Aerucin Awarded Fast Track for HAP/VAP

The Food and Drug Administration (FDA) has granted Fast Track designation to Aerucin (Aridis Pharmaceuticals) for the treatment of hospital-acquired and ventilator-associated pneumonia caused by Pseudomonas aeruginosa.

Investigational MS Tx Reduces Relapse Rate in Trials

Genentech announce positive results from two Phase 3 studies evaluating ocrelizumab compared with Rebif (interferon beta-1a) in patients with relapsing multiple sclerosis (MS).

Eteplirsen NDA Submission Completed for Duchenne Muscular Dystrophy

Sarepta Therapeutics announced that it has completed a rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for eteplirsen.

Emend Efficacious in Preventing Chemotherapy-Induced Nausea and Vomiting

Merck announced results from a Phase 3 study of single-dose Emend (fosaprepitant dimeglumine) for injection in combination with other anti-vomiting medications for the prevention of chemotherapy-induced nausea and vomiting (CINV) in adult cancer patients receiving moderately emetogenic chemotherapy (MEC).

Egg-Free Flu Vaccine Beats Traditional Vaccine, Finds Study

Egg-Free Flu Vaccine Beats Traditional Vaccine, Finds Study

Protein Sciences announced that Flublok Quadrivalent was better at preventing influenza than the traditional influenza vaccine.

FDA to Review NDA for Metastatic Pancreatic Adenocarcinoma Therapy

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for irinotecan liposome injection (MM-398; Merrimack Pharmaceuticals and Baxalta) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Peanut Allergy Patch Gets Closer to FDA Submission

Peanut Allergy Patch Gets Closer to FDA Submission

DBV Technologies announced that based its meeting with the Food and Drug Administration (FDA), it plans to initiate a global Phase 3 study of its investigational Viaskin Peanut epicutaneous immunotherapy (EPIT) patch for the treatment of peanut allergies.

No Virologic Failures With Combo HCV Tx in Study

AbbVie announced results from the Phase 3b TURQUOISE-III study with Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) without ribavirin (RBV) in genotype 1b (GT1b) chronic hepatitis C virus (HCV) infected adult patients with compensated liver cirrhosis.

NDA Submitted for Oral Formulation of OIC Drug Relistor

Valeant Pharmaceuticals and Progenics Pharmaceuticals announced the submission of a New Drug Application (NDA) to the FDA for Oral Relistor (methylnaltrexone bromide) Tablets for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain.

Eliquis Reversal Agent Demonstrates Efficacy in Phase 3 Study

Portola Pharmaceuticals, Bristol-Myers Squibb Company, and Pfizer announced results from the Phase 3 ANNEXA-A (Andexanet Alfa a Novel Antidote to the Anticoagulant Effects of FXa Inhibitors - Apixaban) study with andexanet alfa as a reversal agent for Eliquis (apixaban).

Pradaxa Reversal Agent Works Within Minutes in Phase 3 Study

Pradaxa Reversal Agent Works Within Minutes in Phase 3 Study

Boehringer Ingelheim announced results from an interim analysis of the Phase 3 RE-VERSE AS patient study with idarucizumab for urgent reversal of the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).

ImMucin Designated Orphan Drug for Multiple Myeloma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to ImMucin (Vaxil Bio) for the treatment of multiple myeloma.

Encenicline Granted Fast Track Status for Cognitive Impairment in Schizophrenia

The Food and Drug Administration (FDA) has granted Fast Track designation to encenicline (Forum Pharmaceuticals) for the treatment of cognitive impairment in schizophrenia.

Peanut Allergy Drug Designated Breakthrough Therapy

Peanut Allergy Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AR101, an oral immunotherapy for children and adolescents 4 to 17 years of age who are allergic to peanuts.

New Drug Class for Migraine Prevention Could Be Coming

New Drug Class for Migraine Prevention Could Be Coming

Clinical trials of a new drug class for preventing high-frequency episodic migraine and chronic migraine have shown promising results, according to several studies presented at the American Headache Society's annual Scientific Meeting.

Top-Line Results for Plecanatide in Chronic Idiopathic Constipation Trial

Synergy Pharmaceuticals announced positive results from the first of two Phase 3 clinical trials evaluating the efficacy and safety of plecanatide 3mg and 6mg treatment doses in patients with chronic idiopathic constipation (CIC).

