Volasertib Designated Orphan Drug for Acute Myeloid Leukemia

The FDA has granted Orphan Drug designation to volasertib (Boehringer Ingelheim) for acute myeloid leukemia (AML).

Otrexup Results Published for Rhuematoid Arthritis

Antares Pharma announced the publication of results from its crossover study comparing the relative bioavailability, safety, and tolerability of Otrexup (methotrexate) to oral methotrexate (MTX) in adults with rheumatoid arthritis in the Annals of the Rheumatic Diseases.

AbbVie Launches Veliparib Trial for NSCLC

AbbVie announced the initiation of a Phase 3 trial evaluating the safety and efficacy of veliparib (ABT-888) in patients with previously untreated locally advanced or metastatic squamous non-small cell lung cancer (NSCLC).

BAX 111 Efficacious in Inherited Bleeding Disorder

Baxter announced results from a Phase 3 clinical trial evaluating the safety, efficacy, and pharmacokinetics of BAX 111, a recombinant von Willebrand factor (rVWF) for the treatment of bleeding episodes in patients with von Willebrand disease.

Two Phase 2 Trials Report Positive Sofosbuvir Data in HCV

Gilead Sciences announced promising efficacy results of sofosbuvir (SOF) in combination with ledipasvir and GS-5816 from two Phase 2 clinical trials on chronic hepatitis C virus (HCV) infection.

Positive Simeprevir Data in Multiple Phase 2 and 3 Studies

Positive Simeprevir Data in Multiple Phase 2 and 3 Studies

Janssen announced positive new data from the simeprevir clinical program, including data from the Phase 2 COSMOS study, the Phase 3 RESTORE, QUEST-1, QUEST-2, and the PROMISE studies.

Combination HCV Therapy Achieves SVR Rates in Trials

Enanta announced results from the Phase 3 SAPPHIRE-I and SAPPHIRE-II studies for AbbVie's investigational three direct-acting antiviral regimen containing Enanta's ABT-450 for the treatment of hepatitis C virus (HCV) genotype 1(GT1) infection.

NDA for New HIV-1 Single Tablet Combination Therapy

Bristol-Myers Squibb and Gilead announced that it has submitted to the FDA a New Drug Application (NDA) for a fixed-dose combination of atazanavir sulfate and cobicistat (Gilead) for use in conbination with other antiretroviral agents for the treatment of HIV-1 infection.

3D Antiviral Regimen Shows Efficacy in Chronic HCV Study

Enanta announced results from AbbVie's pivotal Phase 3 TURQUOISE-II study of the investigational three direct-acting (3D) antiviral regimen for genotype 1 (GT1) chronic hepatitis C virus (HCV) infection with compensated liver cirrhosis.

Investigational Chronic HCV Agents Effective in Phase 2 Study

Merck announced additional data from the ongoing Phase 2 C-WORTHy study evaluating the efficacy and safety of MK-5172 and MK-8742 in patients with chronic HCV genotype 1 (GT1) infection.

All-Oral HCV Therapy Results Released

All-Oral HCV Therapy Results Released

Bristol-Myers Squibb announced results from its HALLMARK-Dual Phase 3 study of all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV) and asunaprevir (ASV) in patients with genotype 1b hepatitis C virus infection (HCV).

Eloctate Shows Efficacy in Hemophilia A Trial

Biogen Idec and Swedish Orphan Biovitrum announced positive top-line results for the Kids A-LONG Phase 3 clinical study that evaluated the safety and efficacy of Eloctate (recombinant factor VIII Fc fusion protein) in children with severe hemophilia A.

Results Reinforce Ampion Use in OAK

Ampio announced results of the 20 weeks extension of the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK).

Aripiprazole Lauroxil Shows Efficacy in Schizophrenia Trial

Alkermes announced positive results from its Phase 3 clinical trial of aripiprazole lauroxil in patients with schizophrenia.

Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica

Janssen R&D and Pharmacyclics Submit sNDA for Imbruvica

Janssen R&D and Pharmacyclics announced the submission of a supplemental New Drug Application (sNDA) for Imbruvica (ibrutinib), based on positive data from the Phase 3 RESONATE study in relapsed or refractory chronic lymphocytic leukemia (CLL).

BMS Submits Two NDAs for Hepatitis C Treatment

Bristol-Myers Squibb announced that it has submitted New Drug Applications (NDAs) to the FDA for daclatasvir (DCV) and asunaprevir (ASV) for the treatment of hepatitis C.

Combination Chronic Hep C Therapy Granted Priority Review

The FDA has granted priority review to Gilead's New Drug Application (NDA) for a once-daily fixed-dose combination of ledipasvir (LDV) and sofosbuvir (SOF) for the treatment of chronic hepatitis C genotype 1 infection in adults.

Palbociclib + Letrozole Prolongs PFS in Advanced Breast Cancer Study

Pfizer announced results from the Phase 2 PALOMA-1 study that is investigating the use of palbociclib (PD-0332991) in combination with letrozole in patients with advanced breast cancer.

Amgen Announces Results from Talimogene Laherparepvec Phase 3 Trial

Amgen Announces Results from Talimogene Laherparepvec Phase 3 Trial

Amgen announced top-line results from the primary overall survival (OS) analysis of their Phase 3 trial on talimogene laherparepvec for the treatment of unresected stage IIB, IIIC or IV melanoma.

Primary Endpoint Met in Eye Disorder Study

Santen announced results from its Phase 3 trial evaluating intravitreal injections of sirolimus in patients with non-infectious posterior segment uveitis (NI-PSU).

FDA Fast Tracks Eravacycline for cIAI and cUTI

The FDA granted Fast Track status to the IV and oral formulations of eravacycline (Tetraphase) for the treatment of complicated intra-abdominal infections (cIAI) and complicated urinary tract infections (cUTI).

ERY-ASP Designated Orphan Drug for AML

The FDA has granted ERY-ASP (Erytech Pharma) Orphan Drug Designation for the treatment of acute myeloid leukemia (AML).

Heart Failure Trial Shut Down After Primary Endpoint Met

Novartis announced the early closure of its Phase 3 PARADIGM-HF study, indicating that patients with chronic heart failure with reduced ejection fraction (HF-REF) who received LCZ696 lived longer without being hospitalized for heart failure than those who received standard care with ACE-inhibitor enalapril.

Prostate Cancer Trial Launched for Xofigo

Phase 3 trial launched for Xofigo (radium Ra 223 dichloride; Bayer HealthCare) injection in combination with Zytiga (abiraterone acetate; Janssen) and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (mCRPC).

NDA Submitted for Combination HIV-1 Therapy

Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA for Prezista (darunavir) with cobicistat (Gilead Sciences) for use in combination with other HIV-1 drugs.

Xarelto to be Evaluated in 3 New Thromboembolism Trials

Xarelto to be Evaluated in 3 New Thromboembolism Trials

Janssen R&D announced the addition of three new clinical trials under the EXPLORER global cardiovascular research program for Xarelto (rivaroxaban) to be evaluated for thromboembolic disorders.

Results Announced for Eliquis in Nonvalvular Atrial Fibrillation Trial

Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial that assessed the effect of blood pressure control on outcomes as well as the treatment effect of Eliquis (apixaban) vs. warfarin to blood pressure control in patients with nonvalvular atrial fibrillation (NVAF).

FDA Accepts AVP-825 NDA for Acute Migraine Treatment

FDA Accepts AVP-825 NDA for Acute Migraine Treatment

The FDA has accepted Avanir's New Drug Application (NDA) of AVP-825, its Breath Powered investigational drug-device combination product for the acute treatment of migraine.

Genotropin May be Efficacious for SGA Children

Pfizer announced top-line results from its Phase 3B study evaluating the 24-month efficacy of Genotropin (somatropin) on the height in small-for-gestational-age (SGA) children 24-30 months old.

