Neutrolin Catherter Lock Solution Designated QIDP Status

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to Neutrolin Catheter Lock Solution for oncology, hemodialysis, and intensive care unit patients, where catheter-related blood stream infections and clotting can be life threatening.

Phase 3 Trial of Epilepsy Drug for Cognitive Impairment To Be Initiated

The Alzheimer's Drug Discovery Foundation has awarded a $900,000 grant to AgeneBio to support the initiation of a Phase 3 clinical trial with AGB101 for the treatment of amnestic mild cognitive impairment (aMCI).

Kyprolis sNDA Submitted for Relapsed Multiple Myeloma

Amgen announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Kyprolis (carfilzomib) for Injection for the treatment of patients with relapsed multiple myeloma who have received at least one prior therapy.

Priority Review for Hypercholesterolemia Drug Praluent

The Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for Praluent (alirocumab) for the treatment of hypercholesterolemia.

Three-Month Paliperidone Palmitate NDA Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review for the New Drug Application (NDA) for three-month atypical antipsychotic paliperidone palmitate (Janssen R&D) to treat schizophrenia in adults.

Deflazacort Designated Fast Track Status for Duchenne Muscular Dystrophy

The Food and Drug Administration (FDA) has granted Fast Track designation to deflazacort (Marathon Pharmaceuticals) for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Acute Myeloid Leukemia Therapy Granted Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track status to CPX-351 (cytarabine:daunorubicin; Celator Pharmaceuticals) for the treatment of elderly patients with secondary acute myeloid leukemia (AML).

Phase 2/3 Study Data Announced for Vectibix in Colorectal Cancer

Amgen announced new data from its PEAK and PRIME studies that support Vectibix (panitumumab), in combination with FOLFOX, as first-line therapy in patients with wild-type RAS metastatic colorectal cancer (mCRC)

Treximet sNDA Accepted by FDA for Adolescent Migraine

Treximet sNDA Accepted by FDA for Adolescent Migraine

Pernix announced that the sNDA for Treximet (sumatriptan/naproxen sodium) for use in adolescents aged 12-17 years for the acute treatment of migraine with or without aura has been accepted by the FDA.

Oral HIV Vaccine Undergoing Testing

Oral HIV Vaccine Undergoing Testing

A new oral vaccine to prevent HIV infection that does not contain the HIV virus is currently being tested in clinical trials at the University of Rochester Medical Center.

Sparsentan Gains Orphan Drug Designation for Rare Nephropathy

The Food and Drug Administration (FDA) has granted orphan drug designation for Retrophin's sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS).

Novel Antibiotic Debio 1450 Designated Fast Track Status

Debiopharm announced that the Food and Drug Administration (FDA) has granted Fast Track designation for Debio 1450, an antibiotic for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Positive Results for Elagolix in Endometriosis Study

AbbVie announced positive results from one of two ongoing Phase 3 trials for elagolix in premenopausal women with endometriosis.

Cutaneous T-Cell Lymphoma Tx Designated Fast Track

Soligenix announced that the FDA has granted a Fast Track designation for SGX301 (synthetic hypericin) for the first-line treatment of cutaneous T-cell lymphoma.

Positive Safety, Tolerability Data for ALKS 5461 in MDD Study

Alkermes announced positive results for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD).

Spectrum Submits NDA for Propylene Glycol-Free Melphalan

Spectrum Submits NDA for Propylene Glycol-Free Melphalan

Spectrum announced the submission of an NDA for Captisol-Enabled Melphalan (CE-Melphalan) HCl for injection (propylene glycol-free) for use as high-dose conditioning treatment prior to stem cell transplantation in patients with multiple myeloma, and for the palliative treatment of patients with multiple myeloma for whom oral therapy is not appropriate.

NDA Submitted for Buprenorphine Buccal Film for Pain

Endo and BioDelivery Sciences announced the submission of an NDA for buprenorphine HCl buccal film to the FDA for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Safinamide NDA Resubmitted for Parkinson's Disease

Newron announced the resubmission of its NDA for safinamide to the FDA.

BAX111 BLA Submitted for von Willebrand Disease

BAX111 BLA Submitted for von Willebrand Disease

Baxter announced that it has submitted a biologics license application (BLA) to the Food and Drug Administration (FDA) for BAX111, the first recombinant von Willebrand Factor (rVWF) for patients with von Willebrand disease.

