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.
Contrary to conventional wisdom that says the coronavirus pandemic will generally benefit biopharmaceutical companies, a new Pioneer Institute study finds that many companies will emerge from the pandemic commercially weaker, dealing with delays in new product launches and with fewer resources to invest in research and development. 21 May 2020
An update on AstraZeneca’s COVID-19 vaccine candidate, AZD1222, reveals the firm has secured capacity to make one billion doses, with the first deliveries planned for as early as September 2020. 21 May 2020
US biotech Incyte closed up 3.6% at $98.32 yesterday, after announcing, along with partner German drugmaker MorphoSys, the European Marketing Authorization Application (MAA) for tafasitamab, an anti-CD19 antibody, had been validated. 21 May 2020
The European regulator has accepted a submission from Tokyo’s Astellas Pharma for roxadustat, for the treatment of anemia in adults with chronic kidney disease (CKD). 21 May 2020
Shares of USA-based Inovio Pharmaceuticals gained 22.8% in pre-market trading on Wednesday, and were still up 8.4% at $15.79 by close, after the company released encouraging early data on its coronavirus vaccine candidate. 21 May 2020
Ono Pharmaceutical has launched its Velexbru (tirabrutinib hydrochloride), a Bruton’s tyrosine kinase (BTK) inhibitor, for the treatment of recurrent or refractory primary central nervous system lymphoma in Japan. 21 May 2020
Neuromyelitis optica spectrum disorder (NMOSD) is a rare, but serious autoimmune disease, affecting the central nervous system (CNS). This article discusses current pharmaceutical treatments available for NMOSD and explores what is on the horizon for the management of this rare disease. 20 May 2020
Privately-held Galecto has added some boardroom experience in the shape of Amit Munshi, the chief executive of Arena Pharmaceuticals, and David Shapiro, the former chief medical officer of Intercept Pharmaceuticals. 20 May 2020
While the COVID-19 pandemic has impacted us all in ways that were impossible to predict just a few months ago, it seems that venture capitalists are ploughing away, with a heavy focus on the healthcare sector, as revealed in a report from Optimum Strategic Communications. 20 May 2020
Swiss oncology-focused drug discovery firm ADC Therapeutics yesterday said it has closed its initial public offering (IPO) of 14,082,475 shares of its common shares at a price of $19.00 per share, which included the exercise in full by the underwriters of their option to purchase 1,836,844 additional common shares. 20 May 2020
Genocea Biosciences has announced a material transfer agreement (MTA) and exclusive license option with Japan’s Shionogi to develop a novel Herpes simplex virus (HSV)-2 vaccine using Genocea’s proprietary HSV-2 antigens from the GEN-003 program, which the company discontinued in 2017. 20 May 2020
AveXis today announced the European Commission (EC) granted conditional approval for Zolgensma (onasemnogene abeparvovec) for the treatment of patients with 5q spinal muscular atrophy (SMA) with a bi-allelic mutation in the SMN1 gene and a clinical diagnosis of SMA Type 1; or for patients with 5q SMA with a bi-allelic mutation in the SMN1 gene and up to three copies of the SMN2 gene. 19 May 2020
Mezzion Pharma after-hours on Monday announced that analysis of data from its Phase III FUEL trial showed statistically-significant positive results for an important efficacy endpoint, the myocardial performance index, with the news sending the South Korean biotech firm’s shares up 2.4% to 180,300 won by close of trading today. 19 May 2020
Suzhou, China-based Innovent Biologics has agreed a major collaboration with The University of Texas MD Anderson Cancer Center to co-develop Tyvyt (sintilimab) in rare cancers in the USA. 19 May 2020
New York-based biotech firm Hoth Therapeutics has obtained exclusive worldwide licensing rights to the BioLexa Platform, an antimicrobial therapy focused on treating atopic dermatitis. 18 May 2020
Global contract development and manufacturing organization (CDMO) Vibalogics is to manufacture additional clinical trial material for Johnson & Johnson’s lead COVID-19 vaccine candidate. 18 May 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