Regulation
Refine Search
Pharmaceutical
Ireland is the latest country to put its name forward to host the European Medicines Agency (EMA), should it be relocated following the UK’s Brexit vote. 22 September 2016
Generics
As a major member of Fosun Pharma family, Chongqing-based Yao Pharma is a key part of Fosun Pharma’s global strategy. 22 September 2016
Pharmaceutical
Ireland-incorporated Allergan says that the European Commission has granted Marketing Authorization for Truberzi (eluxadoline) in Europe. 22 September 2016
Biotechnology
US clinical-stage biotech firm bluebird bio revealed that the European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for LentiGlobin drug product in the treatment of patients with transfusion-dependent beta-thalassemia (TDT). 22 September 2016
Pharmaceutical
Apricus Biosciences has announced the launch of Vitaros (alprostadil), Apricus’ novel on-demand topical cream for the treatment of erectile dysfunction (ED), in the Czech Republic and Slovakia by Italian drugmaker Recordati. 22 September 2016
Pharmaceutical
Newron Pharmaceuticals and its partners Zambon and US WorldMeds announced today that Newron has re-submitted the New Drug Application (NDA) for Parkinson’s disease drug Xadago (safinamide) to the US Food and Drug Administration FDA. 22 September 2016
Pharmaceutical
The Russian Ministry of Health is changing the existing procedure for the launch of new drugs on the domestic market, with the aim to speed their withdrawal, according to recent statements by Veronika Skvortsova, Russia’s Minister of Health, reports The Pharma Letter’s local correspondent. 21 September 2016
Pharmaceutical
On August 26, 2016, the US Food and Drug Administration (FDA) issued revised guidance recommending universal testing of donated Whole Blood and blood components for Zika virus in the USA and all of its territories. 21 September 2016
Pharmaceutical
Whereas scores of new diabetes and non-diabetes endocrine drugs have been launched since the mid-1990s, and the demand for new therapies continues to grow, the development process for new diabetes and non-diabetes endocrine drugs is riskier compared to all drug development, according to results of a new study conducted by the Tufts Center for the Study of Drug Development. 21 September 2016
Pharmaceutical
AstraZeneca today announced its decision to withdraw the Marketing Authorization Application (MAA) submitted to the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in June 2015 for cediranib in combination with platinum-based chemotherapy. 21 September 2016
Pharmaceutical
The European Medicines Agency today issues a correction regarding the highlights of the September meeting of the Committee for Medicinal Products for Human Use (CHMP), which were originally published on Friday, September 15, and have now been re-published with a correction. 21 September 2016
Biotechnology
Alnylam Pharmaceuticals is expanding its global footprint with the opening of a new development and commercial hub in Maidenhead, UK, with a multi-million pound investment. 20 September 2016
Pharmaceutical
German pharma major Bayer has received US Food and Drug Administration (FDA) approval for Kyleena (levonorgestrel-releasing intrauterine system) 19.5mg, a progestin-containing intrauterine system (IUS), to prevent pregnancy for up to five years. 19 September 2016
Biotechnology
The US Food and Drug Administration today approved Exondys 51 (eteplirsen) injection, the first drug approved to treat patients with Duchenne muscular dystrophy (DMD). 19 September 2016
Biotechnology
US biotech Viamet Pharmaceuticals has been granted qualified infectious disease product (QIDP) designation by the US Food and Drug Administration (FDA) for VT-1598, a novel candidate for the oral treatment of coccidioidomycosis, or Valley Fever. 19 September 2016
Pharmaceutical
The US Department of Health and Human Services (HHS) has issued a final rule that specifies requirements for registering certain clinical trials and submitting summary results information. 19 September 2016
Biosimilars
Commenting on the release last week of the Biosimilar User Fee Act (II) performance goals letter, trade group Pharmaceutical Research and Manufacturers of America (PhRMA) president and chief executive Stephen Ubl welcomed the move, saying: "The Biosimilar User Fee Act (BsUFA) is critical to supporting the US Food and Drug Administration (FDA) in its core mission of protecting public health.” 19 September 2016
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended eleven medicines for approval at its September meeting. Among these were: 17 September 2016
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended three cancer medicines for approval at its September meeting. 16 September 2016
Pharmaceutical
In its dossier assessment published in early July 2016, the German Institute for Quality and Efficiency in Health Care (IQWiG) determined an indication of a minor added benefit of ticagrelor, Anglo-Swedish pharma major AstraZeneca’s Brilinta, in comparison with the administration of low-dose acetylsalicylic acid (ASA) alone. 16 September 2016
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze