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
Just as the US Senate Committee on Health, Education, Labor and Pensions begins hearings examining the drug delivery system, the Pharmaceutical Care Management Association (PCMA) is releasing a new analysis, "Increasing Prices Set by Drugmakers Not Correlated With Rebates." 13 June 2017
Biotechnology
The Institute of Clinical and Economic Review (ICER) has issued a Final Evidence Report and summary of a public meeting of the Midwest Comparative Effectiveness Public Advisory Council (Midwest CEPAC) that concludes Dupixent (dupilumab) offers good long-term value for patients with moderate-to-severe atopic dermatitis. 12 June 2017
Biotechnology
A New Drug Application has been submitted to the US Food and Drug Administration for an investigational, once-daily single tablet regimen containing bictegravir (50mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF) for the treatment of HIV-1 infection in adults. 12 June 2017
Pharmaceutical
Dutch quango the Medicines Evaluation Board (MEB) has released its annual report, focusing on its role in ensuring the availability of medicines and reducing the use of animal testing in clinical development. 12 June 2017
Pharmaceutical
European, American and Japanese regulators are to work more closely together to engender the development of new antibiotics. 12 June 2017
Biotechnology
Lartruvo (olaratumab), in combination with doxorubicin, has been recommended by the medicines cost-effectiveness watchdog for England and Wales for use as an option for advanced soft tissue sarcoma in adults who have not had any previous systemic chemotherapy for advanced soft tissue sarcoma and cannot have curative treatment with surgery or their disease does not respond to radiotherapy. 12 June 2017
Pharmaceutical
Europe's first oral medication for the treatment of bladder pain syndrome (BPS) characterized by glomerulations or Hunner's lesions has been approved. 12 June 2017
Pharmaceutical
At its June meeting, the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) started a review of Zinbryta (daclizumab) used to treat adults with relapsing forms of multiple sclerosis. 10 June 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has stuck by its recommendation, made last year, that pirfenidone should be reserved for people with moderate idiopathic pulmonary fibrosis (IPF) only and not prescribed on the NHS for people in the early stages of this fatal lung condition. 9 June 2017
Biotechnology
In October 2016, the US Food and Drug Administration placed a clinical hold on a proposed Phase III clinical program for VGX-3100, its investigation therapeutic vaccine for cervical dysplasia caused by the human papillomavirus (HPV). 9 June 2017
Pharmaceutical
The PDUFA renewal bill has cleared its penultimate hurdle in the House of Representatives, as the Energy and Commerce Committee this week cleared a final version to be voted on. 9 June 2017
Biosimilars
Biotech industry trade group EuropaBio has developed recommendations for changes to the Summary of Product Characteristics (SmPC) of biosimilars that would result in an enhanced level of transparency in the label. 9 June 2017
Biotechnology
When setting the price not only of the first drug of its kind to reach the market, but also one that is manufactured for each individual patient, a drugmaker might feel justified in asking for a good return to cover the significant development and manufacturing costs. 9 June 2017
Pharmaceutical
With concern among much of UK life sciences sector at the hard-Brexit rhetoric of Theresa May but Labour Leader Jeremy Corbyn having risked the wrath of pharma by calling for greater nationalization of medical research, it is hard to know what industry executives must be making of the latest surprise result in a UK political vote. 9 June 2017
Pharmaceutical
The US Food and Drug Administration on Thursday called on Endo Pharmaceuticals to voluntarily remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. 9 June 2017
Pharmaceutical
New York, USA-based pharmaceutical giant Pfizer has defended its decision to raise the price of around 100 drugs in the US market by up to 20% in 2017. 8 June 2017
Biotechnology
The US Food and Drug Administration (FDA) has accepted for filing Synergy Pharmaceuticals’ supplemental New Drug Application (sNDA) for Trulance (plecanatide) for the treatment of adults with irritable bowel syndrome with constipation (IBS-C). 8 June 2017
Pharmaceutical
As governments, patients and the pharmaceutical industry take ever more seriously the threat of antimicrobial resistance, German researchers have published a new study that points the finger at globalized drug manufacturing. 8 June 2017
Biosimilars
The Biologics License Application (BLA) for the first biosimilar candidate to the Roche blockbuster cancer drug Avastin (bevacizumab) to be submitted in the USA, is to be reviewed by a Food and Drug Administration (FDA) committee next month. 8 June 2017
Pharmaceutical
The UK subsidiaries of Japan’s Astellas Pharma and Hungarian drugmaker Gedeon Richter have brought discredit upon, and reduced confidence in, the pharmaceutical industry, says trade group the Association of the British Pharmaceutical Industry (ABPI). 8 June 2017
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