Nosocomial Pneumonia Agent Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track status to MedImmune's investigational monoclonal antibody (mAb), MEDI3902 for the prevention of nosocomial pneumonia caused by Pseudomonas aeruginosa.

Olaptesed Pegol Designated Orphan Drug for Glioblastoma

The FDA has granted Orphan Drug designation to olaptesed pegol (NOX-A12; NOXXON Pharma) for the treatment of glioblastoma in conjunction with radiotherapy.

Rayaldee Efficacious in Secondary Hyperparathyroidism Trial

OPKO Health announced top-line results from the final Phase 3 trial of Rayaldee for the treatment of secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Blinatumomab BLA Submitted for Acute Lymphoblastic Leukemia

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for blinatumomab for the treatment of Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Lymphoseek Gains Orphan Drug Designation for Head, Neck Cancer Detection

Navidea announced that the Food and Drug Administration (FDA) has granted Lymphoseek (technetium Tc 99m tilmanocept) injection an Orphan Drug Designation for use in sentinel lymph node detection in patients with head and neck cancer.

Xultophy Shows Improved Glycemic Control, Weight Loss in T2DM

Novo Nordisk announced new data from the Phase 3a DUAL clinical trial comparing Xultophy (insulin degludec and liraglutide [IDegLira]) to insulin degludec (Tresiba) and liraglutide (Victoza) alone in insulin-naive and insulin-treated patients.

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

Head, Neck Cancer Cancer Drug May Overcome Cetuximab Resistance

The investigational drug alpelisib (previously known as BYL719) appears to inhibit activation of the pathway that leads to resistance to cetuximab, an anti-epidermal growth factor receptor agent used in the treatment of head and neck cancer.

Cyramza + Paclitaxel Demonstrates Efficacy in Cancer Trial

Eli Lilly and Company announced results from a global Phase 3 study with Cyramza (ramucirumab) in combination with paclitaxel for patients with advanced gastric cancer or gastroesophageal junction (GEJ) adenocarcinoma.

Omarigliptin Significantly Lowers HbA1c Levels in Trial

Merck announced results from the Phase 3 clinical program for omarigliptin, once-weekly DPP-4 inhibitor for the treatment of type 2 diabetes.

Eylea Granted Breakthrough Therapy for Diabetic Retinopathy

The Food and Drug Administration (FDA) has granted Eylea (afilbercept; Regeneron) Injection Breakthrough Therapy designation for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

Lynovex Designated Orphan Drug for Cystic Fibrosis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Lynovex (NM001; NovaBiotics) for the treatment of cystic fibrosis (CF).

Odanacatib Reduces Fracture Risk in Postmenopausal Women

Merck announced results from the Phase 3 LOFT study with odanacatib in postmenopausal women with osteoporosis.

FDA to Review Tuzistra XR NDA for Cough Cold

The Food and Drug Administration (FDA) has accepted a New Drug Application (NDA) for review for Tuzistra XR (CCP-01; Vernalis and Tris Pharma) in the acute treatment of cough cold.

Vyvanse Under Review for Binge Eating Disorder

The Food and Drug Administration (FDA) has accepted for filing Shire's supplemental New Drug Application (sNDA) with priority review for Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) for the treatment of adults with binge eating disorder (BED).

Results for Humira in Chronic Skin Disease Trial

AbbVie announced results from the Phase 3 PIONEER 1 study with Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

FDA Designates Antifungal Agent Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1129 (Viamet Pharmaceuticals), a selective oral antifungal agent, for the treatment of cryptococcal meningitis.

Rolapitant NDA Submitted for Chemotherapy-Induced Nausea and Vomiting

Tesaro has submitted a New Drug Application (NDA) to the FDA for approval of oral rolapitant for the prevention of chemotherapy-induced nausea and vomiting (CINV).

