEB), as well as a $35 million financing. 4 November 2022
Biotechnology
Shares of US mRNA-focussed biotech Moderna slid more than 11% pre-market yesterday, before recovering to close down 0.76% at $147.50, as it reported financial results. 4 November 2022
Pharmaceutical
Special purpose acquisition company (SPAC) deals were October's order of the month in the pharmaceutical M&A market. 3 November 2022
Generics
Israeli generics company Teva Pharmaceutical Industries was trading more than 2% lower late on Thursday, following the firm’s presentation of its third quarter 2022 financial results. 3 November 2022
Biotechnology
Germany’s Affimed saw its shares leap more than 17% to $1.98 today, after it revealed a collaboration with privately held US biotech Artiva Biotherapeutics. 3 November 2022
Biotechnology
Revenues at Regeneron came in at $2.9 billion in the third quarter of 022, slightly higher than most analysts’ were expecting, but still 15% lower than the same period of 2021. 3 November 2022
Pharmaceutical
A monkeypox vaccine may soon be available from India, as six companies have been identified by The Indian Council of Medical Research (ICMR) and given the go-ahead to make the vaccine, reports The Pharma Letter’s local correspondent. 3 November 2022
Generics
According to the charity Médecins Sans Frontières (MSF), negotiations between the UK and India on a Free Trade Agreement (FTA) were formally launched in January 2022 and are currently accelerating, with high-level meetings between the two governments scheduled this November on the side-lines of the G20 Summit in Indonesia, according to reports. 3 November 2022
Biotechnology
Australia’s CSL Limited has sought to shed light on the promise of its pipeline at its annual R&D investor briefing. 3 November 2022
Biotechnology
Times are tough for cell medicine specialist Rubius Therapeutics, with the firm announcing plans to slash its workforce by 84%, part of a drastic effort to avoid bankruptcy. 3 November 2022
Biotechnology
Ireland-incorporated biotech Alkermes’ shares closed up 3.5% at $24.06 yesterday, as it pleased investors when it revealed that it is to explore separating its commercial-stage neuroscience business and development-stage oncology business. 3 November 2022
Biotechnology
Arcturus Therapeutics, a US messenger RNA (mRNA) company focused on the development of infectious disease vaccines, saw its shares rocket up nearly 24% to $22.63 yesterday on news of what could be an up to $4.5 billion deal relating to its technology. 3 November 2022
Pharmaceutical
Gianfranco Nazzi has stepped down effective November 2 from his role as chief executive of Spanish skincare specialist Almirall (ALM: MC) to pursue new professional opportunities. 3 November 2022
Biotechnology
Boston, USA-based pricing watchdog The Institute for Clinical and Economic Review (ICER) has published an evidence report on the comparative clinical effectiveness of hemophilia treatments. 2 November 2022
Biotechnology
The US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Vemlidy (tenofovir alafenamide) 25mg tablets as a once-daily treatment for chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated liver disease. 2 November 2022
Pharmaceutical
Shares of Danish diabetes care giant Novo Nordisk were up 6.4% at 852.60 kroner by mid-afternoon today, after it released financial results, showing that sales increased by 26% in Danish kroner and by 16% at constant exchange rates (CER) to 128.9 billion kroner ($17.12 billion) in the first nine months of 2022. 2 November 2022
Pharmaceutical
Third quarter 2022 revenues of £7.8 billion ($9 billion) for GSK represent a significant outperform by most analysts’ lights - the consensus ahead of results day was £7.3 billion, according to data from the FT. 2 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