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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
Japanese pharma major Eisai said today that it has submitted its first marketing authorization application for its novel in-house developed anticancer agent lenvatinib mesylate for the treatment of thyroid cancer in Japan. 26 June 2014
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation to idarucizumab, an investigational fully-humanized antibody fragment, or Fab, being studied as a specific antidote to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate), by German family-owned drug major Boehringer Ingelheim. 26 June 2014
Pharmaceutical
Swiss drugmaker Basilea Pharmaceutica saw its shares drop as much as 12% yesterday, after it revealed that the US Food and Drug Administration would require additional Phase III clinical data before it could approve the firm’s ceftobiprole, intended for the treatment of pneumonia, in light of new regulatory requirements for pneumonia in the USA. 26 June 2014
Pharmaceutical
There was disappointment for Anglo-Swedish pharma major AstraZeneca yesterday when a US Food and Drug Administration advisory panel voted against approval of its investigational ovarian cancer drug. 26 June 2014
Pharmaceutical
US specialty pharma firm Insys Therapeutics says that the US Food and Drug Administration has granted orphan drug designation to its pharmaceutical cannabidiol (CBD) for the treatment of Lennox-Gastaut syndrome, a rare pediatric-onset epilepsy. 25 June 2014
Pharmaceutical
The US Food and Drug Administration has completed its safety review and has found no clear evidence of increased cardiovascular risks associated with use of the blood pressure drug olmesartan in diabetic patients. 25 June 2014
Pharmaceutical
The report of an initiative undertaken jointly by the European Medicines Agency and the European network for Health Technology Assessment (EUnetHTA) to make regulators’ reports about scientific assessments of medicines better usable by health technology assessment (HTA) bodies, has been published in Value in Health, the Journal of The International Society for Pharmacoeconomics and Outcomes Research. 25 June 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has issued new final guidance recommending Invokana (canagliflozin), from US health care giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen-Cilag, for treating some people with type 2 diabetes. 25 June 2014
Biotechnology
US biotech firm Vertex Pharmaceuticals saw its share price rocket nearly 52% to $101.20 in extending trading yesterday after the company released new research data with its lumacaftor. 24 June 2014
Pharmaceutical
The US Food and Drug Administration is warning that the intravenous chemotherapy drug docetaxel contains ethanol, also known as alcohol, which may cause patients to experience intoxication or feel drunk during and after treatment. 23 June 2014
Pharmaceutical
The Italian Medicines Agency (Agenzia Italiana del Farmaco) has granted marketing authorization for Iluvien (fluocinolone acetonide intravitreal implant) from US ophthalmic pharma specialist Alimera Sciences. 23 June 2014
Generics
The number of drugs in the Russian market will decline significantly over the next several years, due to state plans to reduce the number of medicines with similar active ingredients, according to Elena Maksimkina, director of department of drug provision and regulation of Russia’s Ministry of Health. 23 June 2014
Pharmaceutical
Australian pharma regulator the Therapeutic Goods Administration (TGA) is reviewing new information regarding ivabradine (Coralan), French independent drugmaker Servier’s cardiovascular drug approved in the European Union as Procoralan, identified in the preliminary results of a study into the medicine. 23 June 2014
Pharmaceutical
Pharmaceutical companies in Cyprus will disclose transfers of value to health care professionals, as part of a Europe-level initiative to apply a stricter self-regulatory framework in the sector and increase transparency. 23 June 2014
Pharmaceutical
The Pharmaceutical Research and Manufacturers of America (PhRMA) has announced the release of a report at the Health Technology Assessment International (HTAi) annual meeting in Washington DC, USA. 23 June 2014
Pharmaceutical
German family-owned pharma major Boehringer Ingelheim revealed that, following a re-evaluation of its strategy in hepatitis C (HCV), the company has decided not to move forward in this therapeutic area. 23 June 2014
Pharmaceutical
The US Food and Drug Administration has approved Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections. 22 June 2014
Pharmaceutical
The US Food and Drug Administration is requiring manufacturers to include a general warning in the drug labeling of all approved testosterone products about the risk of blood clots in the veins. 22 June 2014
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved German pharma major Bayer’s oral multi-kinase inhibitor Nexavar (sorafenib) for the treatment of patients with unresectable differentiated thyroid carcinoma. The MHLW granted Nexavar orphan drug status for thyroid carcinoma in September 2013. 20 June 2014
Pharmaceutical
UK health care watchdog the National Institute for Health and Care Excellence (NICE) has today published updated draft guidance recommending National Health Service use of US pharma major Eli Lilly’s Efient (prasugrel) in combination with aspirin for preventing blood clots in people who have had a heart attack or who have unstable angina and who are also having a procedure to widen narrowed arteries in the heart (percutaneous coronary intervention). 20 June 2014
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