Regulation
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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
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
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has completed a review confirming a small increase in the risk of cardiovascular problems, such as heart attacks and strokes, in patients taking high doses of ibuprofen. 13 April 2015
Pharmaceutical
Japanese drugmakers Daiichi Sankyo and Terumo Corp say that Japan Vaccine Co, an affiliate of Daiichi Sankyo, has filed an application for the manufacture and sales approval in Japan for an intradermal seasonal influenza vaccine. 13 April 2015
Generics
The US Food and Drug Administration has confirmed receipt of the change of ownership letters that formally transfer ownership of 23 generic drug products to IDT Australia. 13 April 2015
Pharmaceutical
The Dutch Medicines Evaluation Board (MEB) has decided to issue a conditional marketing authorization for Thiosix (tioguanine), which can be used in the treatment of Crohn’s disease and ulcerative colitis in adults. 11 April 2015
Pharmaceutical
According to a preliminary review of data by US Food and Drug Administration reviewers, Anglo-Swedish pharma major AstraZeneca’s Onglyza (saxagliptin), a treatment for type 2 diabetes, may pose health risks. 11 April 2015
Pharmaceutical
Neurotrope says that it had received Orphan Drug designation by the US Food and Drug Administration for its lead proprietary drug candidate, bryostatin, in the treatment of Fragile X syndrome (FXS). 10 April 2015
Biotechnology
MedImmune, the biologics arm of Anglo-Swedish drug major AstraZeneca, has announced that it has been granted fast track designation by the US Food and Drug Administration for MEDI8897. 10 April 2015
Biosimilars
January 7, 2015 witnessed the dawning of the era of biosimilars in the United States, writes Cecil Nick, Vice President - Technical, PAREXEL International. 10 April 2015
Pharmaceutical
The US Food and Drug Administration has accepted for filing Ireland-headquartered Shire’s New Drug Application for Lifitegrast and granted a Priority Review designation. 10 April 2015
Pharmaceutical
In a globalized world, the regulatory landscape is changing every day to address, in tandem, old and new challenges, write Paul Dreaden of AbbVie and Dakshina Reddy of Novartis, members of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) African Regulatory Network. 10 April 2015
Pharmaceutical
USA-based Portola Pharmaceuticals has released positive top-line results from the second part of the Phase III ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors – Apixaban) study. 9 April 2015
Biotechnology
MedImmune, the global biologics R&D unit of Anglo-Swedish pharma major AstraZeneca, has received fast track designation from the US Food and Drug Administration for the development of MEDI8897. 9 April 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in a dossier assessment whether nintedanib (trade name Vargatef, from German family-owned pharma major Boehringer Ingelheim) offers an added benefit over the appropriate comparator therapy. 9 April 2015
Pharmaceutical
Mitochondrial and neuromuscular specialist Santhera has received Fast Track designation from the US Food and Drug Administration for Raxone/Catena (idebenone) for Duchenne muscular dystrophy. 9 April 2015
Pharmaceutical
Following a public comment period, the USA’s Federal Trade Commission has approved a final order settling charges that Swiss pharma major Novartis’ $16 billion acquisition of UK peer GlaxoSmithKline’s portfolio of cancer-treatment drugs likely would be anticompetitive. 9 April 2015
Pharmaceutical
US pharma giant Merck & Co’s grazoprevir/elbasvir, an investigational single tablet regimen for the treatment of chronic hepatitis C virus (HCV) infection, has received two new Breakthrough Therapy designations from the US Food and Drug Administration. 8 April 2015
Generics
US drugmaker Perrigo says it has received final approval from the US Food and Drug Administration of its Abbreviated New Drug Application for hydromorphone HCI extended-release tablets.. 8 April 2015
Pharmaceutical
Ireland-headquartered drugmaker Shire has reached an agreement with the US Food and Drug Administration on a clear regulatory path for SHP465 (triple-bead mixed amphetamine salts) for attention-deficit hyperactivity disorder (ADHD). 8 April 2015
Pharmaceutical
On April 1, US injectable drugs and infusion technologies and biosimilars developer Hospira received a warning letter from the US Food and Drug Administration related to an inspection of the company’s pharmaceutical manufacturing facility located in Liscate, Italy. 8 April 2015
Pharmaceutical
Swiss drug major Roche says the European Commission has approved Avastin (bevacizumab) in combination with standard chemotherapy for the treatment of adult patients with persistent, recurrent or metastatic cervical carcinoma. 8 April 2015
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