Regulation
Refine Search
Biosimilars
The European Biosimilar medicines Group (EBG, the sector group of the European Generic and Biosimilar Medicines Association [EGA]) has been keenly involved in the DIA conference over the last two days to promote greater access to biological medicines for patients. 5 November 2015
Pharmaceutical
A proposal on experimental changes to the drug licensing system was adopted by China's top legislature on Wednesday, aiming at promoting pharmaceutical innovation and better quality by giving more incentive to researchers, reports the state news agency Xinhau. 4 November 2015
Generics
Netherlands-incorporated drugmaker Mylan yesterday received tentative approval from the US Federal Trade Commission for the company's proposed acquisition of Perrigo subject to Mylan's divestiture of certain products following the consummation of the offer. 4 November 2015
Biotechnology
US biotech firm Celgene Corp on Wednesday said its Abraxane (nab-paclitaxel) in combination with gemcitabine to treat pancreatic cancer will no longer be available via the England's Cancer Drugs Fund (CDF), starting today. 4 November 2015
Pharmaceutical
Mochida Pharmaceutical has filed a New Drug Application for MD-0901, for the treatment of patients with ulcerative colitis with the Japanese Ministry of Health, Labor and Welfare (MHLW). 4 November 2015
Pharmaceutical
Nearly all later entrants to drug classes had begun clinical testing or were in regulatory review in the USA before the first drug within a pharmacologic class was approved, a newly completed analysis from the Tufts Center for the Study of Drug Development suggests. 4 November 2015
Pharmaceutical
The National Institute for Health and Care Excellence (NICE), the medicines watchdog for England and Wales, has today published final draft guidance recommending Ikervis (ciclosporin), from Japanese drugmaker Santen Pharmaceuticals, for treating severe keratitis in adults with dry eye disease which has not improved despite treatment with artificial tears. 4 November 2015
Pharmaceutical
UK drug major GlaxoSmithKline on Tuesday said it is looking at filing for approval of up to 20 drug candidates with regulators before 2020. 3 November 2015
Biosimilars
The Biosimilars Council, a division of the US Generic Pharmaceutical Association (GPhA), says it is disappointed today by the Centers for Medicare & Medicaid Services’ (CMS) decision to group all biosimilars together under one payment calculation and billing code in Medicare Part B, while using a different code for the reference product. 3 November 2015
Pharmaceutical
Germany’s Merck KGaA on Tuesday said the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved an updated labelling for Glucophage XR (extended release metformin) for type 2 diabetes patients with moderate renal impairment stage or stable chronic heart failure. 3 November 2015
Pharmaceutical
Labels for the prescription antipsychotic drugs Abilify and Abilify Maintena (aripiprazole) have been updated to advise of an increased risk of impulsive behaviors of pathological gambling and hypersexuality, said pharma regulatory agency Health Canada on Monday. 3 November 2015
Pharmaceutical
The US Food and Drug Administration has granted Breakthrough Therapy designation to Keytruda (pembrolizumab), US pharma giant Merck & Co’s anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer 3 November 2015
Pharmaceutical
There are 15,000 production lines of prescription medicines in Europe, of which only 30% currently have the capacity to implement serialization, or the traceability of the origins of prescription medicine packages. 2 November 2015
Pharmaceutical
The Food and Drug Administration has granted Breakthrough Therapy designation to Japanese drug major Daiichi Sankyo and its US subsidiary Plexxikon’s investigational oral CSF-1R inhibitor pexidartinib. 31 October 2015
Pharmaceutical
Ferring Pharmaceuticals said Friday that the Marketing Authorization Application filing for Rekovelle (follitropin delta) has been accepted for review by the European Medicines Agency. 31 October 2015
Pharmaceutical
Bayer has received European approval for Eylea (aflibercept) Injection for the treatment of visual impairment due to myopic choroidal neovascularization (myopic CNV). 30 October 2015
Pharmaceutical
The US Food and Drug Administration has approved the dual combination bronchodilator Utibron Neohaler (indicaterol/glycopyrrolate) and the standalone monotherapy Seebri Neohaler (glycopyrrolate) from Vectura and Novartis/. 30 October 2015
Pharmaceutical
The Russian government has officially announced that it will introduce the practice of mandatory labeling of drugs in Russia, with the aim to start more active monitoring for their quality, reports The Pharma Letter’s local correspondent. 30 October 2015
Biosimilars
The staff of the US Federal Trade Commission has submitted a comment to the Food and Drug Administration in response to the FDA’s request for comment on its draft guidance addressing non-proprietary names for biological products. 29 October 2015
Biotechnology
The National Institute for Health and Care Excellence (NICE) has recommended against routine funding of US biotech firm Celgene Corp’s (Nasdaq: CELG) Abraxane (nab-paclitaxel), to treat pancreatic cancer saying the cost of the drug does not justified the benefits compared to current treatments. 28 October 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
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