Latest Pharma and Biotech News
Biotechnology
26 November 2024 US companies Arrowhead Pharmaceuticals and Sarepta Therapeutics have announced a global licensing and collaboration agreement.
Today's issue
Refine Search
Biotechnology
US healthcare giant Johnson & Johnson has revealed the contract manufacturer for the COVID-10 vaccine developed by its subsidiary Janssen has failed on quality. 3 April 2021
Biotechnology
The US Food and Drug Administration has approved French pharma major Sanofi’s Sarclisa (isatuximab-irfc), in combination with Amgen's Kyprolis (carfilzomib) and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received one to three prior lines of therapy. 2 April 2021
Biotechnology
The US Food and Drug Administration has approved Praluent (alirocumab) injection for adult patients with homozygous familial hypercholesterolemia (HoFH), a genetic condition that causes severely high cholesterol. Praluent is not intended to be used alone but instead added to other treatments for HoFH. 2 April 2021
Biotechnology
Japan’s Taiho Oncology and Taiho Pharmaceutical - both owned by Otsuka Pharmaceutical – have announced that the US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for futibatinib (TAS-120), a covalently-binding FGFR inhibitor. 2 April 2021
Biotechnology
UK pharma major GlaxoSmithKline has reached agreement to sell its royalty interest in two cabozantinib products, brand names Cabometyx and Cometriq, to Royalty Pharma. 2 April 2021
Biotechnology
The UK’s National Institute for Care and Health Excellence (NICE) has recommended Ondexxya (recommend andexanet alfa) for reversing anticoagulation of the direct factor Xa (FXa) inhibitors apixaban or rivaroxaban in adult patients who experience a life-threatening or uncontrolled bleed in the gastrointestinal (GI) tract, US drugmaker Alexion Pharmaceuticals announced today. 1 April 2021
Biotechnology
UK-based biopharma firm Hemogenyx Pharmaceuticals has issued an update on negotiations regarding the future development of its leading product candidate CDX bispecific antibody (CDX) for the treatment of acute myeloid leukemia (AML). 1 April 2021
Biotechnology
Brazil’s medicines regulator has rejected an application from India’s Bharat Biotech for a certificate of Good Manufacturing Practices for its COVID-19 vaccine Covaxin, following an inspection of the company’s site in Hyderabad earlier this month. 1 April 2021
Biotechnology
Three years after launching in the UK, Swedish Orphan Biovitrum's Kineret (anakinra) has secured a positive reimbursement decision from the country’s health technology assessor. 1 April 2021
Biotechnology
California, USA-based BridgeBio Pharma, through its affiliate QED Therapeutics, has entered into a global collaboration and licensing agreement with Swiss firm Helsinn to further develop and commercialize QED Therapeutics’ FGFR1-3 inhibitor, infigratinib, in oncology and all other indications except for skeletal dysplasias (including achondroplasia). 31 March 2021
Biotechnology
There was further encouraging news on the vaccine front on Wednesday as Pfizer and BioNTech announced positive findings on their vaccine from a Phase III trial in adolescents. 31 March 2021
Biotechnology
The US Food and Drug Administration has accepted its New Drug Application (NDA) for atogepant, an investigational, orally-administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant), for the preventive treatment of migraine in adults who meet criteria for episodic migraine. 31 March 2021
Biotechnology
The European Commission has approved Cabometyx (cabozantinib), from French drugmaker Ipsen, in combination with Bristol Myers Squibb’s Opdivo (nivolumab) for the first-line treatment of advanced renal cell carcinoma (aRCC). 31 March 2021
Biotechnology
Japanese company Astellas has become the latest drugmaker to make genetic regulation one of the primary focuses of its research and development (R&D) strategy. 31 March 2021
Biotechnology
US biotech major Amgen has entered into an agreement to acquire Rodeo, a privately held biopharmaceutical company based in Seattle that develops small-molecule therapies designed to promote regeneration and repair of multiple tissues. 31 March 2021
Biotechnology
Germany has again updated its guidance on the use of Vaxzevria, after new reports related to a rare kind of blood clotting occurring in people who had previously received the vaccine. 31 March 2021
Biotechnology
Just two weeks after announcing a worldwide licensing agreement with Pfizer to develop and commercialize multiple antibody drug conjugates, Pyxis Oncology has announced a $152 million Series B financing. 30 March 2021
Biotechnology
Privately-held US biotech Omega Therapeutics has closed an upsized Series C financing of $126 million. 30 March 2021
Biotechnology
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding Merck & Co’s supplemental Biologics License Application (sBLA) seeking approval for Keytruda, for the treatment of patients with high-risk early-stage triple-negative breast cancer (TNBC). 30 March 2021
Biotechnology
Swiss pharma giant Roche has seen its spinal muscular atrophy (SMA) drug Evrysdi (risdiplam) follow up its US approval by getting the green light from the European Commission (EC). 30 March 2021
All news
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze