Regulation
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Pharmaceutical
US drug maker AbbVie said the US Food and Drug Administration has granted Breakthrough Therapy designation for its drug candidate venetoclax in combination with hypomethylating agents (HMAs) to treat acute myeloid leukemia (AML). 29 January 2016
Pharmaceutical
European companies are renowned for their innovation but this is put at risk by industrial espionage. Parliament and the Council have provisionally agreed new rules to better protect them. 29 January 2016
Biosimilars
A total of 61 regulators from 25 countries made progress in improving the generic and biosimilar medicines regulatory landscape for patient needs at the 15th Regulatory and Scientific Affairs Conference organized by the European Generic and Biosimilar medicines Association (EGA), the trade group stated. 29 January 2016
Pharmaceutical
Neos Therapeutics said the US Food and Drug Administration has approved its oral treatment of attention-deficit/hyperactivity disorder (ADHD) in patients six years and older. 28 January 2016
Pharmaceutical
Denmark-based allergy specialist ALK-Abello has gained marketing authorization in France for its new house dust mite sublingual allergy immunotherapy tablet (SLIT-tablet) Acarizax, the company has said. 27 January 2016
Pharmaceutical
The Russian Ministry of Health is considering the proposal of the Federal Antimonopoly Service of the recognition of the results of clinical trials of drugs, conducted in the USA and the European Union in the territory of Russia, according to an official spokesman of Veronika Skvortsova, Russia’s Minister of Health, reports The Pharma Letter’s local correspondent. 27 January 2016
Pharmaceutical
Anglo-Swedish drug major AstraZeneca on Wednesday said the National Institute for Health and Care Excellence (NICE) has recommended its Lynparza (olaparib) to treat ovarian cancer. 27 January 2016
Pharmaceutical
Boehringer Ingelheim’s Ofev (nintedanib) is now recommended for use within the National Health Service (NHS) in England and Wales by medicine watchdog, the National Institute for Health and Care excellence (NICE) for patients with idiopathic pulmonary fibrosis (IPF). 27 January 2016
Pharmaceutical
US drug major Eli Lilly’s ramucirumab (Cyramza) to treat gastric cancer did not make it to the final list of recommendations by the National Institute for Health and Care Excellence (NICE). 27 January 2016
Pharmaceutical
The US Food and Drug Administration’s recent approval of Novartis’ Cosentyx to treat ankylosing spondylitis (AS) and psoriatic arthritis (PsA), will drive the drug to blockbuster status, according to GlobalData. 26 January 2016
Pharmaceutical
In final updated guidance published today, UK medicines cost-effectiveness watchdog the National Institute for Health and Care Excellence (NICE) recommends a number of drugs called biological disease modifying drugs (DMARDs) as options for treating severe rheumatoid arthritis which has not responded to intensive therapy with a combination of conventional DMARDs. 26 January 2016
Pharmaceutical
New Zealand’s Pharmaceutical Management Agency, PHARMAC, is seeking feedback on a proposal to amend the listing of some respiratory products. The proposal is a result of provisional amendments to existing listing agreements with the local units of pharma majors Novartis and AstraZeneca. 26 January 2016
Pharmaceutical
Ireland-headquartered Shire said today it has resubmitted the New Drug Application to the US Food and Drug Administration for its investigational candidate, lifitegrast, for the treatment of signs and symptoms of dry eye disease in adults. 25 January 2016
Biotechnology
The US Food and Drug Administration has approved Pharma major Bristol-Myers Squibb’s Opdivo (nivolumab) in combination with Yervoy (ipilimumab) for the treatment of patients with BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma. 25 January 2016
Biotechnology
Privately-held Steba Biotech says it has completed PCM301, its European Phase III clinical trial of Tookad (padeliporfin di-potassium), a novel investigational treatment for localized prostate cancer and other solid tumors. 25 January 2016
Pharmaceutical
The US Food and Drug Administration is conferring with European regulators after a Phase I clinical study, conducted by French clinical research organization Biotrial, recently resulted in the death of one enrolled subject and neurological injury to four others. 25 January 2016
Pharmaceutical
In order to effectively implement provisions of the Affordable Care Act, the US Centers for Medicare and Medicaid Services (CMS) finalized a rule last week detailing reforms to the rebate and reimbursement systems for Medicaid prescription drugs. 25 January 2016
Pharmaceutical
The European subsidiary of Japanese pharma major Daiichi Sankyo revealed on Friday that the German public health agency, the Federal Joint Committee (G-BA), has granted an indication of a minor additional benefit for Lixiana (edoxaban). 23 January 2016
Pharmaceutical
The US Food and Drug Administration has approved Ireland-incorporated Allergan’s Botox (onabotulinumtoxinA) for the treatment of lower limb spasticity in adult patients to decrease the severity of increased muscle stiffness in ankle and toe muscles. 23 January 2016
Biotechnology
Cholesterol-lowering drug Repatha has been approved by Japan’s Ministry of Health, Labor and Welfare. 23 January 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
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