Regulation
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Pharmaceutical
The US Food and Drug Administration has approved KYTHERA Biopharmaceuticals’ Kybella (deoxycholic acid), a treatment for adults with moderate-to-severe fat below the chin, known as submental fat. 30 April 2015
Generics
The USA’s Generic Pharmaceutical Association (GPhA) has submitted new comments on the Food and Drug Administration’s Proposed Rule to update generic drug labeling requirements, urging the agency to adopt the joint alternative proposal known as the Expedited Agency Review (EAR), that it has put forward with the Pharmaceutical Research and Manufacturers of America (PhRMA). 29 April 2015
Pharmaceutical
French drug major Sanofi has been granted marketing authorization in Europe for Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL) by the European Commission. 29 April 2015
Generics
The US Food and Drug Administration yesterday approved the first generic versions of Bristol-Myers Squibb and Japanese drugmaker Otsuka Pharmaceutical’s Abilify (aripiprazole). 29 April 2015
Pharmaceutical
The US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Anglo-Swedish pharma major AstraZeneca’s Brilinta (ticagrelor) tablets for patients with a history of heart attack. 29 April 2015
Pharmaceutical
Government policies that support UK pharmaceutical science and enhance export income are costing the country’s National Health Service (NHS) millions and undermine the National Institute for Health and Care Excellence. 29 April 2015
Pharmaceutical
Substandard medicines from India continue to be a major problem, with the number of recalls and alerts for defective prescription drugs reaching a new crescendo, reports The Pharma Letter’s India correspondent. 28 April 2015
Pharmaceutical
USA-based Amgen’s marketing application for talimogene laherparepvec (T-Vec) currently does not support it being reviewed under an accelerated approval pathway, according to briefing documents prepared by agency staff released ahead of the US Food and Drug Administration’s advisory committee meeting tomorrow. 28 April 2015
Pharmaceutical
US-based BioMarin Pharmaceutical has completed the rolling submission of a New Drug Application (NDA) to the US Food and Drug Administration for drisapersen to treat Duchenne muscular dystrophy (DMD). 28 April 2015
Pharmaceutical
Swiss drug major Roche’s Avastin (bevacizumab) has been authorized in the UK in combination with standard chemotherapy for the treatment of women with advanced cervical cancer. 28 April 2015
Pharmaceutical
A review of Australia’s Pharmaceutical Benefits Advisory Committee’s (PBAC) submission guidelines has been announced by the country’s Minister for Health Sussan Ley. 27 April 2015
Pharmaceutical
The UK BioIndustry Association (BIA) has called for a separate framework to evaluate and commission medicines and treatments for rare and very rare diseases in response to NHS England (NHSE)’s consultation on investing in specialized services. The consultation opened in January and closes today. 27 April 2015
Biotechnology
Privately held French biotechnology firm MedDay has announced positive results from the pivotal Phase III clinical trial, MS-SPI, with its multiple sclerosis drug candidate MD1003, at the annual meeting of the American Academy of Neurology. 27 April 2015
Pharmaceutical
The European Medicines Agency has confirmed a risk of severe bradycardia or heart block when certain hepatitis C medicines are used in patients who are also taking amiodarone. 27 April 2015
Generics
A total of seven generic drugs were recommended for approval at the April 2015 meeting of the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP). 25 April 2015
Biotechnology
The Food and Drug Administration has accepted US drugmaker AbbVie’s New Drug Application and granted priority review for the company's, all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/r), with ribavirin (RBV). 24 April 2015
Pharmaceutical
How the issue of affordability is addressed around Europe was discussed at the Association of the British Pharmaceutical Industry’s (ABPI) annual conference in London yesterday. 24 April 2015
Pharmaceutical
The US Food and Drug Administration has granted Priority Review to German family-owned drug major Boehringer Ingelheim’s Biologics License Application (BLA) for idarucizumab. 23 April 2015
Pharmaceutical
Japanese drugmaker Ono Pharmaceuticals has submitted an additional indication application for the human anti-human programmed cell death-1 (PD-1) monoclonal antibody Opdivo (nivolumab). 23 April 2015
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a Promising Innovative Medicine (PIM) designation for Swiss pharma giant Novartis’ investigational medicine for patients with heart failure (HF) with reduced ejection fraction, LCZ696 (sacubitril/valsartan). 23 April 2015
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
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