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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
Gastrointestinal specialist Salix Pharmaceuticals and Progenix Pharmaceuticals have had their Relistor (methylnaltrexone bromide) subcutaneous injection approved by the US Food and Drug Administration. 1 October 2014
Pharmaceutical
Japanese drug major Astellas Pharma and Medivation has received extended approval for Xtandi (enzalutamide) from the US Food and Drug Administration for the treatment of metastatic castration-resistant prostate cancer. 1 October 2014
Generics
In a bid to weed out potentially unsafe combinations, the Central Drugs Standards and Control Organization (CDSCO), headed by the Drug Controller General of India (DCGI), is to assess the safety and efficacy of several fixed dose combination drugs permitted for sale in the country, reports The Pharma Letter’s India correspondent. 30 September 2014
Pharmaceutical
The Russian Parliament (State Duma) plans to ease access to innovative and orphan drugs to the Russian market through the introduction of amendments to the existing federal law “On Circulation of Drugs” in Russia. 30 September 2014
Pharmaceutical
US pharma major Bristol-Myers Squibb has announced multiple regulatory milestones for Opdivo (nivolumab), an investigational PD-1 immune checkpoint inhibitor, in the USA and European Union. 30 September 2014
Pharmaceutical
Access to potentially life-extending cancer drugs varies significantly in different regions of the world, two new studies presented at the European Society for Medical Oncology (ESMO) 2014 Congress taking place in Madrid, Spain. 29 September 2014
Pharmaceutical
The Japanese Ministry of Health, Labor and Welfare has granted approval for domestic pharma major Daiichi Sankyo’s Lixiana (edoxaban tosylate) for the prevention of ischemic stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and for the treatment and recurrence prevention of venous thromboembolism (VTE) [deep vein thrombosis (DVT) and pulmonary thromboembolism]. 29 September 2014
Generics
Canadian trade group Research-Based Pharmaceutical Companies (Rx&D) expressed its support to the government of Canada as it reached another milestone in the finalization of the Comprehensive Economic and Trade Agreement (CETA) with the release of text at the Canada-EU Summit held today in Ottawa. 29 September 2014
Pharmaceutical
US ophthalmic drug specialist Alimera Sciences says that the US Food and Drug Administration has approved Iluvien (fluocinolone acetonide intravitreal implant) for the treatment of diabetic macular edema (DME). 28 September 2014
Pharmaceutical
The European Medicines Agency has launched a pilot project to involve patients in the assessment of the benefits and risk of medicines in its Committee for Medicinal Products for Human Use (CHMP). 26 September 2014
Pharmaceutical
Some 15 new medicines have been recommended for approval at the September meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 26 September 2014
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the regulatory approval of Duaklir Genuair (aclidinium bromide/formoterol fumarate), from Spain's largest pharma company Almirall. 26 September 2014
Generics
Ireland-headquartered generics major Actavis has filed an Abbreviated New Drug Application with the US Food and Drug Administration seeking approval to market its Buprenorphine Transdermal System, a generic version of Purdue Pharma’s Butrans. 26 September 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim Pharmaceuticals has received US Food and Drug Administration approval for Spiriva Respimat (tiotropium bromide) inhalation spray. 25 September 2014
Pharmaceutical
The US Food and Drug Administration has approved US drugmaker AbbVie’s Humira (adalimumab) for reducing signs and symptoms, and achieving and maintaining clinical remission, in pediatric Crohn's disease patients. 25 September 2014
Biotechnology
Switzerland-based Celgene International, a wholly-owned subsidiary of US biotech major Celgene, say that Swissmedic, the regulatory authority for Switzerland, has approved Abraxane as a treatment for metastatic pancreatic cancer (in combination with gemcitabine), and as a treatment for metastatic breast cancer 25 September 2014
Pharmaceutical
The number of warning letters sent by the US Food and Drug Administration increased substantially by 78% from 2007 to 2013, with pharma and biotech companies accounting for one of the highest number of warning letters. 25 September 2014
Biotechnology
Gilead Sciences has submitted a New Drug Application to Japan’s Pharmaceutical and Medical Devices Agency (PMDA) for approval of an investigational once-daily fixed-dose combination of ledipasvir (LDV) 90mg and sofosbuvir (SOF) 400mg for the treatment of chronic genotype 1 hepatitis C virus (HCV) infection in adults. 24 September 2014
Biotechnology
The UK’s drug watchdog the National Institute for Health and Care Excellence (NICE) has today issued final guidance recommending US biotech major Celgene’s Revlimid (lenalidomide) as an option for treating some people with myelodysplastic syndromes on the National Health Service. 24 September 2014
Pharmaceutical
Three drugs to treat ulcerative colitis, a chronic bowel condition, have not been proven to be more cost effective than current available treatments, doctors are being told by the UK’s drug spending watch dog, the National Institute for Health and Care Excellence (NICE). 24 September 2014
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