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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
Biosimilars
The US Federal Trade Commission has granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act) in connection with the biosimilars deal between US biotech firm Pfenex and Hospira. 23 March 2015
Pharmaceutical
The Ukrainian pharma organization, the Association of Pharmaceutical Research and Development (APRaD) has visited Brussels to meet with the EFPIA and other European Commission services to discuss the advancement of healthcare reform in Ukraine. 23 March 2015
Biotechnology
Reversing a previous negative opinion, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now come out in favor of now defunct Dendreon’s Provenge (sipuleucel-T) for the treatment of men with metastatic prostate cancer who have few or no symptoms and do not yet require chemotherapy. 23 March 2015
Biosimilars
Speaking at the first Biological Medicines Forum organized by the Associations last week, the president of trade group Farmaindustria, Antoni Esteve, defended the principle of non-interchangeability of biological and biosimilar medicines. “Only an individualized deliberation might advise to change a treatment which is already working well for a given patient,” he said. 21 March 2015
Generics
Indian drugmaker Aurobindo Pharma has received tentative approval from the US Food and Drug Administration for generic lacosamide tablets 50mg, 100mg, 150mg and 200mg. 21 March 2015
Biotechnology
Leading USA-based biotech firm Amgen has filed for approval of Repatha (evolocumab) for the treatment of high cholesterol has been submitted for review to the Ministry of Health, Labor and Welfare in Japan. 20 March 2015
Pharmaceutical
Dilaforette, a portfolio company of Karolinska Development, a Nordic investor in life sciences, has been granted orphan drug designation by the US Food and Drug Administration for its sevuparin. 20 March 2015
Pharmaceutical
The UK pharma sector expects one of its biggest challenges to be the risk of incurring fines as they establish in emerging economies, according to research by MindMetre Research and commissioned by life science consultancy firm Maetrics. 20 March 2015
Pharmaceutical
There was conflicting news yesterday for UK pharma major GlaxoSmithKline and US partner Theravance from a US Food and Drug Administration expert panel review of the companies’ Breo Ellipta (fluticasone furoate/vilanterol [FF/V]). 20 March 2015
Biotechnology
Amicus Therapeutics has had positive meetings with regulatory authorities in Europe and the USA to discuss the approval pathways for the oral small molecule pharmacological chaperone migalastat as a precision medicine monotherapy for Fabry patients who have amenable genetic mutations. 19 March 2015
article
French ophthalmic specialist Nicox has been granted orphan drug designation by the US Food and Drug Administration for naproxcinod in Duchenne Muscular Dystrophy. 19 March 2015
Biotechnology
There was good news for US biotech firm Vertex Pharmaceuticals yesterday, when the US Food and Drug Administration granted approval Kalydeco (ivacaftor) for use in children ages two to five with cystic fibrosis (CF). 18 March 2015
Pharmaceutical
Research from the German Institute for Quality and Efficiency in Healthcare (IQWiG) published in the British Medical Journal has shown that early benefit assessment documentation is a tool with which to increase trial data transparency. 18 March 2015
Biotechnology
EuropaBio, the European Association for Bioindustries, and the Deerfield Institute have partnered to carry out a survey on the current state of regulatory and health technology assessment (HTA) advice with a special focus on small and medium sized enterprises (SMEs). 18 March 2015
Biotechnology
Shares of US biotech firm Aeolus Pharmaceuticals leapt 27.9% to $0.32 yesterday, after the company revealed that it has received notice from the Office of Orphan Products Development at the US Food and Drug Administration granting Orphan Drug Designation for AEOL 10150 for the treatment of idiopathic pulmonary fibrosis (IPF). 18 March 2015
Biotechnology
The European Commission has approved Swiss pharma giant Novartis’ Jakavi (ruxolitinib) for the treatment of adult patients with polycythemia vera (PV) who are resistant to or intolerant of hydroxyurea. 17 March 2015
Generics
The Russian General's Prosecutor Office has issued a warning to a local firm Veropharm, one of Russia’s leading drugmakers, (which was recently acquired by the USA’s Abbott Laboratories about the permissibility of compliance with any anti-Russian sanctions. 16 March 2015
Pharmaceutical
The US Food and Drug Administration has approved the supplemental New Drug Application for Saphris (asenapine), from Ireland-headquartered generics major Actavis. 16 March 2015
Pharmaceutical
The US Food and Drug Administration has cancelled the meeting of the Anesthetic and Analgesic Drug Products Advisory Committee scheduled for March 18, which had planned to discuss US pharma giant Merck & Co’s resubmission of the New Drug Application for sugammadex injection. 14 March 2015
Biosimilars
South Korea-based Samsung Bioepis, a joint venture between Samsung and US biotech firm Biogen Idec, says it has submitted Marketing Authorization Application for SB2, its biosimilar candidate Remicade (infliximab), market in Europe by Johnson & Johnson, to the European Medicines Agency. 13 March 2015
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