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
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
Berlin, Germany-based Eckert & Ziegler Radiopharma has received approval of its proprietary non-carrier added Lutetium-177 chloride, Theralugand, by the European Commission (EC). 27 November 2024
Pharmaceutical
Jeevan Virk, commercial director for the UK and Ireland at French molecular nuclear medicine specialist Advanced Accelerator Applications, admitted that it was not a shock when the National Institute for Health and Care Excellence (NICE) published draft guidance not recommending Lutathera (Lutetium Lu 177 dotatate) for treating neuroendocrine tumors of gastrointestinal and pancreatic origin. 11 August 2017
Pharmaceutical
Lipocine has resubmitted a New Drug Application (NDA) for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy (TRT). 11 August 2017
Biotechnology
Californian biotech firm Gilead Sciences has received priority review status from the US FDA for an investigational combination of HIV candidate bictegravir plus emtricitabine/tenofovir alafenamide. 11 August 2017
Pharmaceutical
TherapeuticsMD saw its shares dip 1.23% to $5.60 in after-hours trading on Thursday after it announced a regulatory update regarding the New Drug Application (NDA) for TX-004HR. 11 August 2017
Generics
A two-tier manufacturing market and forecast increased acquisitions by Indian companies, along with a notable improvement in the international reputation of Indian made pharmaceuticals have been identified in a new report for CPhI titled: 2017 India Pharma Market Report. 10 August 2017
Pharmaceutical
The China Food and Drug Administration (CFDA) has been accepted as a member of the ICH, a global federation of regulators that seeks to harmonize health technology regulations. 10 August 2017
Pharmaceutical
The UK’s National Institute for Health and Care Excellence (NICE) has today released a Final Appraisal Document (FAD) recommending Nexavar (sorafenib) for use on NHS England. 10 August 2017
Pharmaceutical
The Russian government is considering legalizing the parallel importation of drugs into the country in an attempt to force foreign producers to reduce the prices for their range in Russia. 9 August 2017
Pharmaceutical
Ahead of the Prescription Drug User Fee Act (PDUFA) date of August 24, 2017, for its decision on the New Drug Application (NDA) for latanoprostene bunod ophthalmic solution, 0.024%, the US Food and Drug Administration announced another setback for Valeant Pharmaceuticals International. 8 August 2017
Biotechnology
The UK’s health technology assessor has provided Germany’s Merck KGaA with a positive reimbursement decision on Erbitux. 8 August 2017
Biotechnology
Roche subsidiary Genentech has received priority review status for its bid to broaden the label for Zelboraf in the USA. 8 August 2017
Pharmaceutical
Netherlands-based drugmaker Mylan has received marketing authorization from the Drug Controller General of India for its antiretroviral (ARV) drug Avonza (TLE400). 8 August 2017
Biotechnology
In March 2016, Barack Obama became the first US President to visit Cuba since 1928, marking one of the final stages in a progressive thaw in relations that, it was hoped, would usher in a new era of trade and cooperation between the two countries. 7 August 2017
Pharmaceutical
German pharma major Bayer got a boost to its shares this morning after it revealed an important additional indication approval for its cancer drug Stivarga (regorafenib) in the European Union. 7 August 2017
Generics
American generics drugmaker Mylan has received tentative approval to distribute its HIV/AIDS treatment TLD in developing countries under the US President's Emergency Plan for AIDS Relief (PEPFAR). 7 August 2017
Pharmaceutical
The US Food and Drug Administration (FDA) has approved QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a breath-actuated inhaler for the maintenance treatment of asthma as a prophylactic therapy. 7 August 2017
Pharmaceutical
The US Food and Drug Administration has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for CCP-08, a prescription cough cold treatment. 7 August 2017
Biosimilars
The Indian biosimilar drugs industry is poised for exponential growth owing to the increasing acceptance, entry of new players, and successful launch of biosimilar products. 7 August 2017
Biotechnology
In a meeting late July with the Minister of Health, Ricardo Barros, the president of the Brazilian Society of Rheumatology (SBR), Georges Christopoulos, presented an agenda for reviving the benefit of patients with rheumatic diseases, positioning the entity also against the eventual reduction of the medications for rheumatoid arthritis (RA), as has been broadcast in recent weeks. 7 August 2017
Pharmaceutical
There were again a number of important financial results reports in the past week, with three – Pfizer, Shire and Teva Pharmaceutical Industries – attracting most external comments. Clovis Oncology’s deal with Bristol-Myers Squibb on its cancer drug Rubraca had a negative impact on the former’s, share price and - for a change in recent times – there was good news for AstraZeneca with regard to its cancer drug Imfinzi. 7 August 2017
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