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
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 BeOne Medicines, formerly 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
Biotechnology
StemCyte, a subsidiary of StemCyte International, has secured approval from the US Food and Drug Administration for Regenecyte, a cord blood-derived stem cell therapy. 25 November 2024
Biotechnology
Japanese pharma company Takeda and the Belgian biopharma that it is in the process of acquiring, TiGenix, achieved a notable milestone on Friday with the European Commission’s approval of Alofisel (darvadstrocel). 23 March 2018
Biotechnology
The publication of results from the EXPAND Phase III trials of siponimod in secondary progressive multiple sclerosis (SPMS) in The Lancet are timely for the drug’s developer, Novartis. 23 March 2018
Pharmaceutical
Shingrix, which was first approved in Canada in October last year, followed by the USA later the same month, has now added two more important regions were the vaccine is cleared for marketing. 23 March 2018
Pharmaceutical
Anglo-Swedish pharma major AstraZeneca yesterday announced that the European Commission has granted marketing authorization for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalemia. 23 March 2018
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has approved Ozempic (semaglutide), a new once-weekly analogue of human glucagon-like peptide-1 (GLP-1), for the treatment of adults with type 2 diabetes. 23 March 2018
Pharmaceutical
Swiss pharma giant Novartis got a boost late yesterday with an additional indication for its already blockbuster drug to treat children with a rare form of leukemia. 23 March 2018
Pharmaceutical
In a reversal of last week’s decision to reject so-called ‘right to try’ legislation, the US House of Representatives has now given the green light to a bill which would enable terminally ill patients in the USA to gain access to unapproved drug candidates. 22 March 2018
Pharmaceutical
By lunchtime on Thursday, 13% had been wiped off the market value of US drugmaker AbbVie, compared to the previous close. 22 March 2018
Biotechnology
The US Food and Drug Administration has approved a label update that includes pharmacokinetic data showing negligible to low transfer of Cimzia (certolizumab pegol) through placenta and minimal transfer to breast milk from mother to infant. 22 March 2018
Pharmaceutical
Shares in Japanese drugmaker Chugai Pharmaceutical are up almost 5% on news that the China Food and Drug Administration (CFDA) is to consider the firm’s regulatory application for eldecalcitol, an osteoporosis treatment marketed in Japan as Edirol. 22 March 2018
Pharmaceutical
Japan’s Ministry of Health, Labor and Welfare (MHLW) has granted Orphan Drug designation to gilteritinib for the treatment of FLT3mut+ acute myeloid leukemia (AML), the drug’s prospective indication. 22 March 2018
Pharmaceutical
The UK business of Akcea Therapeutics has received a positive scientific opinion for volanesorsen, from the country’s Early Access to Medicines Scheme (EAMS). 21 March 2018
Pharmaceutical
Swedish Orphan Biovitrum says that, after securing reimbursement in Europe for Ravicti (glycerol phenylbutyrate), the company is launching the therapy in several country markets. 21 March 2018
Biotechnology
The US Food and Drug Administration has approved Ilumya (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. 21 March 2018
Pharmaceutical
The Australian government is taking a critical step in helping end the transmission of HIV infection in Australia with the April 1 listing of tenofovir with emtricitabine on the Pharmaceutical Benefits Schedule (PBS), said Health Minister Greg Hunt. 21 March 2018
Biotechnology
The US Food and Drug Administration (FDA) and US biotech Seattle Genetics were keen to play up the FDA’s expansion of its approval for Adcetris (brentuximab vedotin) to treat adult patients with previously untreated stage III or IV classical Hodgkin lymphoma (cHL) in combination with chemotherapy. 21 March 2018
Biotechnology
On Tuesday, US Representative Steve Stivers (Republican, Ohio) and Representative Bill Foster (Democrat, Illinois) introduced HR 5340, the Support Technology & Research for Our Nation’s Growth and Economic Resilience (STRONGER) Patent Act, in order to strengthen the USA’s crippled patent system. 21 March 2018
Biotechnology
The UK’s National Health Service (NHS) and the company leading drug development in cystic fibrosis (CF) remain at loggerheads. 20 March 2018
Pharmaceutical
It was nearly 16 years ago that the last new treatment for Alzheimer’s was approved by European regulators, with the US Food and Drug Administration also approving Namenda (memantine) the following year. 20 March 2018
Biotechnology
Shares of US biotech firm Heron Therapeutics climbed 32% to $28.50 in early US trading Monday after it released new data on an anesthetic used for patients undergoing bunionectomy and hernia repair. 20 March 2018
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