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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
Biotechnology
The European Commission adopted the Committee for Medicinal Products for Human Use (CHMP) recommendation to include the treatment of hereditary angioedema (HAE) attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for Ruconest (recombinant human C1 inhibitor). 7 April 2016
Biotechnology
The trade group representing Australia’s biotech industry has moved to clear up confusion over the proposed Australian Innovation and Manufacturing’ (AIM) Incentive. 7 April 2016
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has completed its examination of Swedish Orphan Biovitrum’s Elocta (efmoroctocog alfa), assessing whether this new drug offers an added benefit over the appropriate comparator therapy both in prevention and in on-demand treatment for people with hemophilia A. 7 April 2016
Pharmaceutical
A US Food and Drug Administration safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. 6 April 2016
Biosimilars
The US Food and Drug Administration yesterday approved Inflectra (infliximab-dyyb) for multiple indications. This is the second biosimilar approved by the FDA and the first biosimilar monoclonal antibody (MAb) medication cleared in the USA. 6 April 2016
Pharmaceutical
The NDA Group, a leading global drug development consultancy, today released findings from its third annual comparison of drug approvals in the USA and Europe, in preparation for this year's DIA EuroMeeting in Hamburg. 5 April 2016
Biosimilars
A critical response has been given to draft new guidance issued by the US Food and Drug Administration on the labeling of biosimilars by the Alliance for Patient Access (AfPA). 5 April 2016
Biotechnology
Hemophilia A treatment Adynovate (antihemophilic factor (recombinant), pegylated) has been approved for usage in Japan. 5 April 2016
Pharmaceutical
The Australian Minister for Health, Sussan Ley, has announced that patients will see the cost of their prescriptions for common medicines drop by as much as 60% as part of government reforms. 4 April 2016
Pharmaceutical
Stronger enforcement is needed to deter pharmaceutical manufacturers from continuing to break the law and defraud federal and state health programs, according to a report from US consumer advocacy group Public Citizen released last week. 4 April 2016
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG) examination of Janssen’s HIV treatment Edurant (rilpivirine) finds no added benefit. 4 April 2016
Pharmaceutical
The USA’s Acadia Pharmaceuticals received a significant boost last week, when a US Food and Drug Administration advisory panel voted to recommend approval of the company’s Nuplazid (pimavanserin) for psychosis associated with Parkinson’s disease, with its shares leaping 25% in pre-market trading the following day. 3 April 2016
Biosimilars
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines, including one advanced therapy medicinal product (ATMP), for approval at its March meeting. 2 April 2016
Generics
The US Generic Pharmaceutical Association (GPhA) and America’s Health Insurance Plans (AHIP) have filed an amicus brief urging the Supreme Court to preserve the inter partes review (IPR) process in promoting a competitive prescription drug market for consumers. 1 April 2016
Biosimilars
The US Food and Drug Administration has issued draft new guidance it will give to industry on the labeling of biosimilar products. 1 April 2016
Biotechnology
US pharma major Bristol-Myers Squibb has had an application validated by the European Medicines Agency (EMA) to extend indications for Opdivo (nivolumab) to treat classical Hodgkin lymphoma (cHL) patients after prior therapies. 1 April 2016
Pharmaceutical
The US Food and Drug Administration has approved new labeling for Mifeprex (mifepristone) allowing the abortion drug to be used through 70 days of pregnancy rather than the previous 49 days. 31 March 2016
Pharmaceutical
Ireland-based biopharma firm Jazz Pharmaceuticals has gained US Food and Drug Administration (FDA) approval for Defitelio. 31 March 2016
Pharmaceutical
US pharma company Radius Health has submitted a new drug application (NDA) for abaloparatide—SC, a once daily treatment for postmenopausal women with osteoporosis. 31 March 2016
article
The European Medicines Agency (EMA) has published today a report on its pilot on parallel scientific advice with health-technology-assessment (HTA) bodies that finished at the end of March 2016. 31 March 2016
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