Gedeptin Granted Orphan Drug Status for Oral and Pharyngeal Cancers

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Gedeptin (adenoviral vector expressing E. coli purine nucleoside phosphorylase gene; PNP Therapeutics) for the intratumoral treatment of anatomically accessible oral and pharyngeal cancers.

Chiasma Submits Octreotide NDA for Acromegaly

Chiasma announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for octreotide capsules for the maintenance treatment of adults with acromegaly.

Ischemic Chronic Heart Failure Drug Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to JVS-100 (Juventas Therapeutics) for the treatment of advanced ischemic chronic heart failure.

Orphan Drug Status Granted to Immune Thrombocytopenia Therapy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to PRTX-100 (Protalex) for the treatment of immune thrombocytopenia (ITP).

Investigational Device Could Deliver Up to a Full Year of GLP-1 Therapy

Investigational Device Could Deliver Up to a Full Year of GLP-1 Therapy

Intarcia Therapeutics announced results from two Phase 3 trials of its investigational drug candidate ITCA 650 (continuous exenatide delivery via subcutaneous osmotic min-pump) at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston, MA.

Short Bowel Syndrome Therapy Designated Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to NTRA-9620 (Nutrinia), an orally-administered drug for treating short bowel syndrome (SBS).

Investigational Peanut Allergy Tx Improves Tolerance in Younger Patients

Investigational Peanut Allergy Tx Improves Tolerance in Younger Patients

Aimmune Therapeutics announced that the Phase 2 study of a novel investigational oral immunotherapy (AR101) for the treatment of peanut allergy met its primary endpoint of tolerating a cumulative amount of peanut protein of at least 443mg.

Study: No Increased CV Risk With Lixisenatide for Diabetes

Study: No Increased CV Risk With Lixisenatide for Diabetes

Sanofi announced the full results of the first event-driven cardiovascular (CV) outcomes study on the safety of lixisenatide in patients with type 2 diabetes and high CV risk at the 75th American Diabetes Association (ADA) Scientific Sessions in Boston, MA.

Canagliflozin + Metformin XR Superior to Either Alone in Study

Janssen R&D announced results from a Phase 3 study on the use of initial combination therapy of canagliflozin and metformin extended-release (XR) in type 2 diabetes patients with higher A1C levels and who treat their type 2 diabetes with diet and exercise only.

Vaccine for Type 1 Diabetes Reversal to Be Studied in Clinical Trial

Vaccine for Type 1 Diabetes Reversal to Be Studied in Clinical Trial

The Food and Drug Administration (FDA) has granted approval to the initiation of a Phase 2 clinical trial evaluating the use of generic vaccine bacillus Calmette-Guerin (BCG) to reverse advanced type 1 diabetes .

Novel Enzyme Designated Breakthrough Therapy for Niemann-Pick Disease

Genzyme announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for olipudase alfa, an enzyme replacement therapy being studied for the treatment of patients with non-neurological manifestations of acid sphingomyelinase deficiency (ASMD).

Novel Agent AMG 416 Effective in Secondary Hyperparathyroidism Trials

Novel Agent AMG 416 Effective in Secondary Hyperparathyroidism Trials

Amgen announced pooled data from two Phase 3 trials evaluating AMG 416 for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD) receiving hemodialysis.

NDA Submitted for Combination Chronic Hepatitis C Therapy

Merck has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for grazoprevir/elbasvir 100mg/50mg for the treatment of adults with chronic hepatitis C genotypes 1, 4, or 6 infection

Coagadex Amended BLA Under Review for Rare Bleeding Disorder

The Food and Drug Administration (FDA) has accepted for review the amended Biologics License Application (BLA) for Coagadex (coagulation factor X, human) for hereditary X deficiency.

Results Announced From Phase 3 Trial of Combo COPD Therapy

Novartis announced results from its Phase 3 EXPEDITION trial for indacaterol/glycopyrronium (QVA149) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

Orphan Drug Status Granted to Ovarian Cancer Therapy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CRLX101 (Cerulean Pharma) for the treatment of ovarian cancer.

Combination COPD Therapy Improves Lung Function in Trials

Boehringer Ingelheim announced new data analyses from the Phase 3 TONADO 1&2 studies of tiotropium/olodaterol delivered via Respimat inhaler for chronic obstructive pulmonary disease (COPD).

