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Biotechnology
The US Food and Drug Administration's streamlining of the process for physicians to seek ‘compassionate use’ of investigational treatments for their patients could make it more unlikely that Sarepta Therapeutics drug eteplirsen will gain accelerated approval. 3 June 2016
Pharmaceutical
Swiss pharma giant Novartis’ Afinitor (everolimus) has been approved by the European Commission for an additional indication. 2 June 2016
Pharmaceutical
UK pharma major GlaxoSmithKline and its US partner Innoviva have brought forward the proposed date for their filing of a New Drug Application (NDA) in the USA for the closed triple combination therapy, fluticasone furoate/umeclidinium/vilanterol, for chronic obstructive pulmonary disease (COPD). 2 June 2016
Biotechnology
Rare disease drug developer BioMarin Pharmaceutical has withdrawn its European Marketing Authorization Application (MAA) for Kyndrisa (drisapersen), an experimental drug for Duchenne muscular dystrophy (DMD). 2 June 2016
Biotechnology
The European Medicines Agency (EMA) has accepted aducanumab, an investigational treatment for early Alzheimer’s disease being developed by US biotech major Biogen, into its Priority Medicines (PRIME) program. 2 June 2016
Biotechnology
RegeneRx Biopharmaceuticals and Hong Kong-based Lee’s Pharmaceutical have announced acceleration of development of RGN-259 in China. 1 June 2016
Pharmaceutical
The European Commission has announced the adoption of two reasoned opinions calling the end of the export restriction systems implemented in Portugal and Slovakia. 1 June 2016
Biotechnology
US biotech Amicus Therapeutics has received approval from the European Commission for Galafold (migalastat) as a treatment for patients diagnosed with Fabry disease and who have an amenable mutation. 1 June 2016
Generics
Teva Pharmaceutical Industries has been asked to provide more information on its New Drug Application for SD-809 (deutetrabenazine) tablets for the treatment of chorea associated Huntington disease (HD) by the US Food and Drug Administration. 1 June 2016
Pharmaceutical
The government of Ukraine is completing preparations for the de-regulation of the national pharmaceutical market, which involves easing access of Western drug imports to the market. 1 June 2016
Biotechnology
UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has asked Janssen, to set out a case for including its leukemia drug Imbruvica (ibrutinib) in the Cancer Drugs Fund (CDF). 1 June 2016
Biosimilars
The European Commission has granted marketing authorization in the European Union for Flixabi, an infliximab biosimilar referencing Remicade, Johnson & Johnson and Merck & Co's Remicade (infliximab). 31 May 2016
Biotechnology
Danish biotech firm Genmab says it has achieved a $30 million milestone in its Darzalex (daratumumab) collaboration with Janssen Biotech. 31 May 2016
Biotechnology
The US Food and Drug Administration Advisory Committee has voted against accelerated approval for eteplirsen, a drug designed to combat Duchenne muscular dystrophy (DMD). The drug was put up for accelerated approval under the FDA Safety and Innovation Act (FDASIA), but the committee found insufficient grounds for approval, noted Dr Nicola Davies in her monthly exclusive FDA Blog for The Pharma Letter. 31 May 2016
Biotechnology
The US Food and Drug Administration on Friday approved Zinbryta (daclizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). 31 May 2016
Biotechnology
The Drugs Controller General India (DCGI) has granted limited approval for manufacturing and marketing of stem cell based biological product Stempeucel for the treatment of Buerger's disease. 31 May 2016
Pharmaceutical
The US Food and Drug Administration has granted accelerated approval to liver disease drug Ocaliva (obeticholic acid), the lead product of US biopharma Intercept. 31 May 2016
Biotechnology
The European Commission has approved Strimvelis, the first ex-vivo stem cell gene therapy to treat patients with a very rare disease called ADA-SCID (severe combined immunodeficiency due to adenosine deaminase deficiency). 31 May 2016
Pharmaceutical
At its Annual Assembly last week, Spanish trade group Farmaindustria gave the green light to the amendment of the Code of Practice by which all companies adhered to it will inform healthcare professionals that transfers of value made from January 1, 2017 (to be disclosed in 2018) derived from their collaboration as far as education, scientific-professional meetings and services provision will be disclosed in an individual manner. 31 May 2016
Pharmaceutical
The European Medicines Agency started a review of the guidelines that describe first-in-human clinical trials and the data needed to enable their appropriate design and allow initiation. This is being done in cooperation with the European Commission and the Member States of the European Union. 27 May 2016
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 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
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