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 National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD) recommending Stelara for ulcerative colitis. 28 April 2020
US drugmaker Vertex Pharmaceuticals and privately-held Affinia Therapeutics have entered into a strategic research collaboration to engineer adeno-associated virus (AAV) capsids for the delivery of gene therapies. 28 April 2020
New one-year data from FIREFISH Part 2, a pivotal global study evaluating risdiplam in infants aged 1 – 7 months old with symptomatic Type 1 spinal muscular atrophy (SMA) showed positive results, according to Swiss pharma giant Roche. 28 April 2020
Shares in Israeli company RedHill Biopharma were 13% higher at the mid-point of Monday’s trading based on an update on the compassionate use program with its investigational drug, Yeliva (opaganib), in six patients with confirmed SARS-CoV-2 infection. 27 April 2020
Partners Sanofi and Regeneron have announced that – following a review by the Independent Data Monitoring Committee (IDMC) – its research work on Kevzara (sarilumab) in COVID-19 will be scaled back. 27 April 2020
The primary endpoint of overall survival (OS) was met in a Phase III trial comparing the PD-1 inhibitor Libtayo (cemiplimab) to platinum doublet chemotherapy in patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) that tested positive for PD-L1 in ≥50% of tumor cells. 27 April 2020
Italy’s Italfarmaco Group has provided an update on the clinical development program of givinostat, its proprietary histone deacetylase inhibitor, in Duchenne muscular dystrophy (DMD). 27 April 2020
Osaka-based pharmaceutical firm Shionogi has announced a new project to develop a vaccine for COVID-19, sending shares in the company up over 3% on Monday. 27 April 2020
The latest positive results of the SAkuraStar Study (NCT02073279), a global Phase III clinical study of satralizumab (development code: SA237) have been published in The Lancet Neurology. 27 April 2020
Shares of Swiss biotech firm Santhera Pharmaceuticals were up 26.75% to 10.14 Swiss francs in early trading, after the company announced a COVID-19 related collaboration. 27 April 2020
Like many companies announcing projects targeting COVID-19, German immunotherapeutics specialist BioNTech experienced a share price fillip when it announced plans for a vaccine in March. 24 April 2020
French vaccines major Sanofi has won US Food and Drug Administration approval for a new quadrivalent meningococcal meningitis vaccine, MenQuadfi. 24 April 2020
Privately-held US firm ProThera Biologics and Japan’s largest drugmaker Takeda have entered into a global licensing agreement to develop a novel plasma-derived Inter-alpha Inhibitor Proteins (IAIP) therapy for the treatment of acute inflammatory conditions 23 April 2020
The China National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) of the precision therapy avapritinib for two indications. 23 April 2020
Nerlynx (neratinib), a new breast cancer drug shown to significantly reduce the risk of cancer recurrence, is now commercially available to Singapore patients. 23 April 2020
Canadian biotech Quest PharmaTech saw its shares tumble 15.4% to C$0.11 by close of trading on Wednesday, after the company revealed that its subsidiary, OncoQuest, was divesting assets. 23 April 2020
Biogen has reported revenue of $3.5 billion for the first quarter of 2020, up 1%, with income at $1.4 billion or $8.08 per share, up from $7.15 per share. 22 April 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