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Pharmaceutical
Amidst concerns about death and overdose risks from narcotic painkillers taken with certain antianxiety or sedative drugs, the US Food and Drug Administration has issued a strong “Boxed Warning” of combination usage. 1 September 2016
Pharmaceutical
The European Commission has approved US pharma giant Pfizer’s Xalkori (crizotinib) for the treatment of adults with ROS1-positive advanced non-small cell lung cancer (NSCLC), the company revealed today. 31 August 2016
Biotechnology
The US Food and Drug Administration has approved a supplemental Biologics License Application (sBLA) for Genmab’s Arzerra (ofatumumab). 31 August 2016
Pharmaceutical
PHARMAC has made decisions to award the Zoladex brand of cancer drug goserelin Sole Subsidized Supply in the community and Hospital Supply Status in District Health Board hospitals and to apply reference pricing to leuprorelin (Eligard and Lucrin) in the community. 31 August 2016
Biosimilars
Sandoz has received US Food and Drug Administration approval for Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) and polyarticular juvenile idiopathic arthritis (JIA). 31 August 2016
Pharmaceutical
In India, 33 drugs supplied to various government hospitals and stores in Arunachal Pradesh were found to be of sub-standard quality during laboratory tests. 30 August 2016
Biotechnology
Seqirus has received US Food and Drug Administration (FDA) approval for its Afluria Quadrivalent influenza vaccine for adults. 30 August 2016
Pharmaceutical
Although the performance and procedural goals for the sixth iteration of the US Prescription Drug User Fee Act (PDUFA) were laid out last month, pharmaceutical companies, including Anglo-Swedish AstraZeneca, and other stakeholders are now detailing additional recommendations on what to include in the program from fiscal years 2018 through 2022. 30 August 2016
Pharmaceutical
The Russian Federal Anti-Monopoly Service (FAS) has started investigations regarding the recent detection of a cartel in the Russian pharmaceutical market, which was created by some leading local drugmakers and global majors operating in the Russian market, according to press-service of the FAS, reports The Pharma Letter’s local correspondent. 26 August 2016
Pharmaceutical
The Ministry of Health of Ukraine has officially approved the conduct of clinical trials of drugs imported to the country – the initiative that has long been lobbied by global pharmaceutical majors, operating in the country. 26 August 2016
Pharmaceutical
Eisai today said that the anticancer agent Treakisym (bendamustine hydrochloride) for Injection 100mg been approved in Japan for an additional indication of chronic lymphocytic leukemia. 26 August 2016
Pharmaceutical
Japanese drugmaker Chugai Pharmaceutical has received approval for an additional indication of its cancer drug Xeloda (capecitabine) in Japan. 26 August 2016
Pharmaceutical
Medicines regulator Health Canada has issued a warning to healthcare professionals on the potential hepatoxicity of Revolade (eltrombopag), a thrombopoietin receptor agonist. 26 August 2016
Pharmaceutical
NICE, the medicines cost-effectiveness watchdog for England and Wales, has issued an updated guideline recommending the use of Esmya (ulipristal acetate 5mg), up to four courses, as first-line treatment for patients presenting with heavy menstrual bleeding and uterine fibroids 3cm or more in diameter. 26 August 2016
Biosimilars
Netherlands-based generics major Mylan and Indian drugmaker Biocon have had their regulatory submission for a trastuzumab biosimilar accepted by the European Medicines Agency (EMA). 25 August 2016
Biotechnology
The Food and Drug Administration has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for Parsabiv (etelcalcetide), a potential treatment for secondary hyperparathyroidism (sHPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. 25 August 2016
Pharmaceutical
Final guidance from the UK's National Institute for Health and Care Excellence (NICE) has recommended Lonsurf (trifluridine/tipiracil), within its marketing authorization, as an option for treating metastatic colorectal cancer, in adults who have had previous treatment. 24 August 2016
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today issued final guidance recommending two drugs for routine use within the National Health Service, both of which were previously available on the now being reformed Cancer Drugs Fund (CDF). 24 August 2016
Biotechnology
German pharma major Bayer has announced that its drug Eylea (aflibercept) has been recommended as a cost-effective treatment by the National Institute for Health and Care Excellence (NICE) for visual impairment due to macular oedema secondary to branch retinal vein occlusion (BRVO). 24 August 2016
Biotechnology
US drugmaker AbbVie has received a positive scientific opinion through the UK’s Early Access to Medicines Scheme (EAMS) for venetoclax, a treatment for Chronic Lymphocytic Leukemia (CLL). 23 August 2016
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
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
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