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Pharmaceutical
At a recent official ceremony, five organizations signed a Memorandum of Understanding regarding the establishment of a Bulgarian Organization for Medicines Verification (BgMVO). 4 September 2015
Biotechnology
ACADIA Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration seeking approval for Nuplazid (pimavanserin) for the treatment of psychosis associated with Parkinson’s disease. 3 September 2015
Pharmaceutical
The US Department of Health and Human Services yesterday announced proposed revisions to the regulations that govern research on individuals who participate in research. 3 September 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines cost watchdog for England and Wales, has published final draft guidance today which does not recommend US biotech major Celgene Otezla (apremilast) for adults with active psoriatic arthritis that has either not responded to disease-modifying antirheumatic drug (DMARD) therapy, or where such therapy is not tolerated. 3 September 2015
Pharmaceutical
In final draft updated guidance published today, UK medicines cost watchdog the National Institute for Health and Care Excellence (NICE) confirms its recommendations for treatment options for people with rheumatoid arthritis. 3 September 2015
Pharmaceutical
The European Commission has approved Revolade (eltrombopag) for the treatment of adults with severe aplastic anemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pre-treated and are unsuitable for hematopoietic stem cell transplant. 2 September 2015
Pharmaceutical
Swiss drug major Novartis said its trial drug to treat heart failure has received a positive scientific opinion from the regulators and that eligible patients will now have access to the treatment before a final European licensing decision. 2 September 2015
Pharmaceutical
The US Food and Drug Administration has approved Varubi (rolapitant) to prevent delayed phase chemotherapy-induced nausea and vomiting (emesis). 2 September 2015
Generics
Health Canada took action last September (The Pharma Letter October 1, 2014) to restrict products coming to Canada from Apotex Pharmachem India and Apotex Research Private in India due to unsatisfactory processes and systems in place to assure Canadians of their quality and safety. 2 September 2015
Biotechnology
The US Food and Drug Administration has accepted for priority review the Biologics License Application (BLA) for Empliciti (elotuzumab), from US pharma majors Bristol-Myers Squibb and AbbVie. 2 September 2015
Pharmaceutical
The European Commission has approved two enzyme replacement therapies, Kanuma (sebelipase alfa) and Strensiq (asfotase alfa), from Alexion. 1 September 2015
Pharmaceutical
After a first early benefit assessment, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined whether afatinib offers an added benefit over the appropriate comparator therapy. 1 September 2015
Biotechnology
AusBiotech, the representative body for the Australian biotech industry, has responded to the Medicines and Medical Devices (MMD) stakeholder forum, discussing the review of medicines and medical devices regulation. 1 September 2015
Pharmaceutical
From today (September 1), patients with melanoma have access to breakthrough medicine Keytruda (pembrolizumab), from US pharma giant Merck & Co, on Australia’s Pharmaceutical Benefits Scheme (PBS), Minister of Health Sussan Ley announced . 1 September 2015
Pharmaceutical
The European Federation of Pharmaceutical Industries and Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE) and the European Association for Bioindustries (EuropaBio), have filed a complaint with the European Commission against the French “RTU Regime,” the first implementing act of which became effective as of September 1, 2015. 1 September 2015
Biosimilars
In March 2015, the Netherlands Medicines Evaluation Board (MEB) updated its stance about biosimilar medicines (The Pharma Letter April 7). 1 September 2015
Pharmaceutical
Swiss drug major Novartis has received approval from the European Commission for the combination of Tafinlar (dabrafenib) and Mekinist (trametinib) to treat adult patients with unresectable or metastatic melanoma with BRAF V600 mutation. 1 September 2015
Biosimilars
The global biosimilars market could reach $35 billion by 2020 from the estimated $1.3 billion in 2013, a new report has suggested. 1 September 2015
Pharmaceutical
Danish allergy specialist ALK-Abello announced it has successfully completed the registration procedure for its house dust mite (HDM) sublingual allergy immunotherapy (SLIT) tablet in 11 European countries. 31 August 2015
Pharmaceutical
The US Food and Drug Administration is warning that the type 2 diabetes medicines sitagliptin, saxagliptin, linagliptin and alogliptin may cause joint pain that can be severe and disabling. 30 August 2015
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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