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
The US approval of Kymriah (tisagenlecleucel) last year enabled the Swiss pharma giant Novartis to boast that it had won the race to market with a CAR T-cell-directed therapy. 2 May 2018
Biotechnology
The National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending that Tremfya (guselkumab) be provided on the UK’s National Health Service (NHS) for patients with moderate to severe plaque psoriasis. 2 May 2018
Biotechnology
Opdivo (nivolumab) has been registered by Australia’s Therapeutic Goods Administration (TGA) as an adjuvant treatment for patients with completely resected melanoma with involvement of lymph nodes or metastatic disease. 1 May 2018
Pharmaceutical
On Monday, the European Commission proposed to ban two new psychoactive substances (NPS) - cycloproplyfentanyl and methoxyacetylfentanyl - across the European Union. 1 May 2018
Biotechnology
The lead developer of drugs for cystic fibrosis (CF) is under pressure to slash the price of Orkambi (lumacaftor/ivacaftor), the first drug directed at treating the cause of the disease in people who have two copies of the F508del mutation, accounting for around 45% of cases. 30 April 2018
Biotechnology
Data from Phase II and Phase I studies was enough for the US Food and Drug Administration (FDA) to accept for priority review the Biologics License Application (BLA) for cemiplimab for metastatic cutaneous squamous cell carcinoma (CSCC) or locally advanced CSCC patients who are not candidates for surgery. 30 April 2018
Pharmaceutical
Central nervous system (CNS) specialist Lundbeck has announced a decision from the Japanese Ministry of Health, Labor and Welfare granting the Danish firm a further two years of market exclusivity on its antidepressant Lexapro (escitalopram oxalate). 27 April 2018
Pharmaceutical
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended three medicines for approval at its April 2018 meeting. 27 April 2018
Biotechnology
The National Institute for Care and Health Excellence (NICE) has issued confirmation today that it recommends the use of Keytruda (pembrolizumab) within the Cancer Drugs Fund (CDF) for untreated locally advanced or metastatic urothelial carcinoma in adults, where chemotherapy is unavailable. 27 April 2018
Pharmaceutical
The UK Minister for Intellectual Property, Sam Gyimah MP, on Thursday (April 26) confirmed that the UK has ratified the Unified Patent Court Agreement (UPCA). 27 April 2018
Biotechnology
Washington, USA-based Omeros has been granted breakthrough therapy designation for its candidate OMS721, a treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) patients. 27 April 2018
Pharmaceutical
The executive branch of the European Union has issued a set of recommendations calling for more cooperation in Europe to combat preventable diseases. 27 April 2018
Pharmaceutical
Biopharmaceutical companies are joining stakeholders across the health care system to pursue flexible ways to pay for medicines that focus on results, lower out-of-pocket costs and enable patients to access the right treatments the first time. 27 April 2018
Pharmaceutical
A new five-year plan from the Medicines and Healthcare products Regulatory Agency (MHRA), the UK’s medicines regulator, sets out the group's aim to “ensure a smooth EU exit under any scenario.” 26 April 2018
Pharmaceutical
The US Food and Drug Administration has put a partial hold on Epizyme’s lead oncology candidate tazemetostat, after a patient in a Phase I pediatric study was found to have developed a secondary lymphoma. 26 April 2018
Pharmaceutical
The US Food and Drug Administration has approved Jynarque (tolvaptan) as the first drug treatment to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD). 26 April 2018
Biotechnology
AbbVie has submitted a Biologics License Application (BLA) to the US Food and Drug Administration for risankizumab, an investigational interleukin-23 (IL-23) inhibitor, being evaluated for treatment of patients with moderate to severe plaque psoriasis. 25 April 2018
Biotechnology
US prices for biologics to treat moderate to severe asthma are to be considered as part of a comparison announced by the Institute for Clinical and Economic Review (ICER). 25 April 2018
Generics
In a statement to the US Senate appropriations committee, Food and Drug Administration Commissioner Scott Gottlieb reiterated his goal of “modernizing generic drug development and review,” with the aim of boosting competition in the sector and increasing rates of generic substitution, ultimately in order to lower drug costs. 25 April 2018
Pharmaceutical
The Russian national Parliament (State Duma) plans to consider the possibility of introducing a ban on the imports of drugs from the USA and some European Union states to Russia at the beginning of the current year, according to Duma press-service. 25 April 2018
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
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