Regulation
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Pharmaceutical
Ireland-incorporated Theravance Biopharma has received marketing approval from the Russian Ministry of Health for Vibativ (telavancin). 30 June 2015
Pharmaceutical
Montreal, Canada-based Telesta Therapeutics has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for MCNA. 30 June 2015
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has adopted a positive scientific opinion under the Early Access to Medicines Scheme (EAMS) for the investigational PD-1 (programmed death-1) immune checkpoint inhibitor, Opdivo (nivolumab), from US Pharma major Bristol-Myers Squibb. 30 June 2015
Biotechnology
US RNA-based drug developer Sarepta Therapeutics says it has completed the rolling submission of a New Drug Application to the US Food and Drug Administration for eteplirsen on June 26, 2015. 29 June 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorization for Swiss pharma giant Novartis’ Odomzo (sonidegib), intended for the treatment of adults with locally advanced basal cell carcinoma (BCC). 28 June 2015
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted positive opinions recommending marketing authorization of US drugmaker Alexion Pharmaceuticals’ Strensiq (asfotase alfa) and Kanuma (sebelipase alfa). 26 June 2015
Pharmaceutical
The European Medicines Agency’s Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorization for Swiss pharma giant Novartis’ Farydak (panobinostat) for the treatment of multiple myeloma. 26 June 2015
Biotechnology
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended extending the use of us drugmaker AbbVie’s Humira (adalimumab) to include treatment of adults with active moderate to severe hidradenitis suppurativa (acne inversa), who have failed to respond to conventional systemic treatments. 26 June 2015
Pharmaceutical
Novo Nordisk today announced that the European Medicines agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the expanded use of Levemir (insulin detemir) in children with diabetes as young as one year old. 26 June 2015
Biotechnology
The marketing authorization application for Alprolix from US biotech firm Biogen and Swedish Orphan Biovitrum (Sobi) has been validated by the European Medicines Agency. 26 June 2015
Pharmaceutical
There was positive news flow for Japanese drug major Daiichi Sankyo this week, with the announcement of approval for its stoke medication in Europe and the filing in Japan for its in-licensed epilepsy drug candidate. 26 June 2015
Pharmaceutical
German pharma major Bayer has received approval from the Ministry of Health, Labor and Welfare (MHLW) in Japan for Eylea (aflibercept solution for injection) for the treatment of patients with macular edema secondary to retinal vein occlusion (RVO). 26 June 2015
Pharmaceutical
Swiss drugmaker Santhera has received a recommendation for marketing authorization for its Raxone (idebenone) from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). 26 June 2015
Pharmaceutical
The New Drug Application for MM-398 (irinotecan liposome injection), also known as "nal-IRI," has been accepted for review by the US Food and Drug Administration (FDA), according to the NDA’s sponsor, Merrimack Pharmaceuticals. 25 June 2015
Pharmaceutical
Allergy Therapeutics has said it would resume its US clinical program for Pollinex Quattro Grass (modified allergen tyrosine absorbate with monophosphoryl lipid A). 25 June 2015
Generics
Medicines regulator Health Canada has requested that Canadian importers voluntarily quarantine drug products with active pharmaceutical ingredients (APIs) manufactured or tested by Polydrug Laboratories, in Ambarnath, Maharashtra, India, due to data integrity concerns. 25 June 2015
Pharmaceutical
The USA’s Center for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) yesterday voted for permissive use of serogroup B meningococcal vaccine for adolescents 16 to 23 years of age, with a preferred age of 16-18. 25 June 2015
Generics
US sterile generics and biosimilars maker Hospira says its Indian subsidiary has received official notification from the US Food and Drug Administration that the inspection of the Visakhapatnam, India facility (the “Vizag facility”) was deemed acceptable for the manufacture of finished dosage drugs. 25 June 2015
Pharmaceutical
The European Commission has granted marketing authorization approval for Fycompa (perampanel) from Eisai as a once-daily adjunctive therapy for primary generalized tonic-clonic (PGTC) seizures in adults and adolescents with idiopathic generalized epilepsy. 25 June 2015
Pharmaceutical
The US Food and Drug Administration is warning that permanent loss of skin color may occur with use of the Daytrana patch (methylphenidate transdermal system) for attention-deficit hyperactivity disorder (ADHD). 25 June 2015
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
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
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