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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
Pharmaceutical
More than 60% of life science companies are not yet ready to meet transparency requirements being set out by the European Federation of Pharmaceutical Industries and Associations (EFPIA), according to a survey. 9 December 2015
Pharmaceutical
The Mexican regulatory authorities have granted marketing authorization to Dengvaxia, developed by French pharma major Sanofi’s Sanofi Pasteur unit, making it the first vaccine to be licensed in the world for the prevention of dengue. 9 December 2015
Pharmaceutical
Danish multinational pharmaceutical company Novo Nordisk has submitted a new drug application (NDA) for faster-acting insulin aspart, it has been announced. 9 December 2015
Biotechnology
The US Food and Drug Administration late Tuesday announced it has approved Vonvendi, (von Willebrand factor [Recombinant]), for use in adults 18 years of age and older who have von Willebrand disease (VWD). 9 December 2015
Pharmaceutical
Eagle Pharmaceuticals has revealed that the US Food and Drug Administration had approved Bendeka (bendamustine hydrochloride) injection, a liquid, low-volume (50mL) and short-time 10-minute infusion formulation of bendamustine. 9 December 2015
Pharmaceutical
An innovative enzyme replacement therapy (ERT) has become the first treatment for patients with lysosomal acid lipase deficiency (LAL-D) to be approved by the US Food and Drug Administration (FDA), it has been announced. 9 December 2015
Biosimilars
Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis said the European Medicines Agency has accepted its Marketing Authorization Application (MAA) for a biosimilar version of US pharma giant Pfizer's Enbrel (etanercept) to treat a range of autoimmune diseases. 8 December 2015
Pharmaceutical
Japanese mid-size drugmaker Otsuka Pharmaceutical has submitted an application for regulatory approval in Japan of the anti-psychotic drug Abilify (aripiprazole) for the additional indication of excitability associated with autistic disorder for juveniles from ages six through 17. 8 December 2015
Biosimilars
South Korean drug developer Samsung Bioepis, a joint venture between Korean conglomerate Samsung and US biotech Biogen, received approval of Renflexis (infliximab), a biosimilar of Merck’s immunology medicine Remicade, by the Ministry of Food and Drug Safety (MFDS) in Korea. 8 December 2015
Biotechnology
The US Food and Drug Administration has granted Breakthrough Therapy designation status to California-headquartered oncology biopharma specialist Kite Pharma’s lead product candidate, KTE-C19. 7 December 2015
Biotechnology
XBiotech has announced that it met the primary endpoint in its European Phase III clinical study of Xilonix, a novel therapy for patients with symptomatic, advanced colorectal cancer. 7 December 2015
Pharmaceutical
A US Food and Drug Administration safety review has resulted in adding warnings to the labels of a specific class of type 2 diabetes medicines called sodium-glucose cotransporter-2 (SGLT2) inhibitors about the risks of too much acid in the blood and of serious urinary tract infections. Both conditions can result in hospitalization. 7 December 2015
Biotechnology
US biotech major Amgen said it has filed a Variation to the Marketing Authorization Application with the European Medicines Agency to expand the indication for Kyprolis (carfilzomib) in combination with dexamethasone to treat multiple myeloma. 7 December 2015
Pharmaceutical
Bial Portela, Portugal’s largest drugmaker, has released positive results for a pivotal Phase III non-inferiority study comparing the efficacy and safety of eslicarbazepine acetate (ESL; trade name Zebinix) to controlled release carbamazepine (CBZ-CR) as monotherapy in newly-diagnosed adult patients with partial-onset seizures (POS). 7 December 2015
Biosimilars
In a global biosimilars market expected to reach a value of $20 billion by the end of 2015 and could hit $55 billion by 2020, according to business intelligence provider GBI Research, the race for applications for approval of such “follow-on biologicals” is heating up. 6 December 2015
Generics
The US Food and Drug Administration’s postponement to July 2016 of a significant patient safety rule leaves open a safety gap for the millions of patients who take generic medications, says consumer advocacy group Public Citizen. 4 December 2015
Pharmaceutical
The German Institute for Quality and Efficiency in Health Care (IQWiG), in a second dossier assessment of Swiss pharma giant Roche’s cancer drug Perjeta (pertuzumab) resulted in a survival advantage for certain patients taking the drug and hence for a hint of a major added benefit. 4 December 2015
Pharmaceutical
Danish diabetes care giant Novo Nordisk today announced the submission to the European Medicines Agency of the Marketing Authorization Application (MAA) for the approval of faster-acting insulin aspart. 4 December 2015
Pharmaceutical
Shares of Repros Therapeutics fell more than 27% to $1.74 after it announced it was facing a delay in US approval of its lead product candidate. 3 December 2015
Pharmaceutical
UK drug major GlaxoSmithKline said the European Commission has granted marketing rights for its drug Nucala (mepolizumab) as an add-on treatment for asthma. 3 December 2015
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