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.
Germany’s Merck KGaA today announced a second Carlsbad, California, USA-based facility for its BioReliance viral and gene therapy service offering, with the company noting that the new 100 million-euro ($109 million) commercial facility is expected to open next year. 22 April 2020
Avacta has announced that, in only four weeks and well ahead of schedule, it has successfully generated multiple Affimer reagents that bind the SARS-COV-2 viral antigen. 22 April 2020
Cellphire says the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, has exercised its third contract option. 22 April 2020
Volatility in some markets due to the COVID-19 pandemic had limited impact on business performance in the first quarter of 2020, said Swiss pharma giant Roche, which this morning reported group sales of 15.14 billion Swiss francs ($15,67 billion), showing growth of 2% (7% at constant exchange rates). 22 April 2020
A new collaboration in immuno-oncology will see Kite, a subsidiary of California’s Gilead Sciences, join forces with Melbourne-based oNKo-innate. 22 April 2020
Myovant Sciences has submitted a New Drug Application (NDA) to the US Food and Drug Administration for once-daily, oral relugolix (120mg) for the treatment of men with advanced prostate cancer. 22 April 2020
The UK government has announced a £1.25 billion ($1.56 billion) support package for innovative businesses during the coronavirus outbreak. 21 April 2020
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics have announced positive top-line data from the Phase III KALM-2 study of Korsuva (CR845/difelikefalin). 21 April 2020
New data published today in Neurology, the medical journal of the American Academy of Neurology, build on existing clinical evidence that Mayzent (siponimod) has proven to slow physical disability progression and provide cognitive benefits in people living with secondary progressive multiple sclerosis (SPMS). 21 April 2020
Shares in Boston, USA-based Alexion Pharmaceuticals rose over 3% on Monday, after the firm announced plans for a Phase III study of Ultomiris (ravulizumab-cwvz) in COVID-19. 21 April 2020
Dutch drugmaker Pharming has described as “encouraging” results from a study of Ruconest (recombinant human C1 inhibitor) in five people with severe pneumonia and COVID-19. 21 April 2020
A UK High Court ruling has invalidated patents held by San Francisco-based FibroGen, clearing the way for Akebia Therapeutics to proceed with a new class of medicine to treat anemia. 20 April 2020
Oncology giant Bristol-Myers Squibb has unveiled positive Phase III data from the CheckMate-743 stuy of Opdivo (nivolumab) plus Yervoy (ipilimumab). 20 April 2020
The US Food and Drug Administration has accepted the supplemental Biologics License Application (sBLA) and the European Medicines Agency has validated the application for a two-hour Ocrevus (ocrelizumab) infusion time, dosed twice-yearly for relapsing or primary progressive multiple sclerosis (MS). 20 April 2020
Swiss biotech Idorsia has announced positive top-line results from the first Phase III study of its dual orexin receptor antagonist, daridorexant. 20 April 2020
US biotechnology firm Incyte’s shares advanced 4.5% to $100.00 by close of trading on Friday, as it revealed that the US Food and Drug Administration has approved Pemazyre (pemigatinib), ahead of the Prescription Drug User Fee Act (PDUFA) target date of May 30, 2020. 18 April 2020
US biotech Seattle Genetics closed up 2.6% at $136.87 on Friday after it revealed that the US regulator had granted approval for its new cancer drug, well ahead of the expected action date of August 20, 2020. 18 April 2020
A new partnership between Porto, Portugal-based FairJourney Biologics and Cambridge, UK-based Iontas will look for effective antibodies for COVID-19. 17 April 2020
Antibody specialist SAB Biotherapeutics has announced it has been awarded “expanded scope” by the US authorities in its program to develop a therapeutic for COVID-19. 17 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