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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
Gilead Sciences on Sunday announced that it has entered into a definitive agreement to acquire antibody-drug conjugate (ADC) specialist Immunomedics. 14 September 2020
Biotechnology
In a statement issued on Saturday, US pharma giant Pfizer and German partner BioNTech announced they have submitted an amended protocol to the US Food and Drug Administration to expand the enrollment of their Phase III pivotal COVID-19 vaccine, dubbed BNT162, trial to up to around 44,000 participants which also allows for the enrollment of new populations. 14 September 2020
Biotechnology
Swiss pharma giant Novartis on Friday presented new data on two of its already marketed multiple sclerosis (MS) drugs, Kesimpta (ofatumumab), and blockbuster hopeful Mayzent (siponimod) at MSVirtual2020: 8th Joint ACTRIMS-ECTRIMS Meeting. 12 September 2020
Biotechnology
Chugai Pharmaceuticals yesterday announced the presentation of new Enspryng (satralizumab [genetical recombination]) data on reducing relapse severity in the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare disease of the central nervous system. 11 September 2020
Biotechnology
Two-year follow-up data for the CD20-positive B cell-targeting biologic Ocrevus (ocrelizumab) could help Roche fend off new competition. 11 September 2020
Biotechnology
Vertex Pharmaceuticals has announced the completion of a global Phase III study of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children ages six through 11 years old with cystic fibrosis (CF) who have either two copies of the F508del mutation or one copy of the F508del mutation and one minimal function mutation. 11 September 2020
Biotechnology
US healthcare giant Johnson & Johnson subsidiary Janssen Biotech today said it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration seeking approval of Darzalex Faspro (daratumumab and hyaluronidase-fihj), a subcutaneous formulation of daratumumab, for the treatment of patients with light chain (AL) amyloidosis, a rare and potentially fatal disease for which there are no currently approved therapies. 10 September 2020
Biotechnology
Boston, USA-based Albireo Pharma has released positive top-line results from the Phase III PEDFIC 1 trial of odevixibat. 10 September 2020
Biotechnology
New Jersey, USA-based Merck & Co has announced that two Phase III studies of V114 met their primary immunogenicity objectives. 10 September 2020
Biotechnology
High-level results from the OSTRO Phase III trial showed that Anglo-Swedish pharma major AstraZeneca’s marketed asthma drug Fasenra (benralizumab) compared with placebo demonstrated a statistically-significant improvement in the size of nasal polyps and in nasal blockage in patients with chronic rhinosinusitis with nasal polyps (CRSwNP). 10 September 2020
Biotechnology
In a Securities Exchange Commission filing yesterday, California-based biotech BioMarin Pharmaceutical revealed it has received the European Medicines Agency's Joint Assessment Report related to the EMA’s ongoing review of the company’s Marketing Authorization Application for ValRox (valoctocogene roxaparvovec) for severe hemophilia A. 10 September 2020
Biotechnology
Full results from the Phase III ARAMIS trial of Nubeqa (darolutamide) have been published in The New England Journal of Medicine. 10 September 2020
Biotechnology
French biotech Valneva, a leading pure play vaccine company, has signed a new contract, lasting up to three years, with the US government Department of Defense (DoD) for the supply of its Japanese encephalitis (JE) vaccine, Ixiaro. 10 September 2020
Biotechnology
Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind. Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients—but many patients still need other therapeutic options. 10 September 2020
Biotechnology
Germany’s Bayer and USA-based Recursion Pharmaceuticals, a digital biology company industrializing drug discovery, have entered into a strategic collaboration. 9 September 2020
Biotechnology
HRA Pharma Rare Diseases has presented positive data from the first ever prospective study designed to confirm the efficacy and safety of metyrapone in people with endogenous Cushing’s syndrome. 9 September 2020
Biotechnology
New York-based Pfizer and German firm BioNTech have agreed with European authorities to supply up to 200 million doses of their investigational COVID-19 vaccine BNT162. 9 September 2020
Biotechnology
Redx Pharma has signed a new research collaboration agreement with Jazz Pharmaceuticals to discover and develop drug candidates for two cancer targets on the Ras/Raf/MAP kinase (MAPK) pathway. 9 September 2020
Biotechnology
Shares in London-based Amryt Pharma were up around 50% in morning trading on Tuesday, following positive top-line results from a Phase III study of Filsuvez (oleogel-S10), a topical therapeutic gel. 9 September 2020
Biotechnology
Shares in US biotech Corbus Pharmaceuticals (Nasdaq: CRBP) plummeted nearly 76% to $2.23 by close of trading on Monday, after the US drugmaker said that top-line data showed no significant differences in the primary and secondary endpoints when comparing its lead candidate lenabasum to placebo, both added to background drug therapy. 9 September 2020
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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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