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
Israel-based clinical-stage company Purple Biotech saw its shares edge up more than 4% to 53.10 shekels today, when it announced a research collaboration with Mor Research Applications (Mor), the technology transfer subsidiary of Clalit Healthcare Services (Clalit). 3 January 2023
Biosimilars
South Korea’s Samsung Bioepis says that Health Canada has approved its Hadlima (also known as SB5) - a citrate-free, high concentration (40mg/0.4 ML) formulation of biosimilar referencing AbbVie’s mega-blockbuster Humira (adalimumab). 3 January 2023
Biotechnology
USA-based Legend Biotech Corporation has announced that China’s National Medical Products Administration (NMPA) has formally accepted its New Drug Application (NDA) for ciltacabtagene autoleucel (cilta-cel). 3 January 2023
Biotechnology
A marketing authorization submission for talquetamab - an immunotherapy with the potential to shake up the multiple myeloma market - is now sat on regulators’ desks at the European Medicines Agency. 3 January 2023
Pharmaceutical
Sir Mike Rawlins, a UK pharmacologist who made a massive impact in the field of medicines reimbursement in his own country and internationally, has died at the age of 81. 3 January 2023
Biotechnology
Slightly earlier than expected, US pharma giant Pfizer last week announced positive top-line results from the Phase III BENEGENE-2 study evaluating fidanacogene elaparvovec, an investigational gene therapy, for the treatment of adult males with moderately severe to severe hemophilia B. 3 January 2023
Pharmaceutical
Italian central nervous system (CNS) specialist Newron Pharmaceuticals has announced what it describes as “very compelling” new results from its study 014, an exploratory trial of the small molecule evenamide. 3 January 2023
Pharmaceutical
Never has the importance of Flanders’ biopharmaceutical output to the international community been more obvious than it was during the COVID-19 crisis. 3 January 2023
Biotechnology
Swedish company Alligator Bioscience yesterday announced an expansion to its research collaboration and license agreement with Finland-based Orion Corporation, to discover and develop together new bispecific antibody cancer therapeutics. 3 January 2023
Generics
The supervisory board of German drugmaker STADA Arzneimittel has appointed Boris Döbler as group chief financial officer (CFO) with effect from January 1, 2023. 3 January 2023
Biotechnology
During the whole of 2022, merger and acquisition (M&A) activity in the pharma and biotech sector showed a slight improvement on 2021, when it fell to a decade low of just 92 deals, with a total number of 109 (See table below). 2 January 2023
Biotechnology
The Food and Drug Administration (FDA) has now approved TG Therapeutics’ Briumvi (ublituximab-xiiy), for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. 31 December 2022
Pharmaceutical
Hungarian drugmaker Gedeon Richter has signed a binding term sheet (BTS) with Belgian women’s health care company Mithra Pharmaceuticals for the commercialization of Donesta. 30 December 2022
Biotechnology
Faith in the transparency of the US regulatory process has been shaken, following an accusatory report from influential congressional committees into the approval of Aduhelm (aducanumab). 30 December 2022
Biotechnology
The Indian pharma market is increasing at an annual growth rate of 15%, twice the world market growth rate, and has become one of the most expansive sectors in India. While the pharma industry is expected to grow to $130 billion by 2030, there are deep seated challenges posed at this industry when it comes to rare disease management. 30 December 2022
Biotechnology
Indian drugmaker Cipla Limited , via its UK subsidiary, has signed definitive agreements for an equity investment of 15 million euros ($16 million) in German biotech Ethris GmbH. 30 December 2022
Generics
A growing number of key starting materials (KSMs) and active pharmaceutical ingredients (APIs) coming into India have become 25% to 35% more expensive as reports of Covid infections spiral out of control in China, squeezing margins and increasing drug prices. The Indian government's production linked incentive (PLI) scheme for the promotion of domestic manufacturing of critical KSMs, drug intermediates (DIs) and APIs is soon set to come to the aid of many domestic players, reports The Pharma Letter’s India correspondent. 29 December 2022
Biotechnology
Paris, France-based neurodegenerative disease specialist Pharnext has attracted a strategic investment from fellow French firm Néovacs. 29 December 2022
Biotechnology
US retinal diseases focussed start-up Opus Genetics has acquired the rights to two pre-clinical-stage AAV-based gene therapy product candidates for inherited retinal diseases (IRDs) from Iveric Bio. 29 December 2022
Pharmaceutical
Britain’s national healthcare provider, the NHS, says the UK is on track to eliminate hepatitis C by 2025, following a “concerted effort to find people at risk.” 28 December 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