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
When the UK’s National Institute for Health and Care Excellence (NICE) published a positive final appraisal determination (FAD) for Ocrevus (ocrelizumab) in relapsing-remitting multiple sclerosis (RRMS) last week, patient groups held back some praise for the decision. 29 June 2018
Pharmaceutical
The European Commission has approved (tofacitinib citrate) 5mg twice daily (BID) in combination with methotrexate (MTX) for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug (DMARD) therapy. 29 June 2018
Biotechnology
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended nine medicines for approval, including six orphan medicines, and two CAR-T therapies, at its June 2018 meeting. 29 June 2018
Pharmaceutical
Controversy and the US Food and Drug Administration (FDA) – the two are certainly not strangers. When it comes to the FDA, controversy, criticism, and speculation are never far behind, says Dr Davies in her monthly FDA blog for The Pharma Letter. 29 June 2018
Pharmaceutical
The UK’s reimbursement agency, the National Institute for Health and Care Excellence (NICE), has loosened the purse strings for Roche’s cancer drug Alecensa (alectinib) as a first-line therapy for certain lung cancer patients. 28 June 2018
Biotechnology
The US Food and Drug Administration has awarded New York-based Pfizer Priority Review designation for glasdegib, an oral smoothened (SMO) inhibitor. 28 June 2018
Biotechnology
US biotech Global Blood Therapeutics is pretty confident that it will have important regulatory news on its sickle cell disease (SCD) candidate voxelotor by Christmas. 28 June 2018
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency, PHARMAC, today announced that it is inviting pharmaceutical suppliers to submit funding applications for medicines for rare disorders. 28 June 2018
Pharmaceutical
Colorado, USA-based biotech firm Array BioPharma has been granted approval from the US regulator to market Braftovi (encorafenib) in combination with Mektovi (binimetinib) for certain metastatic melanoma patients. 28 June 2018
Pharmaceutical
Following a US Senate Finance Committee hearing on the challenges surrounding prescription drug affordability and innovation earlier this week, the Pharmaceutical Care Management Association (PCMA) has issued a statement that might not surprise long-term critics of pharmacy benefit managers (PBMs). 27 June 2018
Pharmaceutical
The European Commission (EC) has approved Dzuveo (sufentanil sublingual tablet; under development in the USA as Dsuvia) for the management of acute moderate to severe pain in adults in medically monitored settings. 27 June 2018
Pharmaceutical
Aiming to reduce the cost of bulk drugs by 20%-25% and to help small and medium pharmaceutical enterprises (SMEs) upgrade their technology, the Indian government is looking to pump in several millions to support and shore up the drug industry, reports The Pharma Letter’s India correspondent. 27 June 2018
Pharmaceutical
The Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee of the US Food and Drug Administration have voted 14 to 3 against the approval of Remoxy (oxycodone extended-release capsules). 27 June 2018
Pharmaceutical
The US Food and Drug Administration has accepted a New Drug Application (NDA) and granted priority review for baloxavir marboxil as a single-dose, oral treatment for acute, uncomplicated influenza in patients 12 years and older. 26 June 2018
Pharmaceutical
Given that it was the first treatment that contains a purified drug substance derived from marijuana to receive regulatory approval in the USA, one might have expected the Food and Drug Administration’s (FDA) green light for Epidiolex (cannabidiol) to lift shares in GW Pharmaceuticals. 26 June 2018
Pharmaceutical
Russia’s President Vladimir Putin has ordered the national government to ease the process of certification of foreign drugs in Russia this year, according to recent statements of the Russian Presidential Administration, reports The Pharma Letter’s local correspondent. 26 June 2018
Biotechnology
The European Commission has granted marketing authorization for Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg; BIC/FTC/TAF), a once-daily single tablet regimen (STR) for the treatment of HIV-1 infection. 25 June 2018
Pharmaceutical
The European Commission’s (EC) proposals for cooperation across states on clinical assessments and scientific consultations have been welcomed by trade groups in Europe. 25 June 2018
Pharmaceutical
The Irish Pharmaceutical Healthcare Association (IPHA) is hopeful that, as it signs up to BeNeLuxA, Ireland will start to mirror the rates of adoption of innovative medicines that are present in the initiative’s other countries. 25 June 2018
Pharmaceutical
Earlier this month, Jiao Hong, Commissioner of the National Drug Administration of China (CNDA), met with the visiting deputy Secretary General of the United Nations and the executive director of the UNAIDS Program, Michel Sidibe, and his party. 25 June 2018
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