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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Generics
Attorneys general from 45 states in the USA have widened the scope of an earlier court action which alleges collusion to fix generic drug prices. 1 November 2017
Pharmaceutical
Today, November 1, marks the coming into operation of further aspects of the mutual recognition agreement between the European Union and the United States to recognize inspections of manufacturing sites for human medicines conducted in their respective territories. 1 November 2017
Biotechnology
The UK’s health technology assessor has unveiled draft guidance recommending I-O therapy Tecentriq to treat advanced urothelial cancer in certain circumstances. 1 November 2017
Pharmaceutical
Humanitarian aid group Médecins Sans Frontières says it has secured a supply of generic hepatitis C medicines at $1.40 per day, or $120 per 12-week treatment course for the two key medicines sofosbuvir and daclatasvir. 31 October 2017
Biotechnology
Swiss drugmaker Novartis is bidding to extend the marketable use of Kymriah (tisagenlecleucel), to include B-cell lymphoma (DLBCL) patients. 31 October 2017
Pharmaceutical
Michael Ellenbogen, who was diagnosed with younger-onset Alzheimer’s disease in 2008, was invited to give a talk to staff at a major pharma company last week. He has provided his speech to The Pharma Letter as part of his drive for urgent action to defeat the disease. 31 October 2017
Biosimilars
US drug giant Pfizer and its South Korean partner Celltrion have armed themselves with more evidence to aid their efforts to replace Remicade’s (infliximab) share of the Crohn’s Disease (CD) market. 31 October 2017
Pharmaceutical
The Indian government is on the war path again. The Department of Pharmaceuticals is looking to change the method of approving prices of new drugs, despite a clear division in its ranks about amending the drug price control order, in a move that would bring non-essential drugs under price control, reports The Pharma Letter’s India correspondent. 30 October 2017
Biotechnology
US pharma giant Merck & Co is having a ghastly Halloween season. 30 October 2017
Pharmaceutical
Last week’s news was largely dominated by financial results, with among many others, Swiss pharma giant Novartis pleasing investors, while Celgene and Gilead Sciences disappointed. Also attracting a good deal of attention was MacroGenics lucrative deal with Incyte for cancer drug candidate MGA012, and Novartis gaining breakthrough status for its melanoma drug combination Tafinlar+Mekinist. 29 October 2017
Biotechnology
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) is recommending further restrictions on the use of the multiple sclerosis medicine Zinbryta (daclizumab) following a review of the medicine’s effects on the liver. 28 October 2017
Pharmaceutical
Hot on the heels of Canadian and US marketing approval of its shingles vaccine Shingrix, UK pharma major GlaxoSmithKline late yesterday received a follow-on boost for its product with a US recommendation as the preferred shingles vaccine from the committee responsible for vaccination policy in the USA. 26 October 2017
Biotechnology
The US Food and Drug Administration’s (FDA) approval of Soliris (eculizumab) in a new indication on Monday was billed as an exciting step forward for a long underserved patient group, but lukewarm investor reaction since reflects a market unsure of whether broad uptake will follow. 25 October 2017
Biotechnology
Chugai has filed an application with the Japanese Ministry of Health, Labor and Welfare (MHLW) for the approval of anti-HER2 humanized monoclonal antibody, Perjeta Infusion (pertuzumab) for the additional indication of adjuvant therapy for HER2-positive early breast cancer. 25 October 2017
Pharmaceutical
On November 20, the question of which country will host the European Medicines Agency post-Brexit will finally be settled, at the European Council’s General Affairs (Art. 50) meeting. 25 October 2017
Biotechnology
Australia’s medicines regulator, the Therapeutic Goods Administration, has announced it will reform the way autologous human cell and tissue products are regulated. 24 October 2017
Pharmaceutical
In New Zealand, from November 1, 2017, Ozurdex (dexamethasone implants) will be funded for eligible people with diabetic macular edema (DMO), a serious complication of type 1 and type 2 diabetes that can cause blindness if untreated. 24 October 2017
Pharmaceutical
One year ago, the European Medicines Agency (EMA) became the first regulatory authority to give open access to clinical data submitted by companies in support of their marketing authorization applications. 24 October 2017
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the adjuvant treatment of patients with stage III melanoma with a BRAF V600 mutation following complete resection. 23 October 2017
Pharmaceutical
The leading trade group for the pharmaceuticals industry is lobbying for the federal 340B drug discount program to be constrained. 23 October 2017
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
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
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