Positive Outcomes Observed with Xalkori in NSCLC Study

Pfizer announced results from PROFILE 1014, a Phase 3 study of Xalkori (crizotinib) in previously untreated patients with anaplastic lymphoma kinase (ALK)-positive advanced non-squamous non-small cell lung cancer (NSCLC).

Investigational Vaccine Efficacious in HSV-2 Trial

Genocea Biosciences announced updated results for its Phase 1/2a study with GEN-003, a vaccine candidate under development for the treatment of herpes simplex virus type 2 (HSV-2) infection.

Guselkumab Shows Improvement in Plaque Psoriasis

Janssen R&D announced results from X-PLORE, a Phase 2b study of guselkumab (CNTO 1959) in patients with moderate to severe plaque psoriasis.

Otezla Shows Improvement in Plaque Psoriasis Studies

Celgene announced the release of new research findings on Otezla (apremilast), a selective inhibitor of phosphodiesterase 4 (PDE4), from the ESTEEM 1 and 2 Phase 3 studies in patients with moderate to severe plaque psoriasis.

Xeljanz Demonstrates Efficacy in Chronic Plaque Psoriasis

Pfizer announced results from OPT Compare (A3921080), a Phase 3 study of Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis.

Positive Results Announced for Rosacea Treatment

Galderma announced results from two Phase 3 trials of ivermectin 1%, an investigational drug being evaluated for the treatment of papulopusular rosacea.

Priority Review Granted for Malignant Hyperthermia Drug

Eagle Pharmaceuticals announced that the FDA has accepted the NDA for Ryanodex (dantrolene sodium) and has granted a priority review classification for the treatment of malignant hyperthermia.

Breakthrough Therapy Designation for Meningococcal B Vaccine Candidate

Pfizer announced that the FDA has granted Breakthrough Therapy Designation for bivalent rLP2086, an investigational vaccine for the prevention of invasive meningococcal disease.

Top-Line Results for Sickle Cell Disease Meet Trial Endpoints

Emmaus Life Sciences announced that preliminary results from its Phase 3 clinical trial evaluating the safety and efficacy of oral L-glutamine for sickle cell anemia and sickle beta-0 thalassemia met both primary and secondary endpoints.

Complete Response Letter Issued for Keratoconus and Corneal Ectasia NDA

Avedro Inc. announced that it has received a Complete Response Letter from the FDA regarding the New Drug Application (NDA) for its riboflavin ophthalmic solution/KXL System.

Evolocumab Significantly Lowers LDL-C in TESLA Study

Evolocumab Significantly Lowers LDL-C in TESLA Study

Amgen announced that the Phase 3 TESLA trial met its primary endpoint of the percent reduction from baseline at Week 12 in low-density lipoprotein cholesterol (LDL-C).

New Phase 3 Study Results Presented for Simeprevir

New Phase 3 Study Results Presented for Simeprevir

Medivir AB announced new Phase 3 results for once-daily simeprevir at the Conference of the Asian Pacific Association for the Study of the Liver (APASL).

Positive Retrospective Analysis Results for Talimogene for Melanoma

Positive Retrospective Analysis Results for Talimogene for Melanoma

Amgen announced results from a pre-specified retrospective analysis of patients with metastatic melanoma that showed talimogene reduced the size of injected tumors and non-injected metastasized tumors.

EPI-743 Awarded Fast Track Status for Friedreich's Ataxia

EPI-743 Awarded Fast Track Status for Friedreich's Ataxia

Edison Pharmaceuticals announced that the FDA has granted Fast Track designation to EPI-743, a study drug for the treatment of Friedreich's ataxia.

Phase 3 Study Results for Severe Eosinophilic Asthma Drug

GlaxoSmithKline announced that the primary endpoint for its Phase 3 study of mepolizumab was met for the reduction in the frequency of exacerbations, in patients with severe eosinophilic asthma.

Extended-Release Drug for Chronic Low Back Pain Meets Endpoint

Purdue Pharma announced results from a Phase 3 study of an extended-release formulation of hydrocodone bitartrate in patients with chronic low back pain.

