Latest Pharma and Biotech News
Biotechnology
28 November 2024 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.
Today's issue
Refine Search
Biotechnology
US biopharma company Greenwich LifeSciences , which is focused on the development of GLSI-100, announced that the Food and Drug Administration (FDA) has removed the clinical hold permitting the Flamingo-01 Phase III clinical trial to proceed. 13 July 2022
Biotechnology
Positive results from the A-SURE study were presented at the 30th International Society on Thrombosis and Hemostasis (ISTH) Congress in London, demonstrating improved prophylactic effectiveness in Elocta (efmoroctocog alfa) treated patients compared to a matched treatment group on SHL FVIII treatments, according to Swedish Orphan Biovitrum, also known as Sobi. 13 July 2022
Pharmaceutical
Shares of Finnish drugmaker Orion Corporation jumped 7.6% to 47.60 euros by mid-morning, as it announced an important collaboration with US pharma giant Merck & Co. 13 July 2022
Biotechnology
Agios Pharmaceuticals, a leader in the field of cellular metabolism pioneering therapies for genetically defined diseases, today announced that effective August 8, 2022, Jackie Fouse will transition to the role of chairwomen of the board of directors and Brian Goff will assume the role of chief executive officer. 13 July 2022
Biotechnology
A firm developing a novel vaccine technology, which could offer safer and more effective protection against infectious diseases, has appointed a new chief executive officer. 13 July 2022
Biotechnology
The cell regeneration medicines market is currently valued at $30.3 billion and is anticipated to reach the valuation of $34.3 billion by the end of 2032 by growing at a CAGR of 14.4%, according to the latest report published by Future Market Insights. 13 July 2022
Biotechnology
Centauri Therapeutics, a UK-based immunotherapy company focused on the treatment of infectious diseases, has announced three senior appointments at once. 12 July 2022
Pharmaceutical
Early research conducted at the University of Birmingham, UK, shows that the novel ATM blocker AZD1390 can promote regeneration of damaged nerve cells, potentially restoring sensory and motor function after a spinal injury. 12 July 2022
Generics
Israeli generics giant Teva Pharmaceutical Industries today announced that its US subsidiary has reached an agreement with the City and County of San Francisco and the People of the State of California that settles opioid-related claims asserted on behalf of the County and City of San Francisco. 12 July 2022
Biotechnology
South Korean company LegoChem Biosciences and Germany’s Glycotope have signed a research collaboration and license agreement to develop an antibody drug conjugate (ADC). 12 July 2022
Biotechnology
California, USA-based biotech Epic Bio, which is developing ultracompact therapies to modulate gene expression in vivo, today announced its launch and Series A financing of $55 million. 12 July 2022
Biosimilars
A proposed biosimilar to Soliris (eculizumab) has shown clinical equivalence in efficacy and safety in people with paroxysmal nocturnal hemoglobinuria (PNH). 12 July 2022
Pharmaceutical
As part of its efforts to keep up with changing technologies and to eliminate obsolete laws and regulations, the Indian government has unveiled a draft of the New Drugs, Medical Devices, and Cosmetics Bill 2022. 12 July 2022
Pharmaceutical
The European Medicines Agency (EMA) has launched a pilot project to assess whether the analysis of ‘raw data’ from clinical trials by regulatory authorities improves the evaluation of marketing authorization applications (MAAs) for new medicines as well as post-authorization applications and to explore the practical aspects of the submission and analysis of such data. 12 July 2022
Pharmaceutical
The pandemic revolutionized data collection and patient engagement in clinical trials. Although the life sciences industry has been historically cautious to adopt emerging technology trends, the sudden shutdown of in-person trial sites in adherence to safety protocols left sponsors and researchers with no choice but to adapt with more agile tools for remote data collection. 12 July 2022
Pharmaceutical
New-York, USA-based Inspirna, a clinical stage biopharmaceutical company developing first-in-class small molecule therapeutics, has raised $50 million in a Series D financing round, co-led by new investors Sands Capital and Vivo Capital, with additional participation from new investor Dreavent 6. 12 July 2022
Biotechnology
Swiss clinical-stage biotech Vaccentis, which is developing patient-specific medicines, today announced the appointment of Martin Munte, a veteran leader in biotech and pharma. 12 July 2022
Pharmaceutical
US drugmaker Vertex Pharmaceuticals (Nasdaq: VRTX) yesterday announced that the company has entered into a definitive agreement under to acquire ViaCyte, a privately held biotechnology company focused on delivering novel stem cell-derived cell replacement therapies as a functional cure for type 1 diabetes (T1D), for $320 million in cash. 12 July 2022
Pharmaceutical
German central nervous system (CNS) specialist Neuraxpharm is to buy two product portfolios within its main therapeutic focus area from French vaccines major Sanofi. 12 July 2022
Biotechnology
The US Department of Health and Human Services (HHS), in collaboration with the Department of Defense (DoD), announced that it has secured 3.2 million doses of Novavax’ COVID-19 vaccine (NVX-CoV2373). 12 July 2022
All news
Biotechnology
During the Belgian Economic Mission to Brazil, a historic Memorandum of Understanding (MoU) was signed between the Brazilian Oswaldo Cruz Foundation (Fiocruz) through its Institute of Technology on Immunobiologicals (Bio-Manguinhos), and the Belgian companies Quantoom Biosciences and Univercells. 29 November 2024
Pharmaceutical
The waiting time for Latin American patients with cancer, central nervous system disorders or rare diseases can take up to 4.75 years from the time a drug receives approval from global health authorities such as the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), until it is approved by their local authority and is available on the market, writes The Pharma Letter's local correspondent. 28 November 2024
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
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 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
Pharmaceutical
The first iteration of the European Shortages Monitoring Platform (ESMP) has gone live. 28 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for govorestat, a novel, central nervous system (CNS)-penetrant aldose reductase inhibitor (ARI), for the treatment of classic galactosemia, under development by Applied Therapeutics. 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
Pharmaceutical
Munich, Germany headquartered contract development and manufacturing organization (CDMO) Adragos Pharma has acquired Baccinex, a Swiss-based expert in aseptic fill-finish manufacturing. 28 November 2024
Pharmaceutical
The board of Spanish plasma-based medicines producer Grifols has announced the termination of discussions with Brookfield Capital Partners (UK) regarding a potential acquisition of Grifols shares. 28 November 2024
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 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
Pharmaceutical
UK-based drugmaker Advanz Pharma has announced that following the grant of a temporary suspension, as announced on last month, the General Court of the European Union (General Court) has decided not to further extend the suspension of the European Commission (EC) decision to revoke the conditional marketing authorization (CMA) for Ocaliva (obeticholic acid) in Europe. 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
Pharmaceutical
According to a report from industry analyst DelveInsight, the market for Down syndrome treatments in the USA is now valued at almost $250 million. 27 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