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
A ground-breaking oral treatment that could increase survival by 10 months has been given the green light for patients with incurable blood cancer in England and Wales. 18 January 2023
Pharmaceutical
In the USA, the National Institute of Allergy and Infectious Diseases (NIAID) has awarded $5.5 million to the Blumberg Institute to research treatments for yellow fever. 18 January 2023
Pharmaceutical
Cost-effectiveness body the Institute for Clinical and Economic Review (ICER) has published its second annual Barriers to Fair Access assessment of prescription drug coverage policies in the USA. 18 January 2023
Pharmaceutical
Sygnature Discovery, which claims to be the UK’s largest independent drug discovery expert and research partner, revealed that it has acquired Scotland-based SB Drug Discovery, a provider of ion channel and receptor drug discovery research delivering cell line generation and compound screening solutions in neuroscience and other therapeutic indications. 18 January 2023
Biotechnology
Phase III success for Moderna will help the company catch up with rivals GSK and Pfizer in the upcoming battle to treat respiratory syncytial virus (RSV) infections. 18 January 2023
Pharmaceutical
French pharma major Sanofi revealed late yesterday that the US Food and Drug Administration (FDA) has approved its Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) during the third trimester of pregnancy to help protect against pertussis, or whooping cough, in infants younger than two months of age. 18 January 2023
Biotechnology
Privately-held US cancer drug biotech Elicio Therapeutics has entered into a definitive merger agreement with Angion Biomedica under which Elicio will merge with a wholly-owned subsidiary of Angion in an all-stock transaction. 18 January 2023
Pharmaceutical
Ohio, USA-based 46brooklyn Research - a non-profit corporation that seeks to improve the accessibility and usability of US drug pricing data - has delivered its latest report on what Americans are paying for their medicines. 17 January 2023
Biotechnology
Spanish plasma-derived medicines specialist Grifols has announced that its plasma-protein based fibrin sealant (FS) for controlling surgical bleeding obtained positive top-line results from a Phase IIIb clinical trial in pediatric patients. 17 January 2023
Biotechnology
Cambridge, Massachusetts-based oncology specialist Leap Therapeutics has bought the privately-owned company Flame Biosciences. 17 January 2023
Biotechnology
Dianthus Therapeutics, a biotechnology company dedicated to advancing the next generation of antibody complement therapeutics, today announced the appointment of Susan Kalled, as chief scientific officer. 17 January 2023
Biotechnology
The European Parliament’s COVI committee has voted to ban officials from US pharma giant Pfizer from attending sessions. 17 January 2023
Biotechnology
CAR-T cell therapy specialist CARsgen Therapeutics has inked a deal with a division of Huadong Medicine for the commercialization of CT053 in China. 17 January 2023
Biotechnology
California, USA-based clinical-stage biopharmaceutical company 89bio’s pegazofermin has potential to become one of the major players in the dyslipidemia space if it is successful in Phase III clinical trials, says analyst. 17 January 2023
Biosimilars
Adding to European Commission clearance in November last year, German drugmaker STADA Arzneimittel and Sweden’s Xbrane Biopharma announced that their Ximluci (ranibizumab), a biosimilar referencing Lucentis, has been granted marketing authorization by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). 17 January 2023
Biotechnology
Rachel Abbott has been appointed chief scientific officer of Pan Cancer T, a biotech spin-off from the Erasmus University Medical Center, in the Netherlands. 17 January 2023
Pharmaceutical
In contrast to overall UK pharma industry claims of falling R&D in the country, the Cell and Gene Therapy Catapult (CGT Catapult) reports the opposite. 17 January 2023
Pharmaceutical
The trade group representing the UK pharmaceutical industry has published a report highlighting significant variation in access to innovative medicines in the country. 17 January 2023
Biotechnology
Following the controversial approval and dismal launch of their first Alzheimer’s drug, Aduhelm (aducanumab), expectations for Eisai and Biogen’s follow on treatment are mixed, given that their anti-amyloid beta (Aβ) monoclonal antibody (MAb), Leqembi (lecanemab) gained approval from the Food and Drug Administration (FDA) under the accelerated approval pathway for the treatment of Alzheimer’s disease (AD) in patients with early AD. 17 January 2023
Generics
India's interim free trade agreement with Australia is set to offer a significant relaxation of factory inspections, which could pave the way for many more commercial deals with developed countries, according to Pharmexcil, India's pharmaceutical export promotion council. 16 January 2023
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