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 UK’s cost-effectiveness watchdog the National Institute for Health and Care Excellence has issued its final guidance on Onivyde (irinotecan liposomal) combination therapy, recommending against routine use in the National Health Service (NHS). 28 March 2017
Generics
A US Congress Subcommittee has heard that pharmaceutical companies can delay competition in the generics space by abusing FDA rules designed to enhance safety. 28 March 2017
Pharmaceutical
A Viagra (sildenafil citrate) alternative, selected painkillers and travel vaccines are among items which the National Health Service (NHS) in England is set to cease prescribing. 28 March 2017
article
Tesaro saw its shares gain 5.9% to $156.73 in after-hours trading on Monday after the US Food and Drug Administration announced approval for its new oral, once-daily poly (ADP-ribose) polymerase (PARP) inhibitor intended for the treatment of ovarian cancer. 28 March 2017
Pharmaceutical
The German Federal Joint Committee (G-BA) has confirmed the additional benefit of Kisplyx (lenvatinib) in combination with everolimus for the treatment of adults with advanced renal cell carcinoma (RCC) versus everolimus alone. 28 March 2017
Biotechnology
The French health authority Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) has approved Eprex (epoetin alfa) for the treatment of symptomatic anemia. 28 March 2017
Biotechnology
European regulators have accepted Kiadis Pharma’s Pediatric Investigation Plan (PIP) for ATIR101 (allodepleted T-cell immunotherapeutics), an important regulatory milestone. 28 March 2017
Biotechnology
The UK BioIndustry Association (BIA) is leading a UK delegation from the biotech sector on a discovery trip to see how Switzerland works with Europe but outside of the EU, to forge new relationships and explore potential opportunities. 28 March 2017
Pharmaceutical
The Australian government is reducing the price of 1,100 medicine brands listed on the Pharmaceutical Benefits Scheme. As a result, the price paid by millions of Australians for prescription medicines will be reduced, from the start of April. 27 March 2017
Generics
The urgent need to foster “Make in India for India” in Active Pharmaceutical Ingredient (API ) manufacturing to capitalize on the lost market share, reduce India’s dependency on China and establish self-sustainability, is highlighted by the ASSOCHAM (Associated Chambers of Commerce & Industry of India)-Sathguru joint study. 27 March 2017
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation status to Rituxan (rituximab) for pemphigus vulgaris. 27 March 2017
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca has received marketing authorization for Tagrisso (osimertinib) in China as a first-in-class treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic non-small cell lung cancer (NSCLC). 27 March 2017
Pharmaceutical
The Institute for Clinical and Economic Review (ICER), a US non-profit organization, has released a Draft Evidence Report assessing the comparative clinical effectiveness of crisaborole for treatment of mild-to-moderate atopic dermatitis in adults and children, and the clinical effectiveness and value of and dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults. 27 March 2017
Pharmaceutical
The new US President Donald Trump suffered a major defeat on Friday, as his flagship legislation to repeal what is commonly referred to as Obamacare, failed to gain sufficient support. Also making headlines was Eli Lilly’s planned investment on infrastructure; a promising abuse-deterrent opioid drug; recommended European approval of a new hemophilia drug; and a setback for Novartis’ serelaxin. 25 March 2017
Pharmaceutical
The new US President Donald Trump suffered a major defeat on Friday, as his flagship legislation to repeal Affordable Care Act, what is commonly referred to as Obamacare, failed to gain sufficient support. 25 March 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended six medicines for approval at its March 20-23, 2017, meeting. 24 March 2017
Pharmaceutical
US pharma major Eli Lilly is to invest $850 million in its US operations in 2017, the company announced on Friday. 24 March 2017
Biotechnology
The European Medicines Agency will review a marketing authorization application from leading Indian drugmaker Sun Pharma and Spain's largest pharma firm Almirall for dermatology candidate tildrakizumab. 24 March 2017
Biosimilars
As it did in the USA, biotech major Amgen has become the first to gain European Union (EU) approval for a biosimilar version of AbbVie's Humira (adalimumab), the world’s best-selling branded drug. 24 March 2017
Biotechnology
The US Food and Drug Administration yesterday granted accelerated approval to Bavencio (avelumab) for the treatment of adults and pediatric patients 12 years and older with metastatic Merkel cell carcinoma (MCC), including those who have not received prior chemotherapy. 24 March 2017
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