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.
Gene therapy specialist Lokon Pharma has expanded a clinical collaboration with Swiss cancer giant Roche, involving the immuno-oncology candidate LOAd703. 28 August 2020
More than 1,200 therapeutics and vaccines have entered the research and development (R&D) pipeline since January 2020, and that number grows every week. 28 August 2020
LSNE Contract Manufacturing says that the Spanish Agency of Medicines and Medical Devices (AEMPS) has approved the manufacturing of clinical stage biotechnology based therapeutic products at its aseptic fill finish facility in León, Spain. 28 August 2020
UK pharma major GlaxoSmithKline today announced that the European Commission has granted conditional marketing authorization for Blenrep (belantamab mafodotin), meaning that the drug is the first B-cell maturation antigen (anti-BCMA) to be cleared for marketing on both sides of the Atlantic. 27 August 2020
The European Commission has granted conditional approval for Idefirix (imlifidase) in highly sensitized kidney transplants patients, says Lund, Sweden-based enzyme specialist Hansa Biopharma. 27 August 2020
Phase I data presented at a meeting of the CDC’s Advisory Committee on Immunization Practices show a positive response to Moderna’s COVID-19 vaccine. 27 August 2020
The impressive effectiveness of Carragelose (carrageenan), a sulfated polymer from red seaweed, against the new SARS-CoV-2 virus is confirmed by more and more studies, says Vienna, Austria-based Marinomed Biotech. 27 August 2020
The Los Angeles, USA-based Lundquist Institute at Harbor-UCLA Medical Center and UCLA Medical Center in Westwood will soon begin recruiting volunteers for Phase III trials of a new investigational COVID-19 vaccine with the first dose expected to be administered in early September. 26 August 2020
Japanese drugmaker Chugai Pharmaceuticals (TYO: 4519) today launched its in-house developed drug Enspryng (satralizumab) subcutaneous injection 120 mg syringe for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD) [including neuromyelitis optica: NMO] 26 August 2020
Trilaciclib’s new drug application (NDA) acceptance signals a significant moment for cancer patients that need support with chemotherapy-induced toxicities - further highlighted by the fact that the therapy has been granted Breakthrough Therapy designation by the US Food and Drug Administration. 26 August 2020
Acadia Pharmaceuticals yesterday said it has acquired fellow USA-based biotech CerSci Therapeutics, a clinical-stage biotechnology company with worldwide rights to a portfolio of novel compounds for neurological conditions, including non-opioid therapies for acute and chronic pain. 26 August 2020
Chicago’s AbbVie has submitted to the US regulator for approval to market Rinvoq (upadacitinib) for people with active ankylosing spondylitis (AS). 25 August 2020
Privately-held Engitix, a biotech developing programs in fibrosis and solid tumors using its proprietary human extracellular matrix (ECM) platform, has entered into a licensing and collaboration agreement with Japanese pharma major Takeda. 25 August 2020
With rates of COVID-19 infection continuing to climb worldwide, and a proven vaccine still at least months away, the value of therapeutic options under development is increasing. 25 August 2020
US oncology specialist Onconova saw its shares decimated after it announced that INSPIRE, the company’s pivotal Phase III study assessing the efficacy and safety of IV rigosertib in higher-risk myelodysplastic syndrome (HR-MDS) patients, did not meet its primary endpoint of improved survival. 25 August 2020
Vaccine research specialist Intravacc has partnered with Therapyx, a company based in Buffalo, New York, on development of the gonorrhea vaccine candidate NGoXIM. 25 August 2020
US biotech Moderna has concluded advanced exploratory talks with the European Commission (EC) to supply 80 million doses of mRNA-1273, its vaccine candidate against COVID-19. 24 August 2020
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
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
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
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
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
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
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
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
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
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Chinese gene therapy firm Kanglin Biotechnology has completed a $20 million series A financing round, with the money earmarked for KL003, an innovative treatment for blood disorders. 26 November 2024
BRL Medicine, a Shanghai-based biotechnology company specializing in cell and gene therapies, has raised nearly 200 million yuan ($27 million) in a series B+ round led by CSPC Fund. 26 November 2024
Italian oncology focused biotech Nerviano Medical Sciences yesterday announced that it has successfully negotiated with Germany’s Merck KGaA to buy back the full world-wide rights of NMS 293 (also known as NMS-03305293). 26 November 2024