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 report by the Courier Mail and other Australia media agencies on Saturday that an agreement has been struck to specifically secure supply, when a vaccine is available, for Queensland, is incorrect, says the country’s leading pharma company CSL Limited. 20 July 2020
Clinical-stage German biotech CureVac has signed a strategic collaboration with UK pharma major GlaxoSmithKline on mRNA vaccine and monoclonal antibody (MAb) research. 20 July 2020
US pharma major Bristol-Myers Squibb today announced that the European Medicines Agency has validated its Marketing Authorization Application (MAA) for lisocabtagene maraleucel (liso-cel). 17 July 2020
Eli Lilly today announced that its mirikizumab, an investigational monoclonal antibody that binds to the p19-subunit of interleukin (IL)23, met the primary and all key secondary endpoints versus placebo at Week 16 (superiority) and all key secondary endpoints versus Cosentyx (secukinumab) at Week 16 (non-inferiority) and Week 52 (superiority) in the OASIS-2 study. 17 July 2020
Nerlynx, (neratinib), a new breast cancer drug shown to significantly reduce the risk of cancer recurrence, is now approved for use in Malaysia. 17 July 2020
US biotech Tricida opened more than a third lower on Thursday after announcing a setback relating to veverimer, the company’s orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). 16 July 2020
UK novel RNA therapeutics firm Silence Therapeutics says Mallinckrodt has exercised the option, under the collaboration forged in July 2019, to obtain exclusive worldwide licenses for two additional complement-targeted RNAi assets from Silence. 16 July 2020
The Japan-based Sosei Group today announced the successful completion of an international offering of new shares and euro-yen denominated convertible bonds due 2025 that has raised a total of approximately $200 million. 16 July 2020
Guangzhou, China-based LintonPharm is launching a Phase III trial program for catumaxomab in peritoneal carcinomatosis, a form of advanced gastric cancer. 16 July 2020
The European Commission has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF). 16 July 2020
Nordic biotech Swedish Orphan Biovitrum today announced its financial results for the second quarter 2020, which failed to impress investors, sending its share down 7.7% to 196.20 Swedish kronor by mid-morning. 16 July 2020
USA-based biotech Glympse Bio has closed an oversubscribed $46.7 million Series B financing. The proceeds from the financing will support continued development of Glympse's novel biosensor platform in fibrotic diseases such as non-alcoholic steatohepatitis (NASH), oncology, and infectious diseases. 15 July 2020
A US Food and Drug Administration (FDA) advisory committee has voted in favor of the demonstrated benefit of treatment with belantamab mafodotin outweighing the risks for relapsed or refractory multiple myeloma patients, who have received at least four prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. 15 July 2020
Shares of US mRNA therapeutics and vaccines biotech Moderna were up more than 17% at $88 in pre-market trading this morning, after announcing the publication of an interim analysis of the open-label Phase I study of mRNA-1273, its vaccine candidate against COVID-19, in The New England Journal of Medicine. 15 July 2020
US clinical-stage biopharma company Scholar Rock today announced the appointment of Tony Kingsley as president and chief executive, effective August 1, 2020. 14 July 2020
Johnson & Johnson’s Janssen unit has announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for adult patients with active psoriatic arthritis (PsA). 14 July 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