Nintedanib Efficacious in Idiopathic Pulmonary Fibrosis Trials

Boehringer Ingelheim announced results from a pre-specified, pooled subgroup sensitivity analysis from the Phase 3 INPULSIS-1 and INPULSIS-2 trials that evaluated the use of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) based on the severity of lung function impairment at baseline.

Tiotropium Improves Lung Function in Asthma Patients

Boehringer Ingelheim announced results from its Phase 3 UniTinA-asthma trial program evaluating tiotropium in adults, adolescents, and pediatric patients with different severities of asthma.

Isavuconazole Under Review for Invasive Fungal Infections

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole (Astellas) for the treatment of invasive aspergillosis and invasive mucormycosis.

Positive Results for Reslizumab in Asthma Trials

Teva announced positive results from its Phase 3 studies of reslizumab in patients with uncontrolled moderate to severe asthma with elevated eosinophils, treated with standard of care therapies.

Basal Insulin Peglispro Efficacious in Type 1 Diabetes Trials

Basal Insulin Peglispro Efficacious in Type 1 Diabetes Trials

Eli Lilly and Company announced results from its IMAGINE-1 and IMAGINE-3 Phase 3 trials with basal insulin peglispro (BIL) in patients with type 1 diabetes.

FDA Fast Tracks Pulmaquin for Chronic Lung Infections

The Food and Drug Administration (FDA) has granted Fast Track status to Pulmaquin for the treatment of non-cystic fibrosis bronchiectasis (non-CF BE) patients who develop chronic lung infections with Pseudomonas aeruginosa.

Relebactam Designated Qualified Infectious Disease Product Status for Complicated Infections

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product with designated Fast Track status to relebactam (MK-7655; Merck) for intravenous use, in the treatment complicated urinary tract infections, complicated intra-abdominal infections, and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Eravacycline Efficacious in Complicated Urinary Tract Infections Study

Tetraphase announced positive results from the lead-in portion of its IGNITE 2 clinical trial with IV and oral formulations of eravacycline for the treatment of complicated urinary tract infections (cUTI).

Eliquis Effective in Reducing All-Cause Hospitalization in Phase 3 Trial

Bristol-Myers Squibb and Pfizer announced results from the pre-specified secondary analysis of the Phase 3 AMPLIFY-EXT trial with Eliquis (apixaban).

Somatuline Depot sNDA Under Review for Gastoenteropancreatic Neuroendocrine Tumors

The Food and Drug Administration (FDA) has accepted and granted Priority Review to Ipsen's sNDA for Somatuline Depot (lanreotide acetate) 120mg injection for the treatment of gastoenteropancreatic neuroendocrine tumors (GEP-NETs).

Myelofibrosis Drug Granted Orphan Drug Status

The Food and Drug Admnistration (FDA) has granted Orphan Drug designation for PRM-151 (Promedior) for the treatment of myelofibrosis.

Nuplazid Designated Breakthrough Therapy for Parkinson's Disease Psychosis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Nuplazid (pimavanserin; Acadia Pharmaceuticals) for the treatment of Parkinson's disease psychosis.

Alirocumab Demonstrates Efficacy in Four Phase 3 Trials

Sanofi and Regeneron announced positive results from four Phase 3 ODYSSEY trials of alirocumab in patients with hypercholesterolemia.

FDA Grants Qualified Infectious Disease Product Status to Two Anti-Infectives

The Food and Drug Administration (FDA) has granted Wockhardt Limited's investigational anti-infectives, WCK 771 and WCK 2349 Qualified Infectious Disease Product (QDIP) status.

Updated Phase 3 Efficacy Results for Ampio

Ampio announced an update to the Phase 3 multicenter, double-blind STEP study of Ampion for osteoarthritis (OA) of the knee.

APD811 Designated Orphan Drug for Pulmonary Arterial Hypertension

The Food and Drug Administration (FDA) has granted Orphan Drug designation to APD811 (Arena Pharmaceuticals) for the treatment of pulmonary arterial hypertension (PAH).

