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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.
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Biotechnology
Eiger BioPharmaceuticals’ hopes of grasping an emergency use authorization (EUA) for peginterferon lambda as a treatment of patients with mild-to-moderate COVID-19 have been all but ended. 6 October 2022
Biotechnology
T-CURX, a CAR-T cell spin-off from the University of Würzburg, has announced the appointment of its co-founder, Ulf Grawunder, as the chief executive of the company. 6 October 2022
Pharmaceutical
LifeMine Therapeutics, a US start-up searching the fungal biosphere for genetically-encoded small molecules (GEMs), today announced the appointments of Martin Stahl, as chief scientific officer and Louis Plamondon, as executive vice president and head of CMC. 6 October 2022
Biotechnology
Yet another biotech start-up emerged from stealth this morning, indicating that there is no shortage of funding for companies with break-through technology. 6 October 2022
Pharmaceutical
The share of counterfeit medicines in the Russian pharmaceutical market has declined to minimal figures in the last five years, which was mainly due to efforts that have been made by the state, according to a recent report published by the Russian pharmaceutical regulator Roszdravnadzor and some local media, reports The Pharma Letter’s local correspondent. 6 October 2022
Biotechnology
A Feature on the deals being done in a lively sub-sector of the pharmaceutical industry. 6 October 2022
Pharmaceutical
The CPHI Annual survey predicts a fast growth for emerging Southeast Asian pharma nations ahead of this month’s CPHI South East Asia. 6 October 2022
Pharmaceutical
The Russian government plans to speed up the development and production of domestic drugs against rare diseases amid the ever tightening pressure caused by sanctions on the country due to its military conflict with Ukraine. 6 October 2022
Biotechnology
In the USA, Eli Lilly and Teva Pharmaceutical will meet in court after a federal judge slapped down an attempt to invalidate three of the latter’s patents. 6 October 2022
Biotechnology
The PERLA Phase II trial of cancer drug Jemperli (dostarlimab) met its primary endpoint of objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) criteria as determined by blinded independent central review, says UK pharma major GSK, which is a late comer to the PD-/PD-Li inhibitors sector. 6 October 2022
Pharmaceutical
The big spenders stayed on holiday during September in pharmaceutical M&A markets—with the exception of Novo Nordisk. 6 October 2022
Pharmaceutical
Glenmark Pharmaceuticals’ shares rose 1.2% to 408.75 rupees today, after the Indian drugmaker announced that it became the first company in India to launch thiazolidinedione lobeglitazone for the treatment of type 2 diabetes in adults. 6 October 2022
Pharmaceutical
Market authorization was granted to 92 new medicines in the European Union (EU) last year.Market authorization was granted to 92 new medicines in the European Union (EU) last year. 5 October 2022
Pharmaceutical
Victor Grifols Roura, who has devoted 50 years to building Spanish plasma-derived drugmaker Grifols (MCE: GRF) in senior roles including chief executive for 30 years, retires as non-executive chairperson. He is designated as chairperson of honor in recognition of his numerous contributions. 5 October 2022
Pharmaceutical
Allecra Therapeutics, a France-based biopharmaceutical company dedicated to the development of novel antibiotics, today revealed that the prestigious Journal of the American Medical Association (JAMA) has published the final results from its Phase III ALLIUM trial investigating the combination of cefepime/enmetazobactam in patients with complicated urinary tract infections (cUTIs). 5 October 2022
Biosimilars
The ability of patent holders to preserve their market exclusivity, a lack of consumer understanding and other factors have held up the widespread adoption of biosimilars in the USA compared to other markets. 5 October 2022
Biotechnology
The US Government has expressed a vote of confidence in Vir Biotechnology, awarding the company a multi-year contract to advance the development of a full portfolio of innovative medicines. 5 October 2022
Biotechnology
US pharma giant Pfizer has presented promising results on its PARP inhibitor Talzenna (talazoparib) alongside Xtandi (enzalutamide) in metastatic castration-resistant prostate cancer (mCRPC). 5 October 2022
Biotechnology
In what was a busy day for the US pharma major, two research collaborations with Bristol Myers Squibb were announced yesterday. 5 October 2022
Biotechnology
Cash rich Pfizer has completed its $11.6 billion acquisition of Biohaven Pharmaceutical, including its money-making calcitonin gene-related peptide (CGRP) programs. 5 October 2022
All news
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
Pharmaceutical
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. 27 November 2024
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