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 European Commission has granted marketing authorization for Rekovelle (follitropin delta), a human recombinant follicle stimulating hormone (human rFSH), following a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in October. 14 December 2016
Pharmaceutical
The UK regulator has ruled on breaches of the Association of British Pharmaceutical Industry code of conduct by five separate pharma companies. 13 December 2016
Pharmaceutical
The Russian Federal Antimonopoly Service (FAS) has designed a mechanism for the withdrawal of licenses on the production of drugs in Russia from their rightful owners, according to Igor Artemyev, head of the FAS. 13 December 2016
Pharmaceutical
US pharma major Eli Lilly has moved to provide up to 40% discounts for US users of its insulin products from the start of 2017, as prices rise on the back of soaring insurance rates. 13 December 2016
Biotechnology
Australian biotech firm CSL Limited has been announced as a co-investor in the government’s Biomedical Translation Fund, developed to stimulate investment in medical science in Australia. 13 December 2016
Pharmaceutical
The Canadian government has announced new legislation aimed at tackling the growing problem of
opioid drug abuse, citing statistics that record numbers of Canadians have died from drug overdoses this year. 13 December 2016
Pharmaceutical
The US Food and Drug Administration has approved Synjardy XR (empagliflozin and metformin hydrochloride extended-release) tablets for adults with type 2 diabetes. 13 December 2016
Pharmaceutical
As a result of an updated review, the US Food and Drug Administration has concluded that use of the type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. 13 December 2016
Biosimilars
South Korea’s Celltrion Healthcare welcomes the publication of the latest position paper from the European Crohn’s and Colitis Organization (ECCO) on the use of biosimilars for inflammatory bowel disease (IBD). 12 December 2016
Pharmaceutical
Rather like Kite’s registrational Zuma-1 trial of KTE-C19 in lymphoma, Novartis’ Eliana study has generated a fileable response rate. In the case of the Swiss firm’s rival CAR-T therapy, CTL019, this is in childhood leukemia patients, says EP Vantage, the editorial arm of the Evaluate group. 10 December 2016
Biotechnology
The US Food and Drug Administration has accepted the first Biologics License Application (BLA) for durvalumab, a PD-L1 human monoclonal antibody (MAb), and granted priority review status with a Prescription Drug User Fee Act (PDUFA) set for the second quarter of 2017. 10 December 2016
Biotechnology
The European Commission has granted an additional indication for Lucentis (ranibizumab) to treat patients with visual impairment due to choroidal neovascularization (CNV) associated with causes other than neovascular age-related macular degeneration (nAMD), or secondary to pathologic myopia (PM). 9 December 2016
Pharmaceutical
Despite the uncertainty that loomed over the pharma and biotech sectors with unexpected outcomes from both the US presidential election and UK’s vote to leave the EU, 2017 may bring renewed energy to the industry with potential for more corporate activity and cash flow. 9 December 2016
Pharmaceutical
A wide-ranging bill promising to fund biomedical research, establish a council to speed up the discovery, development, and delivery of innovative medicines and advance precision medicine, has been passed in the US Senate. 8 December 2016
Generics
Leading Indian drugmaker Sun Pharmaceutical Industries was trading 4.5% lower than it was at Tuesday’s close at a current 675.35 rupees after news that the US Food and Drug Administration (FDA) had raised further concerns about its Halol manufacturing plant in Gujarat. 8 December 2016
Biotechnology
Following a positive recommendation in October from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), the European Commission (EC) has now granted conditional marketing authorization for Venclyxto (venetoclax) monotherapy. 8 December 2016
Biotechnology
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for Dupixent (dupilumab) for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy. 8 December 2016
Biotechnology
Breakthrough immunotherapy Opdivo (nivolumab) has been approved in the European Union for the treatment of classical Hodgkin lymphoma (cHL), a rare and often-aggressive blood cancer. 7 December 2016
Generics
The UK’s Competition and Markets Authority (CMA) today announced that it has fined two compoanies nearly £90 million ($114.4 million) for charging excessive prices to the National Health Service (NHS) for an anti-epilepsy drug. 7 December 2016
Pharmaceutical
Danish diabetes giant Novo Nordisk has pledged to limit its price increases for US patients. 7 December 2016
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