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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
US biotech major Gilead Sciences this morning announced that it has entered into a definitive agreement pursuant to which Gilead will acquire MiroBio for approximately $405 million in cash, subject to customary adjustments. 4 August 2022
Pharmaceutical
German life sciences major Bayer beat consensus estimates with its sales in the second quarter of 2022, with the 12.82 billion euros ($13 billion) total representing an 18% rise on the same period in 2021. 4 August 2022
Pharmaceutical
A new report by stakeholder intelligence firm alva has revealed the leaders in the pharma industry when it comes to equality, diversity and inclusion (EDI)—and Bayer tops the list. 4 August 2022
Biotechnology
Bermuda-based Kiniksa Pharmaceuticals has announced a global license agreement with Swiss pharma giant Roche and its US subsidiary Genentech, for the rights to develop and commercialize vixarelimab, a fully human monoclonal antibody targeting oncostatin M receptor beta (OSMRβ). 4 August 2022
Pharmaceutical
The age-related macular degeneration (AMD) market in the seven major markets (7MM: the USA, France, Germany, Italy, Spain, the UK, and Japan) is set to grow from $7.3 billion in 2021 to $22.8 billion in 2031, driven by the longer-acting anti-vascular endothelial growth factor (VEGF) pipeline therapies as well as potentially first-to-market therapies for geographic atrophy (GA). 4 August 2022
Pharmaceutical
German life sciences and pharma firm Merck KGaA today posted financial results for first-half 2022, showing that net sales increased by 14.3% compared with the second quarter of 2021 to 5,568 million euros ($5.64 billion). 4 August 2022
Pharmaceutical
Privately-held Danish dermatology specialist LEO Pharma has announced the appointment of Sven Hauptmann as its new executive vice president of global product supply. 4 August 2022
Pharmaceutical
Reporting financial results for the first half of 2022 late yesterday, Danish diabetes care giant Novo Nordisk (NOV: N) said that sales increased by 25% in Danish kroner and by 16% at constant exchange rates to 83.3 billion kroner ($11.4 billion) in the six months. 4 August 2022
Pharmaceutical
F2G, a clinical-stage biopharmaceutical company focused on the discovery and development of novel therapies to treat life-threatening rare fungal infections, has announced a $70 million financing. 4 August 2022
Biotechnology
US RNAi therapeutics pioneer Alnylam Pharmaceuticals looked set to close Wednesday’s New York trading with gains in excess of 40%. 3 August 2022
Biotechnology
US biotech major Gilead Sciences is trading 7% higher during Wednesday’s late morning trading in New York after presenting its financial results for the second quarter of 2022. 3 August 2022
Biotechnology
Shares of San Diego, USA-based biotech Poseida Therapeutics were up almost 98% at $4.80 late morning, after it announced it has entered into a broad strategic collaboration and license agreement with Swiss pharm giant Roche, focused on developing allogeneic CAR-T therapies directed to hematologic malignancies. 3 August 2022
Biotechnology
US pharma giant Merck & Co and Japan’s Eisai today announced that the Phase III LEAP-002 trial investigating Keytruda (pembrolizumab), Merck’s anti-PD-1 therapy, plus Lenvima (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, versus Lenvima monotherapy did not meet its dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). 3 August 2022
Biotechnology
Eliem Therapeutics, an Anglo-American biotech focused on developing therapies for neuronal excitability disorders, has reported results from its Phase IIa trial investigating ETX-810 for the treatment of lumbosacral radicular pain (LSRP). 3 August 2022
Pharmaceutical
HERA, the European Commission’s Health Preparedness and Response Authority, has signed a joint procurement framework contract with the Spanish company HIPRA Human Health for the supply of its protein COVID-19 vaccine. 3 August 2022
Pharmaceutical
A feature on renewed interest in an area where the difficulty for drugmakers is matched only by the potential rewards. 3 August 2022
Pharmaceutical
French drugmaker Ipsen saw its shares drop as much as 5% in early trading today, as it announced that the Phase III RESILIENT trial did not meet its primary endpoint of overall survival (OS) compared to topotecan. 3 August 2022
Biotechnology
US biotech Rigel Pharmaceuticals and Forma Therapeutics have entered into an exclusive, worldwide license agreement to develop, manufacture and commercialize olutasidenib, an oral, small molecule inhibitor of mIDH1 being investigated for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) and other malignancies. 3 August 2022
Biosimilars
Yesterday, the US Food and Drug Administration approved Cimerli (ranibizumab-eqrn; FY201) injection, as biosimilar to, and interchangeable with, Lucentis (ranibizumab injection). This is the 37th biosimilar approval in the USA, the agency noted. 3 August 2022
Biotechnology
Swiss biotech AC Immune (Nasdaq: ACIU) on Tuesday announced that its partners presented the first quantitative data from the Alzheimer’s Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) Colombia Trial during a Focused Topic Session at the Alzheimer’s Association International Conference (AAIC). 3 August 2022
All news
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
Pharmaceutical
The European Commission (EC) has approved a single-vial, fully liquid presentation of Menveo (meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial serogroups A, C, W and Y, UK pharma major GSK announced today. 27 November 2024
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