Combination Ovarian Cancer Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to motolimod (VTX-2337; VentiRx) in combination with pegylated liposomal doxorubicin (PLD) for the treatment of women with ovarian cancer whose disease has progressed on or recurred after platinum-based chemotherapy.

BLA for Novel Cholesterol Drug Submitted to FDA

BLA for Novel Cholesterol Drug Submitted to FDA

Amgen announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for evolocumab for the treatment of high cholesterol.

FDA Fast Tracks Clostridium Difficile Vaccine

The Food and Drug Administration (FDA) has granted Fast Track status for Pfizer's investigational Clostridium difficile (C. difficile) vaccine candidate (PF-06425090).

First Treatment for Common Anemia Shows Promise

A recent study has demonstrated potential for lexaptepid pegol as the first treatment for anemia of inflammation, the most common form of anemia.

Chronic Heart Failure Drug Designated Priority Review Status

Chronic Heart Failure Drug Designated Priority Review Status

The Food and Drug Administration (FDA) has granted Priority Review to Amgen's New Drug Application (NDA) for ivabradine for the treatment of chronic heart failure.

Aripiprazole Lauroxil NDA Submitted for Schizophrenia

Alkermes announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for aripiprazole lauroxil for the treatment of schizophrenia.

Ixekizumab vs. Etanercept for Plaque Psoriasis: Phase 3 Results Announced

Eli Lilly and Company announced results from its Phase 3 UNCOVER studies of ixekizumab for the treatment of moderate-to-severe plaque psoriasis, in which ixekizumab was found to be superior to etanercept.

Investigational Hemophilia A Therapy Sees Positive Results

Investigational Hemophilia A Therapy Sees Positive Results

Baxter announced positive results from its Phase 3 trial of BAX 855, an extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A.

Xiaflex Demonstrates Efficacy in Cellulite Study

Auxilium announced positive results from a Phase 2a study of Xiaflex (collagenase clostridium histolyticum [CCH]) for the treatment of edematous fibrosclerotic panniculopathy (EEP), also known as cellulite.

Positive Results for AMG 416 in Secondary Hyperparathyroidism Trial

Amgen announced results from its Phase 3 study evaluating AMG 416 for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD) receiving hemodialysis.

Combination Antibiotic Effective for Complicated Intra-Abdominal Infections

Actavis announced positive topline results from its Phase 3 studies, RECLAIM-1 and -2, evaluating the use of ceftazidime-avibactam for the treatment of hospitalized adults with complicated intra-abdominal infections (cIAI).

Palbociclib NDA Submitted for Advanced Breast Cancer

Palbociclib NDA Submitted for Advanced Breast Cancer

Pfizer announced that it has submitted an NDA to the FDA for palbociclib in combination with letrozole for the treatment of postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for the advanced disease.

Investigational Meningococcal B Vaccine BLA Under Review

The FDA has accepted for review Pfizer's Biologics License Application (BLA) for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in 10-25 year olds.

Rifaximin Efficacious in Irritable Bowel Syndrome with Diarrhea Trial

Salix announced top-line results from its Phase 3 TARGET 3 clinical trial evaluating rifaximin 500mg in patients with irritable bowel syndrome with diarrhea (IBS-D), who respond to an initial treatment course with rifaximin 500mg.

Mocetinostat Designated Orphan Drug for Diffuse Large B-Cell Lymphoma

The FDA has granted Orphan Drug designation to mocetinostat (Mirati Therapeutics) for diffuse large B-cell lymphoma (DLBCL).

Lucentis sBLA Submitted for Diabetic Retinopathy

Genentech has submitted a supplemental Biologics License Application (sBLA) to the FDA for Lucentis (ranibizumab) injection for the treatment of diabetic retinopathy.

BLA Submitted for Investigational IV Anthrax Immune Globulin

Emergent BioSolutions announced that it has submitted a Biologics License Application (BLA) to the FDA for Anthrax Immune Globulin Intravenous (Human) [AIGIV] as an intravenous therapy for inhalation anthrax.

