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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
The companion diagnostic for chronic lymphocytic leukemia (CLL) treatment Venclexta (venetoclax) has received approval a day after the drug itself was given the green light by the US Food and Drug Administration (FDA). 13 April 2016
The European Commission has granted approval for the use of the potentially life-extending cancer immunotherapy, Opdivo (nivolumab) to treat patients with the most common forms of advanced lung and advanced kidney cancer. 13 April 2016
New Zealand’s Pharmaceutical Management Agency PHARMAC announced today its decision to list cinacalcet (Sensipar) on the Pharmaceutical Schedule through an agreement with the local subsidiary of US biotech major Amgen from May 1,2016 for: 12 April 2016
Dutch generics company Synthon has announced that glatiramer acetate, a generic version of Copaxone, for the treatment of relapsing remitting multiple sclerosis (RRMS), has gained approval in Europe. 12 April 2016
The US Food and Drug Administration on Monday granted accelerated approval for US drugmaker AbbVie’s Venclexta (venetoclax) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with at least one prior therapy. 12 April 2016
The Medicines Company has been granted fast-track designation by the Food and Drug Administration for its investigational agent Carbavance (meropenem-vaborbactam) for the treatment of complicated urinary tract infections (cUTI). 12 April 2016
An advisory committee of the US Food and Drug Administration will question on Tuesday whether rociletinib, the lung cancer drug of USA-based Clovis Oncology (Nasdaq: CLVS), is any more effective than drugs which are already available. 11 April 2016
The USA ranks 1st in how its domestic policies support worldwide life sciences innovation, according to an analysis released last week by the Information Technology and Innovation Foundation (ITIF), a global technology policy think tank. 11 April 2016
Stories about the pharmaceutical industry which have made headline news in recent months have not done the sector’s reputation any favors. 11 April 2016
The news last week that China-based Humanwell Healthcare Group and PuraCap Pharmaceutical have entered into a definitive agreement to acquire 100% of privately-held US generic drugs marker Epic Pharma for $550 million seems to have a sub-text: an unidentified product license asset. 11 April 2016
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in an early benefit assessment whether Genvoya (elvitegravir, cobicistat, emtricitabine and tenofovir alafenamide) offers an added benefit for patients in comparison with the appropriate comparator therapy treatment for adults and adolescents infected with HIV-1. 11 April 2016
Responding to mounting evidence, the US Food and Drug Administration said on Friday it is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. 9 April 2016
US biotech firm Celgene expressed disappointment with a draft decision issued today by the drug cost-effectiveness watchdog for England, the National Institute for Health and Care Excellence (NICE). 8 April 2016
Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis, has received approval from the European Commission (EC) for a type II variation for the addition of a subcutaneous (sc) route of administration in Binocrit’s (epoetin alfa) nephrology indication. 8 April 2016
A US Food and Drug Administration Advisory Committee has unanimously recommended accelerated approval of Ocaliva (obeticholic acid) for the treatment of the liver disease primary biliary cholangitis (PBC). 8 April 2016
The European Commission has approved Giotrif (afatinib) for the treatment of patients with advanced squamous cell carcinoma (SqCC) of the lung whose disease has progressed on or after treatment with platinum-based chemotherapy. 8 April 2016
Vectura Group and Hikma Pharmaceuticals have moved closer to US approval for a generic version of GlaxoSmithKline’s asthma drug Advair Diskus (fluticasone propionate and salmeterol inhalation powder). 8 April 2016