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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Pharmaceutical
The US Food and Drug Administration (FDA) has determined that the supplementary New Drug Application (sNDA) for brexpiprazole for the use in the treatment of agitation associated with Alzheimer’s dementia (AAD) is sufficiently complete to permit a substantive review. 9 January 2023
Biotechnology
Among featured research news last week, US pharma giant Pfizer impressed when it released positive Phase III data on its hemophilia B gene therapy fidanacogene elaparvovec. Italian drugmaker Newron Pharmaceuticals last Monday released what it called “compelling” trial results for its antipsychotic candidate evenamide. Also, Deciphera Pharmaceuticals last Tuesday touted the benefits of its gastrointestinal stromal tumor (GIST) drug Qinlock. Kicking off the 2023 M&A season, US mRNA specialist Moderna last Wednesday announced its first ever full acquisition, that of Japanese firm OriCiro Genomics for $85 million. Fate Therapeutics has terminated its deal with Johnson & Johnson subsidiary Janssen to develop CAR-T cell therapies for cancer targets. 8 January 2023
Biotechnology
Having controversially approved the first new Alzheimer’s disease drug Aduhelm (aducanumab) in decades in 2021, dead on schedule, the US Food and Drug Administration on Friday announced its decision on a follow-on product. 7 January 2023
Biotechnology
US biotech bluebird bio on Friday announced that it has entered into a definitive agreement to sell its second Rare Pediatric Disease Priority Review Voucher (PRV). 7 January 2023
Biotechnology
BioRay Pharmaceutical's claim to be China’s leading autoimmune-focused biopharmaceutical firm looks substantially more robust after the company announced a $218 million strategic financing. 6 January 2023
Biotechnology
Nimble Therapeutics, a biotech spun out from Swiss pharma giant Roche in 2019, has expanded its collaboration and executed a license agreement with Genentech, a member of the Roche Group, for the discovery of peptide therapies for the treatment of diseases across multiple therapeutic areas. 6 January 2023
Biotechnology
Chinese contract research, development and manufacturing organization WuXi Biologics has announced a license agreement with UK pharma major GSK. 6 January 2023
Biotechnology
Armed with promising new data from the Phase III interim analysis, Japan’s largest drugmaker Takeda says it aims to seek marketing authorization for TAK-755 as the first recombinant ADAMTS13 (rADAMTS13) for a disorder with considerable unmet patient need. 6 January 2023
Biosimilars
Icelandic firm Alvotech and the US subsidiary of Israel’s Teva Pharmaceutical Industries today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Johnson & Johnson’s Stelara (ustekinumab). 6 January 2023
Biotechnology
Cellular immunotherapy specialist Fate Therapeutics was more than 50% down in Friday’s pre-market trading. 6 January 2023
Biotechnology
One of the pioneers of mRNA technologies, BioNTec, is investing the proceeds of its work during the pandemic on its original focus - cancer vaccines. 6 January 2023
Biotechnology
The US Food and Drug Administration (FDA) yesterday accepted Biologics License Applications (BLAs) from Swiss pharma giant Roche and Belgium’s UCB, and granted them accelerated review. 6 January 2023
Biotechnology
Adding to a deal with a US pharma giant last year, Cambridge, USA-based biotech Orna Therapeutics has now entered into a collaboration with Shanghai Xianbo Biotech, also known as Simnova outside of China, to discover, develop and commercialize multiple potential therapeutics in the area of oncology in China. 6 January 2023
Biotechnology
One of the world’s leading specialists in mRNA therapeutics has partnered with California’s CytomX Therapeutics to create novel cancer meds. 6 January 2023
Pharmaceutical
Professional services company PwC has released a new report, PwC’s Next In Pharma and Life Sciences 2023 Report. This highlights the outlook for the pharmaceutical and life sciences industry, and the biggest c-suite agenda topics that will shape 2023. 6 January 2023
Pharmaceutical
Mergers and acquisition (M&A) activity in India is heating up. The surge in transactions in the pharmaceutical industry saw 16 deals during 2022 - seemingly the largest number in a decade, worth several billion dollars in value. 6 January 2023
Biotechnology
US immunology specialist Acelyrin has acquired ValenzaBio, a privately-held company developing therapies for autoimmune and inflammatory diseases, in an all-stock transaction. 5 January 2023
Biotechnology
US precision medicines firm Frontier Medicines today announced the second and third programs under the company's global partnership with AbbVie have advanced into lead generation. 5 January 2023
Biotechnology
An eye-catching start to life has put Belharra Therapeutics firmly on the biotech map. 5 January 2023
Biotechnology
Privately held Danish biotechnology company MinervaX has appointed Lidia Oostvogels as chief medical officer, bringing a wealth of experience in vaccine development with more than 25 years’ experience in clinical development. 5 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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