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Pharmaceutical
Australian regulator the Therapeutic Goods Administration (TGA) has completed a review of the cardiovascular risks associated with the use of the non-steroidal anti-inflammatory drugs (NSAIDs) diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam. 8 October 2014
Pharmaceutical
Bristol-Myers Squibb has decided that it will not pursue US Food and Drug Administration approval of the dual regimen of daclatasvir and asunaprevir for the treatment of HCV genotype 1b patients in the USA. 8 October 2014
Biotechnology
The US Food and Drug Administration has designated a product from stem cell treatment developer BrainStorm Cell Therapeutics (Nasdaq: BCLI) as a Fast Track product for the treatment of amyotrophic lateral sclerosis (ALS, or Lou Gehrig's Disease). 7 October 2014
Biotechnology
The US Food and Drug Administration has approved biotech firm Regeneron Pharmaceuticals’ Eylea (aflibercept) Injection for the treatment of macular edema following retinal vein occlusion (RVO). 7 October 2014
Pharmaceutical
US drugmaker AbbVie has received approval from the US Food and Drug Administration for an extension of the approved indications for Humira. 6 October 2014
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca today confirmed that the American Heart Association (AHA) and American College of Cardiology (ACC) have updated the guideline for the management of patients with non–ST-elevation acute coronary syndromes (NSTE-ACS). 6 October 2014
Pharmaceutical
Transparency advice for Japanese pharma major Eisai’s Zonegran (zonisamide) monotherapy in the treatment of partial seizures, with or without secondary generalization, in adults with newly-diagnosed epilepsy, has been published by the French National Authority for Health (HAS). 6 October 2014
Biosimilars
When treating patients, patient safety is crucial. Regardless of whether this concerns biological, biosimilar or conventional/synthetic products and regardless of whether treatment is done in hospital or the primary sector, writes Mads Tang Dalsgaard, country director of Amgen in a blog posted on the web site of the Danish Pharmaceutical Association (LIF). 6 October 2014
Biotechnology
The US Food and Drug Administration has granted orphan drug designation for Ireland-headquartered specialty biopharma firm Horizon Pharma’s Actimmune (interferon gamma-1b) for the treatment of Friedreich's ataxia (FA). 4 October 2014
Pharmaceutical
Japanese drug major Daiichi Sankyo has submitted a supplemental New Drug Application (sNDA) in Japan for the synthetic broad-spectrum oral antibacterial agent Cravit (levofloxacin hemihydrate) for the treatment of pulmonary and other tuberculosis disorders. 3 October 2014
Pharmaceutical
US drug major Eli Lilly has received marketing authorization from the European Commission for its Humalog KwikPen 200 units/ml (insulin lispro) in the treatment of diabetes in adults. 3 October 2014
Pharmaceutical
US specialty pharma firm Ariad Pharmaceuticals says that its investigational cancer drug AP26113 has received Breakthrough Therapy designation by the US Food and Drug Administration. 3 October 2014
Pharmaceutical
The International Society for Pharmaceutical Engineering (ISPE) is to release its Drug Shortages Prevention Plan at its annual meeting in Las Vegas. 3 October 2014
Pharmaceutical
In a bid toward greater transparency, the European Medicines Agency has decided to publish the clinical reports that underpin the decision-making on medicines. 3 October 2014
Pharmaceutical
In yet another rejection of the company’s cancer drugs, the UK drugs watchdog, the National Institute for Health and Care Excellence (NICE), has issued new draft guidance for consultation that does not recommend National Health Service use of Swiss pharma major Roche’s Gazyvaro (obinutuzumab) for untreated chronic lymphocytic leukemia. 3 October 2014
Pharmaceutical
Similarities in pricing and reimbursement (P&R) decision criteria and payer requirements in key pharmaceutical markets allow pharma to leverage similar payer value messaging across different markets, according to a report from Decision Resources Group. 2 October 2014
Pharmaceutical
Today’s announcement that the UK’s National Institute for Health and Care Excellence (NICE) recommends the use of Selincro (nalmefene) will be welcome news for around 600,000 alcohol dependent people in England who may be eligible for the treatment, says the drug’s manufacturer, Danish CNS specialist Lundbeck. 2 October 2014
Generics
USA-based injectable generic drugs specialist Hospira revealed in a filing with the US Securities and Exchange Commission that it has received a warning letter from the US Food and Drug Administration related to an inspection of the company’s pharmaceutical manufacturing facility in Mulgrave, Victoria, Australia. 2 October 2014
Pharmaceutical
Portola Pharmaceuticals says that its first Phase III study of andexanet alfa, a potential universal Factor Xa inhibitor antidote and US Food and Drug Administration-designated breakthrough therapy, met its primary and secondary endpoints with high statistical significance. 1 October 2014
Pharmaceutical
Regulator Health Canada has taken action to stop the imports from three Indian manufacturing sites. 1 October 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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