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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Generics
The existing interruptions in the supply of active pharmaceutical ingredients (APIs) to Russia and lack of their production within the country currently remains one of the major reasons for a shortage of various drugs in the local market, reports The Pharma Letter’s local correspondent. 31 January 2023
Biotechnology
An analysis of the recent progress in RNA therapeutics and future opportunities. 31 January 2023
Biotechnology
A rosy future is predicted for Sino-American biotech BeiGene oral Bruton tyrosine kinase inhibitor (BTKi) Brukinsa (zanubrutinib), which recently gained US Food and Drug Administration (FDA) approval for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (SLL). 31 January 2023
Pharmaceutical
Today (January 31) marks the start of the mandatory application of the Clinical Trials Regulation for all new clinical trials. It is a significant milestone in the transformation of the oversight and management of clinical trials in the European Union. 31 January 2023
Pharmaceutical
The Belgian pharmaceutical industry has raised concerns around pressures being applied to the national healthcare budget for innovative medicines. 30 January 2023
Biotechnology
Oxford University spin-out Vaccitech (Nasdaq: VACC today announced the appointment of Nadège Pelletier as chief scientific officer (CSO), to replace Tom Evans, who is retiring but will remain involved as a scientific consultant to the company. 30 January 2023
Pharmaceutical
Analysis from financial services company PwC shows optimism for the year ahead in pharmaceutical M&A in the UK market. 30 January 2023
Pharmaceutical
Pharmaceutical production in Russia in 2022 grew by more than 15% compared to 2021, while the industry continues to increase its technological independence, according to recent statements, by Russia’s Deputy Prime Minister Denis Manturov – a state official personally responsible for the development of pharmaceutical sector in the Russian government, reports The Pharma Letter’s local correspondent. 30 January 2023
Biotechnology
The market for acute lymphocytic leukemia (ALL), the most commonly diagnosed form of leukemia, is expected to see strong growth at a compound annual growth rate (CAGR) of 5% over the next decade across the world’s eight major markets (8MM). 30 January 2023
Pharmaceutical
US Senator Elizabeth Warren (Democrat, Massachusetts) has urged the Federal Trade Commission to look closely at two pending pharmaceutical mergers, insisting that the deals could lead to higher drug prices and prevent "affordable alternatives from entering the market." 30 January 2023
Biotechnology
Preliminary results from the ongoing global Phase III STAND study in sickle cell disease are not what Novartis had hoped. 30 January 2023
Biotechnology
Positive results from the Phase III CARTITUDE-4 study show the novel BCMA-directed T-cell therapy Carvykti (ciltacabtagene autoleucel) performed well in the treatment of multiple myeloma. 30 January 2023
Generics
The US industry has said that India should come out with a research and development (R&D) policy for its pharmaceutical sector. 30 January 2023
Pharmaceutical
The world’s leading biopharma companies experienced growth in market capitalization of 5.4% on average last year, according to industry analyst GlobalData. 30 January 2023
Biotechnology
Adding yet another indication for Sanofi (Euronext: SAN) and Regeneron’s (Nasdaq: REGN) blockbuster interleukin (IL)-13 and IL-4 blocking antibody Dupixent (dupilumab), the European Commission (EC) has expanded the marketing authorization to treat eosinophilic esophagitis (EoE). 30 January 2023
Pharmaceutical
Privately-held Italian drugmaker Chiesi Farmaceutici today announced the appointment of Giuseppe Accogli as company’ new chief executive (CEO). 30 January 2023
Pharmaceutical
Israel-based dermatology focussed biotech Sol-Gel Technologies says it has acquired rights to the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome from US drug developer PellePharm. 30 January 2023
Biotechnology
Patients with myelofibrosis had clinically significant improvement in disease-related symptoms, including anemia and spleen enlargement, when treated with the targeted therapy momelotinib, according to results from the international Phase III MOMENTUM trial led by researchers at University of Texas MD Anderson Cancer Center. 30 January 2023
Biotechnology
Last Monday Japanese pharma giant Takeda announced a licensing deal with China’s Hutchmed for rights to the latter’s colorectal cancer drug Elunate (fruquintinib). On the research front, US pharma giant Merck & Co released new clinical data for its mega-blockbuster cancer drug Keytruda in two therapy settings – one positive and one missing its endpoint. Also, Ocuphire released top-line Phase II data on its diabetic retinopathy candidate APX3330 that failed to meet the primary endpoint of the study. There was also positive news for Merck &Co, with the US Food and Drug Administration granting a new indication for Keytruda as adjuvant treatment in lung cancer. 29 January 2023
Pharmaceutical
The US Food and Drug Administration (FDA) has granted accelerated approval to Jaypirca (pirtobrutinib) for relapsed or refractory mantle cell lymphoma (MCL) - a rare blood disorder - after at least two lines of systemic therapy, including a BTK inhibitor. 28 January 2023
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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