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Former MP to chair Australian Advisory Council on the Medicinal Use of Cannabis

Medical practitioner and politician Andrew Southcott will chair the new Australian Advisory Council on the Medicinal Use of Cannabis. 23 December 2016

Cell therapy company confident on answers to EMA

Belgian biopharma firm TiGenix has submitted its responses to the European Medicines Agency's (EMA) day 120 list of questions for Cx601, its lead product candidate being developed for complex perianal fistulas in Crohn's disease. 23 December 2016

NICE reverses decision on Otezla in psoriatic arthritis

The UK’s National Institute for Health and Care Excellence (NICE) has issued a final appraisal determination (FAD) recommending the use of Otezla (apremilast). 22 December 2016

Japan introduces new measure to cut health spending

Fresh from its decision to intervene over the price of the multi-indication cancer drug Opdivo (nivolumab), the Japanese government has unveiled new plans to reduce the cost of health care. 21 December 2016

Indian government think-tank proposing sweeping changes to boost pharma sector

Sweeping changes are afoot at India's Health Ministry to encourage innovation in the pharmaceutical sector and to ensure speedier approvals for conducting medical research, reports The Pharma Letter's India correspondent. 21 December 2016

FDA Breakthrough and PRIME in EU status for lymphoma drug candidate

The US Food and Drug Administration has granted Breakthrough Therapy designation to investigational drug JCAR017. 21 December 2016

Extended EU treatment access for metformin products

The European Commission (EC) has authorized the extension of the label for all metformin-containing products for all metformin-containing products for the treatment of type 2 diabetes. 21 December 2016

FDA grants accelerated approval for new ovarian cancer treatment

The US Food and Drug Administration today granted accelerated approval to Rubraca (rucaparib) to treat women with a certain type of ovarian cancer. 19 December 2016

Keytruda approved in first and second-line settings for advanced NSCLC in Japan

Merck & Co has received approval in Japan for its immuno-oncology drug Keytruda (pembrolizumab) to treat certain patients with PD-L1-positive unresectable advanced/recurrent non-small cell lung cancer (NSCLC) in the first and second-line treatment settings. 19 December 2016

Nimenrix approved in Europe for infants

The European Commission has approved an expanded indication for Nimenrix (meningococcal group A, C, W-135, and Y conjugate vaccine) for active immunization against invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroups A, C, W-135, and Y (MenACWY) in infants as early as six weeks of age. 19 December 2016

US approval gives Bangladeshi company competitor to B-MS' Glucophage

Bangladeshi generic drugs company Beximco Pharmaceuticals has received approval from the US Food and Drug Administration (FDA) for a generic equivalent of Glucophage XR tablets (metformin hydrochloride). 19 December 2016

FDA lifts Boxed Warning on Chantix and Zyban

Based on a US Food and Drug Administration review of a large clinical trial that FDA required the drug companies to conduct, the agency has determined the risk of serious side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) is lower than previously suspected. 19 December 2016

Japanese approval for hepatitis drug Vemlidy

The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function. 19 December 2016

Seven new drugs recommended for approval at December meeting of EMA/CHMP

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for marketing authorization at its December 2016 meeting. 17 December 2016

Agios shares plunge as it drops development of AG-519

Agios Pharmaceuticals saw its shares drop 20% to $44.74 today, after it announced that development of its second pyruvate kinase-R (PKR) activator, AG-519, was to be discontinued. 16 December 2016

Takeda lashes out again over NICE's no to Adcetris

The publication of a second draft recommendation not recommending use of Takeda’s Adcetris (brentuximab vedotin) in relapsed or refractory Hodgkin lymphoma (R/R HL) on the National Health Service (NHS), has prompted fresh criticism from the Japanese drugmaker. 16 December 2016

FDA Breakthrough status for Grunenthal drug candidate for CRPS

Grünenthal says that the US Food and Drug Administration has granted Breakthrough Therapy designation to neridronic acid. 16 December 2016

NICE again rejects Takeda's Hodgkin's lymphoma drug in draft guidance

The National Institute for Health and Care Excellence (NICE) has published draft guidance not recommending Japanese drugmaker Takeda’s Adcetris (brentuximab vedotin) to treat some patients with Hodgkin’s lymphoma on the National Health Service (NHS). 15 December 2016

Decision relating to anti-VEGF treatments for ophthalmic use in New Zealand

New Zealand’s Pharmaceutical Management Agency PHARMAC consulted on a proposal to list ranibizumab (Lucentis) and aflibercept (Eylea) in Section H of the Pharmaceutical Schedule from November 1, 2016 for the second and third line treatment (respectively) of wet age-related macular degeneration (wAMD). 15 December 2016

GSK files lupus drug for Japanese approval

GlaxoSmithKline has submitted a regulatory application to the Japanese Ministry of Health, Labor and Welfare (MHLW) for belimumab, in adult patients with active, autoantibody-positive systemic lupus erythematosus (SLE) who have an inadequate response to standard therapy. 15 December 2016

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RAPT Thera ends zelnecirnon program after FDA worries

RAPT Therapeutics has announced the termination of its zelnecirnon program following regulatory concerns around safety. 12 November 2024