Sarilumab Improves Physical Function in Rheumatoid Arthritis Trial

Regeneron and Sanofi announced results from their Phase 3 SARIL-RA-TARGET trial of sarilumab in patients with rheumatoid arthritis (RA).

Optina Efficacious in Diabetic Macular Edema Study

Ampio Pharmaceuticals announced positive results from the OptimEyes Trial for Optina in patients with diabetic macular edema (DME).

Dyanavel XR NDA Accepted for FDA Review

Tris Pharma announced that the Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) for Dyanavel XR (amphetamine) CII, an Extended-Release Oral Suspension.

Rare Neurologic Disorder Therapy Designated Orphan Drug

Rare Neurologic Disorder Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to revusiran (Alnylam) for the treatment of transthyretin (TTR)-mediated amyloidosis (ATTR amyloidosis).

Investigational HCV Tx Receives Amended Breakthrough Designation

Investigational HCV Tx Receives Amended Breakthrough Designation

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.

Progression-Free Survival Seen With Enzalutamide for Prostate Cancer in Phase 2 Trial

Astellas Pharma and Medivation announced data from the Phase 2 STRIVE trial comparing Xtandi (enzalutamide) and bicalutamide in non-metastatic (M0) and metastatic (M1) prostate cancer patients whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy of following surgical castration.

Solifenacin + Mirabegron Shows Superiority in Incontinent Overactive Bladder Trial

Astellas Pharma announced results from the Phase 3b BESIDE trial with solifenacin (SOLI) with mirabegron (MIRA) as an add-on therapy in incontinent overactive bladder (OAB) patients.

Luspatercept Fast Tracked for Two Beta-Thalassemia Indications

The Food and Drug Administration (FDA) has granted Fast Track designations to luspatercept (Celgene and Acceleron) for use in two separate indications: for the treatment of patients with transfusion dependent beta-thalassemia and for the treatment of patients with non-transfusion dependent beta-thalassemia.

Humira Designated Orphan Drug for Painful, Inflammatory Skin Disease

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for Humira (adalimumab) as an investigational treatment for moderate-to-severe hidradenitis suppurativa (HS; Hurley Stage II and III disease).

FDA Panel Backs Approval of CF Drug Orkambi

Vertex announced that the Food and Drug Administration's (FDA) Pulmonary-Allergy Drugs Advisory Committee (PADAC) has voted 12 to 1 to recommend that the FDA approve Orkambi (lumacaftor/ivacaftor) for people with cystic fibrosis (CF) aged 12 and older who have two copies of the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Evofosfamide Fast Tracked for Advanced Pancreatic Cancer

The Food and Drug Administration (FDA) has granted Fast Track status to evofosfamide (Merck KGaA) in combination with gemcitabine, for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.

Antifungal Therapy Fast Tracked, Granted QDIP Status by FDA

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) with Fast Track status to CD101 IV (Cidara Therapeutics) for the treatment of candidemia and invasive candidiasis.

Humira for Panuveitis Reduces Vision Loss in Latest Phase 3 Trial

AbbVie announced results from its Phase 3 study VISUAL-1 investigating the efficacy and safety of Humira (adalimumab) in adults with active non-infectious intermediate, posterior, or panuveitis who still experienced intraocular inflammation while on systemic corticosteroid therapy.

Rare Neurologic Disorder Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to its investigational therapy RE-024 (phosphopantothenate replacement therapy; Retrophin), for the treatment of pantothenate kinase-associated neurodegeneration (PKAN).

Venetoclax Desginated Breakthrough Therapy for CLL

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to venetoclax (AbbVie ) for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

Opdivo sBLA Under Priority Review for New Melanoma Indication

The Food and Drug Administration (FDA) has accepted for filing and has granted Priority Review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for the treatment of previously untreated patients with unresectable or metastatic melanoma.

New Brilinta Indication Accepted for Priority Review

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor; AstraZeneca) tablets for patients with a history of heart attack.

New Tx for Relapsing MS Moves Closer to Approval as FDA Accepts BLA for Review

The Food and Drug Administration (FDA) has accepted their Biologics License Application (BLA) for review for Zinbryta (daclizumab high-yield process; Biogen and AbbVie) in relapsing forms of multiple sclerosis (MS).

Rare Lysosomal Disorder Therapy Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation for the development of GZ/SAR402671 (Genzyme), an oral substrate reduction therapy for the treatment of Fabry disease.

