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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Generics
The USA’s largest association of physicians and medical students has proposed a series of policies to promote more transparency in drug pricing to protect patients. 19 June 2017
Pharmaceutical
Netherlands regulator the Medicines Evaluation Board (MEB) has described the terms and conditions which are to be used to assess applications for combination packages of medicinal products. 19 June 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has expanded the approved use of Dysport (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) in lower limb spasticity. 17 June 2017
Generics
The US Food and Drug Administration announced on Friday that it is aware of the ongoing shortage situation affecting several injectable drugs, manufactured by Hospira. 17 June 2017
Pharmaceutical
A US Food and Drug Administration (FDA) advisory committee will next week discuss whether Victoza, the Novo Nordisk type 2 diabetes drug can have cardiovascular safety added to its label. 16 June 2017
Pharmaceutical
As Trump administration officials meet to discuss proposals affecting US drug prices, the consumer rights advocacy group Public Citizen has warned that the plans are likely to make medicines even more unaffordable. 16 June 2017
Pharmaceutical
The Management Board of the European Medicines Agency (EMA) was updated on the Agency’s preparation for the withdrawal of the UK from the European Union at its June meeting. 16 June 2017
Pharmaceutical
Spanish drugmaker PharmaMar says that PM1183 (lurbinectedin), its third molecule of marine origin and analogue of Yondelis (trabectedin), will receive the trade name of Zepsyre. 16 June 2017
Generics
The UK Competition and Markets Authority (CMA) has published the full non-confidential decision following its investigation into unfair pricing for phenytoin sodium capsules in the UK. 16 June 2017
Generics
Shareholders in Adamis Pharmaceuticals were dining out on Thursday night as the company’s stock closed 53% up at $5.75 following the news that its generic version of the EpiPen (epinephrine) device had received regulatory approval in the USA. 16 June 2017
Generics
At the International Generic and Biosimilars Medicines Association (IGBA) meeting currently taking place in Lisbon, Portugal, in addition to international regulatory cooperation, several key studies were presented at the conference that highlight the need for a major overhaul of medicines policies to stimulate more access to generic, biosimilar and value added medicines. 16 June 2017
Pharmaceutical
In research that should be essential reading for anyone involved in attempts to reduce US drug prices, it has been found that more than 40% of the money spent by consumers on pharmaceuticals goes to intermediaries. 15 June 2017
Biotechnology
A new deal on the breast cancer drug trastuzumab emtansine means that it can now be recommended for routine funding, the National Institute of Health and Care Excellence (NICE) announced today. 15 June 2017
Biotechnology
Following release of new clinical evidence in March 2017, the US Institute for Clinical and Economic Review (ICER) has developed a New Evidence Update to its 2015 review of the comparative clinical effectiveness and value of PCSK9 inhibitors for management of high cholesterol. The comparative clinical effectiveness portion of the update is now available. 14 June 2017
Biosimilars
The Association for Accessible Medicines (AAM) says that generic drugs saved the US healthcare system $253 billion last year, and a total of $1.67 trillion in the last decade. 13 June 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) following its review of Kyprolis (carfilzomib) in combination with dexamethasone in multiple myeloma. 13 June 2017
Biosimilars
USA-based Coherus BioSciences lost 24.5% of its value on Monday after receiving a complete response letter (CRL) from the US Food and Drug Administration (FDA) relating to its biosimilar version of Amgen’s Neulasta (pegfilgrastim). 13 June 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) today published draft guidance which does not recommend inotuzumab ozogamicin for the treatment of adults in England and Wales with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukemia (ALL). 13 June 2017
Pharmaceutical
At a government-led meeting in Moscow, the Russian pharmaceutical industry, under the auspices of trade group the Association of Russian Pharmaceutical Manufacturers (ARPM), called into question the transparency of government investment in the sector. 13 June 2017
Biotechnology
Chinese biopharmaceutical company Hutchison China MediTech (AIM: HCM), also known as Chi-Med, says that the China Food and Drug Administration (CFDA) has acknowledged acceptance of the New Drug Application for fruquintinib for the treatment of patients with advanced colorectal cancer. 13 June 2017
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
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