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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
Pharmaceutical
The European Medicines Agency has recommended the granting of marketing authorizations in the European Union for two new combination therapies against chronic (long-term) hepatitis C virus (HCV) infection, Epclusa (sofosbuvir/velpatasvir) and Zepatier (grazoprevir/elbasvir). 27 May 2016
Pharmaceutical
AstraZeneca today announced that the US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application for sodium zirconium cyclosilicate (ZS-9). 27 May 2016
Pharmaceutical
The US Food and Drug Administration has approved Afstyla (antihemophilic Factor [recombinant], single chain), a novel long-lasting recombinant factor VIII single-chain therapy for adults and children with hemophilia A from CSL Behring. 27 May 2016
Pharmaceutical
The US Food and Drug Administration has approved the first buprenorphine implant for the maintenance treatment of opioid dependence. 27 May 2016
Biosimilars
Adoption of the European Parliament’s report on the Single Market Strategy in Plenary has been applauded by Medicines for Europe, which represents generic and biosimilar medicines producers in Europe. 26 May 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend approval for use in the National Health Service of US pharma major Eli Lilly’s Portrazza (necitumumab) for treating lung cancer. 26 May 2016
Pharmaceutical
The US Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday recommended the approval of the New Drug Application (for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. 26 May 2016
Pharmaceutical
US biopharma Intercept Pharmaceuticals is due to find out on Friday whether its liver disease drug Ocaliva (obeticholic acid) receives approval from the Food and Drug Administration (FDA). 25 May 2016
Biotechnology
Sarepta Therapeutics today announced that the US Food and Drug Administration has notified the company that it is continuing its review and internal discussions related to the pending New Drug Application for eteplirsen. 25 May 2016
Pharmaceutical
Sanofi today announced that Jevtana (cabazitaxel) has been recommended for use in combination with prednisone or prednisolone as a treatment option for metastatic hormone-relapsed prostate cancer (mHRPC) in England. 25 May 2016
Pharmaceutical
Canadians face wait times of about 449 days in order to get access to new, potentially lifesaving medicines in public drug plans, according to a new IMS Health Canada report commissioned by Innovative Medicines Canada. 25 May 2016
Pharmaceutical
The National Institute for Health and Clinical Excellence (NICE), the medicines cost-effectiveness watchdog for England and Wales, has today published final guidance recommending three drugs for treating type 2 diabetes. 25 May 2016
Pharmaceutical
The US Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) yesterday voted 16-0, recommending the approval of IDegLira for the treatment of adults with type 2 diabetes. 25 May 2016
Pharmaceutical
Staffers at the US Food and Drug Administration (FDA) have questioned the efficacy of Sanofi’s experimental diabetes drug iGlarLixi. 24 May 2016
Pharmaceutical
According to the European Medicines Agency, adaptive pathways aim to improve timely access to new medicines “primarily in areas of high medical need.” The eligible products would be put on the market earlier for small subsets of patients and their use would gradually be expanded based on additional data generated. 24 May 2016
Biotechnology
The European Commission (EC) has granted conditional approval for US healthcare giant Johnson & Johnson subsidiary Janssen Biotech’s single agent Darzalex (daratumumab), it has been announced. 24 May 2016
Biosimilars
Sandoz, Swiss pharma giant Novartis' generics and biosimilars business, says that the European Medicines Agency has accepted its Marketing Authorization Application for a biosimilar to Roche's blockbuster drug MabThera (rituximab). 24 May 2016
Biosimilars
South Korea-based Samsung Bioepis revealed today that the US Food and Drug Administration (FDA) has accepted for review the company’s Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade (infliximab). 24 May 2016
Pharmaceutical
US pharma major Pfizer has announced that the black triangle safety warning for its smoking cessation drug Champix (varenicline) has been removed in the UK. 23 May 2016
Pharmaceutical
Japanese drugmaker Teijin Pharma has received approval from the Ministry of Health, Labour and Welfare in its home country for Feburic (febuxostat) as an indication for hyperuricemia caused by cancer chemotherapy. 23 May 2016
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