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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
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
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
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Biotechnology
company Regenxbio has entered into an agreement to sell a portion of the royalty rights due to the company from Novartis Gene Therapies (formerly AveXis) from the net sales of Zolgensma (onasemnogene abeparvovec-xioi) to entities managed by Healthcare Royalty Management (HCR) for a gross purchase price of $200 million. 23 December 2020
Biotechnology
US biotech Rhythm Pharmaceuticals today reported top-line results from its pivotal Phase III clinical trial evaluating setmelanotide, the company’s melanocortin-4 receptor (MC4R) agonist, for the treatment of insatiable hunger and severe obesity in individuals with Bardet-Biedl syndrome (BBS) or Alström syndrome, two ultra-rare genetic diseases that often manifest with these symptoms. 22 December 2020
Biotechnology
Miami, USA-based Ridgeback Biotherapeutics has won US regulatory approval for a new Ebola virus treatment, Ebanga (ansuvimab-zykl). 22 December 2020
Biotechnology
Sosei Group and Captor Therapeutics are kicking off a collaboration to discover and develop drugs focused on G protein-coupled receptors (GPCRs). 22 December 2020
Biotechnology
Shares of the Cambridge, Mass, U SA-based Agios Pharmaceuticals closed up more than 28% at $42.62 yesterday, in reaction to the news that it is selling its oncology business, aiming to focus on genetically-defined diseases. 22 December 2020
Biotechnology
British drugmaker AstraZeneca and USA-based Amgen have announced negative results from the Phase III SOURCE trial of tezepelumab. 22 December 2020
Biotechnology
Swedish Orphan Biovitrum, also known as Sobi, has appointed Duane Barnes as the new head of Sobi in North America. 22 December 2020
Biotechnology
Netherlands-based gene therapy company uniQure saw its shares down 15.7% at $38.75 around midday in New York trading today, after it announced that its hemophilia B gene therapy program, including the pivotal, Phase III HOPE-B study, has been placed on clinical hold by the US Food and Drug Administration. 21 December 2020
Biotechnology
UK drugmaker GlaxoSmithKline has inked two early pipeline deals in neurology and immunology, boosting its investment in genetically validated treatments. 21 December 2020
Biotechnology
A Phase III trial of Xospata (gilteritinib) plus azacitidine versus azacitidine alone in newly diagnosed FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML) patients who were ineligible for intensive induction chemotherapy did not meet its primary endpoint of overall survival at a planned interim analysis of the LACEWING trial. 21 December 2020
Biotechnology
The European Medicines Agency’s advisory committee today recommended granting a conditional marketing authorization for Pfizer and BioNTech’s vaccine Comirnaty (previously known as BNT162b2), to prevent COVID-19 in people from 16 years of age. 21 December 2020
Biotechnology
USA-based biotech Aimmune Therapeutics has won European approval for the first peanut allergy treatment, Palforzia (peanut allergen). 21 December 2020
Biotechnology
Swiss pharma giant Roche has announced positive top-line results from two identically designed global Phase III studies, testing the novel biologic faricimab. 21 December 2020
Biotechnology
The US Food and Drug Administration on Friday issued a complete response letter (CRL) regarding the new drug application (NDA) for inclisiran, a potential treatment for hyperlipidemia in adults who have elevated low-density lipoprotein cholesterol (LDL-C) while being on a maximum tolerated dose of a statin therapy. 21 December 2020
Biotechnology
US biotech major Biogen has agreed to pay $22 million to resolve claims that it violated the False Claims Act by illegally using charitable foundations as a conduit to pay the co-pays of Medicare patients taking Biogen’s multiple sclerosis drugs, Avonex (interferon beta 1a) and Tysabri (natalizumab), according to the US Justice Department. 19 December 2020
Biotechnology
Shares of UK-based rare diseases specialist Mereo BioPharma (Nasdaq: MREO) shot up almost 63% to $3.60 on Friday, after it announced a license and collaboration agreement for setrusumab, a monoclonal antibody in clinical development for osteogenesis imperfecta (OI). 19 December 2020
Biotechnology
Janux Therapeutics has announced a strategic collaboration with Merck & Co valued at more than $1 billion to develop novel T cell engager (TRACTr) immunotherapies for the treatment of cancer. 18 December 2020
Biotechnology
Any doubts that Moderna’s (Nasdaq: MRNA) COVID-19 vaccine is moving swiftly closer to patients in the USA and European Union (EU) have all but vanished this week. 18 December 2020
Biotechnology
Privately-held US biopharma firm Cadent Therapeutics has reached a definitive agreement with Novartis, under which the latter will acquire all of the outstanding capital stock of Cadent, and marking the third M&A deal for the Swiss pharma giant this year. 18 December 2020
Biotechnology
Coronavirus vaccine co-developer Pfizer has refuted suggestions that there is any delay to its manufacturing and distribution schedule. 18 December 2020
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