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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
Generics
CPhI Worldwide, organized by UBM EMEA, launches part i of its annual report ahead of CPhI Worldwide 2015 in Madrid (October 13-15) – as CPhI expert Girish Malhotra calls for a radical solution to improve pharma manufacturing processes. 17 September 2015
Pharmaceutical
The UK’s National Audit Office has published the findings from its investigation into the Cancer Drugs Fund, concluding it is no longer sustainable in its current form, and NHS England should develop proposals for reform. 17 September 2015
Pharmaceutical
Voluntary adverse drug event (ADE) reporting in the USA is incomplete, inaccurate and inefficient, which could deny or limit patient access to safe and effective treatments, according to recent studies completed by the Tufts Center for the Study of Drug Development. 17 September 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued its Final Appraisal Determination (FAD) to not recommend US biotech major Celgene’s Abraxane (nab-paclitaxel) in combination with gemcitabine, for adults with previously untreated metastatic adenocarcinoma of the pancreas (metastatic pancreatic cancer). 17 September 2015
Biotechnology
The UK's National Institute for Health and Clinical Excellence (NICE) on Wednesday confirmed its earlier final draft guidance not to recommend collagenase clostridium histolyticum (Xiapex, from Swedish Orphan Biovitrum), to treat Dupuytren’s contracture for routine use. 16 September 2015
Biotechnology
The US Food and Drug Administration has approved independent Swiss biotech firm Octapharma's Nuwiq (simoctocog alfa), antihemophilic Factor (recombinant), an intravenous therapy for adults and children living with hemophilia A. 16 September 2015
Pharmaceutical
US President Barack Obama has nominated Robert Califf for the post of Commissioner of the Food and Drug Administration. 16 September 2015
Pharmaceutical
The US Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about a serious blood condition called severe neutropenia. 16 September 2015
Biotechnology
US biotech company Amgen has submitted a marketing application to the US Food and Drug Administration for a once-a-month dosing of Repatha (evolocumab). 15 September 2015
Pharmaceutical
The Organization of Pharmaceutical Producers of India’s (OPPI) annual human resources summit focused on diversity and inclusion, compliance and employee value proposition. 15 September 2015
Pharmaceutical
US drug developer FORUM Pharmaceuticals said yesterday that, during verbal discussions with the US Food and Drug Administration, it was advised that studies investigating the use of encenicline in Alzheimer’s disease (AD) have been placed on clinical hold. 15 September 2015
Biotechnology
US drug major AbbVie submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration requesting a new indication for Imbruvica (ibrutinib). 14 September 2015
Biotechnology
French biotechnology company TxCell SA on Monday said its T cell immunotherapy to treat a form of eye inflammation has been granted orphan drug designation by the US Food and Drug Administration. 14 September 2015
Pharmaceutical
Indian drug major Dr Reddy’s Laboratories has signed a commercialization deal with Australian firm Hatchtech for its innovative prescription head lice product Xeglyze Lotion. 14 September 2015
Pharmaceutical
The US Food and Drug Administration’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee on Friday voted unanimously to support the approval of Xtampza ER (oxycodone extended-release capsules). 12 September 2015
Pharmaceutical
The US Food and Drug Association has reinforced the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, as well as its impact on bone mineral density. 11 September 2015
Generics
Ireland-incorporated Allergan has received US Food and Drug Administration approval for its Abbreviated New Drug Applications for three Mucinex equivalent products, a brand from Reckitt Benckiser. 11 September 2015
Pharmaceutical
German pharma company Merck has stated its intention to apply for marketing authorization in Europe for cladribine tablets in multiple sclerosis. 11 September 2015
Pharmaceutical
The US Food and Drug Administration has determined that the New Drug Application for the combination product of Abilify (aripiprazole) embedded with an ingestible sensor in a single tablet from privately-held US firm Proteus Digital Health, is sufficiently complete to allow for a substantive review and is considered filed as of September 8, 2015. 11 September 2015
Pharmaceutical
The medicines watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE), has today published preliminary draft guidance which recommends National Health Service use of Ofev (nintedanib), from German family-owned pharma major Boehringer Ingelheim. 11 September 2015
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