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
The US Food and Drug Administration has granted Breakthrough Therapy status to burtomab, an anticancer agent discovered by the cancer center at Memorial Sloan Kettering (MSK). 8 June 2017
Pharmaceutical
In 2015, costs of prescription drugs in the USA increased by 13.5%.1 If this trend continues, all branded pharmaceuticals will have 100% increase in their prices in ten years’ time. This steep escalation in drug prices will not only affect consumers, but also insurance companies who will eventually raise their premium prices to cover the additional cost, says Dr Nicola Davies in her exclusive monthly blog for The Pharma Letter. 7 June 2017
Biotechnology
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee will review the Biologics License Application (BLA) for CTL019 (tisagenlecleucel-T) in relapsed and refractory (r/r) pediatric and young adult patients with B-cell acute lymphoblastic leukemia on July 12. 7 June 2017
Pharmaceutical
The European Commission has now granted marketing authorization for Refixia (nonacog beta pegol; N9-GP) for the treatment of adolescents and adults with hemophilia B. The authorization covers all 28 European Union member states. 7 June 2017
Pharmaceutical
June 7, 2017
The US Food and Drug Administration today granted approval of two-month Aristada (aripiprazole lauroxil), a long-acting antipsychotic treatment for schizophrenia. 6 June 2017
Pharmaceutical
Dublin, Ireland-headquartered Allergan has received a positive recommendation from the UK’s medicines cost-effectiveness agency for Ozurdex (dexamethasone), as a treatment for people with a sight-threatening condition. 6 June 2017
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency PHARMAC today announced the approval of an agreement for the supply of metoprolol succinate long-acting tablets. 6 June 2017
Biotechnology
CEL-SCI Corp has responded to the US Food and Drug Administration’s most recent communication from May 2017 about the clinical hold imposed on the company’s Phase III head and neck cancer study with Multikine (leukocyte interleukin, injection). 6 June 2017
Biotechnology
Amgen today announced the submission of a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and a variation to the marketing authorization to the European Medicines Agency for Repatha (evolocumab), a PCSK9 inhibitor. 5 June 2017
Biotechnology
The German Institute for Quality and Efficiency in Health Care (IQWiG) has examined in two early benefit assessments whether Novartis’ Cosentyx (secukinumab) and Taltz (ixekizumab) from Eli Lilly offer an added benefit for patients in comparison with the appropriate comparator therapies. 5 June 2017
Pharmaceutical
The Chinese Food and Drug Administration has released its annual report detailing findings from inspections of drug manufacturing sites around the world in 2016. 5 June 2017
Pharmaceutical
Ahead of the current and exciting news coming from ASCO over the weekend, hitting the headlines were Johnson & Johnson’s deal with Protagonist, Novartis setting out its future growth plans, small-cap French drugmaker Nicox gaining its first drug approval in the USA, GlaxoSmithKline filing for approval on a combination HIV treatment and Teva Pharmaceutical Industries’ progress with migraine drug candidate fremanezumab. 4 June 2017
Biotechnology
The European Commission (EC) has approved Opdivo (nivolumab) for the treatment of locally-advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. 3 June 2017
article
Maryland will become the first state in the USA to enact a law prohibiting “price gouging” by generic pharmaceutical manufacturers, according to a posting on law firm Hyman, Phelps & McNamara’s FDA Law Blog by David Gibbons and Alan Kirschenbaum. 2 June 2017
Pharmaceutical
The reality of a ‘hard Brexit’ – the UK leaving the European Union (EU) without a trade deal in place between the two parties – could lead to UK medicines being treated as imports by the EU and force drugmakers to set up some operations within member states. 2 June 2017
Pharmaceutical
ViiV Healthcare has submitted applications for regulatory approval in Europe and the USA for a single-tablet, two-drug regimen combining its own dolutegravir with Janssen’s rilpivirine. 2 June 2017
Biotechnology
In a reversal of its draft guidance, following review of additional data, the National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination recommending Opdivo (nivolumab) for the treatment of adult patients with classical Hodgkin lymphoma (cHL). 2 June 2017
Pharmaceutical
A US government estimate suggests that Netherlands-incorporated drugmaker Mylan overcharged American taxpayers by as much as $1.27 billion for its EpiPen (epinephrine) auto-injectors. 1 June 2017
Biotechnology
US biotech Biogen’s Spinraza (nusinersen) has been approved in the European Union (EU) for the treatment of 5q spinal muscular atrophy (SMA). 1 June 2017
Biotechnology
The European Commission has granted marketing authorization for Brineura (cerliponase alfa), the first treatment approved in the European Union for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase 1 (TPP1) deficiency. 1 June 2017
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