Autolus Therapeutics announces FDA approval of Aucatzyl

On November 8, the US Food and Drug Administration approved Aucatzyl (obecabtagene autoleucel; obe-cel) from US biopharma Autolus Therapeutics' 11 November 2024

NMPA cooperation with Danish Medicines Agency

Li Li, Commissioner of China's National Medical Products Administration (NMPA), and Mette Aaboe Hansen, interim director general of Danish Medicines Agency, have signed a letter of intent to promote bilateral cooperation in regulation of drugs and medical devices. 11 November 2024

US FDA to consider Dizal’s first-in-class lung cancer drug

Shanghai-based Dizal has made a submission to the US Food and Drug Administration, seeking approval for sunvozertinib. 8 November 2024

Health Canada approval for Moderna’s RSV vaccine

US mRNA specialist Moderna today announced Health Canada has approved mRESVIA (respiratory syncytial virus mRNA vaccine) for active immunization for the prevention of lower respiratory tract disease caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. 8 November 2024

J&J files with EMA and FDA for Darzalex in high-risk smouldering MM

US healthcare giant Johnson & Johnson today revealed it has submitted applications with the US Food and drug Administration (FDA) and European Medicines Agency (EMA) to expand the approved indications for its Darzalex (daratumumab) subcutaneous (SC) formulation for the treatment of high-risk smouldering multiple myeloma (SMM). 8 November 2024

FDA Rare Pediatric Disease status for AskBio’s AB-1003

Asklepios BioPharmaceutical (AskBio) today announced that AB-1003 (also known as LION-101) has received rare pediatric disease designation and orphan-drug designation from the US Food and Drug Administration (FDA) for the treatment of limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9). 7 November 2024

Acadia Pharma sells priority review voucher for $150 million

USA-based Acadia Pharmaceuticals has entered into a definitive asset purchase agreement to sell its Rare Pediatric Disease Priority Review Voucher (PRV) for $150 million upon the closing of the transaction. 6 November 2024

GSK’s Arexvy receives expanded approval in Canada

GSK’s Arexvy (RSV vaccine) has received an expanded approval in Canada to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults aged 50-59 who are at increased risk. 6 November 2024

Another Dupixent approval in the EU

French pharma major Sanofi’s Dupixent (dupilumab), which notched up sales of 3.5 billion euros ($3.8 billion) in third-quarter 2024, +23.8% year-on-year, has picked up yet another indication in collaboration with Regeneron. 6 November 2024

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FDA approves REMS, advancing new drug disposal option for opioid analgesics

The US Food and Drug Administration (FDA) has announced approval of a modification to the Opioid Analgesic Risk Evaluation and Mitigation Strategy (OA REMS) 6 November 2024

EU sets date for decision on proposed $16.5 billion Catalent buy

European regulators will decide by December 6 whether Novo Holdings, the controlling shareholder of Danish pharma giant Novo Nordisk, can finalize its $16.5 billion acquisition of contract drug manufacturer Catalent. 5 November 2024

Photocure’s Hexvix wins Chinese approval

Photocure, a Norway-based bladder cancer-focused company, has announced that Jiangsu Yahong Meditech, the parent company of its partner Asieris Pharmaceuticals, has received marketing authorization for Hexvix (hexaminolevulinate) in China. 5 November 2024

FDA accepts Ionis NDA for donidalorsen

The US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for donidalorsen, an investigational RNA-targeted medicine for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older, under development by Ionis Pharmaceuticals. 4 November 2024

Disc Medicine leaps as it gets positive FDA feedback

Disc Medicine today announced a successful End of Phase 2 with the US Food and Drug Administration (FDA) supporting the regulatory path forward, including potential for accelerated approval, for bitopertin in erythropoietic protoporphyria (EPP). 4 November 2024

FDA sets up Rare Diseases Innovation Hub

On Friday, the US Food and Drug Administration published the FDA Voices: “FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub,” by Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research (CDER) and Dr Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research (CBER). 4 November 2024

FDA Rare Pediatric Disease designation for BPGbio

The US Food and Drug Administration (FDA) has granted a Rare Pediatric disease designation for BPM31510T, an investigational treatment for epidermolysis (EB) from BPGbio. 4 November 2024

The week in pharma: action, reaction and insight – week to November 1

US pharma major AbbVie last week proposed $1.4 billion acquisition of US CNS drug developer Aliada Therapeutics. Last week saw a bunch of third quarter 2024 financials results, among which were Elil Lilly, AbbVie and Merck & Co. Also of note, Lexicon’s type I diabetes drug Zynquista faced a Food and Drug Administration (FDA) advisory committee review that resulted in largely negative vote against recommendation. 3 November 2024

FDA panel vote leaves Lexicon’s Zynquista hopes hanging by a thread

Texas-based biopharma Lexicon Pharmaceuticals was trading nearly 36% lower on Friday morning. 1 November 2024

Remove barriers for EU firms trading in other markets, group says

Medicines for Europe has launched a study of market barriers faced by European generics and biosimilar pharmaceutical companies operating in 11 key third-country markets. 31 October 2024

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