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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 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
Biotechnology
The Phase III SKYSCRAPER-01 trial has missed its primary endpoint, Swiss cancer giant Roche has reported. 26 November 2024
Biotechnology
US biopharma Biohaven has provided an update regarding the taldefgrobep alfa development programs in spinal muscular atrophy (SMA) and obesity. 25 November 2024
Biotechnology
Cassava Sciences, a US biotech developing a novel, investigational treatment for Alzheimer’s disease (AD) dementia, was trading 83% lower at midday on Thursday. 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Biotechnology
Danish biotech Adcendo today announced the successful closing of an oversubscribed $135 million Series B financing round. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
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Biotechnology
Slow progress in preparing regulatory submissions will see US vaccines developer Novavax send its COVID-19 vaccine, NVX-CoV2373, for approval in the third quarter at the earliest. 11 May 2021
Biotechnology
Life sciences investment group Abingworth has announced the final closing of its new Clinical Co-Development Fund at $582 million. 10 May 2021
Biotechnology
Eli Lilly has inked royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of generic medicines, Cipla, Lupin and Sun Pharmaceutical Industries, to expedite availability of its arthritis drug baricitinib for the treatment of COVID-19 patients in India. 10 May 2021
Biotechnology
Mainz, Germany-based BioNTech has announced plans to expand its global footprint to Asia with the establishment of a new regional headquarters in Singapore. 10 May 2021
Biotechnology
Chugai Pharmaceutical has reached agreement with the Japanese government regarding the antibody cocktail casirivimab and imdevimab (formerly known as REGN-COV2), which is being investigated as a potential treatment for COVID-19. 10 May 2021
Biotechnology
An evenly split vote from the US regulator’s scientific panel sent shares in California’s ChemoCentryx into free fall on Friday. 10 May 2021
Biotechnology
Belgium-based biotech Galapagos has announced operational highlights and plans for refocussing of its clinical pipeline, along with its first-quarter 2021 financial results. 10 May 2021
Biotechnology
The PARP inhibitor pamiparib has received conditional approval from the China National Medical Products Administration (NMPA) for the treatment of patients with germline BRC (gBRCA) mutation-associated recurrent advanced ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more lines of chemotherapy. 8 May 2021
Biotechnology
AstraZeneca’s Tagrisso (osimertinib) is the beneficiary of the UK’s Medicines and Healthcare products Regulatory Agency’s (MHRA) first authorization under Project Orbis, a global program designed to deliver faster patient access to innovative cancer drugs. 7 May 2021
Biotechnology
US pharma giant Pfizer and German partner BioNTech have announced the initiation of a Biologics License Application (BLA) with the US Food and Drug Administration for approval of their mRNA vaccine to prevent COVID-19 – called Comirnaty or BNT162b2 - in individuals 16 years of age and older. 7 May 2021
Biotechnology
Minutes from the May meeting of the European Medicines Agency’s safety committee show the panel has reaffirmed the positive benefit-risk ratio of approved coronavirus vaccines. 7 May 2021
Biotechnology
The European Medicines Agency (EMA) has started a rolling review of data on sotrovimab (previously VIR-7831), an investigational dual-action SARS-CoV-2 monoclonal antibody, for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with coronavirus disease 2019 (COVID-19) who do not require oxygen supplementation and who are at risk of progressing to severe COVID-19. 7 May 2021
Biotechnology
An estimate-beating first quarter performance lifted shares in New York’s Regeneron Pharmaceuticals over 3% on Thursday, with revenues up 38% at $2.5 billion. 7 May 2021
Biotechnology
Swiss–American biotechnology CRISPR Therapeutics and Nkarta, a biopharmaceutical company developing engineered NK cell therapies to treat cancer, have entered a strategic partnership to research, develop, and commercialize CRISPR/Cas9 gene-edited cell therapies for cancer. 7 May 2021
Biotechnology
Positive high-level results from the final analysis of the Phase III POSEIDON study showed the combination of Imfinzi (durvalumab), tremelimumab and chemotherapy demonstrated a statistically-significant and clinically-meaningful overall survival (OS) benefit versus chemotherapy alone, in the first-line treatment of patients with Stage IV (metastatic) non-small cell lung cancer (NSCLC). 7 May 2021
Biotechnology
A 23,650% first quarter revenue increase makes clear the level of fiscal impact a successful coronavirus vaccine can have. 6 May 2021
Biotechnology
Newly-established Swiss biotech MoonLake Immunotherapeutics today announced that full results of a Phase IIb study of its tri-specific nanobody sonelokimab have been published in the prestigious journal The Lancet. 6 May 2021
Biotechnology
The Institute for Clinical and Economic Review (ICER) has released a draft evidence report assessing the comparative clinical effectiveness and value of aducanumab, an investigational treatment for Alzheimer’s disease. 6 May 2021
Biotechnology
UK developer of inhaled therapies developer Vectura and Inspira Pharmaceuticals, a new UK-based biotech focused on developing therapies for respiratory and infectious diseases, today announced an agreement to develop an inhaled formulation of Inspira’s lead drug candidate for the treatment of COVID-19. 6 May 2021
Biotechnology
Irish rare diseases firm Amryt Pharma has signed a definitive agreement to acquire US-headquartered Chiasma in an all-stock combination valued at around $330 million. 6 May 2021
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