Ruxolitinib Demonstrates Effectiveness in Blood Disorder Trial

Incyte announced results from a Phase 3 trial of ruxolitinib compared to best available therapy in patients with polycythemia vera who are resistant to or intolerant of hydroxyurea.

FDA Accepts sNDA for Review for Lymphoseek Label Expansion

The FDA has accepted for review an additional sNDA for the proposed expanded label for Lymphoseek (technetium 99m tilmanocept; Navidea) Injection to support broader and more flexible use in imaging and lymphatic mapping procedure.

FDA Issues Complete Response Letter for Diabetes Drug

FDA Issues Complete Response Letter for Diabetes Drug

The FDA has issued a Complete Response Letter for the New Drug Application (NDA) of empagliflozin (Boehringer Ingelheim and Eli Lilly and Company) for the reduction of blood glucose levels in adults with type 2 diabetes.

Forest Submits Memantine/Donepezil NDA for Alzheimer's Disease

Forest Laboratories has submitted a NDA for a fixed-dose combination of memantine HCl extended release and donepezil HCl for the treatment of moderate to severe dementia related to Alzheimer's disease.

3D Antiviral Regimen Meets Endpoint in Hepatitis C Virus Study

Enanta announced results from the PEARL-III trial studying ABT-450 for the treatment of genotype 1 (GT1) hepatitis C virus (HCV) infection using a three direct-acting antiviral regimen.

Tiotropium as Asthma Add-On Treatment Shows Promise

Tiotropium as Asthma Add-On Treatment Shows Promise

Boehringer Ingelheim has announced positive results from several Phase 3 studies on the once-daily tiotropium Respimat inhaler as an add-on treatment for asthma.

FDA Grants ALS Bio-Drug Orphan Drug Designation

Genervon was granted an orphan drug designation by the FDA for its bio-drug GM604 (also known as GM6) for the treatment of amyotrophic lateral sclerosis (ALS).

Lurasidone Evaluated for Relapse Risk in Schizophrenia Trial

Lurasidone Evaluated for Relapse Risk in Schizophrenia Trial

Sunovion and Takeda announced results from a new study evaluating the efficacy and safety of lurasidone (Latuda; Sunovion) in the maintenance treatment of adults with schizophrenia.

FDA Designates Pracinostat Orphan Drug for Acute Myeloid Leukemia

FDA Designates Pracinostat Orphan Drug for Acute Myeloid Leukemia

The FDA has granted Orphan Drug designation to Pracinostat (MEI Pharma) for the treatment of acute myeloid leukemia (AML).

Exparel Meets Trial Endpoint in Femoral Nerve Block in Knee Arthroplasty

Exparel Meets Trial Endpoint in Femoral Nerve Block in Knee Arthroplasty

Pacira Pharmaceuticals announced that the Phase 3 trial assessing the safety and efficacy of Exparel (bupivacaine liposome injectable suspension) in femoral nerve block for total knee arthroplasty met its primary efficacy endpoint.

Marizomib Designated Orphan Drug Status for Multiple Myeloma

The FDA has granted Triphase Accelerator's marizomib Orphan Drug designation for the treatment of multiple myeloma.

Forest Submits Nebivolol/Valsartan NDA for Hypertension

Forest Labs has announced that it has submitted a New Drug Application (NDA) to the FDA for a once-daily, fixed dose combination (FDC) of nebivolol and valsartan for the treatment of hypertension.

Eliquis Demonstrates Efficacy in Nonvalvular Atrial Fibrillation Trial

Bristol-Myers Squibb and Pfizer announced results of a pre-specified subanalysis of the Phase 3 ARISTOTLE trial according to patient age in patients with nonvalvular atrial fibrillation (NVAF).

Prevnar 13 Landmark Trial Meets Primary Objective

Prevnar 13 Landmark Trial Meets Primary Objective

Pfizer announced that the CAPiTA evaluating the efficacy of Prevnar 13 achieved its primary clinical objective and both secondary clinical objectives.

