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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.
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Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
Kronos Bio, a biotech with a presence on the east and west coasts of the USA, has unveiled a major restructuring plan. 28 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
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
Biotechnology
US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement. 26 November 2024
Biotechnology
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
Biotechnology
Replimune, a clinical-stage biotech focused on oncolytic immunotherapies, has announced plans to raise $125 million through a public offering. 26 November 2024
Biotechnology
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
Biotechnology
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
Biotechnology
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
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Biotechnology
In a flurry of novel coronavirus activity, the European Commission (EC) today concluded an agreement mooted in June with Anglo-Swedish pharma major AstraZeneca to supply up to 400 million doses of its AZD1222 COVID-19 vaccine. 14 August 2020
Biotechnology
The European Commission on Thursday concluded exploratory talks with Johnson & Johnson to purchase a potential vaccine against COVID-19. 14 August 2020
Biotechnology
Bristol Myers Squibb’s Opdivo (nivolumab) is set to become the market leader in gastric in gastro-oesophageal cancer following the latest data from two label expansion trials, which were noted to have met their primary endpoints. 14 August 2020
Biotechnology
US biotech Novavax and SK bioscience, a vaccine business subsidiary of SK Group, today announced a development and supply agreement for the antigen component of NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, for supply to global markets including the COVAX Facility. 13 August 2020
Biotechnology
Shares in Swedish biotech Isofol Medical looked set to close more than 30% higher on Thursday. 13 August 2020
Biotechnology
US biotech Seattle Genetics says that Australian regulatory authorities have approved marketing of Tukysa (tucatinib) in combination with trastuzumab and capecitabine. 13 August 2020
Biotechnology
Danish biotech success story Genmab was 3% higher as Thursday’s trading entered its final third. 13 August 2020
Biotechnology
Privately-held UK oncology company Celleron Therapeutics has paid for worldwide rights to Roche’s emactuzumab. 13 August 2020
Biotechnology
Swedish drugmaker Calliditas Therapeutics has reached an agreement to acquire a controlling interest in Genkyotex, a leader in NOX inhibition therapies, whose shares were up more than 30% at 2.86 euros by midday. 13 August 2020
Biotechnology
The US Food and Drug Administration has accepted for priority review a Biologics License Application (BLA) for evinacumab as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia (HoFH). 12 August 2020
Biotechnology
Privately-held Swiss CNS specialist Arvelle Therapeutics has been informed by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) that a Promising Innovative Medicine (PIM) designation has been issued for cenobamate for the treatment of drug-resistant focal-onset seizures in adults. 12 August 2020
Biotechnology
US mRNA company Moderna was trading more than 10% higher before markets opened on Wednesday. 12 August 2020
Biotechnology
Shares of US biotech Fulcrum Therapeutics crashed more than 48% to $8.90 by close of trading Tuesday, after it announced mixed results from a pre-specified interim analysis of the primary endpoint of the Phase II ReDUX4 trial in subjects with facioscapulohumeral muscular dystrophy (FSHD) treated with losmapimod. 12 August 2020
Biotechnology
The US Food and Drug Administration has awarded Orphan Drug designation (ODD) and Rare Pediatric Disease designation (RPDD) to the drug candidate BBDF-101 for Batten disease, a rare, fatal, genetic disorder of the nervous system for which there is no treatment, under development by French CNS specialist Theranexus. 12 August 2020
Biotechnology
Shares of Japanese drugmaker Eisai closed up 13.7% at 9.811 yen yesterday, after it announced top-line results from Study 211, a Phase II trial evaluating the efficacy and safety of Lenvima (lenvatinib). 12 August 2020
Biotechnology
The US Food and Drug Administration has accepted the Biologics License Application (BLA) and granted Priority Review designation for pegunigalsidase alfa for the proposed treatment of adult patients with Fabry disease, says Israel-based Protalix BioTherapeutics, whose shares closed up 7.4% at 1,309 shekels on the news. 11 August 2020
Biotechnology
Japan’s Daiichi Sankyo has entered into a clinical trial collaboration with UK-based AstraZeneca to evaluate the combination of patritumab deruxtecan (U3-1402), a HER3 directed DXd antibody drug conjugate (ADC), and AstraZeneca’s Tagrisso (osimertinib), 11 August 2020
Biotechnology
UK-based biotech Destiny Pharma has announced a positive interim safety review has been completed by an independent data monitoring committee (IDMC) of its Phase IIb study of its lead asset XF-73 in the prevention of post-surgical bacterial infections. 11 August 2020
Biotechnology
Ligand Pharmaceuticals has announced a deal to buy fellow Californian company Pfenex. 11 August 2020
Biotechnology
Seattle-based biotech Omeros Corporation has reported the results of a compassionate-use study evaluating narsoplimab in COVID-19 patients with acute respiratory distress syndrome (ARDS). 11 August 2020
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