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
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
Generics
The timing of the release of statistics showing that 2016 was a record year for the US Food and Drug Administration’s (FDA) generic drug program “couldn’t be better amid concerns about rising drug prices,” according to a senior figure at the agency. 28 February 2017
Pharmaceutical
The US Food and Drug Administration has approved once-daily Qtern (10mg dapagliflozin and 5mg saxagliptin) for the treatment of type-2 diabetes. 28 February 2017
Pharmaceutical
Bausch + Lomb and French biotech firm NicOx have re-submitted a New Drug Application to the US Food and Drug Administration seeking approval for latanoprostene bunod ophthalmic solution, 0.024%. 28 February 2017
Pharmaceutical
In what is believed to be the first move of its kind ever, healthcare professionals in the UK have resorted to crowdfunding to provide cancer patients access to treatment. 28 February 2017
Pharmaceutical
US healthcare giant Johnson & Johnson has released a 2016 US Transparency Report that includes information on pricing and other business practices, covering everything from discovery to the commercialization of pharmaceuticals. 27 February 2017
Pharmaceutical
At a press conference held last week, the Hellenic Association of Pharmaceutical Companies (SFEE) issued an ultimate distress call and a strong warning against the irreparable detrimental consequences for Greek patients from the imminent Ministry of Health measures. 27 February 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended four new medicines for approval at its February meeting. 25 February 2017
Biotechnology
As well as four new drug approvals, at its February meeting the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended broader use of three already marketed products. 25 February 2017
Pharmaceutical
The mixed messages on drug pricing policy coming from new US President Donald Trump’s administration are starting to harm healthcare stocks, according to an analyst at the independent broker finnCap. 24 February 2017
Biotechnology
US biotech firm Celgene has been approved to market Revlimid (lenalidomide) in the EU as a monotherapy for the maintenance treatment of certain adult patients with newly diagnosed multiple myeloma. 24 February 2017
Pharmaceutical
The US Food and Drug Administration has accepted a supplementary New Drug Application for Zykadia (ceritinib) from Swiss giant Novartis. 24 February 2017
Pharmaceutical
Pharmaceutical firm Zydus Cadila has received approval from Indian regulators to market its tetravalent inactivated influenza vaccine for seasonal flu, VaxiFlu 4. 24 February 2017
Biotechnology
The US Food and Drug Administration has granted Toca 511 & Toca FC Breakthrough Therapy designation for the treatment of patients with recurrent high grade glioma (HGG). 23 February 2017
Pharmaceutical
The chief executive of German pharma major Bayer (BAYN: DE) did not hold back in expressing his views on the year’s politics developments as he presented his company’s annual results for the first time. 23 February 2017
Biotechnology
Australian biotech companies might not have Brexit or an unpredictable new President to worry about, but they are being caused uncertainty by a troubling tax issue. 23 February 2017
Generics
Swiss pharmaceutical firm Dipharma has announced that the European Medicines Agency has validated its Marketing Authorization application for Disanit. 23 February 2017
Biosimilars
Truxima (biosimilar rituximab) has been approved by the European Medicines Agency for use in all indications of the reference product Mabthera, the blockbuster monoclonal antibody developed by Roche. 22 February 2017
Pharmaceutical
China's Food and Drug Administration has announced that two five-year plans (2016-2020) on food and drug safety were issued by the State Council on February 21. 22 February 2017
Pharmaceutical
Amphastar Pharmaceuticals revealed it had received a complete response letter (CRL) from the US Food and Drug Administration regarding its opioid overdose drug. 22 February 2017
Biotechnology
US RNA-based drug developer Sarepta Therapeutics says it has entered into an agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV). 22 February 2017
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