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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
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Pharmaceutical
The US Food and Drug Administration has approved the use of Berinert (esterase inhibitor [human]), CSL Behring’s therapy for treating hereditary angioedema (HAE) attacks, for use in pediatric patients. 19 July 2016
Biotechnology
Bristol-Myers Squibb today announced that both the US Food and Drug Administration and European Medicines Agency have accepted marketing applications to expand the use of Opdivo (nivolumab) for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN). 18 July 2016
Generics
US generic drugmaker ANI Pharmaceuticals today revealed that it has received approval from the US Food and Drug Administration of the Abbreviated New Drug Application for nilutamide tablets. 18 July 2016
Pharmaceutical
Briefing documents prepared for a US Food and Drug Administration advisory committee have raised concerns on a potential suicide risk involving Siliq (brodalumab), a psoriasis treatment being developed by Canada’s Valeant Pharmaceuticals. 18 July 2016
Pharmaceutical
Merck KGaA today said that the European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) of the investigational product cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS). 18 July 2016
Biosimilars
South Korean drug developer Samsung Bioepis has had its marketing authorization application (MAA) for a biosimilar candidate referencing big-selling arthritis drug Humira (adalimumab) accepted for review by the European Medicines Agency. 18 July 2016
Pharmaceutical
The Treat and Reduce Obesity Act aims to improve access to weight management therapy. Over the last few years, obesity has become the hot button issue that legislators can set their sights on and pass meaningful legislation on without ruffling too many feathers, writes Dr Nicolas Davies in her monthly exclusive FDA Blog for The Pharma Letter. 18 July 2016
Pharmaceutical
The Irish Medicines Verification Organization (IMVO) is a new organization being established by a range of stakeholders across the medicines supply chain in Ireland to set up and manage a national repository of the unique identifiers that will be included on the packaging of most medicines placed on the market from February 2019. 18 July 2016
Pharmaceutical
Underlying M&A activity appeared to pick up in the second quarter after a slow start to the year, when tumbling equity markets put the frighteners on dealmakers. 17 July 2016
Pharmaceutical
The US Food and Drug Administration, at a public meeting on Friday, issued a document that contains the performance goals and procedures for the Prescription Drug User Fee Act (PDUFA) reauthorization for fiscal years (FYs) 2018-2022, known as PDUFA VI. It is commonly referred to as the “goals letter” or “commitment letter.” 16 July 2016
Pharmaceutical
Shares in Swiss drugmaker Santhera Pharmaceuticals were sent tumbling on Thursday as markets learnt that the US Food and Drug Administration had not accepted its request for accelerated review of Duchenne muscular dystrophy (DMD) treatment Raxone (idebenone). 15 July 2016
Biotechnology
US biotech firm Celgene says it has obtained approval from the European Commission for the use of Revlimid (lenalidomide) for patients with relapsed/refractory mantle cell lymphoma (MCL). 15 July 2016
Pharmaceutical
The head of Eisai in Europe has pledged to subsidize the cost of thyroid cancer drug Lenvima (lenvatinib) if health bosses agree to include it in the revamped Cancer Drugs Fund (CDF). 14 July 2016
Pharmaceutical
Japanese pharma major Eisai has received regulatory approval to commercialize the obesity drug Venespri (lorcaserin HCI) in Mexico. 14 July 2016
Biotechnology
There have been reported cases of life-threatening, sometimes fatal pancreatitis associated with the use of Blincyto (blinatumomab) in clinical trial and post-market settings. 14 July 2016
Biosimilars
A US Food and Drug Administration advisory committee has unanimously recommended approval of a biosimilar version of the big-selling arthritis drug Enbrel (etanercept). 14 July 2016
Biotechnology
The US Food and Drug Administration has removed the clinical hold on the Phase II clinical trial of JCAR015 in patients with relapsed or refractory B cell acute lymphoblastic leukemia (r/r ALL), the drug's developer Juno Therapeutics has announced. 13 July 2016
Biotechnology
Loxo Oncology has been granted Breakthrough Therapy designation for its investigational drug candidate LOXO-101 by the Food and Drug Administration. 13 July 2016
Biosimilars
The Arthritis Advisory Committee of the US Food and Drug Administration has unanimously recommended approval of ABP 501, a biosimilar being developed by US biotech Amgen, which references Humira (adalimumab), an arthritis drug marketed by US pharma major AbbVie. 13 July 2016
Biosimilars
A wave of expiring biotech patents will lead to a surge in growth for manufacturers of biosimilars during the coming years, notes Bellevue Asset Management's healthcare team. 13 July 2016
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