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
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
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
Biotechnology
The Oncologic Drug Advisory Committee of the US FDA has provided a positive opinion on Mylotarg. 12 July 2017
Biotechnology
What is claimed to be the world's first cell and gene therapy for degenerative arthritis has been approved by South Korea’s Ministry of Food and Drug Safety (MFDS). 12 July 2017
Biotechnology
Californian biotech firm Amgen now has full marketing approval in the USA for Blincyto in a particular kind of acute lymphoblastic leukemia. 12 July 2017
Biotechnology
As well as acting as the regulator to make sure therapies are safe and effective, the US Food and Drug Administration (FDA) is helping to bring precision medicine to people living with diseases that have specific genetic features. 12 July 2017
Biotechnology
The US Food and Drug Administration (FDA) has changed its stance on a Fabry disease drug being developed by US biotech Amicus Therapeutics, paving the way for the company to submit a New Drug Application (NDA) later in 2017. 12 July 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) today published guidance recommending approval of three drugs for the treatment of plaque psoriasis in children and young people. 12 July 2017
Biotechnology
Ocular Therapeutix says it received a Complete Response Letter (CRL) from the US Food and Drug Administration regarding its resubmission of a New Drug Application (NDA) for Dextenza. 12 July 2017
Pharmaceutical
Bristol-Myers Squibb has announced that the US Food and Drug Administration will review the company’s application to broaden the label for Sprycel. 12 July 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has accepted and filed the New Drug Administration (NDA) for abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, and granted it a Priority Review designation. 11 July 2017
Pharmaceutical
Financial analyst Morningstar has expressed confidence in the strength of the US healthcare market, as “continued abatement of concerns over branded drug prices helps valuations.” 11 July 2017
Biotechnology
USA-based Concert Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has lifted the clinical hold on its CTP-543 Phase IIa clinical trial for alopecia areata, a type of hair loss. 11 July 2017
Pharmaceutical
Consumers and health professionals are advised that Danish diabetes care giant Novo Nordisk, in consultation with Australia’s Therapeutic Goods Administration (TGA), is recalling six batches of NovoPen Echo insulin cartridge holders after detecting that there is a risk that they may crack or break if exposed to chemicals in certain cleaning agents. 11 July 2017
Biosimilars
Serving the twin purposes of creating a globally competitive biopharmaceutical industry that addresses India's major concerns around barriers to affordable healthcare, India's Department of Biotechnology (DBT) is set to roll out biosimilar drugs for diseases such as cancer, diabetes and rheumatoid arthritis, reports The Pharma Letter’s India correspondent. 11 July 2017
Pharmaceutical
When plans were announced for a cap on the cost of new drugs in England made available on the National Health Service (NHS) in March, pharma companies were roundly critical of the proposals. 10 July 2017
Biosimilars
Indian drugmaker Biocon closed 4% down at 322.05 Indian rupees on Monday after news emerged in relation to the company’s marketing authorization applications (MAAs) to sell biosimilar versions of three big-selling drugs. 10 July 2017
Pharmaceutical
In a reversal of a negative draft guidance in February, the medicines cost-effectiveness watchdog for England and Wales has today issued final guidance recommending cabozantinib for some kidney cancer patients. 10 July 2017
Pharmaceutical
The Hong Kong Alliance of Patients' Organizations and representatives from numerous cancer concern groups have met with physicians and politicians to discuss ways of improving cancer care in the territory. 10 July 2017
Biotechnology
US biotech major Biogen has received approval from Japan’s Ministry of Health, Labor Welfare (MHLW) for its orphan drug Spinraza (nusinersen) to treat infantile-onset spinal muscular atrophy (SMA), reports The Pharma Letter’s local correspondent Wang Fangqing. 10 July 2017
Pharmaceutical
Isodiol International, a specialist in cannabis-derived pharmaceuticals, has received approval from the Brazilian medicines regulator to market Isoderm, a treatment for epilepsy and Parkinson’s disease. 10 July 2017
Pharmaceutical
Australia is to create a simpler system for members of the public to complain about the advertising of medicines and medical devices. 10 July 2017
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