“Pfizer (NYSE: PFE) announced that the European Commission has approved a label update to expand use of XALKORI (crizotinib) to first-line treatment of adults with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC). The Summary of Product Characteristics also has
“Gilead Sciences (NASDAQ: GILD) announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for an investigational, once-daily fixed-dose combination of the nucleotide analog polymerase inhibitor sofosbuvir (SOF), approved as Sovaldi® in December 20
“Arena Pharma (NASDAQ: ARNA) announced the initiation of patient dosing in a Phase 1b multiple-ascending dose clinical trial of APD371, a selective and potent agonist of the cannabinoid 2 (CB2) receptor.This randomized, double-blind, placebo-controlled Phase 1b clinical trial will enroll approxima
“Rock Creek Pharma (NASDAQ: RCPI) announced the successful completion of its three part Phase I clinical trial conducted in the United Kingdom (UK). The overall objective of the Phase I trial was to evaluate safety, tolerability and pharmacokinetic (PK) profiles of different formulations of the Co
“BioMarin Pharma (NASDAQ: BMRN) announced that the Peripheral and Central Nervous System Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review the New Drug Application (NDA) for drisapersen. The FDA is currently reviewing drisapersen for the treatment of patients with
“Eli Lilly & Co. (NYSE: LLY) and Innovent Biologics, Inc. (Innovent) today announced an expansion of their drug development collaboration, already one of the largest in China between a multi-national and domestic biopharmaceutical company.”
““Before my husband and I learned about the AUGMENT treatment, we struggled with infertility due to my egg quality and felt somewhat discouraged,” said the mother. “Now we are optimistic that our experience will show couples, especially those who suffer from poor egg health, that they have a
“The lawsuit, captioned Amarin Pharma, Inc., et al. v. Food & Drug Administration, et al., was filed in the United States District Court for the Southern District of New York. It seeks a judicial declaration that FDA regulations limiting off-label promotion of such truthful and non-misleading info
“t the Company has completed enrollment in the RADIANCE Phase 3 trial of ozanimod (formerly RPC1063) in patients with Relapsing Multiple Sclerosis (RMS). The trial was over-enrolled by approximately 10% due to strong interest among investigators and patients. The Company is continuing to enroll th
%2BSays%2BData%2Bon%2BANGPTL3Evinacumab%2BPublished%2Bin%2BNEJM%2F12943249.html)
Regeneron (REGN) Says Data on ANGPTL3/Evinacumab Published in NEJM%2BCommences%2BCTP-543%2BPhase%2B1%2F11652172.html)
Concert Pharma (CNCE) Commences CTP-543 Phase 1%2BSays%2BNew%2BSubgroup%2BAnalysis%2Bof%2BOngoing%2BPhase%2B2%2BPilot%2BPANOVA%2BTrial%2Bto%2Bbe%2BPresented%2Bat%2BASCO%2F11650561.html)
Novocure (NVCR) Says New Subgroup Analysis of Ongoing Phase 2 Pilot PANOVA Trial to be Presented at ASCO%2BAnnounces%2BSubmission%2Bof%2BNDA%2Bto%2BFDA%2Bfor%2BInsulin%2BGlargine%2B%252B%2BLixisenatide%2BCombo%2F11174611.html)
