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Pharmaceutical
Medicines Australia, the representative body for the Australian pharma industry, has said it welcomes the recommendations of an independent review into the Therapeutic Goods Administration (TGA). 25 June 2015
Pharmaceutical
Ascletis has become the first Chinese company to file clinical applications for an interferon-free hepatitis C virus treatment. 24 June 2015
Generics
Beximco Pharmaceuticals has become the first Bangladeshi pharmaceutical company to be approved by the US Food and Drug Administration 24 June 2015
Biotechnology
French biotech company TxCell has temporarily put its pilot manufacturing facility activities at Besançon in France on partial hold, in agreement with the French regulator. 24 June 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has published preliminary recommendations on ciclosporen, marketed as Ikervis by Santen and has asked the company for more information. 24 June 2015
Pharmaceutical
Canada’s Valeant Pharmaceuticals International has submitted a New Drug Application to the US Food and Drug Administration for Relistor (methylnaltrexone bromide) tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain. 23 June 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved The Medicines Company’s Kengreal (cangrelor), an intravenous antiplatelet drug that prevents formation of harmful blood clots in the coronary arteries. 23 June 2015
Pharmaceutical
The stakeholder group European Medicines Verification Organization (EMVO) has finalized its contract negotiations with three partners that will be the preferred providers to implement the repositories system in compliance with the Falsified Medicines Directive. 23 June 2015
Pharmaceutical
Japanese drug major Eisai has received approval from the US Food and Drug Administration for an indication expansion regarding the use of its in-house developed antiepileptic agent Fycompa (perampanel hydrate). 22 June 2015
Pharmaceutical
The USA’s National Institutes of Health has submitted interim corrective action plans to the Food and Drug Administration to address problems with sterile manufacturing processes identified in its Pharmaceutical Development Section (PDS) and deficiencies of lesser significance in its pharmacy announced on June 4. 22 June 2015
Biosimilars
The decision announced on Friday by the Australian government that would allow clinicians and pharmacists to give patients themselves the option of substituting cheaper biosimilar version of a biological medicines (The Pharma Letter June 19) has come in for a great deal of criticism, both locally and more vociferously in the USA. 20 June 2015
Pharmaceutical
The European Commission has approved US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab). 20 June 2015
Biosimilars
Australia’s independent Pharmaceutical Benefits Advisory Committee (PBAC) has made a world-first recommendation to allow clinicians and pharmacists to give patients the option of substituting expensive biologic medicines at the chemist if there is a cheaper replacement or ‘biosimilar’ available that has been determined by experts to be a safe, equally-effective treatment. 19 June 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether German pharma major Bayer’s ophthalmic drug Eylea (aflibercept) offers an added benefit over the appropriate comparator therapy. 19 June 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has released new draft updated guidance, recommending several drugs in combination with methotrexate as options for treating severe rheumatoid arthritis where disease has not responded to intensive therapy with a combination of conventional disease-modifying antirheumatics. 19 June 2015
Pharmaceutical
Austrian rare diseases specialist AOP Orphan Pharmaceuticals says it has filed a regulatory submission for tetrabenazine for the treatment of tardive dyskinesia in a decentralized procedure (DCP) for several European countries with UK being reference member state. 19 June 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has opened a consultation on preliminary draft guidance for US biotech giant Gilead Sciences’ Zydelig (idelalisib) for adults with chronic lymphocytic leukemia. 18 June 2015
Generics
Regulatory agency Health Canada is restricting the importation of drugs from manufacturing facilities operated by US injectable drugs and infusion technologies and biosimilars developer Hospira in Liscate, Italy, due to data integrity concerns. 18 June 2015
Biotechnology
The US Biotechnology Industry Organization (BIO) has released a white paper – A Lifecycle Approach to Structured Benefit/Risk Assessment Framework - to encourage companies to incorporate and reflect patient preferences throughout the drug development lifecycle. 18 June 2015
Pharmaceutical
The European Medicines Agency has launched an initiative that offers free-of-charge early pediatric interaction meetings with medicines developers to stimulate early dialogue on the development of their medicines for use in children. A one-year pilot phase started yesterday. 17 June 2015
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
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
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