CRLX101 Fast Tracked for Metastatic Renal Cell Carcinoma

The Food and Drug Administration (FDA) has granted Fast Track designation to CRLX101 (Cerulean Pharma) in combination with Avastin (bevacizumab) for the treatment of metastatic renal cell carcinoma (mRCC) following progression through two or three prior lines of therapy.

Investigational Shingles Vaccine Effective Across Older Age Groups

Investigational Shingles Vaccine Effective Across Older Age Groups

GlaxoSmithKline announced results from the Phase 3 ZOE-50 trial of HZ/su, an investigational vaccine for the prevention of herpes zoster in older adults.

Viekirax + Exviera Demonstrates Virologic Response in HCV Trial

Enanta announced results from AbbVie's ongoing, Phase 3b RUBY-1 study evaluating Viekirax (ombitasvir/paritaprevir/ritonavir) plus Exviera (dasabuvir) with or without ribavirin (RBV) in treatment naïve, non-cirrhotic, genotype 1 (GT1) chronic hepatitis C patients with severe renal impairment (stage 4 or 5), including those on hemodialysis.

SVR12 With Combo Hepatitis C Therapy for Cirrhosis Patients in Study

Bristol-Myers Squibb announced results from the ALLY-1 Phase 3 clinical trial evaluating a 12-week regimen of daclatasvir and sofosbuvir once-daily with ribavirin for the treatment of patients with chronic hepatitis C virus (HCV) infection with either advanced cirrhosis or post-liver transplant recurrence of HCV.

Rare Facial Disorder Drug Designated Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma), a physiocrine-based product for the treatment of facioscapulohumeral muscular dystrophy (FSHD).

Rare Inherited Liver Disorder Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DCR-PH1 for the treatment of primary hyperoxaluria type 1 (PH1).

Priority Status Granted for Combination Genotype 4 HCV Therapy

The Food and Drug Administration (FDA) has accepted AbbVie's NDA and granted priority review to its all-oral, interferon-free, two direct-acting antiviral treatment of ombitasvir, paritaprevir, ritonavir (OBV/PTV/R) with ribavirin (RBV) for the treatment of adults with GT4 hepatitis C virus (HCV) infection.

Single Dalvance Dose As Effective for ABSSSI in Phase 3 Trial

Actavis announced results for its Phase 3 DUR001-303 study of single dose Dalvance for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin resistant Staphylococcus aureus (MRSA).

Priority Review Granted for Pradaxa Reversal Agent

Priority Review Granted for Pradaxa Reversal Agent

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for idarucizumab (Boehringer Ingelheim) to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate) in patients needing emergency intervention or experiencing an uncontrolled or life-threatening bleeding event.

FDA Designates Cantrixil Orphan Drug for Ovarian Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Cantrixil (TRXE-002; CanTx Inc.) for ovarian cancer.

Investigational Malignant Melanoma Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to SRX-1177 (SolaranRx) for the treatment of stage IIB to IV malignant melanoma.

Xalkori Granted Breakthrough Therapy Designation By FDA

The Food and Drug Administration (FDA) granted Breakthrough Therapy designation to Xalkori (crizotinib; Pfizer) for the treatment of patients with ROS1-positive non-small cell lung cancer (NSCLC).

Lonafarnib Fast Tracked for Hepatitis Delta Virus Infection

The FDA has granted Fast Track designation to lonafarnib (Eiger BioPharmaceuticals) in combination with ritonavir for treatment of hepatitis delta virus (HDV) infection.

FDA Agrees to Review Adcetris for Post-Transplant Consolidation Therapy

The FDA has accepted for filing the supplemental Biologics License Application (sBLA) for Adcetris (brentuximab vedotin; Seattle Genetics) in the AETHERA setting for the post-transplant consolidation treatment of Hodgkin lymphoma (HL) patients at high risk of relapse or progression.

sBLA Submitted for Additional Keytruda Indication

Merck announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA for Keytruda (pembrolizumab) for the treatment of advanced non-small cell lung cancer (NSCLC).

Biotin for Progressive Multiple Sclerosis: New Phase 3 Trial Data

MedDay announced results from its Phase 3 MS-SPI clinical trial with MD1003, a highly concentrated pharmaceutical-grade biotin for the treatment of progressive multiple sclerosis.

