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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 USA's Generic Pharmaceutical Association (GPhA) has agreed to support compromise automatic substitution legislation that would allow interchangeable biologics to be automatically substituted at the pharmacy. 11 December 2014
Generics
The German regulator BfArM has suspended drugs including some produced by Dr Reddy’s, Mylan and Stada Arzneimittel over concerns about clinical trials conducted by GVK Biosciences. 11 December 2014
Pharmaceutical
The US Food and Drug Administration yesterday approved pharma giant Merck & Co’s Gardasil 9-valent vaccine (human Papillomavirus 9-valent vaccine, recombinant) for the prevention of certain diseases caused by nine types of human Papilloma virus (HPV). 11 December 2014
Pharmaceutical
In the fifth of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at how the FDA weighs up the risk versus the benefits of new drugs for terminally ill patients. 10 December 2014
Generics
US drugmaker Supernus Pharmaceuticals says that it has received a Paragraph IV Notice Letter from privately-held generic drugmaker Par Pharmaceutical advising Supernus of the filing by Par of an Abbreviated New Drug Application seeking approval for topiramate extended-release capsules. 9 December 2014
Pharmaceutical
The European Commission has granted marketing authorization for Anglo-Swedish pharma major AstraZeneca’s Moventig (naloxegol) for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxative(s). 9 December 2014
Pharmaceutical
Concerns have been raised in China that regulatory delays could defer the introduction of new drugs into the country by up to two years. 9 December 2014
Biotechnology
UK health cost watchdog, the National Institute for Health and Care Excellence (NICE) has opened a consultation on its draft guidance which proposes recommending US health care giant Johnson & Johnson subsidiary Janssen’s Stelara (ustekinumab). 9 December 2014
Biotechnology
USA-based Amgen says the US Food and Drug Administration has approved a new indication for Xgeva (denosumab), for the treatment of hypercalcemia of malignancy (HCM) refractory to bisphosphonate therapy. 8 December 2014
Pharmaceutical
The European Commission has published its fifth Monitoring Report of Patent Settlements in the pharma industry. 8 December 2014
Pharmaceutical
The Scottish Medicines Consortium has decided to grant access to Gazyvaro (obinutuzumab), manufactured by Swiss drug major Roche for the treatment of chronic lymphocytic leukemia. 8 December 2014
Pharmaceutical
A top 20 multi-national pharmaceutical research and manufacturer is utilizing the Xyntek-Antares solution and services to implement an expedited serialization packaging solution in order to meet product serialization requirements for the Chinese market. 8 December 2014
Pharmaceutical
The US Food and Drug Administration approved the labeling update of Abilify Maintena (aripiprazole) for extended-release injectable suspension. The drug is marketed by Danish CNS drug specialist Lundbeck and Japanese drugmaker Otsuka Pharmaceutical. 8 December 2014
Pharmaceutical
German pharma major Bayer has filed an application for marketing authorization to the European Medicines Agency for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults. 6 December 2014
Pharmaceutical
Ireland-headquartered generic drugs major Actavis says that the Anti-Infective Drugs Advisory Committee convened by the US Food and Drug Administration has voted to recommend approval of Actavis' New Drug Application for ceftazidime-avibactam. 6 December 2014
Pharmaceutical
Some European Union member states have decided to suspend the marketing authorizations of medicines that have been approved on the basis of studies conducted at the GVK Biosciences site in Hyderabad, India. 6 December 2014
Pharmaceutical
In one of the opening sessions, cloud-based life sciences provider Veeva’s co-founder and president Matt Wallach asserted that “transparency will force you to understand your cause better, and that will be good for the industry.” 5 December 2014
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined a dossier on Eliquis (apixaban), coming up with mixed conclusions. 5 December 2014
Pharmaceutical
Japanese drug major Takeda Pharmaceutical’s has been granted Breakthrough Therapy designation from the US Food & Drug Administration for its oral proteasome inhibitor, ixazomib (MLN9708), for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis. 5 December 2014
Generics
The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic drugmaker Mylan for its two dosages of abacavir/lamivudine tablets for oral suspension in the treatment of HIV-1 in pediatric patients. 5 December 2014
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