Pacritinib Designated Fast Track for Myelofibrosis

The FDA has granted Fast Track designation to pacritinib (CTI BioPharma) for the treatment of intermediate and high risk myelofibrosis.

Jakafi sNDA Accepted for Polycythemia Vera

The FDA has accepted for filing the supplemental New Drug Application (sNDA) for Jakafi (ruxolitinib) for the treatment of polycythemia vera in patients who have inadequate response to or intolerant of hydroxyurea.

Inhaled Pirfenidone Designated Orphan Drug for IPF

The FDA has granted Orphan Drug designation to pirfenidone (inhaled GP-101) for the treatment of idiopathic pulmonary fibrosis (IPF).

Glioblastoma Multiforme Therapy Designated Orphan Drug

The FDA has granted Orphan Drug designation to AbbVie's ABT-414 for patients with glioblastoma multiforme.

Alirocumab Meets Primary Endpoint in Hypercholesterolemia Trials

Results announced from nine new Phase 3 ODYSSEY trials of alirocumab (Sanofi and Regeneron) in patients with hypercholesterolemia.

FDA Issues Complete Response Letter for Zalviso

The FDA has issued a Complete Response Letter (CRL) for AcelRx's NDA for Zalviso (sufentanil sublingual tablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.

FDA Designates Orphan Drug for Rare Degenerative Eye Disease

The FDA has designated Recombinant Human Nerve Growth Factor (rhNGF; Dompe) Orphan Drug status for the treatment of neurotrophic keratitis.

Neratinib Demonstrates Potential in Breast Cancer Trial

Puma Biotechnology announced results from its Phase 3 ExteNET trial of neratinib (PB272) for the extended adjuvant treatment of breast cancer.

FDA Accepts sBLA, Grants Priority Review for Avastin in Ovarian Cancer

The FDA grants Genentech's sBLA for Avastin (bevacizumab) plus chemotherapy Priority Review for the treatment of women with recurrent platinum-resistant ovarian cancer.

Status Epilepticus Therapy Granted Fast Track Status

The FDA has designated Fast Track status to SAGE-547 (SAGE Therapeutics) for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens.

RG-102 Desginated Orphan Drug for Alport Syndrome

The FDA has granted Orphan Drug designation to RG-012 (Regulus), a single stranded, chemically modified oligonucleotide that binds to and inhibits the function of microRNA-21 for the treatment of Alport syndrome.

Positive Phase 3 Results in Secondary Hyperparathyroidism with AMG 416

Positive Phase 3 results announced for AMG 416 (Amgen) for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease (CKD), receiving hemodialysis.

Eylea Efficacious in Diabetic Macular Edema Trial

Regeneron announced results from its Phase 3 VIVID-DME trial of Eylea (afilbercept) injection for the treatment of diabetic macular edema (DME).

FDA Designates Antifungal Agent QDIP Status

The FDA has designated isavuconazole (Astellas) as a Qualified Infectious Disease Product (QDIP) for the treatment of invasive candidiasis.

Nintedanib Granted Breakthrough Therapy for Idiopathic Pulmonary Fibrosis

The FDA has granted Breakthrough Therapy designation to Boehringer Ingelheim's nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Positive Phase 3 Results for Once Weekly Prophylaxis for Hemophilia B

Pfizer announced positive results of a Phase 3 study comparing BeneFIX Coagulation Factor IX (Recombinant) to on-demand treatment in patients with moderately severe to severe hemophilia B.

Olysio + Sofosbuvir sNDA Designated Priority Review

The FDA has designated Priority Review to the supplemental New Drug Application (sNDA) for Olysio (simeprevir) in combination with sofosbuvir for 12 weeks of treatment in adults with genotype 1 chronic hepatitis C.

