Regulation
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Biotechnology
EuropaBio, the trade association for the European biotech industry, has called on EU policymakers to continue promoting innovation while maintaining safety and efficacy standards. 30 September 2015
Biotechnology
Clovis Oncology yesterday announced two major regulatory milestones for rociletinib. 30 September 2015
Pharmaceutical
Shares in Newron Pharmaceuticals dropped nearly 4.4% on the Swiss Exchange after the company said the US regulators have extended the review of its Parkinson's disease drug by three months. 30 September 2015
Pharmaceutical
CPhI Worldwide, organized by UBM EMEA, today announces the findings of part ii of its 2015 annual report (titled: ‘Quality, metrics and continuous processing’) ahead of CPhI Worldwide 2015 in Madrid, with experts looking at the implications of “quality by design” (QbD), continuous processing, excipient criticality and process validation on pharmaceutical manufacturing. 30 September 2015
Pharmaceutical
The monitoring of adverse drug reactions (ADRs) has become paramount in India, with the country eager to put in place regulatory mechanisms to curb the menace of rising ADRs, as well as continue with its emphasis on collection of data on ADRs to ensure patient safety, reports The Pharma Letter’s India correspondent. 29 September 2015
Pharmaceutical
French drug major Sanofi on Tuesday said the US Food and Drug Administration has accepted a New Drug Application (NDA) for its drug candidate to treat type 2 diabetes. 29 September 2015
Pharmaceutical
Australian ophthalmic drug delivery specialist pSivida says it now plans to file a New Drug Application for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials. 29 September 2015
Pharmaceutical
AbbVie says that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Viekirax (ombitasvir/paritaprevir/ritonavir). 28 September 2015
Pharmaceutical
Merck & Co has received approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for Marizev (omarigliptin) an oral, once-weekly DPP-4 inhibitor indicated for the treatment of adults with type 2 diabetes. 28 September 2015
Biotechnology
The European Commission has granted marketing authorization for Praluent (alirocumab) for the treatment of low-density lipoprotein (LDL) cholesterol, in certain adult patients with hypercholesterolemia. 28 September 2015
Pharmaceutical
How long does it take for a new medicine to be approved by the US Food and Drug Administration? That depends. As with many government agencies around the world, the application and approval process takes many different paths, writes Dr Nicola Davies in her monthly exclusive for The Pharma Letter. 28 September 2015
Pharmaceutical
The US Food and Drug Administration on Friday approved Tresiba (insulin degludec injection) and Ryzodeg 70/30 (insulin degludec/insulin aspart injection) to improve blood sugar (glucose) control in adults with diabetes mellitus. 26 September 2015
Pharmaceutical
The Committee for Medicinal Products for Human use (CHMP) of the European Medicines Agency has issued a positive opinion following an accelerated assessment, recommending European approval of idarucizumab (to be marketed as Praxbind). 26 September 2015
Biotechnology
Gilead Sciences has received a positive opinion form the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency for its investigational, once-daily single tablet regimen Genvoya (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide (TAF) 10mg) for the treatment of HIV-1 infection. 26 September 2015
Biotechnology
Biogen and Swedish Orphan Biovitrum have received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of Elocta (rFVIIIFc). 26 September 2015
Pharmaceutical
Merck KGaA and Pfizer have partnered with Dako to develop avelumab, a trial stage immunology compound to treat various kinds of cancers. 26 September 2015
Biotechnology
The European Medicines Agency has recommended granting a marketing authorisation for Kyprolis (carfilzomib) to treat patients with multiple myeloma whose disease has relapsed. 25 September 2015
Pharmaceutical
Swiss pharma giant Roche said today that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Cotellic (cobimetinib), when used in combination with Zelboraf (vemurafenib), for the treatment of BRAF V600 mutation-positive unresectable or metastatic melanoma. 25 September 2015
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s Xarelto (rivaroxaban) for an additional indication, the treatment and secondary prevention of pulmonary thromboembolism and deep vein thrombosis. 25 September 2015
Biotechnology
Danish biotech company Genmab has been granted accelerated assessment for daratumumab in double refractory multiple myeloma by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. 25 September 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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