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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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Biotechnology
USA and Israel-based-BrainStorm Cell Therapeutics is to submit a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for NurOwn (autologous MSC-NTF cells) to treat amyotrophic lateral sclerosis (ALS). 16 August 2022
Generics
As generic drugmakers are dragged to court by patent holders and the cost of litigation soars for both generic as well as innovative pharma companies, many are settling patent disputes out of court. Generic companies often agree to delay their entry into the market in exchange for certain benefits, such as licenses to other patents, reports The Pharma Letter’s India correspondent. 16 August 2022
Biotechnology
Deerfield Management is to take a stake in Swiss firm ADC Therapeutics, an antibody-drug conjugate company based in Lausanne, as the company restructures its obligations. 16 August 2022
Biotechnology
Swiss pharma giant Roche has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Polivy (polatuzumab vedotin-piiq) in combination with Rituxan (rituximab). 16 August 2022
Pharmaceutical
During much of the last two years, due to the COVID-19 pandemic and the movement restrictions that were imposed, US Food and Drug Administration inspections of manufacturing facilities were seriously limited and resulted in a large number of delays in new drug approvals. 16 August 2022
Pharmaceutical
Japanese pharma major Chugai Pharmaceutical has obtained regulatory approval from the Ministry of Health, Labor andY Welfare (MHLW) for the osteoporosis treatment Edirol (eldecalcitol) Tablet (0.5µg/0.75µg). 16 August 2022
Biotechnology
US biotech major Gilead Sciences has entered into an agreement with China’s Everest Medicines to transfer all development and commercialization rights to Gilead for Trodelvy (sacituzumab govitecan) in Greater China, South Korea, Singapore, Indonesia, Philippines, Vietnam, Thailand, Malaysia and Mongolia. 16 August 2022
Pharmaceutical
UK pharma major AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the USA for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC). 16 August 2022
Biotechnology
US clinical-stage biotech CinCor Pharma, which is developing its lead clinical candidate, baxdrostat, for the treatment of hypertension and other cardio-renal diseases, yesterday announced the closing of its upsized underwritten public offering consisting of an aggregate of 8,625,000 shares of common stock and pre-funded warrants. 16 August 2022
Pharmaceutical
Australia's Opthea, a clinical-stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, has announced a non-dilutive financing transaction for up to $170 million. 15 August 2022
Biotechnology
US biotech major Gilead Sciences’ shares were up 4% at $65.48 in early trading today, as it announced statistically-significant and clinically-meaningful results from the second interim analysis of the key secondary endpoint of overall survival (OS) in the Phase III TROPiCS-02 study evaluating Trodelvy (sacituzumab govitecan-hziy) in patients with HR+/HER2- metastatic breast cancer who received prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemotherapy. 15 August 2022
Pharmaceutical
Chicago-based Aptinyx, a clinical-stage biopharmaceutical company developing therapies for the treatment of brain and nervous system disorders, has announced disappointing results from a Phase IIb study evaluating the effects of NYX-2925 in patients with fibromyalgia. 15 August 2022
Biotechnology
US mRNA biotech Moderna edged up less than 1% pre-market this morning, despite announcing the first-ever approval worldwide for its next-generation bivalent COVID-19 vaccine. 15 August 2022
Biotechnology
Swiss pharma giant Novartis has announced that the Phase III CANOPY-A study evaluating adjuvant treatment with canakinumab, an inhibitor of interleukin-1beta did not meet its primary endpoint of disease-free survival versus placebo. 15 August 2022
Pharmaceutical
An Expert View from Emer Leahy, chief executive, and Dani Brunner, chief innovation officer, of PsychoGenics, on the challenges involved in tackling mental disorders. 15 August 2022
Pharmaceutical
UK-based subsidiary of Japanese ophthalmology firm Santen Pharmaceutical has announced the launch of Ducressa in the UK and Ireland, a fixed dose combination (FDC) of levofloxacin and dexamethasone for use after cataract surgery that also offers a modern and convenient seven-day therapeutic strategy to optimize post-surgery care. 15 August 2022
Biotechnology
Terns Pharmaceuticals saw it shares fly up more than 25% to $3.02 on Friday, after it announced a $65 million underwritten public offering, which is expected to close on August 16, 2022, subject to customary closing conditions. 15 August 2022
Biotechnology
Switzerland-headquartered biotech Addex Therapeutics today announced that its collaboration agreement with UK-based Indivior for discovering and developing novel oral gamma-aminobutyric acid subtype B (GABAB) positive allosteric modulator (PAM) drug candidates has been extended until March 31, 2023. 15 August 2022
Pharmaceutical
Researchers at the USA’s Johns Hopkins Medicine say that an experimental dendrimer nanoparticle treatment called OP-101 substantially reduced the risk of death and need for a ventilator in a study of 24 severely ill adults hospitalized with COVID-19. 15 August 2022
Biotechnology
Investments in research and development continue to pay dividends for British drugmaker AstraZeneca, with the firm’s antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan) passing an important test in breast cancer. 15 August 2022
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