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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 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
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 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
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) today approved the use of Swiss drug major Roche’s MabThera (rituximab) for two potentially life-threatening auto-immune diseases, severe forms of granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA) and which result in the inflammation and damage of small blood vessels and frequently involve multiple organs. 24 January 2014
Biotechnology
Israeli drug developer BioLineRx has received notice from the US Food and Drug Administration confirming an Orphan Drug Designation of BL-8040 as a treatment for stem cell mobilization, in addition to the orphan status previously granted for the compound as a treatment for acute myeloid leukemia (AML). 23 January 2014
Biosimilars
The USA’s Biotechnology Industry Organization (BIO) and the Washington Biotechnology & Biomedical Association yesterday commended the Washington State House and Senate for continuing to advance legislation designed to create a pathway for the substitution of interchangeable biologic medicines, or biosimilars. 23 January 2014
Pharmaceutical
US drug company AMAG Pharmaceuticals (Nasdaq: AMAG) has received a complete response letter from the US Food and Drug Administration for the supplemental new drug application (sNDA) for Feraheme (ferumoxytol) injection for intravenous (IV) use. 23 January 2014
Generics
Generics drug major Actavis has confirmed that its Watson Laboratories unit has submitted an Abbreviated New Drug Application with the US Food and Drug Administration for approval to market a generic version of Allergan’s ophthalmic drug Restasis(cyclosporine ophthalmic emulsion) 0.05% product. 22 January 2014
Pharmaceutical
The quality of clinical trial evidence used by the US Food and Drug Administration as the basis for recent approvals of novel therapeutic agents varies widely, with important implications for patients and physicians, claims a new report in the Journal of the American Medical Association (JAMA). 22 January 2014
Pharmaceutical
The investigational monoclonal antibody amatuximab (development code: MORAb-009), has today been granted orphan drug designation (ODD) for the treatment of malignant mesothelioma by the European Commission, reports Japanese drug major Eisai. 22 January 2014
Pharmaceutical
Lundbeck (LUN: CO) and Takeda Pharmaceutical (TYO: 4502) jointly announced today that Brintellix (vortioxetine) for the treatment of major depressive disorder in adults is available in pharmacies across the USA. 22 January 2014
Pharmaceutical
The European Commission has approved Anglo-Swedish drug major AstraZeneca and soon to be ex-partner USA-based Bristol-Myers Squibb’s Xigduo (dapagliflozin and metformin hydrochloride) for the treatment of type 2 diabetes in the European Union. 22 January 2014
Biotechnology
In final guidance, UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended the use of French drug major Sanofi’s biotech subsidiary Genzyme’s oral multiple sclerosis drug Aubagio (teriflunomide). 22 January 2014
Pharmaceutical
Independent Dutch firm Norgine and its Japanese partner Kissei Pharmaceutical received approval from Japan’s Ministry of Health, Labor and Welfare for their new drug application for Savene (dexrazoxane) injectable for the treatment of anthracycline extravasation. 21 January 2014
Pharmaceutical
Analysis showing the extent to which the UK National Health Service (NHS) is prescribing National Institute for Health and Care Excellence (NICE) recommended medicines has been published today. 21 January 2014
Pharmaceutical
Switzerland-based Santhera Pharmaceuticals (SIX: SANN) announced today that the French National Agency for Medicines and Health Products Safety (ANSM) has granted a temporary authorization for use (ATU) for Raxone (idebenone) in the treatment of Leber's Hereditary Optic Neuropathy (LHON). 21 January 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 81 medicines for human use for marketing authorization in 2013, compared with 57 in 2012. This compares with 87 in 2011, 51 in 2010 and 117 in 2009. 21 January 2014
Pharmaceutical
German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare for riociguat, trade name Adempas, for the treatment of adults with inoperable chronic-thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment in Japan. 20 January 2014
Pharmaceutical
US emerging biotech firm Aegerion Pharmaceuticals says that the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS) has approved Juxtapid (lomitapide). 20 January 2014
Pharmaceutical
Japanese drug major Astellas Pharma has obtained the marketing approval of selective SGLT2 inhibitor Suglat tablets (ipragliflozin L-proline; development code: ASP1941) for the treatment of type 2 diabetes in Japan. Astellas filed an application for approval in March 2013. 20 January 2014
Biotechnology
US antivirals specialist Gilead Sciences has received marketing authorization from the European Commission for Sovaldi (sofosbuvir), a once-daily oral nucleotide analogue polymerase inhibitor for the treatment of chronic hepatitis C (CHC) infection in adults, in combination with other antiviral agents (ribavirin (RBV) and pegylated interferon alpha [peg-IFN]). 20 January 2014
Pharmaceutical
Japan’s largest drugmaker Takeda Pharmaceutical has received approval from the country’s Ministry of Health, Labor and Welfare for Adcetris (brentuximab vedotin) for the treatment for patients with CD30 positive or refractory Hodgkin lymphoma (HL) or relapsed or refractory anaplastic large cell lymphoma (ALCL). 18 January 2014
Biosimilars
Biosimilar drugs, also known as follow-on biologics, may soon be substituted in place of the reference pharmaceutical product in Brazil, under the latest initiative launched by Brazil's National Health Surveillance Agency (ANVISA), writes Juliane Carvalho on Brazil Pharma News 17 January 2014
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