FDA Accepts sBLA for Xiaflex for Concurrent Treatment of Multiple Palpable Cords

The FDA has accepted Auxilium's supplemental Biologics License Application (sBLA) for Xiaflex (collagenase clostridium histolyticum, or CCH) for the treatment of two Dupuytren's contracture (DC) cords concurrently.

DCV Dual Regimen Designated Breakthrough Therapy for Chronic Hepatitis C

The FDA has granted Bristol-Myers Squibb's DCV Dual Regimen (daclatasvir and asunaprevir) Breakthrough Therapy Designation for use as a combination therapy in the treatment of genotype 1b chronic hepatitis C infection (HCV).

Janssen Launches Phase 3 Invokana Trial in Diabetic Nephropathy

Janssen Launches Phase 3 Invokana Trial in Diabetic Nephropathy

Janssen R&D has announced the initiation of the Phase 3 CREDENCE trial, which will examine if the use of Invokana (canagliflozin) can slow the progression of diabetic nephropathy in patients with type 2 diabetes.

SCY-078 Designated QDIP for Invasive Candidiasis

The FDA has designated SCY-078 (Scynexis) Qualified Infectious Disease Product (QDIP) for invasive Candidiasis, including Candidemia, and Aspergillosis.

Bayer HealthCare Initiates Colorectal Cancer Trial with Stivarga

Bayer HealthCare announced that it has begun enrolling patients into the Phase 3 COAST trial studying Stivarga (regorafenib) tablets in colorectal cancer (CRC) patients with resected liver metastases.

UPI-928 Granted Orphan Drug Status for Acute Myeloid Leukemia

The FDA has granted Orphan Drug Status for the use of UPI-928 (Update Pharma) for the treatment of Acute Myeloid Leukemia (AML).

BAY 94-9027 Demonstrates Efficacy in Hemophilia A Trial

Bayer HealthCare announced positive results from the PROTECT VIII trial evaluating BAY 94-9027 in previously treated adults and adolescents with severe hemophilia A.

FDA to Review Lymphoseek sNDA in Head and Neck Cancer

The FDA has accepted the Supplemental New Drug Application (sNDA) and granted it Priority Review for the expanded use of Lymphoseek (technetium 99m tilmanocept; Navidea) Injection for sentinel lymph node (SNL) detection in patients with head and neck cancer.

Complete Response Letter Issued for Posidur for Post-op Analgesia

The FDA has issued a Complete Response Letter (CRL) for Posidur (Saber-Bupivacaine; Durect), an investigational drug for administration into the surgical site to produce post-surgical analgesia.

Female Libido Pill Continues to Stimulate Interest

Female Libido Pill Continues to Stimulate Interest

Sprout Pharmaceuticals will resubmit the NDA for flibanserin, a novel non-hormonal once-daily treatment for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

Eylea Demonstrates Efficacy in Diabetic Macular Edema Study

Eylea Demonstrates Efficacy in Diabetic Macular Edema Study

Regeneron Pharmaceuticals and Bayer HealthCare announced results from Phase 3 VISTA-DME trial of Eylea (aflibercept) Injection for the treatment of diabetic macular edema (DME).

Vyvanse Misses Endpoint in Major Depressive Disorder Trial

Results announced from two Phase 3 studies evaluating Vyvanse (lisdexamfetamine dimesylate; Shire) Capsules (CII) as an adjunctive treatment for major depressive disorder (MDD) in adults with inadequate response to antidepressant monotherapy with SSRI or SNRI.

OMS824 Granted Fast Track Designation for Huntington's Disease

OMS824 Granted Fast Track Designation for Huntington's Disease

FDA has granted Fast Track Designation to Omeros Corporation's OMS824 for cognitive impairment in patients with Huntington's disease.

Positive Results Observed for Eluxadoline in IBS-d Trials

Positive Results Observed for Eluxadoline in IBS-d Trials

Furiex Pharmaceuticals announced top-line results for two Phase 3 clinical trials evaluating the efficacy and safety of eluxadoline in the treatment of diarrhea-predominant irritable bowel syndrome (IBS-d).