FDA Accepts NDA Resubmission for PA32540/PA8140

The FDA has accepted for review Pozen's resubmitted New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.

Priority Review, sBLA Granted for Cervical Cancer Tx

The FDA has accepted Genentech's supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer.

Methylphenidate XR-ODT Effective in Phase 3 ADHD Study

Neos Therapeutics announced the completion of a positive Phase 3 study for its investigational methylphenidate XR-ODT (NT-0102) drug candidate in children with Attention Deficit/Hyperactivity Disorder (ADHD).

Albuterol MDPI NDA Accepted for Review for Bronchospasms

The FDA has accepted for review Teva's New Drug Application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI) for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm (EIB) both in patients ≥12 years of age.

FDA Accepts Investigational Basal Insulin NDA for Review

The FDA has accepted for review the New Drug Application (NDA) for Toujeo (insulin glargine [rDNA origin]; Sanofi) injection, an investigational basal insulin.

NDA Submitted for Brexpiprazole in Schizophrenia, MDD

Otsuka and Lundbeck announced the submission of a New Drug Application (NDA) to the FDA for brexpiprazole for the treatment of schizophrenia and as adjunctive treatment of major depressive disorder (MDD).

sNDA Submitted for Invega Sustenna Label Expansion

Janssen submitted a supplemental New Drug Application (sNDA) to the FDA for a label change to include new data demonstrating significantly delayed time to relapse in patients taking Invega Sustenna (paliperidone palmitate) compared to other selected oral antipsychotics for the treatment of schizophrenia.

Combination Melanoma Therapy Effective in Phase 3 Trial

Genentech announced results from coBRIM, a Phase 3 trial evaluating cobimetinib in combination with Zelboraf (vemurafenib) in previously untreated patients with unresectable locally advanced or metastatic melanoma harboring the BRAFV600 mutation.

Isavuconazole NDA Submitted for Invasive Fungal Infections

Astellas has submitted a New Drug Application (NDA) to the FDA for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis.

Secukinumab Demonstrates Potential in Phase 3 Psoriasis Trials

Novartis announced results from two Phase 3 trials evaluating secukinumab in patients with moderate-to-severe plaque psoriasis.

Positive Results for AuriPro in Pediatric Patients

Otonomy announced positive results from two Phase 3 trials of AuriPro (ciprofloxacin) for intra-operative treatment of middle ear effusion in pediatric patients requiring tympanostomy tube placement surgery.

Low-Volume, Short Infusion Time Tx Designated Orphan Drug for Hematological Cancers

The FDA has granted Orphan Drug designation to bendamustine HCl (Eagle Pharmaceuticals) for the treatment of chronic lymphocytic leukemia (CLL) and indolent B-cell non-Hodgkin's lymphoma (NHL).

NDA Granted Priority Review for Hydrocodone Bitartrate

The FDA has granted Priority Review designation to hydrocodone bitartrate tablets (HYD), an investigational once-daily pain medication.

ENMD-2076 Designated Orphan Drug for Hepatocellular Carcinoma

CASI Pharmaceuticals announced that the FDA has granted Orphan Drug designation to ENMD-2076 for the treatment of hepatocellular carcinoma (HCC).

NDA for Idiopathic Pulmonary Fibrosis Drug Granted Priority Review

The FDA has accepted for filing and granted priority review designation to Boehringer Ingelheim's New Drug Application (NDA) for nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF).

Positive Outcomes for Sebelipase Alfa in Lysosomal Acid Lipase Deficiency Trial

Synageva BioPharma announced that the Phase 3 ARISE trial of sebelipase alfa in patients with lysosomal acid lipase deficiency (LAL Deficiency) met the primary endpoint.

Somatuline Depot sNDA Submitted for GEP-NETs

Ipsen Biopharmaceuticals announced that it has submitted a supplemental New Drug Application (sNDA) to the FDA for Somatuline Depot 120mg injection for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs).

