Regulation
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Biotechnology
Doctors in the UK are calling on health ministers and NHS England to intervene to make Swiss pharma giant Roche's blockbuster cancer drug Avastin (bevacizumab) routinely available on the National Health Service for people with a debilitating eye condition known as wet age-related macular degeneration (AMD). 25 February 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has recommended Inlyta (axitinib), marketed by Pfizer as a second-line treatment for kidney cancer. 25 February 2015
Pharmaceutical
The US Federal Trade Commission has put conditions on the proposed acquisition by Novartis of GlaxoSmithKline’s oncology drugs. 24 February 2015
Biotechnology
As the era of personalized medicine dawns on health care, the need to understand an individual’s genetic information through genomic testing has risen. 24 February 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved Swiss pharma giant Novartis’ Farydak (panobinostat, previously known as LBH589) capsules in combination with bortezomib (Takeda’s Velcade) and dexamethasone for the treatment of patients with multiple myeloma. 24 February 2015
Pharmaceutical
US pharma major Eli Lilly says it is delaying the submission of its basal insulin peglispro (BIL) to regulatory agencies beyond the first quarter of 2015. 23 February 2015
Biosimilars
Indian biopharma company Intas has become the first Indian company to launch a biosimilar in highly regulated territories such as the EU, the USA and Japan. 23 February 2015
Biotechnology
The US Food and Drug Administration has accepted for review the Biologics License Application for Kanuma (sebelipase alfa), produced by Synageva BioPharma. 23 February 2015
Biotechnology
The European Commission has granted a conditional marketing authorization, under Regulation (EC) No 726/2004, to Holoclar, an advanced therapy based on autologous stem cells and capable to restore the eyesight of patients with severe cornea damage. 22 February 2015
Generics
Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration on its Abbreviated New Drug Application for a generic version of the UK-based consumer goods giant Reckitt Benckiser's Subutex (buprenorphine 2mg and 8mg sublingual tablets). 22 February 2015
Biotechnology
US biotech firm Celgene’s European subsidiary has received approval from the European Commission for Revlimid (lenalidomide) for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. 20 February 2015
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined data on independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa), concluding that an added benefit cannot be derived from the dossier because the drug manufacturer did not submit any suitable data. 20 February 2015
Pharmaceutical
Genentech, part of the Roche Group, says that the US Food and Drug Administration has accepted and granted priority review for its New Drug Application for cobimetinib in combination with Zelboraf (vemurafenib) in BRAF V600 mutation-positive advanced melanoma. 20 February 2015
Pharmaceutical
Major European health care stakeholders have taken a major step to secure the legitimate pharmaceutical supply chain against the risk of falsified medicines, as required by the European Union Falsified Medicines Directive. 20 February 2015
Pharmaceutical
In a preliminary recommendation issued today, England’s health costs watchdog the National Institute for Health and Care Excellence (NICE) has recommended German pharma major Bayer’s Eylea (aflibercept) as an option for the treatment of diabetic macular edema (DME). 20 February 2015
Pharmaceutical
The UK’s National Institutes of Health and Care Excellence has recommended Ozurdex (dexamethasone), produced by Allergan, to treat diabetic macular edema. 20 February 2015
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has published its final draft guidance recommending Targaxan (rifaximin), produced by independent Dutch pharma company Norgine, for hepatic encephalopathy. 19 February 2015
Pharmaceutical
A new report from Lund University in Sweden claims to show how the pharmaceutical industry, time and again, violates regulations on the marketing of drugs. 19 February 2015
Biotechnology
US biotech firm Celgene revealed that the US Food and Drug Administration has expanded the existing indication for Revlimid (lenalidomide) in combination with dexamethasone to include patients newly-diagnosed with multiple myeloma (NDMM). 18 February 2015
Biotechnology
Privately-held US biotech firm aTyr Pharma says that the European Commission has granted Orphan Drug designation to Resolaris for the treatment of facioscapulohumeral muscular dystrophy (FSHD). 18 February 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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