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Biosimilars
EuropaBio has published a statement giving the perspective of the health care biotechnology industry on the labeling of biosimilars. 18 September 2014
Pharmaceutical
In draft guidance published today UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has recommended US health care giant Johnson & Johnson subsidiary Janssen’s Olysio (simeprevir) as a treatment option for some people with chronic hepatitis C. 18 September 2014
Pharmaceutical
UK drugs watchdog the National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending UK pharma giant GlaxoSmithKline’s Tafinlar (dabrafenib) for the treatment of melanoma which has spread or can’t be completely removed by surgery and tests positive for the BRAF V600 mutation. 18 September 2014
Biotechnology
The UK’s Department of Health announced that DCVax-L, the dendritic cell-based vaccine from US company Northwest Biotherapeutics, will be the first drug to be awarded Promising Innovative Medicine (PIM) status, covering all malignant gliomas, including glioblastoma multiforme. 17 September 2014
Pharmaceutical
The US Food and Drug Administration yesterday approved Movantik (naloxegol), an oral treatment for opioid-induced constipation in adults with chronic non-cancer pain from Anglo-Swedish pharma major AstraZeneca. 17 September 2014
Biotechnology
US biotech firm Regeneron Pharmaceuticals says that the US Food and Drug Administration has granted Eylea (aflibercept) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema. 16 September 2014
Pharmaceutical
The US Food and Drug Administration has confirmed that the New Drug Application for Tuzistra XR, a prescription cough/cold candidate from UK biotech company Vernalis and privately-held USA-based Tris Pharma, has been accepted for full review. 15 September 2014
Pharmaceutical
Ireland-headquartered drugmaker Shire has received acceptance for its filing with priority review for a supplemental New Drug Application for Vyvanse (lisdexamfetamine dimesylate) as a treatment for adults with binge-eating disorder. 15 September 2014
Pharmaceutical
In the second of a monthly FDA-focused blog published exclusively by The Pharma Letter, Dr Nicola Davies looks at whether transparent clinical trials could impact FDA approval. 15 September 2014
Pharmaceutical
In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG), the German Institute for Quality and Efficiency in Health Care (IQWiG) found that US health care giant Johnson & Johnson subsidiary Janssen’s Olysio (simeprevir) offers an added benefit over the appropriate comparator therapy in adult patients with chronic hepatitis C infection. 15 September 2014
Pharmaceutical
The pan-European medicines verification system that the European Federation of Pharmaceutical Industries and Associations is currently implementing with all supply chain stakeholders in Europe, will put an end to the resale of stolen and counterfeit drugs in the legitimate supply chain. 15 September 2014
Pharmaceutical
Swiss drug major Roche has said that compromised vials of its arthritis and cancer drug MabThera had been found in Germany. 15 September 2014
Biotechnology
The US Food and Drug Administration on Friday approved Baxter International’s and Halozyme Therapeutics’ subcutaneous treatment for adult patients with primary immunodeficiency, HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase). 14 September 2014
Pharmaceutical
Shares of US biotech firm Amarin Corp tanked 23.7% to $1.38 on Friday in heavy trading, when the company revealed that the US Food and Drug Administration’s Office of New Drugs had denied its appeal of the FDA's rescission of the ANCHOR clinical trial Special Protocol Assessment agreement relating to Vascepa (icosapent ethyl). 14 September 2014
Pharmaceutical
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee has concluded its regular benefit-risk assessment (known as a periodic safety update report or PSUR) of Valdoxan/Thymanax (agomelatine), two identical medicines from independent French drugmaker Laboratoires Servier used to treat major depression in adults. 14 September 2014
Pharmaceutical
Based on the initial experience gained from its adaptive licensing pilot project, the European Medicines Agency has released a document to address the most frequently asked questions from companies and to clarify the terms of engagement and expected outputs for prospective applicants. 12 September 2014
Pharmaceutical
Consumer advocacy group Health Action International says it is “appalled” by the European Commission’s opaque and unjustified decision to move SANCO Units D5 (Medicinal Products – Authorizations, European Medicines Agency) and D6 (Medicinal Products – Quality, Safety and Efficacy) from the Directorate General (DG) for Health and Consumers to DG Enterprise and Industry. 12 September 2014
Pharmaceutical
The Association of the British Pharmaceutical Industry (ABPI) and the UK Department of Health have announced the second payment by industry to underwrite the growth of the medicines bill under the 2014 Pharmaceutical Price Regulation Scheme (PPRS). 12 September 2014
Pharmaceutical
There was good news for Danish diabetes care giant Novo Nordisk yesterday, when the US Food and drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee panelists voted in favor of approving the company’s liraglutide – intended trade name Saxenda - for the treatment of obesity. 12 September 2014
Pharmaceutical
After considerable delay, the US Food and Drug Administration late yesterday finally granted approval for the weight-loss drug Contrave (naltrexone and bupropion) extended-release tablets. 11 September 2014
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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