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Pharmaceutical
The US Food and Drug Administration has announced actions to provide important information about the risks of using German pharma major Bayer’s birth control implant Essure and to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization. 1 March 2016
Pharmaceutical
The Chinese Food and Drug Administration (CFDA) now requires all imported drugs to comply with the newest version of the China Pharmacopoeia (CP) released in 2015, reports The Pharma Letter’s local correspondent Wang Fangqing. Previously, such a requirement only targeted drugs manufactured inside mainland China. 29 February 2016
Pharmaceutical
AbbVie says that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has granted a positive opinion for the use of Viekirax (ombitasvir/paritaprevir/ritonavir tablets) + Exviera (dasabuvir tablets). 29 February 2016
Pharmaceutical
US Senator Ted Cruz wants to change the way the Food and Drug Administration approves drugs. Indeed, the introduction of his “Reciprocity Ensures Streamlined Use of Lifesaving Treatments (RESULT) Act” has sparked hot debate, says Dr Nicola Davies in her monthly FDA Blog for The Pharma Letter. 29 February 2016
Biosimilars
Even as Asia appears to be struggling to come into its own with biosimilar drugs, India seems to be offering a better market to drugmakers chasing the over $1 billion global biosimilar industry in regulated markets, reports The Pharma Letter’s India correspondent. 29 February 2016
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare has granted Orphan Drug designation to drug major Takeda Pharmaceutical’s ixazomib (MLN9708), an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. 27 February 2016
Biotechnology
US biotech firm Genentech, a subsidiary of Swiss pharma giant Roche, has received approval from the US Food and Drug Administration for Gazyva (obinutuzumab) plus bendamustine chemotherapy followed by Gazyva alone as a new treatment for people with follicular lymphoma who did not respond to a Rituxan (rituximab)-containing regimen, or whose follicular lymphoma returned after such treatment. 27 February 2016
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six new medicines, two of which were Orphan designated, for marketing authorization at its February 2016 meeting. 26 February 2016
Pharmaceutical
Leading US drugmakers represented by US Pharmaceutical Research and Manufacturers of America (PhRMA) have called on the Russian government to stop discriminating against their business in the Russian pharmaceutical market, reports The Pharma Letter’s local correspondent. 26 February 2016
Pharmaceutical
Building strong quality culture, adapting quality metrics, and demystifying data reliability issues were some of the broad issues discussed at the Indian Pharmaceutical Forum, organized by leading Indian pharma companies including Sun Pharmaceuticals, Lupin, Torrent, Cadila and Cipla. 26 February 2016
Biotechnology
Gilead Sciences revealed today that the Marketing Authorization Application tenofovir alafenamide (as fumarate; TAF) 25mg – an investigational, once-daily treatment for adults with chronic hepatitis B virus (HBV) infection – has been fully validated and is now under assessment by the European Medicines Agency. 25 February 2016
Pharmaceutical
The Food and Drug Administration has approved US pharma giant Pfizer’s Xeljanz XR (tofacitinib citrate) extended-release tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX). 25 February 2016
Pharmaceutical
US pharma major Eli Lilly today announced that the European Commission has granted a marketing authorization for its cancer drug Portrazza (necitumumab). 24 February 2016
Pharmaceutical
Sanofi Pasteur, the vaccines business of French pharma major Sanofi, says that Health Canada has approved its Fluzone 's High-Dose vaccine. 24 February 2016
Pharmaceutical
Australia’s Parliament has today passed the Turnbull Government’s historic legislation delivering the “missing piece” for Australian patients and their doctors to access a safe, legal and reliable supply of medicinal cannabis products for the management of painful and chronic conditions. 24 February 2016
Pharmaceutical
Shares in US pharma company PTC Therapeutics plunged more than 50%, after the company received a Refuse to File letter from the US Food and Drug Administration regarding the company’s new drug application for Translarna (ataluren). 23 February 2016
Pharmaceutical
US drug regulators have agreed to consider approving a fixed-ratio combination of Lantus (insulin glargine) and Lyxumia (lixisenatide) for the treatment of adults with type 2 diabetes. 23 February 2016
Biotechnology
France’s LFB Group (formerly called Laboratoire francais du Fractionnement et des Biotechnologies) has obtained the first three European marketing authorizations for its human fibrinogen, FibCLOT in Germany, Denmark and Hungary, via a decentralized licensing procedure. 23 February 2016
Pharmaceutical
Merck & Co has released positive top-line results from the company’s Phase III pivotal trial, ONCEMRK. ONCEMRK is evaluating an investigational once-daily formulation of Isentress (raltegravir) for previously untreated HIV-1 infected adults. 23 February 2016
Pharmaceutical
German pharma major Bayer has received approval from the European Commission of Kovaltry (antihemophilic Factor [recombinant]) for the treatment of hemophilia A in patients of all age groups. 22 February 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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