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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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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
All news
Pharmaceutical
US pharma giant Pfizer has been told to pay £63 million ($75 million) and its UK distributor Flynn Pharma £6.7 million in the latest development in a long-running price gouging dispute. 21 July 2022
Biotechnology
Cancer Research UK and Sosei Heptares have agreed a deal to bring the Japanese drugmaker’s cancer immunotherapy drug candidate into a first-in-human trial. 21 July 2022
Pharmaceutical
Karyopharm Therapeutics’ shares were trading up 9% at $5.22 pre-market, as it announced that the European Commission (EC) has granted Marketing Authorization for Nexpovio (selinexor), a first-in-class, oral exportin 1 (XPO1) inhibitor, in combination with once-weekly bortezomib (Velcade) and low-dose dexamethasone (SVd) for the treatment of adults with multiple myeloma who have received at least one prior therapy. 21 July 2022
Biotechnology
CAMP4 Therapeutics, a biotech promising to harness the power of RNA to restore healthy protein expression, has announced the close of a $100 million Series B financing round, led by Enavate Sciences. 21 July 2022
Biotechnology
Avista Therapeutics, which recently launched as a spin-out of the University of Pittsburgh Medical Center (UPMC), aims to develop innovative gene therapies for rare ophthalmic conditions. The new company today announced a partnership with Swiss pharma giant Roche to develop novel AAV gene therapy vectors for the eyes. 21 July 2022
Pharmaceutical
Swiss drugmaker Roche announced its financial results for the first half of 2022 on Thursday, as well as revealing that chief executive Severin Schwan will step down next March after 15 years in the top job. 21 July 2022
Biosimilars
Sandoz, the generic and biosimilar medicines business of Swiss pharma giant Novartis, today announced that the US Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for a high concentration formulation of 100 mg/mL (HCF) of its biosimilar Hyrimoz (adalimumab-adaz). 21 July 2022
Biotechnology
People with head and neck cancer did not receive a statistically-significant benefit from treatment with Merck & Co’s Keytruda (pembrolizumab) in the KEYNOTE-412 trial. 21 July 2022
Biotechnology
Shares of Innate Pharma shot up as much as 10% in an initial reaction to its announcement that French pharma major Sanofi has made the decision to progress IPH6401/SAR’514 into investigational new drug (IND)-enabling studies, triggering a 3 million-euro ($3.1 million) milestone payment. 21 July 2022
Biotechnology
The UK’s R&D tax relief regime will continue to support innovative life sciences and biotech companies to conduct essential clinical trials and some pre-clinical work overseas following the publication of new draft legislation. 21 July 2022
Biotechnology
Specialty vaccines company Valneva has salvaged part of a deal to supply its coronavirus shot to Europe. 21 July 2022
Biotechnology
US clinical-stage immuno-oncology company Portage Biotech says it has acquired the outstanding ownership interest (approximately 22%) of its invariant natural killer T cell (iNKT agonist) platform and now fully owns the worldwide rights to its small molecule iNKT agonists, including lead programs PORT-2 and PORT-3. 21 July 2022
Biotechnology
Biotech company BigHat Biosciences raised a $75 million Series B round led by Section 32. 21 July 2022
Pharmaceutical
US drugmaker AbbVie has expanded its eye care portfolio in a deal with Belgian company iSTAR Medical. 20 July 2022
Biotechnology
New Jersey, USA-based rare disease drug developer PTC Therapeutics today announced that Upstaza (eladocagene exuparvovec) was granted marketing authorization by the European Commission. 20 July 2022
Biotechnology
Unofficial American cost-effectiveness watchdog the Institute for Clinical and Economic Review (ICER) has published a Final Evidence Report on betibeglogene autotemcel for the treatment of beta thalassemia. 20 July 2022
Biotechnology
Versanis Bio, a privately-held biotech advancing novel therapeutics for cardiometabolic diseases, has announced the appointment of Mark Pruzanski as chairman and chief executive 20 July 2022
Biotechnology
US biotech major Biogen today reported second quarter 2022 financial results. 20 July 2022
Pharmaceutical
In a rare disappointment for leading PARP inhibitor Lynparza (olaparib), researchers are to stop the Phase III LYNK-003 trial after independent monitors judged it likely to fail. 20 July 2022
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical has announced the establishment and start of an investment business of Ono Digital health Investment, GK (ODhI) as a corporate venture capital (CVC) that invests in venture companies in the field of healthcare, other than the ethical pharmaceutical drug-related field. 20 July 2022
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