Regulation
Refine Search
Pharmaceutical
The 2016 European Society of Cardiology (ESC) guidelines on acute and chronic heart failure strongly recommend treating iron deficiency with Ferinject (ferric carboxymaltose), a drug marketed by Vifor Pharma, part of Switzerland-based Galenica Group. 23 May 2016
Pharmaceutical
A US Food and Drug Administration (FDA) advisory panel briefing document has questioned the effectiveness of IDegLira, Novo Nordisk’s insulin degludec (IDeg) Tresiba and liraglutide (Victoza) treatment for type 2 diabetes mellitus (T2DM). 23 May 2016
Pharmaceutical
A decision by the US Food and Drug Administration to revoke designation of a drug (or a biological product) as an orphan drug is a rare event, notes Kurt Karst writing on US law firm Hyman, Phelps & McNamara’s FDA Law Blog. 23 May 2016
Pharmaceutical
Regulatory bodies in India and Japan will work together more closely, both countries vowed at a meeting of politicians and government officials. 23 May 2016
Pharmaceutical
The Russian national Parliament (State Duma) has put forward an initiative to provide financial support to domestic and multinational pharmaceutical producers (operating their plants in Russia), that will freeze the prices for their drugs for the period up to three years. 21 May 2016
Pharmaceutical
Entresto (sacubitril/valsartan), from Swiss pharma giant Novartis, has been given a Class I recommendation, the strongest endorsement, from professional bodies in the USA and EU. 21 May 2016
Pharmaceutical
The US Food and Drug Administration is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. 20 May 2016
Biotechnology
The National Institute for Health and Care Excellence (NICE) has today issued draft guidance not recommending Perjeta (pertuzumab), from Swiss pharma giant Roche, to treat HER2-positive breast cancer because it is uncertain how the responses to treatment seen in the clinical trials translate into long term benefits for patients. 20 May 2016
Biotechnology
The US Food and Drug Administration has granted accelerated approval to Tecentriq (atezolizumab injection) from Genentech, for the treatment of a specific type of bladder cancer. 19 May 2016
Biotechnology
The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) in combination with fludarabine and cyclophosphamide (FC) for to treat relapsed chronic lymphocytic leukemia (CLL) patients. 18 May 2016
Pharmaceutical
Olmutinib (BI 1482694/HM61713) has been approved in South Korea for the treatment of patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). 18 May 2016
Pharmaceutical
The US Food and Drug Adminstration has approved Bristol-Myers Squibb’s Opdivo (nivolumab) as a treatment for patients with a rare blood cancer, marking the first approval of a PD-1 inhibitor in a hematological malignancy. 18 May 2016
Pharmaceutical
Large innovative US pharmaceutical companies are expected to continue targeted acquisitions as the need for larger transactions has declined, according to Fitch Ratings. 18 May 2016
Biotechnology
US rare diseases focused biopharma company Catalyst Pharmaceuticals today announced that the company is reducing its workforce by approximately 30%. 17 May 2016
Biotechnology
Switzerland-based Actelion has received European Commission marketing authorization for Uptravi (selexipag), its selective IP prostacyclin receptor agonist, as a long-term treatment of pulmonary arterial hypertension (PAH), in the European Union. 17 May 2016
Pharmaceutical
Serious, sometimes life-threatening and fatal cases of diabetic ketoacidosis (DKA) have been reported in patients on sodium glucose co-transporter 2 (SGLT2) inhibitors for type 1 and type 2 diabetes, warns medicines regulator Health Canada. 17 May 2016
Pharmaceutical
US Pharma major Bristol-Myers Squibb will not seek reimbursement for multiple myeloma drug Empliciti (elotuzumab) in the UK and the Republic of Ireland because the company cannot demonstrate cost-effectiveness, it has been revealed. 16 May 2016
Generics
BioIntegrator, a member of the Russian ChemRar group of companies, announced today the successful launch in Belorussia of Nescler, a unique oral formulation of fingolimod. 16 May 2016
Pharmaceutical
Danish diabetes care giant Novo Nordisk said today it has submitted a Biologics License Application for the approval of long-acting factor IX, nonacog beta pegol to the US Food and Drug Administration. 16 May 2016
Pharmaceutical
Medicines regulator Health Canada announced on Friday that the department will propose a regulatory amendment to allow access to diacetylmorphine under Health Canada's Special Access Program (SAP). 16 May 2016
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
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
A US biotech company dedicated to creating oral drugs with an emphasis on indications in virology and immunology.
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze