Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
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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
Biotechnology
A patient in Neurogene’s ongoing Phase I/II trial for Rett syndrome—who was dosed on November 5 with 3E15 vg of NGN-401—has now died from a treatment-related serious adverse event (SAE). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
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Biotechnology
German biotech BioNTech has entered into a purchase agreement to acquire Gilead Sciences’ subsidiary Kite’s solid tumor neoantigen T cell receptor (TCR) R&D platform and clinical manufacturing facility in Gaithersburg, Maryland. 19 July 2021
Biotechnology
New York, USA-based Regeneron is set to invest around $1.8 billion in its home state, with a major expansion of its research and development facilities. 19 July 2021
Biotechnology
Imfinzi (durvalumab) has been approved in China for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC), in combination with standard of care platinum chemotherapy (etoposide plus a choice of either carboplatin or cisplatin). 19 July 2021
Biotechnology
Melbourne, Australia-based stem cell company Mesoblast has presented more data from a trial of remestemcel-L in ventilator-dependent COVID-19 patients. 16 July 2021
Biotechnology
The European Medicines Agency has validated and accepted the marketing authorization application (MAA) for surufatinib for the treatment of pancreatic and extra-pancreatic (non-pancreatic) neuroendocrine tumors (NETs), submitted by China’s Hutchmed. 16 July 2021
Biotechnology
Looking to overturn a regulatory rebuff, New Jersey, USA’s Merck & Co has announced positive event-free survival (EFS) data from the pivotal neoadjuvant/adjuvant Phase III study KEYNOTE-522. 16 July 2021
Biotechnology
Positive top-line results from a Phase III study evaluating the safety and efficacy of Ultomiris (ravulizumab-cwvz) in adults with generalized myasthenia gravis (gMG) were announced yesterday by Alexion Pharmaceuticals, whose shares nevertheless dipped 3.3% to $180.51 by close of trading. 16 July 2021
Biotechnology
Swiss biotech firm Polyphor saw its shares plunge more than 10% to 2.12 Swiss francs this morning, on revealing another setback for its breast candidate, compounding a 70% decimation last month after it reported the failure of its leading investigational asset, balixafortide, to meet its late-stage trial goal. 16 July 2021
Biotechnology
XOMA Corp has acquired the royalty interest position Swiss biotech Kuros Biosciences holds in Checkmate Pharmaceuticals’ vidutolimod (CMP-001), an advanced-generation Toll-like receptor 9 agonist packaged in a virus-like particle, for $7.0 million upfront plus sales milestones. 16 July 2021
Biotechnology
Privately-held Irish company Shorla Pharma has announced its arrival in the USA by locating a base in Boston's Cambridge biotech cluster. 15 July 2021
Biotechnology
Positive data from the Phase III REACH3 study have been published in The New England Journal of Medicine (NEJM) demonstrating that treatment with Jakafi (ruxolitinib) resulted in significantly improved outcomes in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (GVHD) compared to best available therapy (BAT). 15 July 2021
Biotechnology
The US Food and Drug Administration has lifted a partial clinical hold, previously announced on April 8, 2021, on the first-in-human (FIH) Phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (high-risk MDS), being conducted in the USA, Poland largest biotech Ryvu Therapeutics (WSE: RVU) announced today. 14 July 2021
Biotechnology
Cambridge, USA-based biotech Ribon Therapeutics has closed a $65 million financing, which the company says will be used to support the clinical development of its novel precision medicine candidates. 14 July 2021
Biotechnology
British pharma major and coronavirus vaccine developer AstraZeneca has cleared the final regulatory hurdle in its acquisition of Alexion Pharmaceuticals. 14 July 2021
Biotechnology
Cambridge, Massachusetts-based Prime Medicine, a company delivering on the promise of Prime Editing to provide lifelong cures to patients, has announced its launch with $315 million in financing. 14 July 2021
Biotechnology
German contract development and manufacturing company ProBioGen yesterday announced that they have entered into a research license agreement with US biotech Heat Biologics for both ProBioGen's Transposase System DirectedLuck as well as for its proprietary suspension HEK293 cell line. 14 July 2021
Biotechnology
US biotech major Biogen has entered into a license and collaboration agreement for orelabrutinib, an oral small molecule Bruton’s tyrosine kinase inhibitor (BTKi) for the potential treatment of multiple sclerosis (MS), with China’s InnoCare Pharma. 13 July 2021
Biotechnology
The Russian government is considering allowing foreign vaccines against COVID-19 to enter the domestic market, according to recent statements by some senior state officials and some local media reports, reports The Pharma Letter’s local correspondent. 13 July 2021
Biotechnology
Ionis Pharmaceuticals has exercised its option and entered into an exclusive worldwide license and collaboration agreement with Bicycle Therapeutics for tissue-targeted delivery of oligonucleotide therapeutics. 13 July 2021
Biotechnology
The US Food and Drug Administration has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor. 13 July 2021
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