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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
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
Pharmaceutical
Ireland-headquartered Shire has had its marketing authorization extended for its short bowel syndrome (SBS) treatment Revestive (teduglutide) by the European Commission to allow for use by pediatric patients. 7 July 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has today recommended National Health Service use of US pharma giant Pfizer’s Bosulif (bosutinib) for treating some people with chronic myeloid leukemia. 7 July 2016
Pharmaceutical
The Spanish government has confirmed its interest in Spain hosting the European Medicines Agency (EMA) if it moves from its current UK base following the vote for Brexit in last month’s referendum. 6 July 2016
Biotechnology
US-based specialty pharma company Insys Therapeutics has received US Food and Drug Administration (approval for its cannabis-derived drug Syndros. 6 July 2016
Biotechnology
The European Commission (EC) has granted marketing authorization for Zinbryta (daclizumab) to treat adults with relapsing forms of multiple sclerosis (RMS). 6 July 2016
Pharmaceutical
After listening to what New Zealanders had to say, the country’s Pharmaceutical Management Agency PHARMAC said today that it has changed the way it makes decisions - the most significant change to its decision making in its 23 year history. 6 July 2016
Pharmaceutical
Russian pharmaceutical companies plan to significantly increase the volume of investments in the conduct of clinical trials of their drugs over the next few years, according to recent statements of drugmakers. 5 July 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), has today issued draft guidance for the use of Opdivo (nivolumab) for previously treated advanced renal cell carcinoma in adults, saying it does not recommend this Bristol-Myers Squibb drug for this kidney cancer indication. 5 July 2016
Pharmaceutical
Bial said today that its Ongentys (opicapone) for the treatment of adult Parkinson´s disease patients with motor fluctuations was approved by the European Commission. 5 July 2016
Pharmaceutical
AbbVie’s Humira (adalimumab) has today received approval from the European Medicines Agency as the first and only biologic medicine authorized for patients with certain types of non-infectious uveitis, an inflammatory, painful eye condition that can lead to blindness. 5 July 2016
Biotechnology
French pharma major Sanofi and US biotech firm Regeneron Pharmaceuticals have received Japanese approval for Praluent (alirocumab) to treat uncontrolled low-density lipoprotein (LDL) cholesterol, in certain patients with hypercholesterolemia at high cardiovascular risk. 5 July 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) assessed the added benefit of ticagrelor for patients with acute coronary syndrome already in 2011 in its very first dossier assessment, just after the Act on the Reform of the Market for Medicinal Products (AMNOG) had come into force. 5 July 2016
Pharmaceutical
The European Medicines Agency today said it has concluded its second inquiry within the framework of its infringement procedure against Swiss pharma giant Roche. 4 July 2016
Pharmaceutical
Daiichi Sankyo and Belgian drugmaker UCB today announced the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Vimpat (lacosamide). 4 July 2016
Pharmaceutical
Takeda Pharmaceutical has submitted a New Drug Application (NDA) to the Ministry of Health, Labor and Welfare in Japan for ixazomib. 4 July 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has recommended privately-held Switzerland-headquartered drugmaker Ferring Pharmaceuticals’ Firmagon (degarelix) for a group of men with advanced hormone-dependent prostate cancer – those with spinal metastases. 1 July 2016
Pharmaceutical
US pharma major AbbVie says that the US Food and Drug Administration has approved Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. 1 July 2016
Pharmaceutical
Ampio Pharmaceuticals today announced disappointing results of the Ampion PIVOT clinical trial as well as a comprehensive analysis that integrates trial data from three single injection studies that will be presented to the Food and Drug Administration. 30 June 2016
Pharmaceutical
Medicines regulator Health Canada published final regulations in the Canada Gazette, Part II requiring mandatory reporting by industry of drug shortages and discontinuances of sales. Health Canada is on track to implement these regulations, which will be supported by a new third party reporting website, by spring 2017. 30 June 2016
Generics
Earlier this week, iPR Pharmaceuticals, the owner of NDA 021366 for Crestor (rosuvastatin calcium) and Anglo-Swedish pharma major AstraZeneca (LSE: AZN), which markets the cholesterol drug, filed a Complaint a in the US District Court for the District of Columbia seeking to block the US Food and Drug Administration’s approval of Abbreviated New Drug Applications (ANDAs) for generic Crestor tablets. 30 June 2016
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