Sanofi (SNY) Announces Submission of NDA to FDA for Insulin Glargine + Lixisenatide Combo%2BCompletes%2BNBI-98854%2BPhase%2B1b%2BT-Force%2BStudy%253B%2B31%2525%2BMean%2BReducation%2BObserved%2F11159627.html)
Neurocrine Biosciences (NBIX) Completes NBI-98854 Phase 1b T-Force Study; 31% Mean Reducation Observed%2BInitiates%2BPhase%2BIII%2BStudy%2Bof%2BAffinity%2BEnhanced%2BT-Cell%2BTherapy%2BTargeting%2BMAGE-A10%2Bin%2BNSCLC%2F11162696.html)
Adaptimmune (ADAP) Initiates Phase I/II Study of Affinity Enhanced T-Cell Therapy Targeting MAGE-A10 in NSCLC%2BComplete%2BRolling%2BNDA%2BSubmission%2Bto%2BFDA%2Bfor%2BFirdapse%2F11161624.html)
Catyalyst Pharma (CPRX) Complete Rolling NDA Submission to FDA for Firdapse%2BAnnounces%2BFDA%2BSubmission%2Bof%2BNADA%2Bfor%2BKIND-012%2F11162041.html)
Kindred Biosciences (KIN) Announces FDA Submission of NADA for KIND-012%2BInitiates%2BSTARTRK-NG%2BPhase%2B11b%2BPediatric%2BClinical%2BTrial%2Bof%2BEntrectinib%2F11138586.html)
Ignyta (RXDX) Initiates STARTRK-NG Phase 1/1b Pediatric Clinical Trial of Entrectinib%2BReceives%2BEC%2BApproval%2Bfor%2BExpanded%2BXALKORI%2BIndication%2F11106562.html)
Pfizer (PFE) Receives EC Approval for Expanded XALKORI Indication%2BAnnounces%2BSubmission%2Bof%2BSofosbuvir%2B%252B%2BVelpatasvir%2BNDA%2Bto%2BFDA%2Bas%2BHCV%2BTreatment%2F11012434.html)
Gilead Sciences (GILD) Announces Submission of Sofosbuvir + Velpatasvir NDA to FDA as HCV Treatment%2BAnnounces%2BInitiation%2Bof%2BAPD371%2BPhase%2B1b%2F11014000.html)
Arena Pharma (ARNA) Announces Initiation of APD371 Phase 1b%2BCompletes%2BAnatabine%2BCitrate%2BPhase%2B1%2BTrial%2Bin%2BU.K.%2F10974813.html)
Rock Creek Pharma (RCPI) Completes Anatabine Citrate Phase 1 Trial in U.K.%2BAnnounces%2BFDA%2BCommittee%2BReview%2Bof%2BDrisapersen%2BNDA%2Bin%2BDMD%2BAmenable%2Bto%2BExon%2B51%2BSkipping%2F10973904.html)
BioMarin Pharma (BMRN) Announces FDA Committee Review of Drisapersen NDA in DMD Amenable to Exon 51 Skipping%252C%2BInnovent%2BBiologics%2Bto%2BExpand%2BDrug%2BDevelopment%2BCollaboration%2F10963123.html)
Eli Lilly & Co. (LLY), Innovent Biologics to Expand Drug Development Collaboration%2BAnnounces%2BInitiation%2Bof%2BISIS-HTTRx%2BPhase%2B12a%2Bin%2BHD%2BPatients%2F10737018.html)
Isis Pharma (ISIS) Announces Initiation of ISIS-HTTRx Phase 1/2a in HD Patients%2BAnnounces%2BFirst%2BBaby%2BBorn%2Bwith%2BAUGMENT%2BFertility%2BTreatment%2F10533684.html)
Ovascience (OVAS) Announces First Baby Born with AUGMENT Fertility Treatment%2Bon%2BWatch%2BAfter%2BFDA%2BPosts%2BBriefing%2BDocs%2Bfor%2BOrkambi%2Bto%2BTreat%2BCF%2F10539170.html)
Vertex Pharma (VRTX) on Watch After FDA Posts Briefing Docs for Orkambi to Treat CF%2BFiles%2BSuit%2BAgainst%2BFDA%2BRelated%2Bto%2BOff-Label%2BPromotion%2F10536594.html)
Amarin (AMRN) Files Suit Against FDA Related to Off-Label Promotion%2BAnnounces%2BCompletion%2Bof%2BRADIANCE%2BPhase%2B3%2BEnrollment%2F10421840.html)
Receptos (RCPT) Announces Completion of RADIANCE Phase 3 Enrollment