Regulation
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Pharmaceutical
Cost-effectiveness watchdog for England and Wales the National Institute for Health and Care Excellence (NICE) has issued final guidance recommending cabazitaxel, which is marketed as Jevtana by French pharma major Sanofi, for some prostate cancer patients. 22 April 2016
Pharmaceutical
Merck & Co says that its Keytruda (pembrolizumab) has received conditional approval for the treatment of Canadians living with metastatic non-small cell lung cancer (NSCLC). 21 April 2016
Biosimilars
Some 88.6% of doctors know what biosimilar medicines are and 59% have already prescribed biosimilar medicines as a high quality treatment for their patients, according to EuropaBio paper on physician preference regarding biosimilar labels (SmPC). 21 April 2016
Biosimilars
Physicians in Europe would like to have more information in the biosimilar label than is currently available for these biological copy drugs. 20 April 2016
Biotechnology
US biopharma company Chiasma suffered a share price collapse, after it revealed the news that the US Food and Drug Administration would require further clinical evidence in order to approve its Mycapssa (octreotide). 20 April 2016
Pharmaceutical
After its assessment in 2013, the German Institute for Quality and Efficiency in Health Care (IQWiG) has reassessed the added benefit of Xalkori (crizotinib) in comparison with the appropriate comparator therapy, concluded that an added benefit of crizotinib for the first-line treatment of advanced bronchial carcinoma is not proven. 19 April 2016
Biotechnology
Israeli biotech firm RedHill Biopharma has announced that its RHB-105 combination for the treatment of H. pylori infection has taken steps closer to approval in the USA. 19 April 2016
Biosimilars
The British Biosimilars Association (BBA) was formally launched on Monday, April 18. 18 April 2016
Pharmaceutical
Australian regulator the Therapeutic Goods Administration (TGA) has approved a variation to expand the current therapeutic indication for Volibris (ambrisentan) to include its use in combination treatment with tadalafil for patients with pulmonary arterial hypertension (PAH) in Australia. 18 April 2016
Pharmaceutical
Boehringer Ingelheim said on Friday that the US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) for its lung cancer therapy Gilotrif (afatinib). 16 April 2016
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) on Friday recommended Translarna (ataluren), from US pharma company PTC Therapeutics for treating children aged five and over with Duchenne muscular dystrophy (DMD) caused by a nonsense mutation. 16 April 2016
Pharmaceutical
The Strategic Advisory Group of Experts on Immunization (SAGE) has issued its recommendations to the World Health Organization on the use of Dengvaxia dengue vaccine, from Sanofi Pasteur. 15 April 2016
Pharmaceutical
New European Union rules to help companies win legal redress against theft or misuse of their trade secrets were voted by Parliament today (April 14). 14 April 2016
Pharmaceutical
The USA’s Physicians Payment Sunshine Act, proposed in 2010 and started in 2013, was created to make the financial relationship between health care providers and the pharmaceutical industry more transparent. 14 April 2016
Biotechnology
The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) from pharma major Bristol-Myers Squibb, which seeks to expand the use of Opdivo (nivolumab) to patients with classical Hodgkin lymphoma (cHL) after prior therapies. 14 April 2016
Pharmaceutical
US drug giant Merck & Co is a step closer to making Keytruda (pembrolizumab), its already marketed cancer drug, as a treatment for head and neck cancer, available to patients. 14 April 2016
Pharmaceutical
The Russian government has designed a new package of measures aimed at providing support to domestic drugmakers as well as global majors, operating their plants within the country. 14 April 2016
Pharmaceutical
The European Medicines Agency and the European network for Health Technology Assessment (EUnetHTA) today published a report on their joint work plan covering the period between November 2012 and December 2015. 14 April 2016
Biotechnology
USA’s Merck & Co and Japanese drugmaker Taiho, a subsidiary of Otsuka, have announced a co-promotion agreement in Japan for the cancer treatment pembrolizumab. 13 April 2016
Biotechnology
USA-based biopharma company Clovis Oncology has suffered a major setback as it seeks approval for lung cancer drug rociletinib. 13 April 2016
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 BeOne Medicines, formerly 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 (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Pharmaceutical
In what could be construed to be India's quest for pharmaceutical supremacy, a clarion call has been made for the country to set its indigenous standards. 25 November 2024
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