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Biosimilars
South Korea’s Celltrion has received approval to sell its Remsima from the Ministry of Health of the Russian Federation (Minzdrav) on July 13, reported BusinessKorea. 15 July 2015
Pharmaceutical
Takeda Pharmaceutical says it has submitted a New Drug Application to the US Food and Drug Administration for ixazomib. 15 July 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved Anglo-Swedish pharma major AstraZeneca’s Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). 14 July 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has recommended a new treatment to help patients suffering from blood clots in the legs and lungs. 13 July 2015
Pharmaceutical
The US House of Representatives has voted 344 to 77 in favor of the 21st Century Cures Act, which would speed up the approval of drugs and medical devices and boost funding for research. 13 July 2015
Pharmaceutical
The European Medicines Agency announced today that it has started a review of human papillomavirus (HPV) vaccines to further clarify aspects of their safety profile. 13 July 2015
Pharmaceutical
Medicines Australia, the representative body for the pharma industry, has tabled a submission to urge the Australian Parliament to pass legislation creating the Medical Research Future Fund (MRFF). 13 July 2015
Pharmaceutical
The US Food and Drug Administration has approved Rexulti (brexpiprazole), from Japanese drugmaker Otsuka and Danish CNS specialist Lundbeck. 11 July 2015
Pharmaceutical
The European Commission has approved Janssen-Cilag’s Imbruvica (ibrutinib) capsules as a treatment option for adult patients with Waldenström's macroglobulinemia (WM). 10 July 2015
article
The pharma sector is poorly prepared for the major changes in data protection that the EU General Data Protection Regulation will bring, according to a survey by Crown Records Management. 10 July 2015
Pharmaceutical
An advisory panel to the US Food and Drug Administration has informally supported approval of necitumumab, an experimental lung cancer drug from Eli Lilly while recommending mitigating the drug’s risks. 10 July 2015
Pharmaceutical
The US Food and Drug Administration is strengthening an existing label warning that non-aspirin non-steroidal anti-inflammatory drugs (NSAIDs) increase the chance of a heart attack or stroke. 10 July 2015
Biotechnology
Trade group EuropaBio once again called on European policymakers to remove the hurdles preventing European patients’ access to personalized medicine (PM). 10 July 2015
Pharmaceutical
The Austrade Industry Capability Report (Clinical Trials) points out the distinct advantages that Australia presents as a place to conduct clinical trials. 10 July 2015
Pharmaceutical
A drug to treat Crohn’s disease has been recommended for routine National Health service funding in England by the medicine costs watchdog the National Institute for Health and Care Excellence (NICE). 10 July 2015
Generics
Israel-based generics giant Teva Pharmaceutical Industries has launched its generic version of the migraine drug Axert (almotriptan malate) tablets in the USA. 9 July 2015
Pharmaceutical
The US Food and Drug Administration has posted briefing documents on its website saying that Eli Lilly’s necitumumab extended overall survival but also raised the risk of potentially fatal thromboembolic events. 8 July 2015
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca and USA-based Ironwood Pharmaceuticals say that top-line data demonstrate linaclotide met all primary and secondary endpoints, covering multiple abdominal and constipation symptoms, in a Phase III clinical trial of adults with irritable bowel syndrome with constipation (IBS-C). 8 July 2015
Pharmaceutical
The European Commission has announced that Hetlioz (tasimelteon) from US pharma company Vanda Pharmaceuticals has been approved to treat non-24-hour sleep-wake disorder in totally blind adults. 8 July 2015
Pharmaceutical
China will begin regular surprise inspections on pharmaceutical and medical device firms from September 1, according to the China Food and Drug Administration (CFDA) reported by the state news agency Xinhau. 8 July 2015
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
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