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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
Privately-held biotech HemoShear Therapeutics has kicked off a new research collaboration and service agreement with Japan's largest drugmaker Takeda Pharmaceutical. 22 October 2020
Biotechnology
Danish biotech Genmab late Wednesday released positive top-line results from the second part of the Phase III CASSIOPEIA (MMY3006) study of cancer drug daratumumab monotherapy as maintenance treatment versus observation (no treatment) for patients with newly-diagnosed multiple myeloma eligible for autologous stem cell transplant (ASCT). 22 October 2020
Biotechnology
US pharma major Bristol Myers Squibb’s blockbuster combination of Opdivo (nivolumab) and Yervoy (ipilimumab) is facing increasing scrutiny in various oncology indications as to whether the financial burden and clinical toxicity added by Yervoy is worth it. 22 October 2020
Biotechnology
The Brazilian arm of AstraZeneca’s Phase III COVID-19 vaccine study will continue, notwithstanding the death of a participant, the country’s health authority Anvisa said on Wednesday. 22 October 2020
Biotechnology
Ireland-based biotech Prothena saw its shares close up 6.1% at $11.95, after it announced that, based on positive signals of efficacy consistent with disease modification in the PASADENA study, Swiss pharma giant Roche and Prothena plan to advance prasinezumab into a Phase IIb study in patients with early Parkinson’s disease. 22 October 2020
Biotechnology
Biogen saw its shares fall 2.36% to $260.82 by mid-morning after it presented financial results for the third quarter of 2020, showing that earnings missed analysts’ expectations. 21 October 2020
Biotechnology
Antibiotics accelerator CARB-X is awarding up to $3.9 million to privately-held Cellics Therapeutics to develop a new treatment for sepsis caused by drug-resistant Gram-positive and Gram-negative bacteria. 21 October 2020
Biotechnology
Evrysdi (risdiplam) has been approved in Brazil by the National Health Surveillance Agency (ANVISA) for the treatment of spinal muscular atrophy (SMA), the drug’s developer, PTC Therapeutics, said today. 21 October 2020
Biotechnology
Japanese drug major Chugai Pharmaceutical has entered into a license agreement with Denmark’s Novo Nordisk, for global non-exclusive rights related to its antibody engineering technologies. 21 October 2020
Biotechnology
As the healthcare industry continues to face financial strains brought on by the COVID-19 pandemic, the USA’s Medicaid programs need ways to reduce drug spend. 21 October 2020
Biotechnology
US clinical-stage Aptinyx biotech said yesterday that it intends to offer and sell 12,000,000 shares of its common stock in an underwritten public offering. 21 October 2020
Biotechnology
Australia’s CSL Limited is active in multiple therapeutic areas and across different scientific platforms, from immunology to respiratory and from plasma fractionation to egg-based vaccines. 20 October 2020
Biotechnology
Sacubitril-valsartan (trade name Entresto) has been proven to decrease hospitalization and reduce death due to heart failure with reduced ejection fraction (HFrEF) also known as systolic heart failure, according to a new study. 20 October 2020
Biotechnology
Privately-held US biopharma company Synspira Therapeutics today announced that the Cystic Fibrosis Foundation has made equity and structured investments in the company of up to $14 million in additional funding. 20 October 2020
Biotechnology
UK-based drugmaker AstraZeneca has been granted Priority Review for a bid to broaden the label for Tagrisso (osimertinib) in the USA. 20 October 2020
Biotechnology
Aptinyx has announced positive results from the first Phase II study of its novel NMDA receptor modulator, NYX-783, in 153 patients with post-traumatic stress disorder (PTSD). 20 October 2020
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released an Evidence Report assessing the comparative clinical effectiveness and value of BioMarin Pharmaceutical’s Roctavian (valoctocogene roxaparvovec) and Roche’s Hemlibra (emicizumab) for the treatment of hemophilia A. 20 October 2020
Biotechnology
ImmunoGen has announced an exclusive collaboration with Hangzhou Zhongmei Huadong Pharmaceutical to develop and commercialize mirvetuximab soravtansine in mainland China, Hong Kong, Macau, and Taiwan (Greater China). 20 October 2020
Biotechnology
Contract development and manufacturing organization (CDMO) Akron Biotechnology has inked a deal with London-listed firm Synairgen, for the provision of SNG001. 19 October 2020
Biotechnology
US cancer metabolism specialist Agios Pharmaceuticals late Friday announced the withdrawal of its European Marketing Authorization Application (MAA) for Tibsovo (ivosidenib tablets) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) mutation. 19 October 2020
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