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
The Russian Federal Anti-Monopoly Service (FAS) has announced its plans to submit a proposal to the national government to speed up state registration of innovative drugs and to create a centralized mechanism for their purchase in the country, according to an official spokesman of head of FAS Sergey Artemyev, reports The Pharma Letter’s local correspondent. 16 February 2018
Pharmaceutical
Recognizing an “urgent need for new medical treatments” for many neurological disorders, the FDA says it's revising its product review team structure and changing the way it communicates scientific and regulatory guidance. 16 February 2018
Pharmaceutical
It has been nearly two years since the UK voted to leave the European Union. While we find ourselves only a year away from the official exit, significant ambiguity remains, and important negotiations still must take place, notes Paul Brooks, executive director of the Regulatory Affairs Professionals Society (RAPS). 16 February 2018
Biotechnology
The USA-based Institute for Clinical and Economic Review (ICER) on Wednesday released a Final Evidence Report and Report-at-a-Glance on Luxturna (voretigene neparvovec; VN) for the treatment of vision loss associated with RPE65-mediated retinal disease. 15 February 2018
Pharmaceutical
Nexavar (sorafenib) is by no means Bayer’s newest cancer drug but there is life in the blockbuster yet – as shown by a new recommendation from the National Institute for Health and Care Excellence (NICE). 15 February 2018
Pharmaceutical
Ipsen’s good day has got even better with news that the National Institute for Health and Care Excellence (NICE) has recommended Cometriq (cabozantinib) for reimbursement via the National Health Service (NHS) in England and Wales. 15 February 2018
Pharmaceutical
The once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 has received Breakthrough Therapy designation from the US Food and Drug Administration for the treatment of patients with moderate-to-severe atopic dermatitis (AD). 15 February 2018
Biotechnology
The US Food and Drug Administration has approved Erleada (apalutamide) for the treatment of patients with prostate cancer that has not spread (non-metastatic), but that continues to grow despite treatment with hormone therapy (castration-resistant). 15 February 2018
Biotechnology
The US Food and Drug Administration has provided guidance on the regulatory path forward to support the New Drug Application (NDA) for opicapone, an investigational drug for Parkinson's disease, after receiving meeting minutes from the January 2018 meeting with the FDA. 15 February 2018
Pharmaceutical
The Irish Health Minister is to begin discussions with a group of other European countries about joining their bloc for negotiating pharma deals with manufacturers. 14 February 2018
Pharmaceutical
In a fast-moving COPD field where triple combination therapies are driving much of the momentum, GlaxoSmithKline has sought to widen its patient population in Europe. 14 February 2018
Biosimilars
The European Commission (EC) has approved Herzuma (trastuzumab biosimilar) for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification. 14 February 2018
Pharmaceutical
The US Food and Drug Administration has issued an approving statement relating to President Trump’s budget proposal, noting the inclusion of “about $400 million in additional funding,” which would in part “further promote innovation and competition.” 14 February 2018
Biotechnology
NICE has published draft guidance that does not recommend Brineura (cerliponase alfa) and made by US rare disease drug developer BioMarin Pharmaceutical. 14 February 2018
Pharmaceutical
Chris Miller, scientific lead at 3D Communications, provides his perspective on the regulatory challenges facing pharmaceutical companies that are developing opioid products designed to deter abuse in an Expert View piece. 14 February 2018
Pharmaceutical
US President Donald Trump has issued a borrowing-heavy budget proposal which would allocate just $68.4 billion to Department of Health and Human Services, a fifth lower than what the agency received last year. 13 February 2018
Pharmaceutical
The safety board of the European Medicines Agency says that doctors should stop initiating treatment with Esmya (ulipristal acetate), pending a safety investigation. 13 February 2018
Biotechnology
A new report from US-based Biotechnology Innovation Organization (BIO) advocates greater levels of investment in analgesics and addiction therapeutics. 13 February 2018
Biotechnology
The Prescription Drug User Fee Act (PDUFA) date for volanesorsen, an investigational therapy for the treatment of familial chylomicronemia syndrome (FCS), has been set by the US Food and Drug Administration for August 30 this year. 13 February 2018
Pharmaceutical
Trade group Medicines Australia welcomes the passing of the PBS National Health Amendment (Pharmaceutical Benefits - Budget and Other Measures) Bill 2017. 13 February 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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