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
Pharmaceutical
The Australian government has said that its establishment of an expert panel for the Life Saving Drugs Program (LSDP) will improve the scheme’s ability to provide free medicines for rare and life-threatening diseases to those who need them. 31 August 2018
Pharmaceutical
The US Food and Drug Administration yesterday warned that cases of a rare but serious infection of the genitals and area around the genitals have been reported with the class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors. 31 August 2018
Biotechnology
Some 12 years after the drug’s first US Food and Drug Administration (FDA) approval in leukemia, Bristol-Myers Squibb is still targeting new patients with Sprycel (dasatinib). 31 August 2018
Biotechnology
Weeks after a landmark approval in the USA, Alnylam Pharmaceuticals’ RNA interference (RNAi) therapeutic has been approved by the European Commission (EC). 30 August 2018
Biotechnology
There was positive news today for Germany’s largest pharma company, with approval for its latest hemophilia A drug in the USA, which hopefully will provide a near term boost to its hemophilia portfolio. 30 August 2018
Pharmaceutical
US Food and Drug Administration Commissioner Scott Gottlieb has announced new measures to help combat the growing problem of addiction to opioids in the USA. 30 August 2018
Biotechnology
The European Commission has granted marketing authorization for Nucala (mepolizumab) as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients aged six up to 17 years. 30 August 2018
Pharmaceutical
The code of regulations that dictates how pharma should and should not promote its medicines in the UK is set to be updated, with proposed changes now open to consultation. 30 August 2018
Pharmaceutical
On Wednesday, the US Food and Drug Administration announced a new pilot program (complex innovative designs [CID] pilot meeting program) in which drug and biologic companies who participate in the pilot program will have additional opportunities to meet with agency staff to discuss the use of novel complex innovative trial designs (CID) for their clinical development programs. 30 August 2018
Pharmaceutical
The US Food and Drug Administration has granted approval of Xerava (eravacycline) for the treatment of complicated intra-abdominal infections (cIAI). 29 August 2018
Biotechnology
Imbruvica (ibrutinib) has received US approval in combination with rituximab as the first chemotherapy-free combination in adults with Waldenström's macroglobulinemia. 29 August 2018
Pharmaceutical
Family-owned German firm Grünenthal has won European approval for Duzallo (lesinurad/allopurinol), a fixed-dose combination therapy for hyperuricaemia in adult gout patients. 29 August 2018
Biotechnology
US biotech major Amgen has received the green light from the European Commission (EC) to start marketing Blincyto (blinatumomab) to a new patient group. 29 August 2018
Pharmaceutical
Swiss pharma giant Novartis has won European approval for a combination of Tafinlar (dabrafenib) and Mekinist (trametinib), as an adjuvant treatment for certain melanoma patients. 29 August 2018
Biosimilars
A lawyer’s look into the competition provided by biosimilars to biologic therapies has highlighted how this contest differs from generic competitors challenging branded drugs. 29 August 2018
Pharmaceutical
The European Commission approved Vyxeos (daunorubicin and cytarabine, liposomal formulation) 44mg/100mg powder for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). 28 August 2018
Biotechnology
With both therapies already approved in the USA and backed by strong data sets, getting European health technology assessment (HTA) bodies on board over Yescarta (axicabtagene ciloleucel) and Kymriah (tisagenlecleucel) was always going to be a bigger battle than getting regulatory approval. 28 August 2018
Biotechnology
Shares in Californian company Ionis Pharmaceuticals opened 12% down on Tuesday. 28 August 2018
Pharmaceutical
Sanofi Genzyme, the specialty care global business unit of French multinational pharma company Sanofi, has recently launched its multiple sclerosis (MS) drug Aubagio (teriflunomide, 14mg) in India. 28 August 2018
Biotechnology
The European Commission has granted marketing authorization for Yescarta (axicabtagene ciloleucel) as a treatment for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and primary mediastinal large B-cell lymphoma (PMBCL), after two or more lines of systemic therapy. 28 August 2018
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