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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
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Pharmaceutical
US pharma major Bristol Myers Squibb’s (NYSE: BMY) dipped 2% to $73.63 pre-market today, as it released financial results for the second quarter of 2022, which it said reflect continued in-line product growth, strong momentum across the new product portfolio and continued pipeline progress. 27 July 2022
Pharmaceutical
US biopharma Mycovia Pharmaceuticals has announced the publication of positive Phase III data on Vivjoa (oteseconazole) capsules in patients with recurrent vulvovaginal candidiasis (RVVC) in the July edition of NEJM Evidence. 27 July 2022
Pharmaceutical
The Johnson & Johnson subsidiary Janssen UK has named Maria Walsh its business unit director, oncology and hematology, cell and gene therapy and pulmonary hypertension. 27 July 2022
Pharmaceutical
The US Food and Drug Administration (FDA) today announced the availability of a final guidance for industry entitled General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products. 27 July 2022
Pharmaceutical
The European Medicines Agency (EMA) has initiated a series of actions to respond to the ongoing monkeypox outbreak, which has been escalated by the World Health Organization (WHO) to a Public Health Emergency of International Concern (PHEIC) on July 23. 27 July 2022
Pharmaceutical
Global contract development and manufacturing organization (CDMO) PCI Pharma Services (PCI) today announced a significant expansion of its world-class facility in Tredegar, Wales, UK, designed to help keep pace with the market growth of powerful, targeted oncology therapies. 27 July 2022
Generics
Shares of Israeli generics giant Teva Pharmaceutical Industries were up 14.7% at 2,856 shekels this morning, as it announced it has reached an agreement in principle with the working group of US States’ Attorneys General, counsel for Native American Tribes, and plaintiffs’ lawyers representing the States and subdivisions, on the primary financial terms of a nationwide opioids settlement. 27 July 2022
Pharmaceutical
Russia plans to take additional measures to speed registration of new drugs in the domestic market – in a move, that will allow the country to avoid a potential shortage caused by sanctions and their consequences, reports The Pharma Letter’s local correspondent. 27 July 2022
Biotechnology
AbbVie's Rinvoq (upadacitinib) has been approved by the European Commission for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent. 26 July 2022
Pharmaceutical
The European Union welcomes today's appeal arbitration award by the World Trade Organization (WTO) in the case the EU brought against Turkey on pharmaceutical products, according to a press statement by the Commission. 26 July 2022
Pharmaceutical
Geropharm, one of Russia’s largest drugmakers and a leading producer of insulin, is eyeing accelerating its foreign expansion as well as increasing its output by almost five-fold, according to recent statements by Petr Rodionov, the firm’s general director. 26 July 2022
Biotechnology
Dutch firm NewAmsterdam Pharma Holding and Frazier Lifesciences Acquisition Corporation, a special purpose acquisition company (SPAC) sponsored by an affiliate of Frazier Healthcare Partners, have agreed to merge. 26 July 2022
Biotechnology
The US Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for tofersen, an investigational drug for superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS). 26 July 2022
Pharmaceutical
Netherlands-based specialty pharma firm Pleco Therapeutics today announced its expansion, with the incorporation if a US subsidiary, Pleco Therapeutics USA. 26 July 2022
Biotechnology
Enhertu (trastuzumab deruxtecan) has been granted priority review in a new indication in the USA following results from the DESTINY-Breast04 Phase III trial showing that it is the first HER2-directed therapy to demonstrate a survival benefit in patients with HER2-low metastatic breast cancer. 26 July 2022
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted British marketing authorization for Global Blood Therapeutics’ Oxbryta (voxelotor) for the treatment of hemolytic anemia due to sickle cell disease (SCD) in eligible adult and pediatric patients aged 12 years and older as monotherapy or in combination with hydroxycarbamide (hydroxyurea). 26 July 2022
Pharmaceutical
Ginkgo Bioworks — a leader in horizontal platform for cell programming — and the biotechnology company Zymergen have entered into a definitive agreement under which Ginkgo will acquire the latter in an all-stock transaction that values Zymergen at an approximately $300 million market capitalization. 26 July 2022
Biotechnology
Valo Therapeutics, a developer of immunotherapy platforms for cancer and infectious diseases, has announced the acquisition of an innovative tumor ‘fingerprint’ identification technology, called PeptiCHIP. 25 July 2022
Biotechnology
US discoverer of precision medicines for cancer and other diseases, Flare Therapeutics, today announced the appointment of Amit Rakhit as president and chief executive. 25 July 2022
Pharmaceutical
The Indian government has launched three schemes to strengthen the micro, small and medium enterprises (MSMEs) in the pharmaceutical sector, with an aim to support pharma clusters and MSME units to enhance quality and technology improvement. 25 July 2022
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