Vatiquinone Designated Orphan Drug Status for Friedreich's Ataxia

Vatiquinone Designated Orphan Drug Status for Friedreich's Ataxia

The FDA has granted Orphan Drug status to vatiquinone (EPI-743; Edison Pharmaceuticals) for the treatment of Friedreich's ataxia.

Palbociclib + Letrozole Improve Survival in Breast Cancer

Palbociclib + Letrozole Improve Survival in Breast Cancer

Pfizer announced that the Phase 2 PALOMA-1 trial met its primary endpoint by achieving a statistically significant and clinically meaningful improvement in progression-free survival for the combination of palbociclib and letrozole vs. letrozole alone in postmenopausal women with ER+, HER2- advanced breast cancer.

Lenvatinib Meets Primary Endpoint in Phase 3 SELECT Trial

Lenvatinib Meets Primary Endpoint in Phase 3 SELECT Trial

Lenvatinib showed a highly statistically significant improvement in progression free survival (PFS) in patients with RR-DTC compared to placebo.

Promacta Designated Breakthrough Therapy for Severe Aplastic Anemia

Promacta Designated Breakthrough Therapy for Severe Aplastic Anemia

The FDA has granted Breakthrough Therapy designation for Promacta (eltrombopag; GlaxoSmithKline) for the treatment of cytopenias in patients with severe aplastic anemia (SAA) who have had insufficient response to immunosuppressive therapy.

Avanir Submits AVP-825 NDA for Migraines

Avanir Submits AVP-825 NDA for Migraines

Avanir announced that it has submitted a New Drug Application (NDA) to the FDA for AVP-825, an investigational drug-device combination product for the acute treatment of migraines.

FDA Accepts NDA for Budesonide Rectal Foam

FDA Accepts NDA for Budesonide Rectal Foam

The FDA has accepted Salix's New Drug Application (NDA) for filing for Budesonide 2mg Rectal Foam for the induction of remission in patients with active mild to moderate distal ulcerative colitis extending up to 40cm from the anal verge.

Evolocumab Efficacious in Hypercholesterolemia Trial

Evolocumab Efficacious in Hypercholesterolemia Trial

Amgen has announced results from its Phase 3 RUTHERFORD-2 trial evaluating evolocumab in combination with statins and other lipid-lowering therapies in patients with heterozygous familial hypercholesterolemia (HeFH).

Interferon-Free Therapy Demonstrates Efficacy in GT1 HCV Infection Trials

Interferon-Free Therapy Demonstrates Efficacy in GT1 HCV Infection Trials

AbbVie announced results for studies from its Phase 3 clinical program designed to assess oral, interferon-free therapy with or without ribavirin (RBV) in patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection.

Positive Results from Evolocumab Phase 3 Trial

Positive Results from Evolocumab Phase 3 Trial

Amgen announced positive top-line results from its Phase 3 LAPLACE-2 trial of evolocumab (AMG 145) in combination with statin therapy for the treatment of high cholesterol.

Positive Results for Prostate Cancer Treatment with Xtandi

Positive Results for Prostate Cancer Treatment with Xtandi

Medivation and Astellas Pharma announced results from their Phase 3 PREVAIL trial of Xtandi (enzalutamide) in patients with chemotherapy-naive metastatic prostate cancer who have failed androgen deprivation therapy and have few or no symptoms.

FDA to Review MPI-2505 NDA for RA, Psoriasis

FDA to Review MPI-2505 NDA for RA, Psoriasis

Medac Pharma announced that the FDA has accepted for review its New Drug Application (NDA) for its lead product candidate MPI-2505 (methotrexate).

BEMA Buprenorphine Effective for Chronic Pain in Trials

BEMA Buprenorphine Effective for Chronic Pain in Trials

Endo Pharmaceuticals announced positive top-line results from its Phase 3 efficacy study of BEMA Buprenorphine in opioid naïve subjects for the treatment of moderate to severe chronic pain.

