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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Biosimilars
Zacks Equity Research has issued a statement discussing the pharma industry, noting that drug pricing issues will remain a headwind. 3 March 2017
Pharmaceutical
Three major trade federations representing pharmaceutical companies in Europe have welcomed the findings reached by a European Commission (EC) study into off-label use of pharmaceutical products. 3 March 2017
Generics
The UK’s Competition and Markets Authority (CMA) today alleged that Concordia and Actavis UK signed illegal agreements which enabled high prices for a life-saving drug to be prolonged. 3 March 2017
Pharmaceutical
The USA and the European Union have completed an exchange of letters to amend the Pharmaceutical Annex to the 1998 US-EU Mutual Recognition Agreement. 3 March 2017
Pharmaceutical
New medicine prices in the European Union have risen over the past few decades, to the point of being unaffordable for many EU citizens and threatening the sustainability of national health care systems, say Members of the European Parliament (MEPs) in a resolution voted on Thursday. 2 March 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) says it is now at the half-way point of its requested review of drugs, approved and still available only through the old Cancer Drugs Fund (CDF). 2 March 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has approved Ocaliva (obeticholic acid) for routine use by the National Health Service (NHS) in England, Wales and Northern Ireland. 2 March 2017
Pharmaceutical
Tuesday night, President Donald Trump gave his joint address to the nation. In it, he suggested that the US Food and Drug Administration prevents a host of new medications and medical devices from hitting the market. 2 March 2017
Biotechnology
The New Drug Application (NDA) for enasidenib (AG-221/CC-90007) for the treatment of patients with relapsed or refractory acute myeloid leukemia (AML) with an isocitrate dehydrogenase 2 (IDH2) mutation has been accepted by the US Food and Drug Administration. 2 March 2017
Pharmaceutical
Eye disease specialist Aerie Pharmaceuticals has resubmitted its New Drug Application for Rhopressa (netarsudil ophthalmic solution) to the US Food and Drug Administration. 2 March 2017
Biotechnology
Danish allergy immunotherapy specialists ALK-Abelló today announced it has received FDA approval for its house dust mite sublingual allergy immunotherapy (SLIT) tablet. 2 March 2017
Pharmaceutical
Erbitux (cetuximab) is closer to being available on the UK’s National Health Service (UK) as an option for RAS wild type metastatic colorectal cancer (mCRC). 2 March 2017
Pharmaceutical
US Senators Cory Booker (Democrat, New Jersey), Bernie Sanders (Independent, Vermont) and Bob Casey (Dem, Pennsylvania) introduced legislation Tuesday to lower the skyrocketing cost of prescription drugs by allowing Americans to import safe, low-cost medicine from Canada. 1 March 2017
Biotechnology
The European Medicines Agency has granted access to its Priority Medicines (PRIME) scheme for givosiran (ALN-AS1), an investigational RNAi therapeutic targeting aminolevulinic acid synthase 1 (ALAS1) for the treatment of acute hepatic porphyrias. 1 March 2017
Biotechnology
Shares in Lexicon Pharmaceuticals rose more than 5% in pre-market trading, following the announcement that the Texan biopharmaceutical company had received FDA approval for its carcinoid syndrome diarrhea treatment. 1 March 2017
Biotechnology
Health plans partnering with Express Scripts are delivering high-quality, affordable pharmacy care to millions of individuals enrolled in government-sponsored programs, but this record is at risk without decisive action to advance additional pro-patient and pro-payer policy changes, according to new research. 1 March 2017
Pharmaceutical
Having filed submissions in the USA, Canada and Europe, Danish diabetes giant Novo Nordisk has now set its sights on Japan as it seeks to gain approval for semaglutide, a glucagon-like peptide-1 (GLP-1) analogue administrated once-weekly, for the treatment of adults with type 2 diabetes. 28 February 2017
Biotechnology
The National Institute for Health and Care Excellence (NICE) today published draft guidance which does not recommend Keytruda (pembrolizumab) for untreated PD-L1-positive metastatic lung cancer. 28 February 2017
Biotechnology
The US FDA has accepted for Priority Review the Biologics License Application (BLA) for avelumab, as a treatment for patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy. 28 February 2017
Pharmaceutical
A report on orphan drugs has shown that the median cost per patient is 5.5 times higher for orphan drugs compared to other medicines. 28 February 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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