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Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
USA-based Pharmacyclics says that the US Food and Drug Administration has accepted for filing its supplemental New Drug Application to support the review of Imbruvica (ibrutinib) in the treatment of patients with chronic lymphocytic leukemia and small lymphocytic lymphoma who have received at least one prior therapy for a full approval. 9 June 2014
Generics
US generics major Mylan has launched carboplatin injection, 50mg/5ml, in multi-dose vials, which is the generic version of Bristol-Myers Squibb's Paraplatin injection, in the USA. 9 June 2014
Pharmaceutical
Canadian drugmaker Valeant Pharmaceuticals International’s US subsidiary has received approval from the US Food and Drug Administration for its New Drug Application for Jublia (efinaconazole 10% topical solution), for the treatment of onychomycosis of the toenails. 9 June 2014
Pharmaceutical
The European Commission has endorsed the recent Committee for Medicinal Products for Human Use (CHMP) positive opinion recommending the expanded use of Swiss drug major Novartis’ blockbuster drug Gilenya (fingolimod) for adult patients with highly active relapsing-remitting multiple sclerosis. 9 June 2014
Biotechnology
USA-based Momenta Pharmaceuticals says that its novel oncology candidate, necuparanib (formerly M402), has received orphan drug designation from the US Food and Drug Administration for the treatment of pancreatic cancer. 9 June 2014
Pharmaceutical
The US Food and Drug Administration has granted orphan drug status to privately-held US pharma company Edison Pharmaceuticals’ vatiquinone for the treatment of Leigh syndrome. 9 June 2014
Biotechnology
There was good news for US antivirals major Gilead Sciences, when France’s health technology assessment agency, Commission de la Transparence, issued a positive recommendation for the firm’s new breakthrough chronic hepatitis C treatment Sovaldi (sofosbuvir). 9 June 2014
Biotechnology
The US Food and Drug Administration on Friday approved US biotech firm Biogen Idec’s Eloctate, antihemophilic factor (Recombinant), Fc fusion protein, for use in adults and children who have hemophilia A. The company’s shares edged 1% higher in after hours trading to $320.70. 9 June 2014
Pharmaceutical
The European Commission (EC) has approved the use of Janssen-Cilag International's Sylvant (siltuximab) for the treatment of adult patients with multicentric Castleman's disease (MCD) who are human immunodeficiency virus (HIV) negative and human herpes virus-8 (HHV-8) negative. 8 June 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim said today that its blood thinner Pradaxa (dabigatran etexilate) has been approved by the European Commission for the treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism. 6 June 2014
Pharmaceutical
The US Food and Drug Administration has granted Fast Track designation to UK-based GW Pharmaceuticals’ investigational cannabidiol (CBD) product, Epidiolex, in the treatment of Dravet syndrome, a treatment-resistant form of childhood epilepsy. 6 June 2014
Pharmaceutical
The European Medicines Agency has released a draft guide on the monitoring of medical literature and the entry of relevant information into the EudraVigilance database, for a two-month public consultation, on which stakeholders are invited to comment, no later than July 27. 6 June 2014
Generics
European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice at Indian drugmaker Ranbaxy Laboratories’ manufacturing site in Toansa, India, that had led to the suspension of the GMP certificate for the site in the European Union, regulators have concluded. 5 June 2014
Biotechnology
US biotech firm Halozyme Therapeutics saw its shares rise after revealing that the US Food and Drug Administration has removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase II trial evaluating PEGPH20 in patients with pancreatic cancer permitting the study to resume under a revised protocol. 5 June 2014
Pharmaceutical
The Brazilian National Health Surveillance Agency (ANVISA) recently presented a proposal with new rules to speed up the authorization of clinical trials of medical products in Brazil, writes Juliane Carvalho of Brazil Pharma News. 5 June 2014
Pharmaceutical
The European Medicines Agency has validated a Marketing Authorization Application (MAA) for Leber’s hereditary optic neuropathy (LHON) from Swiss drugmaker Santhera Pharmaceuticals. 5 June 2014
Biosimilars
The increased number of health related proposed country specific recommendations (CSR) to European Union member states by the European Commission for 2014-2015 offers an opportunity to promote healthcare reforms that support improved access to medicines, says the European Generic Medicines Association (EGA). 5 June 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim said this morning that the European Medicines Agency has accepted an accelerated marketing authorization application for the review of nintedanib, an investigational tyrosine kinase inhibitor for the treatment of idiopathic pulmonary fibrosis. 5 June 2014
Pharmaceutical
The European Medicines Agency has published a revised guideline on the acceptability of names for human medicines processed through the centralized procedure. 4 June 2014
Biosimilars
The European Generic Medicines Association (EGA) has welcomed the 67th World Health Assembly’s Resolution on Access to biotherapeutic products including similar biotherapeutic products and ensuring their quality, safety and efficacy and the Resolution on Regulatory system strengthening for medical products. 4 June 2014
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