Motif pummelled as FDA asks for more data on antibioticShares in UK biotech Motif Bio fell more than 50% after its much-delayed antibiotic was held up at Share XMotif pummelled as FDA asks for more data on antibiotichttps://pharmaphorum.com/news/motif-pummelled-as-fda-asks-for-more-data-on-antibiotic/
Celgene gets MS blockbuster-in-waiting ozanimod back on trackRegulators in the US and EU have formally started their review of Celgene’s oral drug ozanimod for multiple Share XCelgene gets MS blockbuster-in-waiting ozanimod back on trackhttps://pharmaphorum.com/news/celgene-gets-ms-blockbuster-in-waiting-ozanimod-back-on-track/
Celgene gets speedy review for thalassaemia drug luspaterceptIt’s shaping up to be a landmark year for the community of patients with rare blood disorder beta Share XCelgene gets speedy review for thalassaemia drug luspatercepthttps://pharmaphorum.com/news/celgene-gets-speedy-review-for-thalassaemia-drug-luspatercept/
Orkambi parents start ‘buyers club’ to import generic version of CF drugA group of parents in the UK have taken matters into their own hands in an effort to Share XOrkambi parents start ‘buyers club’ to import generic version of CF drughttps://pharmaphorum.com/news/orkambi-parents-start-buyers-club-to-import-generic-version-of-cf-drug/
Lilly’s migraine drug gets key cluster headache approvalThe FDA has approved Eli Lilly’s Emgality (galcanezumab-gnlm) for the treatment of episodic cluster headache in adults, giving Share XLilly’s migraine drug gets key cluster headache approvalhttps://pharmaphorum.com/news/lillys-migraine-drug-gets-key-cluster-headache-approval/
bluebird claims first approval for gene therapy Zynteglo in EUbluebird bio has its first ever product approval, getting a green light from the EMA for Zynteglo, its Share Xbluebird claims first approval for gene therapy Zynteglo in EUhttps://pharmaphorum.com/news/bluebird-claims-first-approval-for-gene-therapy-zynteglo-in-eu/
Mitsubishi Tanabe pulls ALS drug from EMA assessmentMitsubishi Tanabe Pharma has withdrawn its EU application for ALS drug Radicava (edaravone), citing ‘unwarranted’ additional data requirements Share XMitsubishi Tanabe pulls ALS drug from EMA assessmenthttps://pharmaphorum.com/news/mitsubishi-tanabe-pulls-als-drug-from-ema-assessment/
Amarin’s Vascepa gets priority review for cardiovascular label expansionAmarin’s cardio drug Vascepa (icosapent ethyl) has been granted Priority Review designation by the FDA after trial results Share XAmarin’s Vascepa gets priority review for cardiovascular label expansionhttps://pharmaphorum.com/news/amarins-vascepa-gets-priority-review-for-cardiovascular-label-expansion/
AZ pulls back on Inovio immuno-oncology pactAstraZeneca has decided to trim back its 2015 alliance with Inovio Pharmaceuticals, which focused on combining the biotech’s Share XAZ pulls back on Inovio immuno-oncology pacthttps://pharmaphorum.com/news/az-pulls-back-on-inovio-immuno-oncology-pact/
Bayer’s Aliqopa gets speedy review for marginal zone lymphomaThe FDA has granted Breakthrough Therapy Designation to Bayer’s PI3K inhibitor Aliqopa (copanlisib) for marginal zone lymphoma (MZL) Share XBayer’s Aliqopa gets speedy review for marginal zone lymphomahttps://pharmaphorum.com/news/bayers-aliqopa-gets-speedy-review-for-marginal-zone-lymphoma/
Lilly cuts $1bn deal for Centrexion’s non-opioid painkillerEli Lilly has signed another bolt-on deal to bulk up its pipeline, this time paying $47.5 million upfront Share XLilly cuts $1bn deal for Centrexion’s non-opioid painkillerhttps://pharmaphorum.com/news/lilly-cuts-1bn-deal-for-centrexions-non-opioid-painkiller/
Novartis scores first approval for PIK3CA breast cancer drugThe FDA has approved Novartis’ breast cancer drug Piqray (alpelisib), making it the first marketed treatment targeting the Share XNovartis scores first approval for PIK3CA breast cancer drughttps://pharmaphorum.com/news/novartis-scores-first-approval-for-pik3ca-breast-cancer-drug/
Newron faces delay to would-be schizophrenia blockbusterNewron has been forced to delay the start of a pivotal trial of its schizophrenia candidate evenamide – Share XNewron faces delay to would-be schizophrenia blockbusterhttps://pharmaphorum.com/news/newron-faces-delay-to-would-be-schizophrenia-blockbuster/
Novartis gets okay for SMA gene therapy, with $2m price tagAfter all the anticipation, Novartis has the FDA approval it has been seeking for Zolgensma, its gene therapy Share XNovartis gets okay for SMA gene therapy, with $2m price taghttps://pharmaphorum.com/news/novartis-gets-okay-for-sma-gene-therapy-with-2m-price-tag/
NHS England improves offer to Vertex over CF drugsNHS officials in England have made an improved two-year pricing deal to Vertex Pharmaceuticals in a bid to Share XNHS England improves offer to Vertex over CF drugshttps://pharmaphorum.com/news/nhs-england-improves-offer-to-vertex-over-cf-drugs/
Lilly moves Crohn’s drug into phase 3, faces safety setback in JapanEli Lilly has had a mixed few days, posting promising trial results for mid-stage Crohn’s disease drug mirikizumab, Share XLilly moves Crohn’s drug into phase 3, faces safety setback in Japanhttps://pharmaphorum.com/news/lilly-moves-crohns-drug-mirikizumab/
After years of delays, NICE backs Celgene’s Revlimid in first-line MMAfter years of delays caused by wrangling over price, NICE has recommended regular NHS funding for Celgene’s Revlimid Share XAfter years of delays, NICE backs Celgene’s Revlimid in first-line MMhttps://pharmaphorum.com/news/after-years-of-delays-nice-backs-celgenes-revlimid-in-first-line-mm/
Gilead faces lawsuit over HIV drug pricingGilead and other pharma companies stand accused of engaging in a scheme to block cheaper competitors to life-saving Share XGilead faces lawsuit over HIV drug pricinghttps://pharmaphorum.com/news/gilead-faces-lawsuit-over-hiv-drug-pricing/
