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Biotechnology
US biotech firm Celgene Corp’s Otezla (apremilast) to treat chronic plaque psoriasis, has been dropped from the list of recommendations by the National Institute for Health and Care Excellence (NICE). 26 November 2015
Pharmaceutical
The Peripheral and Central Nervous System Drugs Advisory Committee of the US Food and Drug Administration met to discuss the data submitted to support USA-based BioMarin Pharmaceutical's New Drug Application for Kyndrisa (drisapersen). 25 November 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved pharma major Eli Lilly’s Portrazza (necitumumab) in combination with two forms of chemotherapy to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) who have not previously received medication specifically for treating their advanced lung cancer. 25 November 2015
Biotechnology
The European Commission has approved Elocta (rFVIIIFc) for the treatment of hemophilia A in all 28 European Union member states, as well as Iceland, Liechtenstein and Norway. 24 November 2015
Pharmaceutical
British pharmaceuticals giant GlaxoSmithKline has announced it has received European Commission (EC) approval to widen the application of its drug Volibris (ambrisentan). 24 November 2015
Generics
China’s Food and Drug Administration (CFDA) recently issued a policy, aiming to shake off its long-term reputation for being extremely slow on new drug approvals, as well as largely improve the quality of Chinese made generics, reports The Pharma Letter’s local correspondent, Wang Fangqing. 24 November 2015
Pharmaceutical
The US Food and Drug Administration yesterday approved US pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma. 24 November 2015
Biotechnology
US biotech company Amgen on Tuesday said the European Commission (EC) has granted conditional marketing authorization for its Blincyto (blinatumomab) to treat Philadelphia chromosome-negative (Ph-) relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL). 24 November 2015
Pharmaceutical
Swiss pharma major Novartis on Tuesday said the European Commission (EC) has approved its Entresto (sacubitril/valsartan) to treat symptomatic chronic heart failure. 24 November 2015
Pharmaceutical
The European Commission has approved Novartis’ Cosentyx (secukinumab) for the treatment of people living with ankylosing spondylitis (AS) and psoriatic arthritis (PsA), it has been announced. 23 November 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE) has provisionally recommended BioMarin’s Vimizin (elosulfase alfa), it has been announced. 23 November 2015
Biotechnology
The European Commission has granted marketing authorization for US biotech giant Gilead Sciences' once-daily single tablet regimen Genvoya for HIV-1 infection. 23 November 2015
Biotechnology
The reviewers at the US Food and Drug Association are not convinced by the data for biotech company BioMarin Pharmaceuticals' drisapersen, to treat Duchenne muscular dystrophy (DMD), and said the clinical trial data does not show substantial evidence necessary for approval. 23 November 2015
Biosimilars
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 10 medicines for marketing authorization at its November 2015 meeting. 22 November 2015
Pharmaceutical
On Friday the US Food and Drug Administration granted approval for Takeda Pharmaceutical's Ninlaro (ixazomib) in combination with two other therapies to treat people with multiple myeloma who have received at least one prior therapy. 21 November 2015
Pharmaceutical
The US subsidiary of Swiss pharma giant Novartis has finalized the settlement in principle, which was previously disclosed, to resolve a civil suit filed by the US Attorney's Office for the Southern District of New York related to Novartis Pharmaceutical Corp’s (NPC) interactions with specialty pharmacies for the drugs Exjade (deferasirox) and Myfortic (mycophenolate mofetil) . 21 November 2015
Pharmaceutical
Proposals to transform the UK’s Cancer Drugs Fund (CDF) to give early access to ‘promising’ drugs have been welcomed by the Association of the British Pharmaceutical Industry (ABPI). 20 November 2015
Biotechnology
Amgen yesterday announced that the European Commission has granted marketing authorization for Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. 20 November 2015
Pharmaceutical
The second, and final, report from the Australian Independent Review of Medicines and Medical Devices Regulation has been released. 20 November 2015
Generics
Beximco has become the first Bangladeshi company to receive US Food and Drug Administration approval for a prescription drug manufactured in the country for export to the USA. 19 November 2015
Biotechnology
PTC Therapeutics is to sell its rare pediatric disease priority review voucher (PRV) for $150 million. 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
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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