Pharma & Biotech Pricing, Policy & Regulation
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
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Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 28 November 2024
Pharmaceutical
A new indication for olverembatinib, developed by Suzhou-based Ascentage Pharma will be added to China’s National Reimbursement Drug List (NRDL) from next year. 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
Biotechnology
The US Food and Drug Administration’s (FDA) approval of an expanded label for Cabometyx (cabozantinib) has kept Exelixis climbing in the stock market throughout Wednesday morning. 20 December 2017
Biotechnology
In what is seen as a historic move, the US Food and Drug Administration has approved Luxturna (voretigene neparvovec-rzyl), a new gene therapy, to treat children and adult patients with an inherited form of vision loss that may result in blindness. 20 December 2017
Pharmaceutical
The UK’s health technology assessor NICE - the National Institute for Health and Care Excellence - has provided a draft recommendation against granting reimbursement for Scenesse (afamelanotide) for treating the rare disease erythropoietic protoporphyria (EPP). 20 December 2017
Biotechnology
Pfizer has received US Food and Drug Administration approved of its supplemental New Drug Application (sNDA) to expand the indication for Bosulif (bosutinib) to include adult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML). 20 December 2017
Biotechnology
The UK’s National Institute for Health and Care Excellence has today published draft guidance recommending multiple sclerosis drug Extavia (beta 1b interferon), from Swiss pharma giant Novartis, for routine funding on the National Health Service (NHS). 20 December 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending Ninlaro (ixazomib) in combination with lenalidomide and dexamethasone (Rd) for the treatment of multiple myeloma patients who have received two or three prior lines of therapy. 20 December 2017
Pharmaceutical
The US Food and Drug Administration has approved Rhopressa (netarsudil ophthalmic solution) 0.02% for the lowering of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. 19 December 2017
Biotechnology
Two months after filing with the US FDA, embattled generics giant Teva Pharmaceutical Industries’ has been given priority review and fast track designation for fremanezumab, a novel biologic for the preventive treatment of migraine. 19 December 2017
Pharmaceutical
The European Commission says that it has closed the infringement procedure taken against Swiss pharma giant Roche for failure to meet certain pharmacovigilance obligations. 19 December 2017
Biotechnology
Australia’s Senate has determined that an inquiry is needed to consider the latest proposed legislation to improve public access to therapeutics. 19 December 2017
Pharmaceutical
The UK government’s narrow defeat (Wednesday November 13) on amendment seven of the European Union withdrawal bill, demanding that Parliament have a binding vote on the final Brexit deal, has fuelled debate on whether the UK could now be heading for a softer Brexit and what impact this will have on leading industries like UK pharma. 19 December 2017
Biotechnology
Top US Republicans Senator John Cornyn and Representative Kevin Brady said on Sunday morning talk shows that they were confident their tax overhaul would become law by the end of the week. 18 December 2017
Biotechnology
US drug giant Pfizer’s Xeljanz (tofacitinib) is already fighting a battle for market share in one of pharma’s most competitive indications – and now it is about to enter another crowded but potentially lucrative space. 18 December 2017
Pharmaceutical
The US Food and Drug Administration has agreed to review a supplemental New Drug Application (sNDA) for the use of Tagrisso (osimertinib) for a new indication. 18 December 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended five new medicines for approval at its December 2017 meeting, including two orphan medicines, one of which is also an advanced therapy medicinal product (ATMP), and one biosimilar. 16 December 2017
Biotechnology
The US Food and Drug Administration has lifted the hold on clinical studies with fitusiran, including the Phase II open-label extension (OLE) study and the ATLAS Phase III program. 15 December 2017
Generics
Changes to Japan’s drug reimbursement system care are inevitable. The only questions are the extent of changes and when they will be implemented. We should have answers to these questions at year end so they can be implemented in April 2018, says P Reed Maurer, long-time Japan pharma watcher and president of International Alliances Limited in his regular column for The Pharma Letter. 15 December 2017
Pharmaceutical
The management board of the European Medicines Agency has provided a statement with highlights from its December 2017 meeting, including a look ahead to the agency’s agenda for next year. 15 December 2017
Pharmaceutical
US FDA commissioner Scott Gottlieb has provided a review of current scheduled regulatory developments within the purview of the agency. 15 December 2017
Pharmaceutical
Dr Nicola Davies discusses the US Food and Drug Administration’s (FDA) new framework on regenerative medicine that is aimed at spurring innovation in transformative products while ensuring safety and efficacy. 15 December 2017
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