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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
For the third time in one year, the German Institute for Quality and Efficiency in Health Care (IQWiG) reviewed aflibercept, drug major Bayer’s ophthalmic drug Eylea, returning a negative opinion. 8 January 2014
Pharmaceutical
In an early benefit assessment under the German Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) examined whether UK pharma giant GlaxoSmithKline’s drug Tafinlar (dabrafenib) offers an added benefit over the appropriate comparator therapy. 7 January 2014
Pharmaceutical
US biotech company Celgene’s European subsidiary today announced that the European Commission has granted approval for Abraxane in combination with gemcitabine for first-line treatment of adult patients with metastatic pancreatic cancer. 7 January 2014
Pharmaceutical
Brazil-based pharma firm moksha8 has filed applications with the Brazilian regulatory authority, ANVISA, for approval of Viibryd (vilazodone) for major depressive disorders and Colobreathe (colistimethate sodium) to treat lung infections in patients with cystic fibrosis. 6 January 2014
Biotechnology
US clinical-stage biotech firm DiaVacs has granted orphan drug designation for its type 1 diabetes mellitus (T1DM) therapy DV-0100 from the Office of Orphan Products Development of the Food and Drug Administration. 6 January 2014
Pharmaceutical
US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) has received Fast Track designation from the US Food and Drug Administration for its investigational immunotherapy bavituximab for the treatment of second-line non-small cell lung cancer (NSCLC). 6 January 2014
Pharmaceutical
The UK House of Commons Public Accounts Committee is calling for all data on drugs being prescribed in the UK to be made available. The lack of data on the effectiveness of medicines available to doctors and researchers is "of extreme concern," say the group of Members of Parliament (MPs). 6 January 2014
Biotechnology
The European Commission has granted orphan drug designation to US biotech firm NPS Pharmaceuticals Natpara (recombinant human parathyroid hormone (rhPTH [1-84]) for the treatment of hypoparathyroidism. 4 January 2014
Pharmaceutical
China’s Food and Drug Administration announced on January 2 that the country’s three leading manufacturers of hepatitis B vaccine in China have suspended production, reports the state news agency Xinhua. 3 January 2014
Pharmaceutical
Treatment Action Movement (TAM), a coalition of HIV treatment activists in Nigeria, in collaboration with the AIDS Healthcare Foundation (AHF-Nigeria) has instituted a campaign to eliminate the supply of sub-standard antiretrovirals (ARVs) at treatment centers in Nigeria, reports the AllAfrica news service. 3 January 2014
Biotechnology
US biotech firm Cell Therapeutics has received notification from the US Food and Drug Administration that the partial clinical hold on tosedostat (IND 075503) has been removed and all studies underway with the drug may continue. 2 January 2014
Pharmaceutical
The USA’s global share of biomedical research spending fell from 51% in 2007 to 45% in 2012, while Japan and China saw dramatic increases in research spending. 2 January 2014
Pharmaceutical
The new German coalition government has decided to partially revoke the AMNOG (Act on the Reform of the Market for Medical Products), pharmaceutical pricing legislation that was introduced in December 2010. 2 January 2014
Pharmaceutical
The US Food and Drug Administration has accepted Cubist Pharmaceuticals’ New Drug Application for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review. 31 December 2013
Biotechnology
US biotech firm Cell Therapeutics’ Pixuvri (pixantrone), a treatment for an aggressive type of cancer that develops in the body’s immune system, has been given the green light in final draft guidance from UK drugs watchdog the National Institute for Health and Care Excellence (NICE). 31 December 2013
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has today announced that Germany-based Bayer’s Eylea (aflibercept solution for intravitreal injection should be recommended as a treatment option for visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO). 31 December 2013
Biosimilars
The US Federal Trade Commission announced its one-day public workshop on competition and follow-on biologics, or biosimilars, has been rescheduled for February 4, 2014. 31 December 2013
Pharmaceutical
Japanese drugmaker Ono Pharmaceutical has filed an application to obtain a manufacturing and marketing approval in Japan for its nivolumab (ONO-4538/BMS-936558) for treatment of malignant melanoma. 30 December 2013
Pharmaceutical
Denmark’s Veloxis Pharmaceuticals has submitted a New Drug Application to the US Food and Drug Administration seeking approval for the marketing and sale of Envarsus (once-daily tacrolimus; formerly LCP-Tacro) for the prevention of organ rejection in kidney transplant recipients. 30 December 2013
Pharmaceutical
There was a significant disappointment this morning for French drug major Sanofi, when it revealed that its US biotech subsidiary Genzyme had received a Complete Response Letter from the US Food and Drug Administration for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. 30 December 2013
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