Latest Pharma and Biotech News
Pharmaceutical
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.
Today's issue
Refine Search
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Biotechnology
A report from industry analyst DelveInsight highlights progress in the myotonic dystrophy treatment landscape, with more than 20 companies developing over 22 innovative treatments. 28 November 2024
Biotechnology
The UK subsidiary of Dutch drugmaker argenx confirmed today that its investigational therapy, subcutaneous efgartigimod alfa has been granted Promising Innovative Medicine (PIM) designation by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP). 28 November 2024
Biotechnology
Privately-held French drugmaker Servier has announced the inauguration of its first unit dedicated to the production of biological medicines from its R&D pipeline. 28 November 2024
Biotechnology
The US Food and Drug Administration has received new reports of hematologic malignancies, including life-threatening cases of myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML), following treatment of early, active cerebral adrenoleukodystrophy (CALD) patients with Skysona (elivaldogene autotemcel). 28 November 2024
Biotechnology
San Diago, USA-based Acadia Pharmaceuticals yesterday announced it has entered into an exclusive worldwide license agreement with Denmark’s Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-α3 positive allosteric modulator. 28 November 2024
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
All news
Biotechnology
Subsequent to discussions with regulatory authorities, Regeneron Pharmaceuticals says it has submitted a request to the US Food and Drug Administration for an Emergency Use Authorization (EUA) for its REGN-COV2 investigational antibody combination for the treatment of COVID-19. 8 October 2020
Biotechnology
German contract development and manufacturing organization (CDMO), Rentschler Biopharma, is to provide cGMP manufacturing services for the mRNA-based vaccine candidate being developed by BioNTech and Pfizer against SARS-CoV-2. 8 October 2020
Biotechnology
The US Food and Drug Administration over the last couple of day has issued two coveted Rare Pediatric Disease designations (RPDD). 8 October 2020
Biotechnology
US biotech major Biogen has entered a research collaboration with molecular engineering company Scribe Therapeutics to develop and commercialize CRISPR-based therapies that address an underlying genetic cause of amyotrophic lateral sclerosis (ALS). 7 October 2020
Biotechnology
US immunology company Vir Biotechnology and UK pharma major GlaxoSmithKline have announced the global expansion to Phase III of the COMET-ICE study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization. 7 October 2020
Biotechnology
California, USA-based biotech A2 Biotherapeutics has closed its $71.5 million Series B financing. 7 October 2020
Biotechnology
Shares of New York-based Axovant Gene Therapies climbed more than 15% Monday morning to $5.25, after the company said it plans to announce six-month safety and efficacy data from the second cohort of study of its investigational gene therapy for Parkinson's disease, AXO-Lenti-PD, on October 6. 7 October 2020
Biotechnology
Germany’s life sciences and pharma major Merck KGaA has entered into an out-licensing agreement with Swiss giant Novartis, for the development of M6495, an anti-ADAMTS5 nanobody for the potential treatment of osteoarthritis (OA). 6 October 2020
Biotechnology
Less than a week after the European Medicines Agency (EMA) started the first ‘rolling review’ of a COVID-19 vaccine, the regulator has begun another. 6 October 2020
Biotechnology
Confirming outline plans revealed last year that were paused for lack of agreement, BridgeBio Pharma and Eidos Therapeutics have now entered into a definitive agreement under which BridgeBio has agreed to acquire all of the outstanding common stock of Eidos it does not already own, representing around 36.3% of Eidos’ outstanding shares. 6 October 2020
Biotechnology
Privately-held US biotech Allele Biotechnology and Pharmaceuticals has filed two patent infringement lawsuits – one in New York against Regeneron Pharmaceuticals and the other in California against Pfizer and BioNTech. 6 October 2020
Biotechnology
Bone Therapeutics has signed an exclusive license agreement with Link Health and Shenzhen Pregene Biopharma for the manufacturing, clinical development and commercialization of its allogeneic, off-the-shelf, bone cell therapy platform ALLOB in China, Taiwan, Singapore, South Korea, and Thailand. 5 October 2020
Biotechnology
US biotech Gilead Sciences has presented data on HIV patients switching to its once-daily, single tablet regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), from boosted protease inhibitor-based regimens, showing that they maintained virologic suppression with no emergent resistance, through a maximum of 156 weeks. 5 October 2020
Biotechnology
After 13 years of research, India's first personalized medicine for Duchenne muscular dystrophy (DMD) has received the green signal from the Drug Controller General of India (DCGI), paving the way for clinical trials. 5 October 2020
Biotechnology
The US Food and Drug Administration had issued a Complete Response Letter to Mesoblast's Biologics License Application (BLA) for Ryoncil (remestemcel-L) for the treatment of pediatric steroid-refractory acute graft versus host disease (SR-aGVHD). 5 October 2020
Biotechnology
A new drug that has passed safety tests in adults is likely to be effective against the aggressive childhood cancer neuroblastoma, Cancer Research UK-funded scientists have found. 5 October 2020
Biotechnology
The US Food and Drug Administration has approved Opdivo (nivolumab) + Yervoy (ipilimumab) for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM). 3 October 2020
Biotechnology
Family-owned Italian firm Chiesi Farmaceutici and Israeli biopharma Protalix BioTherapeutics have announced the launch of an expanded access program (EAP) in the USA for pegunigalsidase alfa for the proposed treatment of Fabry disease. 2 October 2020
Biotechnology
The European Commission (EC) has approved Crysvita (burosumab) for use in older adolescents and adults with the rare disease X-linked hypophosphatemia (XLH), Japanese drugmaker Kyowa Kirin announced today. 2 October 2020
Biotechnology
Synthetic Biologics today announced disappointing results of a planned interim futility analysis of the investigator-sponsored Phase IIb clinical study of SYN-010 being conducted by Cedars-Sinai Medical Center (CSMC). 2 October 2020
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