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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
Pharmaceutical
Danish CNS drug specialist Lundbeck on Tuesday with Takeda Pharmaceutical (TYO: 4502) said the US Food and Drug Administration has accepted a supplemental New Drug Application for antidepressant Brintellix (vortioxetine). 11 August 2015
Generics
Though India’s Central Drugs Standard Control Organization (CDSCO) has issued a comprehensive list of fixed-dose combination (FDC) drugs approved by the Drugs Control General of India (DCGI), which includes a total of 1,125 FDCs covering all therapeutic categories, millions of unapproved formulations continue to be sold across the counter in India, sometimes proving lethal, reports The Pharma Letter’s India correspondent. 10 August 2015
Pharmaceutical
August 10, 2015
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Swiss pharma giant Novartis’ Jakavi (ruxolitinib) offers an added benefit over the appropriate comparator therapy. 7 August 2015
Pharmaceutical
UK pharma major GlaxoSmithKline and Theravance have received regulatory approval for their drug to treat adult asthma in Canada. 7 August 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has recommended Lixiana (edoxaban) from Daiichi Sankyo for preventing stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF). 7 August 2015
Pharmaceutical
UK biopharma company GW Pharmaceuticals has been granted Fast Track designation by the US Food and Drug Administration for its proprietary intravenous form of cannabidiol to treat neonatal hypoxic-ischemic encephalopathy (NHIE). 6 August 2015
Pharmaceutical
India has deferred its trade talks with Europe following an EU decision to ban the sale of around 700 pharmaceutical products that had been tested by GVK Biosciences, an Indian contract research organization. 6 August 2015
Pharmaceutical
The UK Competition and Markets Authority (CMA) has today issued a statement of objections to the pharmaceutical suppliers Pfizer and Flynn Pharma alleging that they have breached competition law. 6 August 2015
Pharmaceutical
The UK’s National Institute for health and Care Excellence (NICE) has opened a second consultation on preliminary draft guidance on Lynparza (olaparib) from AstraZeneca, asking the company for more information. 6 August 2015
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has officially received a license for the production of drugs in Russia at its local plant, that will be soon be commissioned in the Vorsino industrial park in the Kaluga region. 5 August 2015
Pharmaceutical
The US Food and Drug Administration yesterday issued a warning that a case of definite progressive multifocal leukoencephalopathy (PML) and a case of probable PML have been reported in patients taking Gilenya (fingolimod) for multiple sclerosis (MS). 5 August 2015
Biotechnology
AusBiotech, on Tuesday said it is proposing greater incentives for investors pledging support for start-up and pre-revenue companies. The trade group said it has submitted a supplementary proposal for the government’s tax review and white paper process. 4 August 2015
Pharmaceutical
The Belgian representative body for the pharma industry, pharma.be, has signed an agreement with the Minister for Public Health, Maggie De Block, focusing on concrete measures to benefit Belgian patients. 4 August 2015
Pharmaceutical
US privately-held specialty company Aprecia Pharmaceuticals says that the US Food and Drug Administration has approved Spritam (levetiracetam). 4 August 2015
Pharmaceutical
The US Food and Drug Administration has approved German pharma major Bayer’s Finacea (azelaic acid) Foam, 15% for the topical treatment of the inflammatory papules and pustules of mild to moderate rosacea 4 August 2015
Biotechnology
Shares of Clovis Oncology gained nearly 2% to $86.21 in early trading today, when the company announced regulatory filings in the USA and Europe for its lung cancer drug candidate rociletinib. 3 August 2015
Pharmaceutical
AbbVie says that its mega blockbuster drug Humira (adalimumab) is now approved in the European Union for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa). 3 August 2015
Generics
Government authorities in Romania are investigating charges of corruption against domestic units of nearly a dozen big pharma companies including Roche (SIX: ROG), GlaxoSmithKline, Pfizer and Novartis, according to reports. 3 August 2015
Pharmaceutical
Co-administration of the oral antidiabetic agent repaglinide and oral antiplatelet drug clopidogrel (a known CYP2C8 inhibitor), may lead to a significant decrease in blood glucose levels due to a drug-drug interaction, according to a recent recall and alerts posting on pharma regulator Health Canada’s web site. 1 August 2015
Pharmaceutical
Takeda Pharmaceutical says it has completed the study to fulfill the post-marketing commitment and submissions of data to regulatory authorities from the Pan European Multi-Database Bladder Cancer Risk Characterization Study for pioglitazone containing medicines. 31 July 2015
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