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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
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care examined whether Swiss drug major Novartis’ Jakavi (ruxolitinib) offers an added benefit over the appropriate comparator therapy specified by the Federal Joint Committee for the treatment of adults with myelofibrosis. 20 August 2014
Pharmaceutical
The National Health and Medical Research Council (NHMRC), tasked with implementing a range of initiatives designed to make the process of initiating and conducting clinical trials in Australia significantly more efficient and cost-effective, has reported on the progress of work under the initiative and advised it will update the information monthly. 20 August 2014
Pharmaceutical
Japanese drug major Eisai has submitted a marketing authorization application to the European Commission for its anti-epileptic Fycompa (perampanel). 20 August 2014
Biotechnology
UK drugs watch dog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending US biotech firm Celgene’s Revlimid (lenalidomide) as an option, for treating myelodysplastic syndromes, reversing an earlier negative decision. 20 August 2014
Biotechnology
The US Food and Drug Administration late yesterday approved Cerdelga (eliglustat) for the long-term treatment of adult patients with the type 1 form of Gaucher disease, a rare genetic disorder. 20 August 2014
Biosimilars
The US Food and Drug Administration yesterday granted tentative approval for Basaglar (insulin glargine injection), which is indicated to improve glycemic control in adults with type 2 diabetes and in combination with mealtime insulin in adults and pediatric patients with type 1 diabetes. 19 August 2014
Pharmaceutical
US pharma giant Pfizer says it has completed the submission of a New Drug Application to the US Food and Drug Administration for its breast cancer drug candidate palbociclib. 19 August 2014
Pharmaceutical
Privately-held US biotech firm Globavir Biosciences said yesterday that it intends to develop its lead drug candidate, GBV006, for the treatment of the current Ebola virus outbreak in West Africa. 19 August 2014
Pharmaceutical
The UK’s clinical standards body, NICE, has agreed to re-review Ferring Pharmaceuticals’ Firmagon (degarelix) as an option for treating advanced hormone-dependent prostate cancer. 18 August 2014
Pharmaceutical
Brazilian House Bill 6763/13 introduced by Gorete Pereira (PR-EC) sets the standards to ensure the quality of medicines sold in the country, writes Juliane Carvalho on Brazil Pharma News. 18 August 2014
Pharmaceutical
Japanese pharma major Eisai has filed applications with the US Food and Drug Administration and the European Medicines Agency for the use of lenvatinib mesylate in the treatment of patients with progressive radioiodine-refractory differentiated thyroid cancer (RR-DTC). 18 August 2014
Biotechnology
The US Food and Drug Administration has approved US biotech firm Biogen Idec’s (Nasdaq: BIIB) Plegridy (peginterferon beta-1a), a new treatment for people with relapsing forms of multiple sclerosis (RMS), the company announced on Friday. 17 August 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Healthcare (IQWiG) has said that epilepsy drug Fycompa (perampanel) from Japanese drug major Eisai provides "no additional benefit" over appropriate comparators to treat partial onset seizures, with or without secondarily generalized seizures, in patients with epilepsy aged 12 years and older. 17 August 2014
Pharmaceutical
The Brazilian Ministry of Health has opened a public consultation to establish the criteria for product development partnerships (PDPs) for the health sector, writes Juliane Carvalho on Brazil Pharma News. 15 August 2014
Pharmaceutical
In the first of a new monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at whether stringent FDA regulations are causing drug shortages. 15 August 2014
Biotechnology
USA-based Amgen initiated a voluntary recall on June 26 for nine packaged lots of anemia drug Aranesp (darbepoetin alfa; 500mcg) prefilled syringes from non-US distributors, wholesalers and a number of hospital pharmacies due to the potential presence of cellulose and/or polyester particles observed in a small number of syringes during a routine quality examination. 15 August 2014
Biotechnology
Australian biotech industry leaders including AusBiotech, Cook Medical Australia and the Export Council of Australia have proposed an Australian Innovation & Manufacturing Incentive in their submission to the senate’s inquiry into the state of innovation in the country. 15 August 2014
Pharmaceutical
The US Food and Drug Administration has accepted for review the Biologics License Application for bivalent recombinant LP2086 (rLP2086), pharma giant Pfizer’s vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10 through 25 year olds. 15 August 2014
Pharmaceutical
Swiss drug major Roche has received approval from the US Food and Drug Administration for its drug Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan for the treatment of persistent, recurrent or metastatic carcinoma of the cervix. 15 August 2014
Pharmaceutical
There was good news late yesterday for German family-owned pharma major Boehringer Ingelheim, when an advisory panel of the US Food and Drug Administration came back with a majority vote to recommend approval of the firm’s lung disease drug. 15 August 2014
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