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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
The US Food and Drug Administration has granted Breakthrough Therapy designation to pharma behemoth Pfizer’s vaccine candidate, bivalent rLP2086, currently under investigation for the prevention of invasive meningococcal disease due to Neisseria meningitidis serogroup B in people aged 10 to 25 years. 20 March 2014
Pharmaceutical
The Brazilian Senate's Social Affairs Committee (CAS) held a hearing on March 18 to debate the progress and challenges of clinical research of medicines in Brazil. The event was attended by representatives of the government's regulatory agencies involved in human clinical research as well as and members of the scientific communities in the country, says Juliane Carvalho writing on Brazil Pharma News. 20 March 2014
Pharmaceutical
The US Food and Drug Administration yesterday approved Canada-headquartered Paladin Impavido (miltefosine) to treat a tropical disease called leishmaniasis. Paladin was acquired by the USA’s Endo Health Solutions in a $1.6 billion deal completed last month (The Pharma Letter November 6 2013). 20 March 2014
Pharmaceutical
The European Medicines Agency has published its work program for 2014 with a focus on legislative developments. 19 March 2014
Biosimilars
This week, the Alliance for Safe Biologic Medicines (ASBM) disclosed the results of a survey of 470 European physicians, that took place in the third quarter of 2013, across five EU countries (France, Germany, Italy, Spain, and the UK), regarding their prescribing habits and knowledge of biosimilar medicines. 19 March 2014
Biosimilars
The European Union must remove barriers to competition and free trade by introducing common sense reforms to European pharmaceutical intellectual property rules, according to a statement following the European Generic medicines Association 10th Legal Affairs Forum. 19 March 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has re-assessed the added benefit of ipilimumab, US pharma major Bristol-Myers Squibb’s Yervoy, this time seeing the data as uncertain. 19 March 2014
Pharmaceutical
Japanese drug major Astellas Pharma and US partner Medivation have filed a supplemental New Drug Application with the US Food and Drug Administration seeking approval of Xtandi (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer who have not received chemotherapy. 18 March 2014
Biotechnology
The US Food and Drug Administration has extended the initial Prescription Drug User Fee Act date for its review of US biotech firm Biogen Idec’s Biologics License Application for Plegridy (peginterferon beta-1a), a subcutaneous pegylated interferon candidate for relapsing forms of multiple sclerosis (RMS). 18 March 2014
Pharmaceutical
UK specialty pharma company the Clinigen Group today announced that the European Commission has ratified the positive opinion in January 2014 from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) to lift the Europe-wide suspension of Marketing Authorization for Vibativ (telavancin). 18 March 2014
Pharmaceutical
Pierre Fabre Dermatologie has obtained marketing authorization from the US Food and Drug Administration for the pediatric drug Hemangeol (propranolol hydrochloride), which is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy.” 18 March 2014
Biotechnology
Australia’s Therapeutic Goods Administration revealed today that it is monitoring reports of melanoma in patients being treated with natalizumab and encourages consumers and health professionals to report all such cases. 18 March 2014
Pharmaceutical
Japanese drugmaker Kyowa Hakko Kirin has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma and cutaneous T-cell lymphoma for Poteligeo (mogamulizumab injection) from Japan's Ministry of Health, Labor and Welfare. 18 March 2014
Pharmaceutical
The president of pharma giant Merck & Co’s (NYSE: MRK) operations in Europe and Canada Bruno Strigini spoke about pharma innovation in action at The Economist’s Pharma Summit in London on Thursday. 17 March 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and care Excellence (NICE) this morning issued new draft guidance recommending German family-owned drug major Boehringer Ingelheim’s Giotrif (afatinib) as an option for treating locally-advanced or metastatic non-small-cell lung cancer (NSCLC) in people whose tumors test positive for the EGFR-TK mutation and have not received a EGFR-TK inhibitor. 17 March 2014
Pharmaceutical
The US Food and Drug Administration has approved pharma major Bristol-Myers Squibb’s supplemental New Drug Application for blood thinner Eliquis (apixaban) for the prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery. 16 March 2014
Pharmaceutical
Innovative medicines and other new therapies have extended life expectancy by some 10 years since the 1950s, and contributed significantly to the UK’s prosperity. But Licensed to Cure?, a new report published this week by the UCL School of Pharmacy, UK, warns that if bodies such as the UK’s National Institute for Health and Care Excellence (NICE) under‐estimate the value of their benefits this will undermine investment in research and treatment development. 14 March 2014
Pharmaceutical
Severely ill patients in the UK, and those with rare debilitating conditions, could be given new medicines years before they are licensed, under new regulations, according to plans outlined by UK Health Secretary Jeremy Hunt. 14 March 2014
Generics
Even as India-based drug majors Ranbaxy and Wockhardt reel under the impact of US Food and Drug Administration import bans on certain products, the drug regulator has issued another import alert, this time on Sun Pharmaceuticals' Karkhadi plant, in Gujarat, which saw its shares decline 6.5% on the news, reports The Pharma Letter’s India correspondent. 14 March 2014
Biotechnology
The UK drugs watchdog, the National Institute for Health and care Excellence (NICE) says that, based on the current information available of US biotech major Celgene’s Revlimid (lenalidomide) for treating the blood cancer multiple myeloma after one prior treatment with bortezomib, it does not recommend this drug for this indication. 14 March 2014
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