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 US Food and Drug Administration has approved the expanded use of Zykadia (ceritinib) to include the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive, as detected by an FDA-approved test. 27 May 2017
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), in its final decision has recommended Afinitor (everolimus) for the treatment of well- or moderately-differentiated unresectable or metastatic neuroendocrine tumors (NETs) of pancreatic origin in adults with progressive disease. 27 May 2017
Pharmaceutical
The US Food and Drug Administration on May 26 issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for SUN-101/eFlow (glycopyrrolate). 27 May 2017
Pharmaceutical
On the occasion of the World Clinical Trials Day last week, the Hellenic Association of Pharmaceutical Industries (SFEE) held an event to raise awareness of the crucial role of clinical studies both for patients and for the economy, as well as to warn against the imminent threat posed to clinical research in the country by the implementation of new measures. 26 May 2017
Generics
Even as India’s National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 31 more drug formulations, in yet another crackdown on prices, India's premier policy formulating agency Niti Aayog has proposed a change in the manner the government should identify drugs to be brought under price control. 26 May 2017
Pharmaceutical
America’s Merck & Co is to collaborate with health services company Optum to draft reimbursement models driven by health outcomes data. 26 May 2017
Biotechnology
The European Medicines Agency has granted "PRIME eligibility" for Myrcludex B, a first in class entry inhibitor for hepatitis Delta (D) virus. 26 May 2017
Biosimilars
The US Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of the proposed epoetin alfa biosimilar across all indications by a vote of 14 to one. 26 May 2017
Generics
Global drugmakers operating in Russia have called on the country’s government to impose a ban on the registration of generics before the expiration of the patent protection of original drugs. 25 May 2017
Biotechnology
USA-based Puma Biotechnology took its share price rise for the week to nearly 100% after the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee voted 12 to four to recommend approval of neratinib for the extended adjuvant treatment of HER2-positive early stage breast cancer. 25 May 2017
Biotechnology
The European Commission has granted a standard marketing authorization for Fampyra (prolonged-release fampridine tablets) for walking improvement in people with multiple sclerosis (MS). 25 May 2017
Biotechnology
The US Food and Drug Administration accepted a supplemental Biologics License Application (sBLA) that seeks to extend the use of Opdivo (nivolumab) to patients with hepatocellular carcinoma (HCC), or liver cancer, after prior treatment with sorafenib (Bayer’s Nexavar). 25 May 2017
Biotechnology
The US Food and Drug Administration has accepted the Biologics License Application (BLA) for tildrakizumab. 24 May 2017
Pharmaceutical
The member states of the World Health Organization (WHO) have elected Tedros Adhanom Ghebreyesus (pictured above) as the agency’s new director-general. 24 May 2017
Biotechnology
America’s Merck & Co has received yet another US FDA approval, the second in as many weeks, for its immuno-oncology drug Keytruda (pembrolizumab). 24 May 2017
Biosimilars
The European Union commitment to ensuring equity of access to healthcare is challenged by the limited financial capacity of governments to cover growing demand for healthcare services. Generic and biosimilar medicines provide the greatest opportunity to improve access to safe and effective medicines through efficient medicines policies. 23 May 2017
Pharmaceutical
Portugal's largest drugmaker Bial and Japanese pharma major Eisai have announced approval from the European Medicines Agency to market Zebinix (eslicarbazepine acetate) as a monotherapy to treat epilepsy. 23 May 2017
Biotechnology
The US Food and Drug Administration has approved Kevzara (sarilumab) for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX). 23 May 2017
Biotechnology
Shares in USA-based Puma Biotechnology closed 39% higher on Monday at $52.60 as investors sought to predict the position a US Food and Drug Administration (FDA) advisory panel would adopt on neratinib. 23 May 2017
Pharmaceutical
The UK Competition and Markets Authority (CMA) today issued a statement of objections to the pharmaceutical company Merck Sharp & Dohme (MSD). 23 May 2017
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