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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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
Biotechnology
The US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for belantamab mafodotin in combinations with bortezomib plus dexamethasone (BorDex [BVd]) and pomalidomide plus dexamethasone (PomDex [BPd]) for multiple myeloma patients who have received at least one prior line of therapy. 25 November 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Imkeldi (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers, from privately-held US-Ireland-based pharmaceutical company Shorla Oncology. 25 November 2024
Pharmaceutical
Science writer David Levine provides the latest quarterly Special Report piece, looking at the drug prices in one therapy area that are getting on people's nerves so much that they might prompt drastic action from the White House to bring down the cost of medicines across the board. 29 September 2017
Pharmaceutical
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has endorsed an update of the European Union label with immediate effect for Tresiba (insulin degludec) to include results from the DEVOTE trial on severe hypoglycemia. 29 September 2017
Pharmaceutical
A new analysis from QuintilesIMS, which draws on the Medicines Use and Spending in the U.S. — A Review of 2016 and Outlook to 2021 report and the Outlook for Global Medicines Through 2021: Balancing Cost and Value, takes an in-depth look at the true drivers of US medicine spending. 29 September 2017
Biosimilars
A group representing the industry that supplies more than 60% of Europe’s medicines has hit out at the low prices being paid for these drugs. 29 September 2017
Biotechnology
Before Bioverativ found a way to extend the half life of recombinant factor therapies, hemophilia patients required a transfusion as often as every other day, resulting in higher bleed frequency and associated morbidity. 29 September 2017
Biotechnology
Shares of US pharma major Eli Lilly were barely moved yesterday even though the company received approval from the US Food and Drug Administration for Verzenio (abemaciclib), under the agency’s Breakthrough and Priority Review designation programs. 29 September 2017
Biotechnology
Rare diseases had long been ignored in China until very recently. In May, China’s Food and Drug Administration (CFDA) drafted a policy to accelerate the approval process for innovative medical devices and drugs, including those for rare diseases, reports The Pharma Letter’s local correspondent Wang Fangqing. 29 September 2017
Pharmaceutical
As advancements in cancer therapies have been making headlines in recent years, cancer drug prices have significantly increased. The remaining question is, what are the economic impacts of the differentiations in cost of Food and Drug Administration-approved drugs and the purchasing power of individuals around the world? 29 September 2017
Biotechnology
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Imbruvica (ibrutinib), within its marketing authorization, for use on the Cancer Drugs Fund (CDF) as an option for treating Waldenström’s macroglobulinemia (WM) in adults who have had at least one prior therapy, only if the conditions in the managed access agreement for ibrutinib are followed. 28 September 2017
Pharmaceutical
The US pharmaceutical industry has signaled its support for severe limitations on the length of opioid prescriptions, saying it would be happy if the current 30-day maximum was reduced to just seven days. 28 September 2017
Pharmaceutical
Cancer is on the rise in India. With 1 million people diagnosed with it every year, some 700,000 of them die, making it one of the leading causes of death in the country, reports The Pharma Letter’s India correspondent. 28 September 2017
Pharmaceutical
The European Commission (EC) approval of a combination involving Kisqali (ribociclib) for a large breast cancer indication last month led a senior executive from Swiss pharma giant Novartis to proclaim that it proved the company’s ‘recognized leadership in cancer research’. 27 September 2017
Biotechnology
European pharma/biotech groups today issued their views and aims to support European competitiveness in the biomedical sector, and to avoid unnecessary delays for patient access to such innovative medicines whilst ensuring patient and environmental safety. 27 September 2017
Biotechnology
Markets reacted accordingly on Tuesday as PTC Therapeutics suffered the latest blow to its hopes to gain approval in the USA for Translarna (ataluren) as a treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD). 27 September 2017
Pharmaceutical
Danish diabetes care giant Novo Nordisk today announced that the China Food and Drug Administration (CFDA) has approved Tresiba (insulin degludec) for the treatment of diabetes in China, which it said has the world's highest number of adult diabetes patients. 27 September 2017
Pharmaceutical
An attack on the US drugmaker AbbVie has sought to put the issue of rising drug prices back in the public eye again. 26 September 2017
Pharmaceutical
The Final Budget Outcome papers released today reveal the enormous efforts of the members of Medicines Australia to keep expenditure low on the Pharmaceutical Benefits Scheme (PBS) while providing Australians with incredible access to breakthrough medicines. 26 September 2017
Pharmaceutical
Families from across Europe are on Tuesday having their say on an epilepsy drug that raises the risk of birth defects. 26 September 2017
Pharmaceutical
As part of the ongoing Ease of Doing Export Business - Rapid Results Initiative (RRI), the Medicines Control Authority of Zimbabwe (MCAZ), through the Ministry of Health and Child Care recently reduced the cost of two permits that are essential for exporting pharmaceutical products, reports local newspaper The Herald. 26 September 2017
Biotechnology
The China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. 25 September 2017
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