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
Three months after the US FDA put a partial hold on three clinical trials investigating Opdivo combinations in multiple myeloma, the agency has given Bristol-Myers Squibb and its collaborators the all clear to continue two of the studies. 6 December 2017
Pharmaceutical
British lawmakers have revealed details of a new industrial strategy for the life sciences sector, aimed at supporting economic development in the wake of Brexit. 6 December 2017
Pharmaceutical
The British pharmaceutical industry’s leading trade group told a UK government committee this morning that it would favor “a pragmatic agreement” where parts of the European Medicines Agency would stay in London after Brexit. 5 December 2017
Biotechnology
There was disappointing news today for Swiss pharma giants Novartis and Roche when the UK’s National Institute for Health and Care Excellence (NICE) published draft guidance on technology appraisals turning down drugs from the companies for regular use on the National Health Service (NHS). 5 December 2017
Biotechnology
The US Food and Drug Administration has granted Amgen a label extension for Repatha, to include prevention of heart attacks and strokes. 4 December 2017
Pharmaceutical
Canada has launched proposals to amend regulations covering patented medicines, saying it hopes to “better protect Canadian consumers from the high prices of patented drugs.” 4 December 2017
Pharmaceutical
The Chinese Food and Drug Administration has approved Brintellix (vortioxetine) for the treatment of major depressive disorders (MDD) in that country. 4 December 2017
Pharmaceutical
The European Medicines Agency today released highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) meeting that was held November 27-30, 2017. 1 December 2017
Pharmaceutical
Speaking before a congressional committee in the US House of Representatives, FDA Commissioner Scott Gottlieb confirmed Thursday that his agency is honing in on new ways to approve certain drugs faster. 1 December 2017
Pharmaceutical
A leading trade group for pharmacy benefit managers (PBM) has issued a highly critical response to a recent report from the pharmaceutical industry blaming PBMs for high drug prices in the USA. 1 December 2017
Pharmaceutical
The US Food and Drug Administration has approved Sublocade (buprenorphine extended- release) injection for subcutaneous use (CIII), the first and only once-monthly injectable buprenorphine formulation for the treatment of moderate to severe opioid use disorder (OUD). 1 December 2017
Pharmaceutical
The US Department of Veterans Affairs (VA) has placed the first new Food and Drug Administration-approved treatment option for amyotrophic lateral sclerosis (ALS) in more than 20 years on its National Formulary for coverage. 30 November 2017
Biotechnology
Switzerland’s Novartis today has published in the prestigious New England Journal of Medicine positive results from the Phase III STRIVE study, which is designed to evaluate the firm’s migraine candidate erenumab. 30 November 2017
Biotechnology
French drugmaker Sanofi says it expects to take a post-tax hit of about 100 million Euros ($118 million) after new safety data from showed its dengue vaccine Dengvaxia could be harmful to those not previously infected with the disease. 30 November 2017
Pharmaceutical
The 25 recommendations released in the Australian Senate Select Committee report reveal the challenges the country faces to ensure that all Australians get access to the treatments and medicines they need when they need them, regardless of the type of disease. 30 November 2017
Pharmaceutical
American lawmakers meeting in a closed-door session reportedly received assurances from President Trump that he would be willing to support measures that would bolster the wobbling Obamacare exchange markets, in return for an end to the individual mandate. 29 November 2017
Pharmaceutical
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has today announced Viagra Connect (containing sildenafil 5mg) will be formally classified from a prescription-only medicine (POM) to a pharmacy medicine (P). 29 November 2017
Pharmaceutical
Multiple trade groups representing the pharmaceuticals industry in Europe have issued a joint statement calling on the UK and EU to agree to a Brexit transition period. 28 November 2017
Biotechnology
Shares of Japanese drugmaker Kyowa Hakko Kirin moved up more than 2% to 2,086 yen today, after the company announced that the US Food and Drug Administration had agreed to review the company CTCL candidate under priority status. 28 November 2017
Pharmaceutical
The UK managing directors (MDs) of three US pharma majors have given a House of Lords Committee their views on how to make the UK more competitive in attracting investment in the life sciences. 28 November 2017
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
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