Regulation
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Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has welcomed a new treatment guideline which recommends its Brilinta (ticagrelor) over clopidogrel in acute coronary syndrome (ACS). 31 March 2016
Pharmaceutical
If you believe you know all there is to know about Japan’s pharma market, it is time for a refresher course. 30 March 2016
Pharmaceutical
Privately-held UK manufacturer of plasma-derived protein therapies Bio Products Laboratory has been granted marketing approval by the European Medicines Agency for Coagadex (human coagulation factor X). 30 March 2016
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter (CRL) to OPKO Health’s (NYSE: OPK) New Drug Application (NDA) for Rayaldee (calcifediol) as a treatment for secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. 30 March 2016
Pharmaceutical
The benefits of using Nuplazid (pimavanserin) for psychosis associated with Parkinson’s disease outweigh the risks, according to a vote of the US Food and Drug Administration Psychopharmacologic Drugs Advisory Committee. 30 March 2016
Pharmaceutical
The US Food and Drug Administration has issued a complete response letter (CRL) for the supplemental new drug application (sNDA) to include new data in the clinical trials section of the US label of Brintellix (vortioxetine) for treating certain aspects of cognitive dysfunction in adults with major depressive disorder (MDD). 30 March 2016
Pharmaceutical
US Congress has written to the National Institutes of Health (NIH) questioning the price Americans are charged for the prostate cancer drug Xtandi (enzalutamide) by Japanese company Astellas Pharma. 30 March 2016
Pharmaceutical
Italian CNS-focused drug developer Newron Pharmaceuticals and its partners Zambon and US WorldMeds have received a complete response letter from the US Food and Drug Administration relating to their Parkinson’s disease treatment Xadago (safinamide). 30 March 2016
Biotechnology
Puma Biotechnology says that, following recent meetings with the Food and Drug Administration, the company now plans to submit its New Drug Application (NDA) for the approval of neratinib for the treatment of extended adjuvant breast cancer in mid-2016. 29 March 2016
Biotechnology
US biotech firm Placon Therapeutics has been launched as an independent company. Placon was spun out from Blend Therapeutics (now Tarveda Therapeutics) to distinctly focus on a pipeline of innovative platinum-based assets. 29 March 2016
Generics
Shares in Indian drugmaker Natco Pharma were 13% down on Monday after the company provided an update on the US Food and Drug Administration inspection of its manufacturing facilities. 29 March 2016
Pharmaceutical
The outgoing chief executive of under-siege Canadian drugmaker Valeant Pharmaceuticals will be grilled by a US Senate panel over rising drug prices. 29 March 2016
Pharmaceutical
GlaxoSmithKline revealed this morning that the Japanese Ministry of Health, Labor and Welfare (MHLW) has granted approval for Nucala (mepolizumab). 29 March 2016
Biosimilars
Biocon says that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved its biosimilar insulin glargine. 29 March 2016
Pharmaceutical
Alexion Pharmaceuticals said on Monday that Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Kanuma (sebelipase alfa) for the treatment of patients of all ages in Japan with lysosomal acid lipase deficiency (LAL-D). 29 March 2016
Pharmaceutical
In our weekly expert view piece, Mark De Simone, chief executive of Aegate, a company which operates a highly secure real-time system to verify the authenticity of medicines, examines the recently published Falsified Medicines Directive (FMD). 28 March 2016
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Tagrisso (osimertinib, AZD9291). 28 March 2016
Pharmaceutical
Earlier this month, the China Food and Drug Administration (CFDA) formally launched a new classification system for chemical drugs, with the release of the Reform Scheme of the Classification System for Registration of Chemical Drugs. 28 March 2016
Biosimilars
In 2015, the US Food and Drug Administration set a new record for the number of drugs approved in one year, with 56 drugs getting the green light from the federal agency. 28 March 2016
Biotechnology
The US Food and Drug Administration has approved Cinqair (reslizumab) Injection, an interleukin 5 antagonist monoclonal antibody (IgG4 kappa) indicated for add-on maintenance treatment of patients with severe asthma aged 18 years and older, and with an eosinophilic phenotype. 24 March 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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