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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
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
Pharmaceutical
Lexicon Pharmaceuticals has announced a major strategic shift, prioritizing its late-stage pipeline following a rejection by the US Food and Drug Administration (FDA). 25 November 2024
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for the treatment of adults with ATTR-CM to reduce cardiovascular death and cardiovascular-related hospitalization. 25 November 2024
Pharmaceutical
Efforts to combat antimicrobial resistance (AMR) are gaining momentum in Europe, with the introduction of innovative measures to drive the development of new antimicrobials. 25 November 2024
Biotechnology
Research news last week included US biotech releasing early data for its FT819 in the treatment of systemic lupus erythematosus (SLE), which sent the firm’s shares leaping as much as 70%. Also, Netherlands-based NewAmsterdam Pharma announced positive data on its obicetrapib and ezetimibe combination in cardiovascular disease. On the regulatory front, Dutch firm argenX and China’s Zai Lab gained approval from the Chinese medicines regulator for their Vyvgart Hytrulo in chronic inflammatory demyelinating polyneuropathy (CIDP) care. Meantime, USA-based Kura Oncology signed a collaboration with Japan’s Kyowa Kirin on the development of ziftomenib for myeloid leukemia (ALS). 24 November 2024
Pharmaceutical
Japanese pharma major Takeda Pharmaceutical has expressed its disappointment at preliminary draft guidance from the National Institute for Health and Care Excellence (NICE) which does not recommend Adcetris (brentuximab vedotin) – a drug which is on the UK’s Cancer Drugs Fund (CDF) list. 10 August 2016
Pharmaceutical
The US Food and Drug Administration granted accelerated approval to for pharma giant Merck & Co’s Keytruda (pembrolizumab) for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. 9 August 2016
Biotechnology
The UK's National Institute for Health and Care Excellence (NICE) has gone back on its initial view after publishing final draft guidance which recommends talimogene laherparepvec for advanced melanoma that has spread and cannot be surgically removed. 9 August 2016
Pharmaceutical
The Australian government wants its new requirements over medicine labels to make important information about drugs easier to find. 9 August 2016
Biotechnology
Alkermes has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration for a two-month dosing interval of Aristada (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. 9 August 2016
Pharmaceutical
Takeda Pharmaceutical has received approval from medicines regulator Health Canada for Ninlaro (ixazomib). 8 August 2016
Biotechnology
New Zealand’s Pharmaceutical Management Agency PHARMAC today announced the approval of an agreement with Boehringer Ingelheim for the listing of Praxbind (idarucizumab) for use in District Health Board (DHB) hospitals, along with price reductions for anticoagulant Pradaxa (dabigatran). 8 August 2016
Pharmaceutical
In a joint article published last week by Drug Discovery Today, the European Medicines Agency (EMA) and the Therapeutic Goods Administration (TGA) in Australia describe their positive experiences with the publication of assessment reports for medicines – known as European public assessment reports (EPARs) in Europe and Australian Public Assessment Reports (AusPARs) in Australia. 5 August 2016
Pharmaceutical
The European Commission has approved under the EU Merger Regulation the proposed acquisition of the consumer health business of Germany's Boehringer Ingelheim by French pharma major Sanofi, subject to conditions. 5 August 2016
Biotechnology
USA-based Bellicum Pharmaceuticals has received orphan drug designations from the European Commission for both its lead T-cell therapy product candidate BPX-501 for hematopoietic stem cell transplantation (HSCT), and for activator agent rimiducid for the treatment of Graft versus Host Disease (GvHD). 5 August 2016
Generics
Indian generics firm Natco Pharma says it has received final approval of its Abbreviated New Drug Application filed with the US Food and Drug Administration for oseltamivir phosphate oral capsules. 5 August 2016
Biotechnology
In draft guidance published today, the National Institute for Health and Care Excellence (NICE), the drug cost-effectiveness watchdog for England and Wales, has recommended innovative new drug Cosentyx (secukinumab) from Swiss pharma giant Novartis for treating ankylosing spondylitis. 4 August 2016
Pharmaceutical
A European pilot project which aims to give faster access to promising medicines in areas of unmet medical need has been hailed a success by the European Medicines Agency (EMA). 4 August 2016
Pharmaceutical
Patents are granted to stimulate creativity and innovation among competing drug manufacturers. They are not easy to come by and so innovators who target new areas of health are rewarded with enough time to recoup the typically high costs incurred during the research and development phase, writes Dr Nicola Davies in her exclusive monthly FDA Blog for The Pharma Letter. 3 August 2016
Biotechnology
US rare and orphan disease focussed biotech firm Amicus Therapeutics plans to submit a Japanese New Drug Application (J-NDA) to request marketing authorization for migalastat, an oral precision medicine for Fabry disease, in the first half of 2017. 3 August 2016
Biotechnology
The drug cost-effectiveness watchdog for England and Wales, the National Institute for Health and Care Excellence (NICE), has published draft guidance recommending apremilast, a drug marketed by US biotech firm Celgene as Otezla, for psoriasis patients. 3 August 2016
Pharmaceutical
Swiss pharma giant Novartis has received US Food and Drug Administration Breakthrough Therapy designation for LEE011 (ribociclib), in combination with letrozole, for hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. 3 August 2016
Pharmaceutical
The European Commission has approved US pharma giant Merck & Co’s Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, at a dose of 2mg/kg every three weeks, for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 and who have received at least one prior chemotherapy regimen. 3 August 2016
Pharmaceutical
The High Court in Britain has overturned a decision by NHS England to remove Pre-Exposure Prophylaxix (PrEP) for HIV from its commissioning process. 2 August 2016
Pharmaceutical
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) is inviting interested parties to provide feedback on Clinical Trial Regulation guidance documents. 2 August 2016
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