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
Today's issue
Refine Search
Pharmaceutical
Leading domestic drugmakers in Russia have called on the national government to introduce additional restrictions on the participation of foreign companies in public procurements in the country, reports The Pharma Letter’s Russia correspondent. 10 August 2018
Pharmaceutical
Ironshore Pharmaceuticals & Development has been given the green light to market Jornay PM (methylphenidate) to treat attention deficit hyperactivity disorder (ADHD) in the USA. 10 August 2018
Biotechnology
For the second time in four months, Japanese drugmaker Kyowa Hakko Kirin is celebrating receiving US Food and Drug Administration (FDA) approval for a rare disease drug. 9 August 2018
Pharmaceutical
Investigation and treatment of China’s State Council's investigation team on Changchun Changsheng Bio-tech's illegal production of rabies vaccine cases is under way, and the China National Drug Administration (CNDA) is maintaining communication with the World Health Organization’s (WHO) representative office in China. 9 August 2018
Pharmaceutical
Following an appeal from New York’s Pfizer, the UK’s health technology assessor has decided to offer reimbursement for Besponsa (inotuzumab ozogamicin) as a treatment for certain acute lymphoblastic leukaemia (ALL) patients. 9 August 2018
Generics
Apotex's potassium chloride has become the first generic drug to be granted Competitive Generic Therapy designation by the US Food and Drug Administration (FDA). 9 August 2018
Biotechnology
It was a black, black Wednesday for Ampio Pharmaceuticals (NYSE: AMPE) as its stock slumped to a value of just $0.61. 9 August 2018
Pharmaceutical
A new antibiotic, the first of its class, has received a positive review from the US Food and Drug Administration's (FDA) Antimicrobial Drug Discovery Committee ahead of a full FDA decision in October. 9 August 2018
Pharmaceutical
It’s been an important week for clinical research, with two important documents published which should go a long way in helping to support clinical research as the UK leaves the European Union, writes Dr Sheuli Porkess, deputy chief scientific officer at the Association of the British Pharmaceutical Industry (ABPI). 9 August 2018
Pharmaceutical
In an Expert View piece, Mark Davison, head of operations in the European Union for software company RFXCEL, outlines everything marketing authorization holders need to know and what you need to do for a seamless serialization process – before regulators remove your right to trade. 8 August 2018
Pharmaceutical
Glenmark Pharmaceuticals today announced that the US Food and Drug Administration has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltris. 8 August 2018
Pharmaceutical
Yesterday, delivering on proposals in President Trump’s American Patients First blueprint, the USA’s Health and Human Services (HHS) Department announced that Medicare Advantage plans will be able to use tools employed by private-sector insurers to negotiate lower prescription drug prices for patients. 8 August 2018
Pharmaceutical
The USA’s leading pharmacy benefit manager (PBM) has published its list of 2019 National Preferred Formulary exclusions. 8 August 2018
Biotechnology
The US Food and Drug Administration as approved Orkambi (lumacaftor/ivacaftor) to include use in children ages two through five years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation. 8 August 2018
Biosimilars
The UK's Department for Health has launched a consultation on its plans to begin applying price controls to biosimilars, proposals that have promptly been ridiculed. 7 August 2018
Biotechnology
The industry-funded ARM Foundation for Cell and Gene Medicine has launched a new health economic analysis of regenerative medicine therapies, which includes a review of academic literature, health technology assessments, and value frameworks. 7 August 2018
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation for Braftovi (encorafenib), in combination with Mektovi (binimetinib) and cetuximab, intended to expedite development and review of drugs for serious conditions, where preliminary clinical evidence indicates that they may demonstrate substantial improvement over existing therapies. 7 August 2018
Pharmaceutical
I-MAK, a pressure group composed of lawyers, health professionals and academics, has published a report excoriating pharma giants for allegedly exploiting patent laws in order to drive up prices. 7 August 2018
Pharmaceutical
The China National Drug Administration (CNDA) has granted approval of Ibrance (palbociclib), the first cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor, for the treatment of hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2) advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women. 7 August 2018
article
No need for anxiety — that’s the line at the launch of a new white paper from contract research organization IQVIA, tackling the uncertainty facing UK biopharma ahead of the country’s departure from the European Union. 7 August 2018
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze