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
China’s Innovent Biologics has announced that the updated 2024 National Reimbursement Drug List (NRDL) now includes Sintbilo (tafolecimab) injection, an anti-PCSK9 monoclonal antibody for the first time. The updated NRDL will be officially effective from January 1, 2025. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
Based on data from two clinical trials halted about two months ago, the US Food and Drug Administration on Thursday issued a statement to inform the public, health care professionals, and oncology clinical investigators about the risks associated with the use of Keytruda (pembrolizumab) in combination with dexamethasone and an immunomodulatory agent (lenalidomide or pomalidomide) for the treatment of patients with multiple myeloma. 1 September 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has today published draft guidance for public consultation which does not recommend AstraZeneca’s (LSE: AZN) Faslodex (fulvestrant) as an option for NHS England use for delaying the growth of a particular type of breast cancer. 1 September 2017
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on data demonstrating that Kyprolis (carfilzomib) and dexamethasone reduced the risk of death and increased overall survival versus Velcade (bortezomib) and dexamethasone in patients with relapsed or refractory multiple myeloma. 31 August 2017
Pharmaceutical
The Institute for Clinical and Economic Review, a Boston, USA-based health economic research group, has released a report assessing the comparative clinical effectiveness and value of three PARP inhibitors in ovarian cancer. 31 August 2017
Biotechnology
Swiss drugmaker Santhera Pharmaceuticals has been given approval by the Ministry of Health Israel for Raxone (idebenone) for the treatment of visual impairment in adolescent and adult patients with Leber's hereditary optic neuropathy (LHON). 31 August 2017
Pharmaceutical
Tokyo’s Sumitomo Dainippon Pharma has applied to extend its Japanese marketing authorization for Parkinson’s disease therapy Trerief. 31 August 2017
Pharmaceutical
The US Food and Drug Administration has approved Vabomere for adults with complicated urinary tract infections (cUTI), including a type of kidney infection, pyelonephritis, caused by specific bacteria. 31 August 2017
Biotechnology
On the day that the US Food and Drug Administration (FDA) announced its approval of the first CAR T-cell-directed therapy, the regulator has stressed its awareness of the potentially life-threatening side effects of these advanced new treatments. 31 August 2017
Pharmaceutical
The US Food and Drug Administration has approved Teva Pharmaceutical Industries’ Austedo (deutetrabenazine) tablets for the treatment of tardive dyskinesia in adults. 31 August 2017
Biotechnology
Switzerland’s Novartis has won the race to market a CAR T-cell-directed therapy, receiving US Food and Drug Administration approval for its Kymriah infusion. It’s also the first US FDA-approved therapy based on gene transfer technology. 30 August 2017
Pharmaceutical
The Australian government is listing almost half a billion dollars’ worth of new medicines, providing sufferers of both common and rare diseases access to life-changing drugs for as little as A$6.30 ($5.00) per script. 30 August 2017
Biotechnology
A potential rheumatoid arthritis (RA) blockbuster could yet be available in the USA within the next year after its manufacturers were given the go-ahead to complete a re-submission package without the need for a new clinical study. 30 August 2017
Pharmaceutical
Dr Nicola Davies debates the efficacy of US Food and Drug Administration approvals given the speed over safety angle. 30 August 2017
Pharmaceutical
The life sciences did not feature prominently in mainstream debates on membership of the European Union (EU), but the UK government is going the right way about ensuring that the sector thrives as the country prepares to leave the trade bloc, according to industry’s response to new proposals. 30 August 2017
Biotechnology
Basel, Switzerland-based Roche has been granted priority review status for its bid to broaden the label for blood cancer drug Gazyva in the USA. 30 August 2017
Biotechnology
Tokyo’s Daiichi Sankyo has been given breakthrough therapy designation by the US Food and Drug Administration for its breast cancer candidate DS-8201. 30 August 2017
Biosimilars
Expensive medicines that can generate billions of dollars in sales for drugmakers and the US Supreme Court's decision to speed access to copycat biologic drugs has found an echo in India, with the Indian biogenerics industry poised to exploit the opportunity similar to the generics potential, reports The Pharma Letter’s India correspondent. 30 August 2017
Pharmaceutical
The US Food and Drug Administration today granted accelerated approval to benznidazole for use in children ages 2 to 12 years old with Chagas disease. It is the first treatment approved in the USA for the treatment of Chagas disease. 30 August 2017
Biotechnology
More than 24% was taken off the market value of neurological disorders specialist Acorda Therapeutics on Tuesday after the company received a Refusal to File (RTF) letter from the US Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for Inbrija (levodopa inhalation powder). 30 August 2017
Biotechnology
New York’s Pfizer and UK-based Avillion have applied to regulators in Europe and the USA to expand the label for chronic myeloid leukemia drug Bosulif. 30 August 2017
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