Regulation
Refine Search
Pharmaceutical
Drugs that treat central nervous system (CNS) diseases take more than a year longer to develop and are less than half as likely to obtain marketing approval as other drugs, according to a newly-completed study by the Tufts Center for the Study of Drug Development. 5 November 2014
Biosimilars
The European Generic medicines Association (EGA) and the European Biosimilars Group (EBG), a sector group of the EGA, congratulate the European Medicines Agency and its Committee for Medicinal Products for Human Use (CHMP) and Biosimilar Medicines Working Party (BMWP) for adopting its revised overarching guideline on biosimilar medicines (The Pharma Letter October 30). 4 November 2014
Pharmaceutical
Following a benefit:cost re-assessment, the German Institute for Quality and Efficiency in Health Care has concluded that an additional benefit exists of Japanese drug major Eisai’s Halaven (eribulin). 4 November 2014
Pharmaceutical
In an early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products, the German Institute for Quality and Efficiency in Health Care examined whether Entyvio (vedolizumab) from Japan’s largest drugmaker Takeda Pharma offers an added benefit. 4 November 2014
Biosimilars
Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such as cancer and rheumatoid arthritis could cut spending on biologics in the USA by $44 billion over the next decade, according to new analysis from the RAND Corp. 4 November 2014
Pharmaceutical
German family-owned drug major Boehringer Ingelheim has had its Spiriva Respimat (tiotropium bromide) inhalation spray New Drug Application accepted for review by the US Food and Drug Administration with respect to the treatment of asthma. 4 November 2014
Pharmaceutical
The UK’s National Institute for Health and Care Excellence has issued new preliminary draft guidance for consultation proposing to recommend ofatumumab with chlorambucil for untreated chronic lymphocytic leukemia. 4 November 2014
Pharmaceutical
The Netherlands Medicines Evaluation Board (MEB) has defined policy regarding the use of QR codes on the outer packaging and/or in the package leaflet for medicinal products. The policy outlines the conditions that QR code (a type of two dimensional barcode) use must fulfil. 3 November 2014
Pharmaceutical
A study carried out by the US Food and Drug Administration on Pradaxa (dabigatran etexilate mesylate) has found that the drug was associated with significantly reduced risks of ischemic stroke, intracranial hemorrhage and death, and a significantly increased risk of major gastrointestinal hemorrhage, compared with warfarin in patients with non-valvular atrial fibrillation. 3 November 2014
Pharmaceutical
Spanish pharma trade group Farmaindustria’s general assembly gathered in Madrid last week to hold an extraordinary session in which it appointed Antoni Esteve as the new president of the Association for the next two years. 3 November 2014
Pharmaceutical
Fycompa (perampanel), manufactured by Japanese drug major Eisai, has been approved for reimbursement in Australia for the treatment of partial-onset seizures, the most common form of epilepsy. 3 November 2014
Pharmaceutical
A US Food and Drug advisory panel has voted in favor of the use of Japanese pharma major Daiichi Sankyo’s Savaysa (edoxaban), but there was some ambivalence over labelling. 3 November 2014
Biotechnology
Biotechnology companies Biogen Idec of the USA and Swedish Orphan Biovitrum said on Friday that the European Medicines Agency has validated the Marketing Authorization Application (MAA) of Elocta (rFVIIIFc), for the treatment of hemophilia A. 1 November 2014
Pharmaceutical
In what is viewed as an unusual step, the US Food and Drug Administration made a website posting of its discussions with biotech firm Sarepta Therapeutics on its investigational Duchenne muscular dystrophy (DMD) drug. 31 October 2014
Biotechnology
Australian biopharma company Specialised Therapeutics is to have its Abraxane (nanoparticle albumin-bound paclitaxel) in combination with gemcitabine, reimbursed via the Pharmaceutical Benefits Scheme (PBS) for patients with metastatic pancreatic cancer from November 1. 31 October 2014
Pharmaceutical
Swedish drugmaker Medivir says it has entered into an agreement with Swedish county councils regarding the treatment of hepatitis C with Olysio (simeprevir). 31 October 2014
Pharmaceutical
A coalition of five USA-based health care and drug manufacturing advocacy organizations yesterday expressed opposition to a newly introduced San Francisco drug disposal ordinance. 31 October 2014
Pharmaceutical
In draft guidance published today, the UK health costs watchdog the National Institute for Health and Care Excellence (NICE) has recommended German family-owned pharma major Boehringer Ingelheim’s anti-blood clotting drug Pradaxa (dabigatran) as an option for treating and preventing recurrent and potentially fatal blood clots in the legs (deep vein thrombosis, DVT) and lungs (pulmonary embolism; PE) in adults. 31 October 2014
Pharmaceutical
The US Food and Drug Administration has approved Anglo-Swedish pharma major AstraZeneca’s once-daily Xigduo XR (dapagliflozin and metformin hydrochloride extended-release) for the treatment of adults with type 2 diabetes. 30 October 2014
Biosimilars
The European Medicines Agency has published its revised overarching guideline on biosimilars, or follow-on biologic medicines. 30 October 2014
Biotechnology
AstraZeneca and Daiichi Sankyo’s breast cancer med Enhertu (trastuzumab deruxtecan) will be included in China’s state-run health insurance scheme from next year, boosting availability at the cost of reduced pricing. 29 November 2024
Pharmaceutical
The Danish Ministry of Interior and Health has announced that the political parties have decided to permanently legalize treatment with medical cannabis in Denmark. 29 November 2024
Pharmaceutical
Industry is showing a very high level of readiness for upcoming new packaging and labelling measures impacting the UK market, according to the Medicines and Healthcare products Regulatory Agency (MHRA). 29 November 2024
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 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
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