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.
The first ever therapy for active and adult-onset Still’s disease (AOSD) has been approved in the USA, providing hope for people with the rare autoinflammatory condition. 17 June 2020
London-listed biotech firm PureTech Health’s founded entity, Akili Interactive, has gained US Food and Drug Administration clearance for EndeavorRx (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). 16 June 2020
US RNA (mRNA) therapeutics and vaccines specialist Moderna today announced that Ray Jordan has joined the firm as chief corporate affairs officer, effective Monday, June 15, 2020. 16 June 2020
Detailed data for bimekizumab show strong efficacy in psoriasis, raising the prospect that UCB’s dual IL-17 blocker could make a bigger splash in the market than had been expected. 16 June 2020
The US Food and Drug Administration (FDA) has approved Zepzelca (lurbinectedin) to treat metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. 16 June 2020
Having risen a percentage point rise in earlier trading, Japanese drugmaker Kyowa Kirin’s shares closed down almost 2% at 2,725 yen, despite announcing the roll-out of its rare blood cancer diseases drug Poteligeo (mogamulizumab) in Europe. 15 June 2020
UK drugmaker AstraZeneca has announced progress lining up manufacturing capacity in Europe for its investigational COVID-19 vaccine, AZD1222. 15 June 2020
Janssen has announced new long-term plaque psoriasis data for Tremfya (guselkumab), a first-in-class treatment showing consistent, high levels of skin clearance at week 100 and week 204 (four years) in adult patients with moderate to severe plaque psoriasis. 15 June 2020
UK health technology assessor the National Institute for Health and Care Excellence (NICE) has granted a positive final appraisal document (FAD) for the use of Rozlytrek (entrectinib) in adults with ROS1-positive non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 15 June 2020
The US Food and Drug Administration on Thursday approved Uplizna (inebilizumab-cdon) injection for intravenous use for the treatment of neuromyelitis optica spectrum disorder (NMOSD), also called Sjögren’s syndrome, in adult patients with a particular antibody (patients who are anti-aquaporin-4 or AQP4 antibody positive). 12 June 2020
New Jersey, USA-based Regeneron Pharmaceuticals has kicked off its first trial of REGN-COV2, an antibody combo for the prevention and treatment of COVID-19. 12 June 2020
New results from the NURTURE study show ongoing benefits for people with spinal muscular atrophy (SMA), when treated with Spinraza (nusinersen). 12 June 2020
The European Medicines Agency has validated the marketing authorization application (MAA) for tralokinumab, an investigational product for the treatment of adult patients with moderate-to-severe atopic dermatitis (AD) under development by privately-held Danish dermatology specialist LEO Pharma. 12 June 2020
A strategic licensing agreement has been reached between Stockholm’s Swedish Orphan Biovitrum and Massachusetts-based Selecta Biosciences. 12 June 2020
In its first full acquisition in the last couple of years, Danish diabetes care giant Novo Nordisk (NOV: N) today announced that it has entered into a definitive agreement to buy Corvidia Therapeutics, a privately held, clinical stage company focused on the research and development of transformative therapies for cardio-renal diseases. 11 June 2020
Following the rapid progress made by AstraZeneca, another COVID-19 vaccine candidate is advancing apace, with Moderna’s option mRNA-1273 due to enter Phase III testing next month. 11 June 2020
While there are re-purposed drugs in use for the treatment of COVID-19, the first that was designed specifically for the virus has just entered production. 11 June 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