Latest Pharma and Biotech News
Pharmaceutical
9 January 2025 Intelligence provider Clarivate has released the 12th annual Drugs to Watch report, a guide to the therapies poised to redefine the future of healthcare.
Today's issue
Refine Search
Pharmaceutical
Among significant news last week, the US Food and Drug Administration (FDA) required Agios Pharmaceuticals to amend the label for its hemolytic anemia drug Pyrukynd to reflect the risk of liver injury. Swiss ophthalmic drugs developer Oculis Holdings released positive Phase II results for its OCS-05. US drug developer Climb Bio entered into a licensing deal with China-based Mabworks Biotech on the latter’s monoclonal antibody CLYM116/MIL116. Also of note, US CRISPR gene editing company Intellia Therapeutics announced strategic plans which included cuts in programs and workforce. 12 January 2025
Biotechnology
Sage Therapeutics’ shares jumped over 45% to $8.09 in after-hours on Friday, after the company confirmed that biotech major Biogen has made a nonbinding proposal to acquire all of the outstanding shares of Sage not already owned by Biogen for $7.22 per share. 11 January 2025
Biosimilars
South Korean biosimilars developer Samsung Bioepis and Israel’s Teva Pharmaceutical Industries have entered into a license, development and commercialization agreement for Epysqli (eculizumab-aagh), Samsung Bioepis’ copy of Soliris (eculizumab-aagh), in the USA. 11 January 2025
Pharmaceutical
Artbio, a radiopharmaceutical company developing a new class of targeted alpha radioligand therapies (ARTs), has named Margaret Yu its chief medical officer (CMO). 10 January 2025
Biotechnology
US biopharma Vertex Pharmaceuticals has entered an exclusive collaboration and license agreement with China’s Zai Lab for the development and commercialization of Vertex’s povetacicept (pove) in mainland China, Hong Kong SAR, Macau SAR, Taiwan region and Singapore (the licensed territory). 10 January 2025
Biotechnology
US pharma giant Pfizer today announced positive top-line results from its pivotal Phase III CREST trial evaluating sasanlimab, an investigational anti-PD-1 monoclonal antibody (MAb), in combination with Bacillus Calmette-Guérin (BCG). 10 January 2025
Pharmaceutical
Chinese metabolic diseases specialist Hangzhou Sciwind Biosciences has announced details of a deal with Verdiva Bio for the global development and commercialization of a portfolio of therapies in territories outside of China and South Korea. 10 January 2025
Pharmaceutical
USA-based Light Horse Therapeutics has been established as a new small molecule therapeutics developer, with a $62 million Series A financing led by founding investor Versant Ventures and partnered with Novartis to identify and develop potentially advanced therapeutics. 10 January 2025
Biotechnology
Maryland, USA-based Veralox Therapeutics has picked up an option to acquire Nudge Therapeutics, along with its portfolio of preclinical cGAS inhibitor compounds. 10 January 2025
Biotechnology
German biotech CatalYm has appointed Scott Clarke as chief executive (CEO), noting that he brings over two decades of executive leadership experience in driving company growth, developing products, and shaping and executing transactions in the biopharmaceutical industry. 10 January 2025
Biotechnology
USA-based biotech builder Mountainfield Venture Partners and China’s Keymed Biosciences (HKEX: 02162) have joined forces to launch Timberlyne Therapeutics. 10 January 2025
Biotechnology
Intellia Therapeutics, a US gene editing company developing CRISPR-based therapies, announced late Thursday its strategic priorities and key anticipated 2025 milestones. 10 January 2025
Pharmaceutical
The glaucoma market across the seven major markets is forecast to increase at a compound annual growth rate (CAGR) of 2.1% from $2.1 billion in 2023 to $2.5 billion in 2033. 10 January 2025
Biosimilars
The US Food and Drug Administration approved 50 novel drugs in 2024, continuing to outpace its global regulatory peers. 10 January 2025
Biotechnology
European biotech start-ups Numab Therapeutics and AnaCardio have raised new funding to advance their pipelines, adding positive momentum to the sector at the start of the new year. 10 January 2025
Biotechnology
USA-based Climb Bio said yesterday it has entered into an exclusive license agreement with Beijing Mabworks Biotech for rights to develop and commercialize MIL116 (now CLYM116), an anti-APRIL (A PRoliferation-Inducing Ligand) monoclonal antibody, in the territory outside of Greater China. 10 January 2025
Biotechnology
Belgian biopharmaceutical company UCB has entered into a license agreement with Ailux Biologics, the biologics discovery division of XtalPi, to leverage its AI platform. 9 January 2025
Biotechnology
Spanish firm Grifols has submitted a Biologics License Application (BLA) for its new potential fibrinogen treatment to the US Food and Drug Administration (FDA). 9 January 2025
Biotechnology
German family-owned pharma major Boehringer Ingelheim has licensed antibody-drug conjugates ADC technology from Netherlands-based Synaffix, a Lonza company. 9 January 2025
Biotechnology
Shares in French food allergy biotech DBV Technologies looked set to close more than 10% higher on Thursday. 9 January 2025
All news
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 28 November 2024
Biotechnology
Johnson & Johnson has made significant strides in multiple myeloma treatment, with breakthroughs in targeted therapies like CAR-T and bispecific antibodies. At the 2024 ASH meeting, J&J aims to showcase progress, with a goal of achieving a functional cure for multiple myeloma. 28 November 2024
Biotechnology
The European medicines regulator has approved a combo therapy starring PD-1 inhibitor Tevimbra (tislelizumab), from cancer firm 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
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