Results Halt Opdivo NSCLC Trial Early

Bristol Myers Squibb announced results from its Phase 3 CheckMate-057 study of Opdivo (nivolumab) vs. docetaxel in previously treated patients with advanced non-squamous cell lung cancer (NSCLC).

Samcyprone Designated Orphan Drug for Malignant Melanoma

The FDA has granted Orphan Drug designation to Samcyprone (diphenylcylcopropenone, DPCP; RXi Pharmaceuticals) for the treatment of malignant melanoma Stage IIb to IV.

Gencaro Fast Tracked for A-fib in Genetically Modified Heart Failure

The FDA has granted Fast Track designation to Gencaro (bucindolol HCl) for the prevention of atrial fibrillation/atrial flutter in a genetically modified heart failure population (heart failure patients with reduced left ventricular ejection fraction, [HFREF]).

Investigational RSV Therapy Granted Fast Track Status

MedImmune announced that the FDA has granted Fast Track designation to MEDI8897 for the prevention of lower respiratory tract illness (LRTI) caused by respiratory syncytial virus (RSV) in infants and young children.

Grazoprevir/Elbasvir Designated Breakthrough Therapy for Chronic Hepatitis C

The FDA has granted Breakthrough Therapy designation to grazoprevir/elbasvir (Merck) for the treatment of patients with chronic hepatitis C virus (HCV) genotype 4 (GT4) infection, and for the treatment of chronic HCV genotype 1 (GT1) infection in patients with end stage renal disease on hemodialysis.

Fixed-Dose Combo HIV Drug Under FDA Review

Gilead Sciences announced that it has submitted a New Drug Application (NDA) to the FDA for two doses of the fixed-dose combination of emtricitabine and tenofovir alafenamide (F/TAF) for the treatment of HIV-1 infections in patients ≥12 years old, in combination with other HIV antiretroviral agents.

Lifitegrast for Dry Eye Disease Under FDA Review

The FDA has accepted for filing and granted Priority Review designation to the New Drug Application (NDA) for lifitegrast (Shire) for the treatment of signs and symptoms of dry eye disease in adults.

Ovarian Cancer Therapy Granted Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation to rucaparib (Clovis Oncology) as monotherapy treatment of advanced ovarian cancer in patients who have received at least two lines of prior platinum-containing therapy, with BRCA-mutated tumors, inclusive of both germline BRCA (gBRCA) and somatic BRCA (sBRCA) mutations.

FDA Accepts sNDA for New Pradaxa Indication

Boehringer Ingelheim announced that the FDA has accepted for filing the supplemental New Drug Application (sNDA) for Pradaxa (dabigatran etexilate mesylate) for the prophylaxis of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have had primary elective total hip replacement surgery.

Progression-Free Survival With Encalutamide for Prostate Cancer: New Trial Results

Astellas Pharma and Medivation announced topline results from the Phase 2 STRIVE trial comparing enzalutamide with bicalutamide in men with non-metastatic or metastatic castration-resistant prostate cancer.

Anticogulant Reversal Agent Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to PER977 (Perosphere), an anticoagulant reversal agent.

FDA to Review Kyprolis for Relapsed Multiple Myeloma

The Food and Drug Administration (FDA) has accepted for priority review the supplemental New Drug Application (sNDA) of Kyprolis (carfilzomib; Amgen) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

Three-Month Paliperidone Palmitate to Delay Relapse in Schizophrenia: Phase 3 Data Published

Janssen R&D announced that results from a Phase 3 clinical study with three-month paliperidone palmitate have been published in JAMA Psychiatry.

Orphan Drug Status Granted to Mesothelioma Therapy

Aduro Biotech announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to CRS-207 for the treatment of mesothelioma.

Ebola Vaccine Based on Current Strain Provokes Immune Response in First Phase 1 Trial

Ebola Vaccine Based on Current Strain Provokes Immune Response in First Phase 1 Trial

Researchers have published results from the first Phase 1 trial of an Ebola vaccine developed based on the 2014 Zaire Guinea Ebola strain in The Lancet.

Non-Alcohol Formula of Docetaxel Injection Submitted for FDA Review

Teikoku Pharma USA announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Docetaxel Injection Concentrate, Non-Alcohol Formula for the treatment of breast cancer, non-small cell lung cancer (NSCLC), prostate cancer, gastric adenocarcinoma, and head and neck cancer.

