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26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
US health technology assessor the Institute for Clinical and Economic Review (ICER) today released its revised Evidence Report assessing the comparative clinical effectiveness and value of Biogen’s aducanumab – now trade-named Aduhelm - for the treatment of Alzheimer’s disease. 30 June 2021
Biotechnology
Japanese drug major Chugai Pharmaceutical has filed a new drug application with the Ministry of Health, Labor and Welfare (MHLW) for the antibody cocktail casirivimab and imdevimab (formerly known as REGN-COV2) for the treatment of COVID-19. 30 June 2021
Biotechnology
Japan’s FUJIFILM Corporation today announced a 90 billion yen ($850 million) investment package to accelerate the growth of its core Bio Contract Development and Manufacturing Organization (CDMO) subsidiary, Fujifilm Diosynth Biotechnologies. 30 June 2021
Biotechnology
US pharma major Bristol Myers Squibb has picked up European approval for its immuno-oncology combo treatment Opdivo (nivolumab) plus Yervoy (ipilimumab) in bowel cancer. 30 June 2021
Biotechnology
Dutch gene therapy company uniQure recently announced the enrolment of the first two patients in the second cohort of a Phase I/II clinical trial of AMT-130, a micro ribonucleic acid (miRNA) gene therapy, in development for Huntington’s disease (HD). 30 June 2021
Biotechnology
The new Biotech-Report describing the situation of medical biotechnology in Germany is now available. It was provided by Boston Consulting Group and vfa bio, Germany’s industry association for research-based biotechnology companies. 30 June 2021
Biotechnology
Adding to a similar approval from the US Food and Drug Administration in March this year, the European Commission (EC) today approved Keytruda (pembrolizumab), Merck & Co’s anti-PD-1 therapy,00 in a new indication. 29 June 2021
Biotechnology
Dutch biotech firm Vivoryon Therapeutics saw its share rise nearly 8% to 17.60 euros in late morning trading, after it announced a regional licensing partnership with China-based Simcere Pharmaceutical to develop and commercialize medicines targeting the neurotoxic amyloid species N3pE (pGlu-Abeta) to treat Alzheimer’s disease (AD) in Greater China. 29 June 2021
Biotechnology
Results from a study evaluating the impact of mixing different coronavirus vaccines has found that all tested combinations produced a potent immune response among participants. 29 June 2021
Biotechnology
French drugmaker Sanofi has made a statement of intent in the mRNA vaccines space. 29 June 2021
Biotechnology
US biotech firm Gilead Sciences says it has completed submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval of lenacapavir. 29 June 2021
Biotechnology
Gilead Sciences’ subsidiary Kite has announced top-line results from the primary analysis of ZUMA-7, a global Phase III study showing superiority of Yescarta (axicabtagene ciloleucel) compared to standard of care (SOC) in second-line relapsed or refractory large B-cell lymphoma (LBCL). 29 June 2021
Biotechnology
Colorado, USA-based SomaLogic yesterday said it is adding to its list of collaborative agreements with Danish diabetes care giant Novo Nordisk. 29 June 2021
Biotechnology
Shares in USA-based CEL-SCI fell by almost half on Monday, following long-awaited results from a Phase III trial of Multikine (leukocyte interleukin), a novel kind of immunotherapy. 29 June 2021
Biotechnology
The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee recently voted in favor of USA-based Provention Bio’s teplizumab by 10 yes to 7 no, on the question: "Does the information provided in the background documents and presentations by the Applicant and FDA show that the benefits of teplizumab outweigh the risks in support of approval to delay clinical type 1 diabetes mellitus?" 29 June 2021
Biotechnology
The European Commission (EC) has approved Enspryng (satralizumab), from Swiss pharma giant Roche, for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). 28 June 2021
Biotechnology
Nirsevimab, a promising biologic for the passive inoculation of preterm infants against respiratory syncytial virus (RSV), has scored positive results in the Phase II/III MEDLEY trial. 28 June 2021
Biotechnology
The first participants in a Phase II/III trial for AstraZeneca’s (LSE: AZN) COVID-19 variant vaccine AZD2816 have been vaccinated. 28 June 2021
Biotechnology
AbbVie saw its share close down 1.5% at $112.98 on Friday, after it revealed that the US Food and Drug Administration has informed the company that the FDA will not meet the Prescription Drug User Fee Act (PDUFA) action dates for the supplemental New Drug Applications (sNDAs) for Rinvoq (upadacitinib) for the treatment of adults with active psoriatic arthritis and adults with active ankylosing spondylitis. 28 June 2021
Biotechnology
The Alzheimer’s community, together with the share price of USA-based developer Biogen (Nasdaq: BIIB), was given a considerable fillip at the start of June, with the approval of Aduhelm (aducanumab). 28 June 2021
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