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.
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
South African-Australian private equity firm LeapFrog Investments has announced the close of its fourth fund (Fund IV), with commitments and designated co-investments totalling $1.02 billion. 26 November 2024
Pyxis Oncology has announced encouraging preliminary data from a Phase I trial of PYX-201, its lead antibody-drug conjugate (ADC), in solid tumors. 26 November 2024
USA-based Locus Biosciences, a biotech developing CRISPR-enhanced precision antibacterial products, has announced a $12.5 billion partnership with Combatting Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) that takes its total investment pledges since the start of 2019 close to $1 billion. 10 November 2020
Stepping up the fight against the novel coronavirus, a new therapy to treat mild-to-moderate cases of COVID-19 has been approved by the US regulator, through an emergency use authorization (EUA). 10 November 2020
Hot on the heels of positive interim data for Pfizer and BioNTech’s candidate, another coronavirus vaccine program appears to be moving forward apace. 10 November 2020
US biotech Biogen gained 44% on Wednesday of last week when the US Food and Drug Administration (FDA) posted encouraging briefing documents on the company’s aducanumab filing for members of the Peripheral and Central Nervous System (PCNS) Drugs Advisory Committee Meeting. 9 November 2020
Swedish biotech Calliditas Therapeutics has announced positive top-line results from Part A of the global Phase III trial NefIgArd, which investigated the effect of Nefecon (budesonide) versus placebo in patients with primary IgA nephropathy (IgAN). 9 November 2020
Germany’s Merck KGaA has out-licensed its investigational therapy atacicept to San Francisco’s Vera Therapeutics, in return for a 10% equity stake in the firm. 9 November 2020
Monday will likely feel brighter than it has done for many months for much of the world’s population amid the news that US pharma giant Pfizer and German company BioNTech have achieved success with their COVID-19 vaccine in a Phase III trial. 9 November 2020
The Institute for Clinical and Economic Review (ICER) has weighed up the comparative clinical effectiveness and value of two drugs in development for non-muscle invasive bladder cancer (NMIBC) that is unresponsive to Bacillus Calmette-Guerin (BCG) intravesical therapy. 6 November 2020
Swiss pharma giant Novartis has released disappointing data from an interim analysis of its CAN-COVID trial, testing the IL-1 blocker canakinumab in COVID-19. 6 November 2020
Some six months on from its last acquisition, US pharma giant Merck & Co has announced that it is to acquire VelosBio for $2.75 billion. 5 November 2020
US biotech Regeneron Pharmaceuticals exceeded analysts’ estimates on both revenue and earnings with its third-quarter financial results. 5 November 2020
A couple of days after Bristol-Myers Squibb presented market-pleasing data on its immune-mediated diseases pipeline asset deucravacitinib, the US drugmaker has kept the good news coming with an encouraging set of quarterly financial results. 5 November 2020
US biotech bluebird bio looked set to open Thursday’s trading almost 14% lower after announcing an update on its US filing of LentiGlobin for sickle cell disease (bb1111). 5 November 2020
Regular pharma market observers distracted by the US elections had cause to suddenly look back towards the industry on Wednesday morning. 4 November 2020
US biotech firm Novavax, which is developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-binding ‘heads of terms’ document with the Australian government to supply 40 million doses of the company’s COVID-19 vaccine candidate, NVX-CoV2373, for the Australian community. 4 November 2020
Californian cytokine storm syndrome specialist Humanigen has executed its first licensing deal in the Asia-Pacific Region, with Telcon RF Pharmaceutical and KPM Tech. 4 November 2020