Keytruda Results May Halt Melanoma Trial Early

Merck announced results from the Phase 3 KEYNOTE-006 study investigating Keytruda (pembrolizumab) vs. ipilimumab in the first-line treatment of patients with advanced melanoma.

FDA Lifts Clinical Hold, Tanezumab Trial to be Resumed

Pfizer and Eli Lilly and Company announced that they are preparing to resume the Phase 3 clinical pain program for tanezumab.

New Data Shows Tofacitinib Effective for Plaque Psoriasis

Pfizer announced results from two Phase 3 studies from the Oral treatment Psoriasis Trials (OPT) program for tofacitinib citrate in adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

Long-Term Efficacy Data for Otezla in Plaque Psoriasis Announced

Celgene announced results from the ESTEEM Phase 3 clinical program for Otezla (apremilast) in patients with moderate to severe plaque psoriasis.

Combo Acne Drug Reduces Lesion Count in Trial

Galderma announced positive Phase 3 results for adapalene 0.3%/benzoyl peroxide 2.5% (0.3% A/BPO) topical gel.

Orphan Status Granted to Investigational Pulmonary Arterial Hypertension Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to tacrolimus (SPI-026; Selten Pharma) for the treatment of pulmonary arterial hypertension.

Imbruvica Significantly Delays Disease Progression in CLL/SLL Study

Results have been announced from a pre-planned interim analysis of the Phase 3 HELIOS (CLL3001) trial studying the combination of Imbruvica (ibrutinib; Pharmacyclics and Janssen Biotech) plus bendamustine and rituximab (BR) vs. placebo plus BR in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

Novel Anti-Clotting Therapy Trial Permanently Halted Due to AEs

Regado BioSciences announced the permanent hold of the Phase 3 REGULATE-PCI trial in August 2014, which compared Revolixys Kit (pegnivacogin/anivamersen; REG1 Anticoagulation System) to bivalirudin in patients undergoing percutaneous coronary intervention (PCI).

New Data on Novel Investigational Cholesterol Drug, CV Events

New Data on Novel Investigational Cholesterol Drug, CV Events

Amgen announced one-year results from prespecified exploratory endpoints of adjudicated cardiovascular events in the Phase 2 (OSLER-1) and Phase 3 (OSLER-2) open-label extension studies of Repatha (evolocumab) for the treatment of high cholesterol.

BAX 817 for Hemophilia A/B: New Results from Phase 3 Trial

BAX 817 for Hemophilia A/B: New Results from Phase 3 Trial

Baxter announced positive results from a Phase 3 trial evaluating BAX 817 for the treatment of patients with hemophilia A or B who develop inhibitors.

Combo Hepatitis C Genotype 3 Tx To Be Reviewed By FDA

Bristol-Myers Squibb announced that the FDA has accepted for review the resubmitted New Drug Application (NDA) of daclatasvir in combination with sofosbuvir for the treatment of chronic hepatitis C (HCV) genotype 3.

Unituxin Approval Leads to Rare Priority Review Voucher Award

The Food and Drug Administration (FDA) has granted a Rare Pediatric Priority Review Voucher (PPRV) as part of the Biologics License Application (BLA) approval for Unituxin (dinutuximab) for neuroblastoma.

Potential Drug for Post-Cataract Surgery Inflammation and Pain Demonstrates Efficacy

Ocular Therapeutix announced positive topline data from the first of two Phase 3 clinical trials evaluating the safety and efficacy of OTX-DP (Sustained Release Dexamethasone), for the treatment of ocular inflammation and pain following cataract surgery.

New Hemophilia A Treatment Option to Get FDA Review

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for Kovaltry (BAY 81-8973), a recombinant Factor VIII compound for the treatment of hemophilia A in children and adults.

Melanoma Treatment Under Review for Preventing, Delaying Recurrence

The Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Yervoy (ipilimumab; Bristol-Myers Squibb) for the adjuvant treatment of patients with stage 3 melanoma who are at high risk of recurrence following complete surgical resection.

FDA to Review Investigational Parkinson's Disease Drug Xadago

The FDA has accepted for filing the New Drug Application (NDA) for Xadago (safinamide; Newron and Zambon) as add-on therapy in both early and mid-to-late stage Parkinson's disease (PD) patients who are inadequately managed on their current treatment.

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