ALO-02 Shows Top-Line Results in Phase 3 Trial

ALO-02 Shows Top-Line Results in Phase 3 Trial

Pfizer announced that the investigational agent ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) has met the primary efficacy endpoint, demonstrating a statistically significant difference from placebo in patients with moderate-to-severe chronic low back pain.

Positive Results with Evolocumab for High Cholesterol

Positive Results with Evolocumab for High Cholesterol

Amgen has announced positive top-line results from its GAUSS-2 trial of evolocumab (AMG 145) for the treatment of high cholesterol in patients who cannot tolerate statins.

Soliris Designated Orphan Drug for Prevention of Delayed Graft Function

The FDA has granted Orphan Drug designation to Soliris (eculizumab; Alexion), a first-in-class terminal complement inhibitor for the prevention of delayed graft function (DGF) in renal transplant patients.

FDA to Evaluate Idelalisib for Indolent Non-Hodgkin's Lymphoma

FDA to Evaluate Idelalisib for Indolent Non-Hodgkin's Lymphoma

The FDA has accepted for review Gilead Sciences' New Drug Application (NDA) for idelalisib, a targeted oral inhibitor of PI3K delta, for the treatment of indolent non-Hodgkin's lymphoma (iNHL).

FDA to Review Zorvolex for Osteoarthritis Pain

The FDA has accepted for review the supplemental New Drug Application (sNDA) for Zorvolex (diclofenac; Iroko), a lower dose nonsteroidal anti-inflammatory drug (NSAID) for the treatment of osteoarthritis pain in adults.

Positive Results with ZS-9 for Hyperkalemia

ZS Pharma announced top-line results from its Extended Treatment Phase of ZS003, a Phase 3 trial of ZS-9 for the treatment of hyperkalemia.

CRLX101 Demonstrates Efficacy in Ovarian Cancer Trial

Cerulean Pharma has announced that CRLX101 has met its primary efficacy endpoint in a Phase 2 monotherapy clinical trial in relapsed ovarian cancer.

Daiichi Sankyo Submits Savaysa NDA for Thromboembolic Disorders

Daiichi Sankyo has announced that a New Drug Application (NDA) has been submitted to the FDA for Savaysa (edoxaban) Tablets for the reduction in risk of stroke and systemic embolic events (SEE) in patients with non-valvular atrial fibrillation (NVAF), as well as for the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE) and for the prevention of recurrence of symptomatic venous thromboembolism (VTE).

FDA to Review Natpara BLA for Hypoparathyroidism

The FDA has accepted for review NPS Pharmaceuticals' Biologics License Application (BLA) for Natpara (recombinant human parathyroid hormone 1-84, rhPTH[1-84]) for the treatment of hypoparathyroidism.

DiaVacs Hopes Immunotherapy Drug Will Reverse Type 1 Diabetes

The FDA has granted Orphan Drug designation to DiaVacs' DV-0100 for type 1 diabetes (TD1M).

Thymosin Beta 4 Designated Orphan Drug for Eye Disorder

The FDA has granted RegeneRx's drug candidate, Thymosin beta 4 (Tβ4) Orphan Drug designation for the treatment of Neurotrophic Keratopathy (NK).

Tedizolid Accepted for Priority Review in Acute Skin and Skin Structure Infections

Cubist announced that the FDA has accepted the New Drug Application (NDA) for tedizolid phosphate (TR-701) with Priority Review for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

NDA Submitted for Envarsus in Kidney Transplant Prophylaxis

Veloxis announced the submission of a New Drug Application (NDA) to the FDA for Envarsus (tacrolimus; formerly LCP-Tacro) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

FDA Needs More Data for Lemtrada in MS Trials

Genzyme announced that it has received a Complete Response Letter from the FDA for its supplemental Biologics License Application for Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

Envarsus Designated Orphan Drug for Kidney Transplant Rejection Prophylaxis

The FDA has granted Orphan Drug designation to Envarsus (tacrolimus; Veloxis) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants.

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