Positive Response with Repeat Rifaximin Treatment in IBS-D

Salix announced results from the Phase 3 TARGET 3 trial evaluating the use of repeat treatment with rifaximin 550mg in patients with irritable bowel syndrome with diarrhea (IBS-D).

Emend Shows Potential in Pediatric Chemotherapy-Induced Nausea, Vomiting

Merck announced results from a Phase 3 Emend (aprepitant) study in the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric cancer patients, aged 6 months to 17 years.

Pradaxa Antidote, Idarucizumab Designated Breakthrough Therapy

The FDA has granted Breakthrough Therapy designation to idarucizumab (Boehringer Ingelheim), an investigational fully humanized antibody fragment (Fab), being evaluated as a specific antidote for Pradaxa (dabigatran etexilate mesylate).

Superior Overall Survival with Nivolumab in Skin Cancer Trial

Bristol-Myers Squibb's Phase 3 study, CheckMate -066 evaluating nivolumab vs. dacarbazine (DTIC) in patients with previously untreated BRAF wild-type advanced melanoma was stopped early due to an analysis demonstrating evidence of superior overall survival in patients receiving nivolumab compared to the control arm.

Combo Cystic Fibrosis Therapy Promising in Trials

Vertex announced results from two Phase 3 studies of lumacaftor in combination with ivacaftor in patients with cystic fibrosis (CF) who have two copies of F508del mutation in the CFTR gene.

FDA Accepts Combination Antibiotic NDA for Priority Review

The FDA has accepted Cubist's NDA for ceftolozane/tazobactam with priority review for the treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI).

Aripiprazole Lauroxil Effective in Schizophrenia Trial

Alkermes announced results from its Phase 3 trial of aripiprazole lauroxil, an investigational drug for the treatment of schizophrenia.

Empagliflozin NDA Resubmitted to FDA

Empagliflozin NDA Resubmitted to FDA

Boehringer Ingelheim and Eli Lilly and Company announced the resubmission of the empagliflozin NDA to the FDA for the treatment of adults with type 2 diabetes.

Results for Perampanel in Tonic-Clonic Seizure Trial

Eisai announced results from a Phase 3 Study 332 trial of perampanel, an AMPA receptor antagonist in patients with primary generalized tonic-clonic (PGTC) seizures.

Mocetinostat Granted Orphan Drug for MDS

The FDA has granted Orphan Drug designation to mocetinostat (Mirati Therapeutics), a selective HDAC inhibitor for the treatment of myelodysplastic syndrome (MDS).

DNX-2401 Granted Fast Track for Recurrent Glioblastoma

The FDA has granted Fast Track status for DNX-2401 (DNAtrix), a replication competent adenovirus for patients with recurrent glioblastoma.

Soliris Designated Orphan Drug for Rare Neurological Disorder

The FDA has granted Orphan Drug designation to Soliris (eculizumab) for the treatment of patients with myasthenia gravis.

Pfizer Submits BLA for Meningococcal B Vaccine

Pfizer announced the submission of a BLA to the FDA for bivalent recombinant LP2086 (rLP2086), a vaccine candidate for the prevention of invasive meningococcal disease caused by Neisseria meningitides serogroup B in 10-25 year olds.

NDA Accepted for Review for Fixed-Dose Combo Hypertension Drug

The FDA has accepted Symplmed's NDA for review for Prestalia, a fixed-dose combination (FDC) of perindopril arginine and amlodipine besylate for the treatment of hypertension.

New Data on Basal Insulin Peglispro Mechanism Released

Eli Lilly and Company released new data regarding the mechanism of action of basal insulin peglispro (BIL) at the 2014 American Diabetes Association Scientific Sessions.

Once-Weekly Dulaglutide Non-Inferior to Once-Daily Liraglutide

At the 2014 American Diabetes Association Scientific Sessions, Eli Lilly and Company presented favorable results from dulaglutide's sixth AWARD trial.

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