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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
Anglo-Swedish drug major AstraZeneca has received marketing authorization from the European Commission for Lynparza (olaparib) capsules for certain kinds of ovarian, fallopian tube, or primary peritoneal cancer. 18 December 2014
Pharmaceutical
The US Food and Drug Administration today approved Xtoro (finafloxacin otic suspension), a new drug used to treat acute otitis externa, commonly known as swimmer’s ear. Xtoro is manufactured Alcon Laboratories. 18 December 2014
Pharmaceutical
Halaven (eribulin) manufactured by Japanese drug major Eisai is now available in Russia. 18 December 2014
Pharmaceutical
The US Food and Drug Administration has approved Somatuline Depot (lanreotide) injection 120mg, manufactured by Ipsen for adult patients with unresectable, well- or moderately-differentiated, locally advanced or metastatic gastroenteropancreatic neuroendocrine tumors. 17 December 2014
Pharmaceutical
In final guidance published today, UK health cost watchdog the National Institute for Health and Care Excellence (NICE) has recommended German family-owned pharma major Boehringer Ingelheim’s anti-blood clotting drug Pradaxa (dabigatran) for additional uses. 17 December 2014
Pharmaceutical
European research and generic/biosimilar industry associatins have called for an integrated life science strategy for Europe ahead of the adoption of the European Commission Work Program. 16 December 2014
Pharmaceutical
The US Food and Drug Administration has approved Swiss pharma giant Novartis’ Signifor (pasireotide) long-acting release (LAR) for injectable suspension, for intramuscular use, for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. 16 December 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has issued new final draft guidance recommending National Health Service use of US pharma giant Pfizer’s Inlyta (axitinib), for advanced kidney cancer. 16 December 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has compared trial data on German pharma major Bayer’s Eylea (aflibercept) and Swiss peers Roche and Novartis' Lucentis (ranibizumab) for the treatment of diabetic macular edema (DME), concluding that there was no relevant difference between the two. 16 December 2014
Pharmaceutical
UK health costs watchdog the National Institute for Health and Care Excellence (NICE) have recommended German pharma major Bayer’s Xofigo (radium 223 dichloride) in their preliminary Appraisal Consultation Document (ACD). 15 December 2014
Biotechnology
Genentech, the US biotech subsidiary of Swiss Pharma major Roche Group, has submitted a New Drug Application for cobimetinib to the US Food and Drug Administration for treatment, in combination with Zelboraf (vemurafenib). 15 December 2014
Pharmaceutical
The National Pharmaceutical Pricing Authority (NPPA) of India has issued a notice capping prices of 52 essential drugs. 15 December 2014
Pharmaceutical
The Mid-Year Economic and Fiscal Outlook released by the Australian government did not indicate any cost increases for the Pharmaceutical Benefits Scheme. 15 December 2014
Pharmaceutical
The US Food and Drug Administration on Friday expanded the approved use of pharma major Eli Lilly’s Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC). 13 December 2014
Pharmaceutical
French pharma major Sanofi’s vaccines division, Sanofi Pasteur, has received approval from the US Food and Drug Administration for its supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine. 13 December 2014
Pharmaceutical
UK health care cost watchdog the National Institute for Health and Care Excellence (NICE) has issued its final appraisal document (FAD) on Merck & Co’s Remicade (infliximab) and Simponi (golimumab), and AbbVie’s Humira (adalimumab). 12 December 2014
Pharmaceutical
The US Food and Drug Administration has so far approved 35 novel drugs this year, compared to 27 last year, including new molecular entities (NMEs), submitted in New Drug Applications (NDAs) and new therapeutic biologics in Biologics License Applications (BLAs). 12 December 2014
Pharmaceutical
The US Food and Drug Administration is warning that the antipsychotic drug ziprasidone (marketed under the brand name Geodon by pharma giant Pfizer, and its generics) is associated with a rare but serious skin reaction that can progress to affect other parts of the body. 11 December 2014
Pharmaceutical
The UK pharma industry has made its third quarter payment to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme. 11 December 2014
Pharmaceutical
UK pharma major GlaxoSmithKline says it has filed a regulatory submission to the European Medicines Agency for a variation to the Marketing Authorization for Volibris (ambrisentan), to extend the current therapeutic indication to include its use in initial combination therapy for patients with pulmonary arterial hypertension (PAH). 11 December 2014
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