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Biotechnology
The US Food and Drug Administration (FDA) has approved Eli Lilly’s monoclonal antibody Taltz (ixekizumab) to treat adults with moderate-to-severe plaque psoriasis, it has been announced. 23 March 2016
Pharmaceutical
Anglo-Swedish pharma firm AstraZeneca has reported disappointing top-line results from the Socrates trial testing the efficacy of Brilinta (ticagrelor) tablets to prevent strokes. 23 March 2016
Pharmaceutical
In a continuing effort to educate prescribers and patients about the potential risks related to opioid use, the US Food and Drug Administration yesterday announced required class-wide safety labeling changes for immediate-release (IR) opioid pain medications. 23 March 2016
Biotechnology
US pharma firm Vertex has slammed the UK cost watchdog, the National Institute for Health and Care Excellence (NICE), for its failure to recommend the company’s treatment for cystic fibrosis. 23 March 2016
Pharmaceutical
In the next five years, where is China’s pharma industry heading to? How should pharma companies allocate their resources to ensure the reward? The answers lie in the recently released guidance for the pharma industry five-year development from China’s top authority – the State Council, reports The Pharma Letter’s local correspondent Wang Fangqing. 22 March 2016
Pharmaceutical
The US subsidiary of Japanese pharma major Eisai has agreed to revise the joint promotion agreement with Switzerland’s Helsinn Healthcare for their chemotherapy-induced nausea and vomiting (CINV) franchise. 22 March 2016
Pharmaceutical
Australian regulator the Therapeutics Goods Administration (TGA) has been closely monitoring reports of adverse events following immunization with Bexsero meningococcal B vaccine, specifically those relating to fever in infants and children. 22 March 2016
Pharmaceutical
US biopharmaceutical firm Elusys Therapeutics has received Food and Drug Administration approval for its Anthim (obiltoxaximab) injection for the treatment of inhalational anthrax. 22 March 2016
Pharmaceutical
The UK cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) has recommended abiraterone for some prostate cancer patients in a move described as “a big victory for men” by London-based charity The Institute of Cancer Research (ICR). 21 March 2016
Pharmaceutical
Danish company LEO Pharma has received scientific approval for its psoriasis treatment Enstilar in the European Union (EU). 21 March 2016
Pharmaceutical
German drug cost-effectiveness regulator the German Institute for Quality and Efficiency in Health Care (IQWiG) has released results of several recent reviews on cancer drugs, coming to various conclusions. 21 March 2016
Pharmaceutical
Latest figures show that the Spanish pharmaceutical industry invested 382 million euros ($431 million) in contracts with the National Health system during 2014, maintaining once again its leading position in the private sector as far as public-private collaboration in Spain is concerned. 21 March 2016
Pharmaceutical
Novartis says that the UK’s National Institute for Health and Care Excellence (NICE) has now recommend Entresto (sacubitril/valsartan) in its final draft guidance. 21 March 2016
Pharmaceutical
In a surprise move last week, the charity Médecins Sans Frontières (MSF), for the first time ever, filed a ‘patent opposition’ in India, with the aim of preventing US pharma giant Pfizer from getting a patent on the pneumococcal conjugate vaccine (PCV13), sold under the Prevenar trade name. 20 March 2016
Pharmaceutical
Shares of USA-based Eagle Pharmaceuticals slumped on Friday afternoon, after the Food and Drug Administration rejected its drug Kangio (bivalirudin injection). 19 March 2016
Biotechnology
Following the announcement last week that it had been asked by the European Commission to start a review of the cancer medicine Zydelig (idelalisib), relating to concerns over serious adverse events in ongoing clinical trials, the European Medicines Agency’s today said its Pharmacovigilance Risk Assessment Committee (PRAC) is issuing provisional advice for doctors and patients using to ensure that the drug continues to be used as safely as possible. 18 March 2016
Generics
The US Generic Pharmaceutical Association (GPhA) welcomed the holding of Senate Aging Committee discussions on Thursday over what it calls the ‘anti-competitive business practices’ of some brand manufacturers to stifle generics. 18 March 2016
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation to Swiss biotech firm Novimmune’s NI-0501 for the treatment of patients with primary hemophagocytic lymphohistiocytosis (HLH) with refractory disease, or with recurrent or progressive disease during conventional therapy. 18 March 2016
Generics
Allergan today confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration seeking approval to market paclitaxel protein-bound particles for injectable suspension. 17 March 2016
Pharmaceutical
The US Federal Trade Commission (FTC) has urged the Court of Appeals to correct four errors in a district court’s analysis of an alleged reverse-payment agreement involving UK pharma giant GlaxoSmithKline and generics firms Teva Pharmaceuticals and Anchen Pharmaceuticals. 17 March 2016
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 BeOne Medicines, formerly 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
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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