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
Pharmaceutical
The Medical Technologies, Biotechnologies and Pharmaceuticals Industry Growth Centre – and trade group Medicines Australia, have signed a memorandum of understanding (MoU) to work collaboratively to boost the innovative pharmaceutical industry in Australia. 25 January 2017
Pharmaceutical
Anticipating an early 2018 launch for Infacort (hydrocortisone), Diurnal Group has signed an agreement with two subsidiaries of UDG Healthcare to build up sales and medical infrastructure in the EU. 25 January 2017
Generics
Beximco Pharmaceuticals has entered into a collaboration with Malaysia’s BioCare Manufacturing, in what will be the Bangladeshi generics firm’s first overseas manufacturing deal. 25 January 2017
Pharmaceutical
The US pharmaceutical industry has launched a new offensive in the ongoing battle for the hearts and minds of patients, policymakers and customers. 24 January 2017
Biotechnology
AbbVie says its marketing authorization application (MAA) has been validated and is now under accelerated assessment by the European Medicines Agency for the investigational, pan-genotypic regimen of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) for the treatment of all major chronic hepatitis C virus (HCV) genotypes. 24 January 2017
Pharmaceutical
Dutch supplier Bedrocan has become the world’s first producer of medicinal cannabis to be compliant with the European Medicines Agency’s good manufacturing practice (GMP) standards. 24 January 2017
Pharmaceutical
USA-based biotech firm Ocular Therapeutix has confirmed that a New Drug Application (NDA) for Dextenza (dexamethasone) has been re-submitted to the US Food and Drug Administration. 24 January 2017
Pharmaceutical
Medicines regulator Health Canada says its safety review of oral and injectable fluoroquinolones, a class of antibiotics, found that in rare cases some known side effects may be persistent or disabling. 24 January 2017
Pharmaceutical
The UK Prime Minister has set out detailed plans for the country’s new industrial strategy for post-Brexit Britain, and the focus on science and innovation has been praised by figures from pharma and the research community. 23 January 2017
Biosimilars
Today, the European Commission published a unique Q&A for patients with reliable information on biosimilar medicines. 23 January 2017
Pharmaceutical
Bayer has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted priority review status to the company’s anticancer agent regorafenib, as a second-line treatment for liver cancer. 20 January 2017
Pharmaceutical
Privately-held US pharma Kaléo has announced the relaunch date and details of an access program for its AUVI-Q (epinephrine injection, USP) auto-injector to treat life-threatening allergic reactions. 20 January 2017
Biotechnology
US-based biotech firm Gilead Sciences has received notice that the European Medicines Agency (EMA) has validated and will review its Marketing Authorization Application for a new hepatology product. 20 January 2017
Biotechnology
The US Food and Drug Administration on Thursday day approved Trulance (plecanatide) for the treatment of chronic idiopathic constipation (CIC) in adult patients. 20 January 2017
Biotechnology
US pharma major Bristol-Myers Squibb was down 6.2% at $52.08 in after-hours trading on Thursday, after it revealed disappointing news on a proposed combination lung cancer drug. 20 January 2017
Pharmaceutical
The trade group the Association for the British Pharmaceutical Industry has outlined its objections to new NICE/NHS England proposals on evaluating and funding new medicines. 20 January 2017
Pharmaceutical
The US Food and Drug Administration (FDA) is weighing up potential changes to its advisory committees (ACs) and their role in making decisions on pharmaceutical and other products. 20 January 2017
Pharmaceutical
Belgian drugmaker UCB has filed a supplemental New Drug Application (sNDA) with the US Food and Drug Administration to extend the label for epilepsy drug Briviact (brivaracetam). 20 January 2017
Pharmaceutical
The US Food and Drug Administration has approved Vantrela ER (hydrocodone bitartrate) extended-release tablets [CII] formulated with Teva Pharmaceutical Industries’ (NYSE: TEVA) proprietary abuse deterrence technology. 19 January 2017
Biotechnology
UCB (Euronext: UCB) and Dermira (Nasdaq: DERM) have said they expect to file for regulatory approval later this year of their anti-inflammatory drug following the latest positive clinical trial results. 19 January 2017
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