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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
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
Biotechnology
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
Biotechnology
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
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Biotechnology
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
Biotechnology
The gastric and gastroesophageal adenocarcinoma (G/GEJAC) market will grow from $1.6 billion in 2019 to $3.9 billion in 2029 across the eight major markets at a moderate compound annual growth rate (CAGR) of 9.3, says GlobalData. 4 November 2020
Biotechnology
Brazil’s public research institution Fundação Oswaldo Cruz (Fiocruz) has published online the terms of its agreement with UK pharma major AstraZeneca for the production of a potential future COVID-19 vaccine, signed on September 9, 2020. 4 November 2020
Biotechnology
Positive Phase III data will help boost the position of India’s leading drugmaker Sun Pharmaceutical Industries in moderate-to-severe plaque psoriasis. 4 November 2020
Biotechnology
Whether most Americans remember November 3, 2020 with fondness depends on the result of the Presidential election, but Bristol Myers Squibb executives and shareholders will definitely have a happy memory where another outcome is concerned. 3 November 2020
Biotechnology
Given that the task of tackling the coronavirus pandemic is arguably the biggest – and certainly the highest profile – challenge that the pharmaceutical industry has faced this century, it is appropriate that the world’s largest pharma company is among the leaders of the race to find a vaccine. 3 November 2020
Biotechnology
CEPI, the Coalition for Epidemic Preparedness Innovations, today announced that it will fund the development of the protein-based S-Trimer COVID-19 vaccine candidate by China’s Clover Biopharmaceuticals, through a global pivotal Phase II/III efficacy clinical trial and to licensure in China and globally, if the vaccine is proven to be safe and effective. 3 November 2020
Biotechnology
Despite the high unmet needs within hepatocellular carcinoma (HCC), the market was stagnant from 2007 until 2018, when the FDA approved Eisai’s Lenvima (lenvatinib) in first-line advanced HCC, the most common form of liver cancer. 3 November 2020
Biotechnology
An analysis published in the journal Alzheimer's & Dementia, authored by David Knopman, David Jones and Michael Greicius, has stated that a further Phase III trial of the investigational Alzheimer’s drug aducanumab has failed to demonstrate efficacy and should undergo a further Phase III study. 3 November 2020
Biotechnology
The Food and Drug Administration has accepted for priority review the supplemental Biologics License Application (sBLA) for PD-1 inhibitor Libtayo (cemiplimab-rwlc) to treat patients with first-line locally advanced or metastatic non-small cell lung cancer (NSCLC) with ≥50% PD-L1 expression. 3 November 2020
Biotechnology
A submission for European marketing authorization for filgotinib in ulcerative colitis (UC) has been validated, and will be reviewed by the European Medicines Agency. 3 November 2020
Biotechnology
Canadian company Fusion Pharmaceuticals has announced a collaboration with Anglo-Swedish pharma major AstraZeneca (LSE: AZN) to develop and commercialize next-generation alpha-emitting radiopharmaceuticals and combination therapies for the treatment of cancer. 2 November 2020
Biotechnology
Aditum Bio, the biotech investment firm co-founded in 2019 by former Novartis chief executive Joe Jimenez and former president of the Novartis Institutes for BioMedical Research (NIBR) Dr Mark Fishman, today announced the formation of Tempero Bio. 2 November 2020
Biotechnology
Japanese drugmaker Shionogi has announced that BPN14770, a drug candidate for the treatment of brain disorders associated with cognitive and memory deficits, has shown positive top-line results from Phase III exploratory study in adult patients with Fragile X syndrome (FXS). 2 November 2020
Biotechnology
Novartis’ shares edged up 1% to 72.21 Swiss francs by late-morning, after the Swiss pharma giant announced that HER-MES, the first Phase IV, randomized, double-blind, double-dummy, head-to-head study of Aimovig (erenumab) against topiramate, an anticonvulsant, in patients with episodic and chronic migraine met its primary and secondary endpoints. 2 November 2020
Biotechnology
Swiss cancer giant Roche has picked up European approval for a combination therapy of Tecentriq (atezolizumab) plus Avastin (bevacizumab), in liver cancer. 2 November 2020
Biotechnology
Shares of Netherlands-based biotech Kiadis Pharma skyrocketed 238% to 4.95 euros in early trading this morning, after it revealed a definitive agreement to be acquired by French pharma major Sanofi. 2 November 2020
Biotechnology
Trials of a leading antibody cocktail for COVID-19 have been suspended due to safety concerns, with parts of the study continuing in people with less severe cases of the disease. 2 November 2020
Biotechnology
The European Investment Bank (EIB), backed by the European Fund for Strategic Investments (EFSI), will provide 25 million euros ($29 million) of financing to Minoryx Therapeutics, a Spanish biotech company specializing in the advancement of treatments for rare central nervous system disorders. 1 November 2020
Biotechnology
BioCryst Pharmaceuticals revealed on Friday that the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has granted oral, once-daily berotralstat a positive scientific opinion through the Early Access to Medicines Scheme (EAMS). 31 October 2020
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