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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
Generics
The US Food and Drug Administration (FDA) yesterday announced its Fiscal Year 2025 Generic Drug User Fee Amendments (GDUFA). 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
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
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
Novartis announced today that the European Commission (EC) has approved Kisqali (ribociclib) in combination with an aromatase inhibitor (AI) for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer (EBC) at high risk of recurrence. 27 November 2024
Biotechnology
Chengdu-based Kelun-Biotech has received marketing authorization in China for sacituzumab tirumotecan (sac-TMT), a Trop2-directed antibody-drug conjugate (ADC). 27 November 2024
Pharmaceutical
The Biden administration has proposed a new rule that could significantly expand Medicare and Medicaid coverage for obesity medications, potentially benefiting millions of Americans. 27 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has extended the review period for Soleno Therapeutics’ the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets 27 November 2024
Pharmaceutical
Japanese drugmaker Otsuka has announced the submission of a New Drug Application (NDA) to the Japanese Ministry of Health, Labor and Welfare (MHLW) for the manufacture and sale in Japan of bempedoic acid - trade name Nexletol in Japan - for the treatment of hypercholesterolemia and familial hypercholesterolemia. 27 November 2024
Pharmaceutical
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
A ‘huge blow to patients’ and the realization of ‘our worst fears' about the re-launched Cancer Drugs Fund (CDF) is how one charity has reacted to the recommended discontinuation of oncology treatments in England. 18 August 2016
Biotechnology
At a time when the inability of UK patients to access certain potentially lifesaving cancer drugs has come under fire, one company executive has praised the stance taken by the British government on a treatment of advanced renal cell carcinoma (RCC). 17 August 2016
Biotechnology
The Directorate General of Foreign Trade in India has laid down the conditions for import and export of human biological samples for commercial purposes recently. 17 August 2016
Pharmaceutical
The US Food and Drug Administration (FDA) has granted esketamine, an investigational antidepressant medication, Breakthrough Therapy Designation for the treatment of major depressive disorder with imminent risk for suicide. 16 August 2016
Pharmaceutical
Politically unaccountable groups, having their own agendas, should not be dictating the practice of medicine in the form of guidelines to be required by Medicare, states the Association of American Physicians and Surgeons (AAPS) in comments it submitted on Saturday (August 13) to the Centers for Medicare & Medicaid Services (CMS) on its proposed new regulation. 16 August 2016
Pharmaceutical
A report on why UK cancer patients are missing out on drugs available elsewhere is ‘too simplistic’ in attributing the problem to failed negotiations with pharma companies, according to the Association of the British Pharmaceuticals Industry (ABPI). 15 August 2016
Biosimilars
The European Medicines Agency has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), titled “Product- or population-specific considerations II: Biological medicinal products.” 15 August 2016
Pharmaceutical
The US Food and Drug Administration, with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the USA. 12 August 2016
Pharmaceutical
Endo International said today that, based on an August 11, 2016 discussion with the US Food and Drug Administration, the company has decided to withdraw its supplemental New Drug Application (sNDA) relating to specific abuse deterrent labeling for its opioid antagonist Opana ER without prejudice to re-filing. 12 August 2016
Biotechnology
In Australia, product Information documents for US biotech major Amgen’s denosumab have been updated regarding the potential risk of QT interval prolongation associated with hypocalcemia. 12 August 2016
Pharmaceutical
In draft guidance published today, Anglo-Swedish pharma major AstraZeneca’s Brilique (ticagrelor) has been recommended for National Health Service use by the medicines cost-effectiveness watchdog for England and Wales. 12 August 2016
Biotechnology
NHS England has launched a 45-day public consultation on a proposed clinical commissioning policy for Pre-Exposure Prophylaxis (PrEP) for HIV. 11 August 2016
Pharmaceutical
The US Food and Drug Administration (FDA) has created a model Drug Facts Label (DFL) to help drugmakers submit new drug applications for over-the-counter (OTD) versions of a drug that combats the effects of an opioid overdose. 11 August 2016
Pharmaceutical
The US Food and Drug Administration (FDA) has granted Priority Review status to privately-held Marathon Pharmaceuticals’ investigational drug deflazacort for Duchenne Muscular Dystrophy (DMD). 11 August 2016
Pharmaceutical
A European Medicines Agency (EMA) report on its adaptive pathways pilot fails to address concerns about how real world data can be used to draw reliable conclusions after drug approval, says Germany's Institute for Quality and Efficiency in Healthcare (IQWiG). 10 August 2016
Pharmaceutical
Following a pre-planned interim analysis for MONARCH 2, an independent Data Monitoring Committee (DMC) recommended the study continue without modification as the interim efficacy criteria were not met, says US pharma major Eli Lilly. 10 August 2016
Biotechnology
US specialty biotech group Heron Therapeutics says it has received US Food and Drug Administration approval for its Sustol (granisetron) extended-release injection. 10 August 2016
Pharmaceutical
Canada’s Cardiome Pharma says that Xydalba (dalbavancin) has been approved by the European Medicines Agency for administration as a single, 30 minute, 1500mg infusion (three 500mg vials). 10 August 2016
Pharmaceutical
Astellas Pharma has submitted a new drug application to the Ministry of Health, Labor and Welfare in Japan for extended-release tablets of quetiapine fumarate (FK949E) for the indication of improvement of depressive symptoms associated with bipolar disorder. 10 August 2016
Biotechnology
The US Food and Drug Administration has given the nod for Japanese pharma major Eisai and US biotech Biogen to take their investigational oral beta-secretase cleaving enzyme (BACE) inhibitor E2609 into Phase III studies in Alzheimer’s. 10 August 2016
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