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
By expanding the approved use of Kalydeco (ivacaftor) in cystic fibrosis (CF), the US Food and Drug Administration (FDA) has tripled the number of rare gene mutations that the drug can now treat. 18 May 2017
Biotechnology
US healthcare giant Johnson & Johnson’s pharma unit Janssen expects more than 10 of its new ‘blockbuster’ products to be launched or filed for regulatory approval by 2021. 17 May 2017
Biotechnology
Days after revealing a potential half-billion dollar collaboration in hemophilia with Pfizer, US gene editing specialist Sangamo Therapeutics announced that the US regulator has granted Fast Track designation to SB-525. 17 May 2017
Pharmaceutical
US regulators have granted Priority Review designation to copanlisib, a non-Hodgkin lymphoma candidate under development by Germany's largest drugmaker Bayer. 17 May 2017
Pharmaceutical
The US Food and Drug Administration says that canagliflozin, marketed by Johnson & Johnson as Invokana, causes an increased risk of leg and foot amputations. 17 May 2017
Generics
Taiwan’s Pharmadax has received approval from the US Food and Drug Administration (FDA) to market a generic equivalent of the anti-psychotic drug Seroquel XR (quetiapine fumarate) at five different strengths. 16 May 2017
Pharmaceutical
American lawmakers are reintroducing a bill that would limit the ability of pharmaceutical companies to raise drug prices, with tougher language to prevent medium-term hikes. 16 May 2017
Biotechnology
In non-small cell lung cancer (NSCLC) that has already formed metastases, the suitable treatment depends, among other factors, on the genes that are activated in the tumor cells and whether mutations have occurred that make certain treatments ineffective. 16 May 2017
Generics
South African drugmaker Aspen Pharma has confirmed that the European Commission has opened proceedings to investigate certain actions of Aspen Holdings and certain of its European subsidiaries. 16 May 2017
Pharmaceutical
European politicians have lent voice to calls for more funding to treat and prevent drug-resistant tuberculosis (TB), at an event organized by charities fighting the disease. 15 May 2017
Pharmaceutical
Research published in the Journal of the American Medical Association (JAMA) has found that a third of drugs approved by US regulators are subsequently flagged for a safety event. 15 May 2017
Pharmaceutical
The New Zealand government has announced an additional investment of NZ$60 million ($42 million) towards new medicines. 15 May 2017
Biotechnology
The USA’s Institute for Clinical and Economic Review (ICER), a non-profit organization, has released an Evidence Report assessing the comparative clinical effectiveness and value of dupilumab and crisaborole for the treatment of atopic dermatitis. 14 May 2017
Biotechnology
The Food and Drug Administration has expanded a previously granted Breakthrough Therapy designation (BTD) for setmelanotide, a novel melanocortin-4 receptor (MC4R) agonist from Boston, USA-based biotech firm Rhythm Pharmaceuticals. 13 May 2017
Pharmaceutical
The World Health Organization (WHO) has held a forum on the cost of medicines in a stated attempt to facilitate discussion leading to ‘fairer price setting and a system that is sustainable for health systems and for innovation’. 12 May 2017
Pharmaceutical
A clinical trial has found that the oncology drug Avastin (bevacizumab) is about as effective as Eylea (aflibercept) in treating central retinal vein occlusion (CRVO), an eye condition. 11 May 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has issued a second Appraisal Consultation Document (ACD) not recommending the routine National Health Service use of Venclexta (venetoclax) for patients with certain types of difficult-to-treat relapsed and refractory chronic lymphocytic leukemia (CLL). 11 May 2017
Pharmaceutical
The European Medicines Agency’s 2016 annual report published today focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life. 11 May 2017
Biotechnology
Merck & Co’s gamble on an early bid to bring the first ever dual chemo and immuno-oncology therapy to market has paid off. 11 May 2017
Generics
Hikma Pharmaceuticals has revealed receipt of a complete response letter (CRL) from the US Food and Drug Administration in relation to its Abbreviated New Drug Application (ANDA) for VR315, its generic version of Advair Diskus (fluticasone propionate and salmeterol inhalation powder). 11 May 2017
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