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
A Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the US Food and Drug Administration. 22 February 2017
Biosimilars
Trade group Medicines for Europe says it welcomes the approval by the European Parliament of the European Union and Canada Comprehensive Economic and Trade Agreement (CETA) that can be an opportunity for medicine manufacturers in the two regions. 22 February 2017
Biotechnology
UK Medicines cost-effectiveness watchdog The National Institute for Health and Care Excellence (NICE) has today published draft guidance that does not recommend cabozantinib for previously treated advanced renal cell carcinoma. 21 February 2017
Pharmaceutical
Swiss pharmaceutical giant Roche has been granted conditional approval from the European Medicines Agency (EMA) for its lung cancer therapy Alecensa (alectinib). 21 February 2017
Pharmaceutical
In Russia, the vast majority of pharmaceutical sales are attributed to imported drugs, something that President Vladimir Putin’s “Pharma 2020” project - an initiative to stimulate local pharmaceutical development and manufacturing - aims to change. 20 February 2017
Biotechnology
Chugai Pharmaceutical has filed a new drug application to the Ministry of Health, Labor and Welfare (MHLW), for engineered anti PD-L1 monoclonal antibody atezolizumab (genetic recombinant) for the treatment of unresectable advanced or recurrent non-small cell lung cancer (NSCLC). 20 February 2017
Pharmaceutical
Rare and specialty diseases specialist Mereo BioPharma Group was trading 2% higher on Monday lunchtime at £2.90 after more positive news on an asset which it acquired from Swiss pharma major Novartis in 2015. 20 February 2017
Generics
Momenta Pharmaceuticals announced that Sandoz’s contracted fill/finish manufacturing partner has received a US Food and Drug Administration warning letter. 20 February 2017
Pharmaceutical
While developments at the USA’s White House were much in focus politically last week, the heat was off the Pharma sector, at least for the time being. Last week’s news for sector centered more on clinical trials results, drug approvals and some financial reports. 19 February 2017
Pharmaceutical
Medicines regulatory Health Canada approved Rexulti (brexpiprazole) for the treatment of schizophrenia in adults. 19 February 2017
Pharmaceutical
Children with asthma in the USA aged six years and above can receive the Boehringer Ingelheim treatment Spiriva (tiotropium) Respimat, as opposed to those aged at least 12 years as was previously the case. 17 February 2017
Biotechnology
Health Canada has granted a Notice of Compliance (NOC) for Odefsey (emtricitabine 200mg/rilpivirine 25mg/tenofovir alafenamide 25mg) tablets as a complete regimen for the treatment of adults with HIV-1 infection. 17 February 2017
Pharmaceutical
The tug of war continues. Even as the Indian Pharmaceutical Alliance, the domestic drug industry lobby group, has appealed to the US Trade Representative to remove India from its Priority Watch List - the latter includes countries that are alleged violators of US patent laws - Pharmaceutical Research and Manufacturers of America (PhRMA), in its submission, has requested the USTR to continue to keep India on the Priority Watch List in the 2017 Special 301 Report, reports The Pharma Letter’s India correspondent. 16 February 2017
Biosimilars
Netherlands-based generics major Mylan and Indian drugmaker Biocon have had their Biologics License Application (BMA) for a second biosimilar accepted by the US Food and Drug Administration (FDA). 16 February 2017
Pharmaceutical
USA-based Evoke Pharma said yesterday that it has received a letter from the Food and Drug Administration exempting its late stage product, Gimoti from a Human Factors (HF) validation study requirement prior to submission of a New Drug Application (NDA). 16 February 2017
Pharmaceutical
The US Food and Drug Administration yesterday approved Siliq (brodalumab) to treat adults with moderate-to-severe plaque psoriasis. 16 February 2017
Biosimilars
The Generic Pharmaceutical Association (GPhA), the USA’s largest trade group representing generic pharmaceutical and biosimilar companies, has rebranded itself as the Association for Accessible Medicines (AAM). 15 February 2017
Pharmaceutical
Days after receiving a backlash from a pharma company for its decision not to recommend a new treatment for a certain patient group, the National Institute for Care and Excellence (NICE) has again shown that it will take a stance against drugs which it does not judge to be cost-effective. 15 February 2017
Pharmaceutical
In the newly-released “opinions on policies for drug manufacturing and distribution” by the State Council, which holds the highest power in China, the focus is made clear – keep improving drug quality and cutting drug prices, reports The Pharma Letter’s local correspondent Wang Fangqing. 15 February 2017
Biotechnology
US biotech firm Amicus Therapeutics today announced new positive data analyses for the oral small molecule pharmacological chaperone migalastat HCl for Fabry disease at WORLDSymposium 2017 in San Diego, California, USA. 15 February 2017
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