First-in-Class Hepatitis D Tx Granted Orphan Drug Status

Eiger BioPharmaceuticals announced that the Food and Drug Administration (FDA) has granted lonafarnib an Orphan Designation for the treatment of hepatitis delta virus (HDV) infection.

FDA Designates Translara Orphan Drug for Mucopolysaccharidosis I

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Translarna (ataluren) for the treatment of patients with Mucopolysaccharidosis I (MPS I).

Malignant Pleural Mesothelioma Therapy Designated Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to ADI-PEG 20 (pegylated arginine deiminase; Polaris) for the treatment of malignant pleural mesothelioma (MPM).

Eravacycline Demonstrates Non-Inferiority in Intra-Abdominal Infection Trial

Tetraphase Pharmaceuticals announced positive results from Phase 3 IGNITE 1 trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem.

Postherpetic Neuralgia Therapy Efficacious in Phase 3 Study

Pfizer announced top-line results from a Phase 3 study evaluating pregabalin controlled-release (CR) formulation in adult patients with postherpetic neuralgia (PHN).

FDA Issues Complete Response Letter for Yosprala

The Food and Drug Administration (FDA) has issued a second Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Yosprala (aspirin and omeprazole delayed-release tablets) 81/40 and 325/40.

Bayer Submits BLA for Investigational Hemophilia A Drug

Bayer Healthcare has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for BAY 81-8973, a recombinant Factor VIII (rFVIII) compound, for the treatment of hemophilia A in children and adults.

BLA Submitted for Investigational Hemophilia B Therapy

CSL Behring announced that it has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for rIX-FP (Coagulation Factor IX [Recombinant], Albumin Fusion Protein), its long-acting fusion protein linking recombinant coagulation factor IX with recombinant albumin for patients with hemophilia B.

Genentech Submits NDA for Combination Melanoma Therapy

Genentech has submitted a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

New Injection Site under FDA Review for Abilify Maintena

The Food and Drug Administration (FDA) has accepted for review Otsuka and Lundbeck's supplemental New Drug Application (sNDA) for a proposed new injection site, the deltoid muscle of the arm for Abilify Maintena (aripiprazole extended-release injectable suspension).

Improvement in ADHD Symptoms Observed in Dasotraline Trial

Sunovion announced positive results from the first placebo-controlled clinical trial of dasotraline for the treatment of adults with attention deficit hyperactivity disorder (ADHD).

Potential Ebola Hemorrhagic Fever Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Recombinant Nematode Anticoagulation Protein c2 (rNAPc2; ARCA biopharma) as a potential treatment of viral hemorrhagic fever post-exposure to Ebola virus.

Venetoclax Achieves Complete Response in Acute Myelogenous Leukemia Study

AbbVie announced results from a Phase 2 study of venetoclax (ABT-199/GDC-0199) in patients with acute myelogenous leukemia (AML).

NDA Accepted for Filing for Investigational ZipDose Technology

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for the first product using its proprietary ZipDose technology.

Baricitinib Demonstrates Efficacy in Rheumatoid Arthritis

Eli Lilly and Company and Incyte Corp. announced results from the Phase 3 RA-BEACON study of baricitinib in patients with active rheumatoid arthritis (RA).

Four-Year Survival Data Presented for Adcetris in ALCL

Seattle Genetics and Takeda announced long-term overall survival (OS) data or Adcetris (brentuximab vedotin) from a Phase 2 trial in patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL).

Kyprolis Extends Survival in Multiple Myeloma

Kyprolis Extends Survival in Multiple Myeloma

Amgen and Onyx announced results from the Phase 3 ASPIRE trial, which assessed Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone vs. Revlimid (lenalidomide; Celgene) and dexamethasone in patients with relapsed multiple myeloma.

Phase 3 Data for Brivaracetam in Partial-Onset Seizures Announced

UCB announced primary Phase 3 study data for brivaracetam as adjunctive treatment in adult epilepsy patients with partial-onset seizures.

Positive Phase 3 Trial Results Announced for Zubsolv

Orexo announced positive results from the ISTART study on Zubsolv (buprenorphine and naloxone) sublingual tablets.

Aptiom sNDA Submitted for Monotherapy Treatment for Partial-Onset Seizures

Sunovion announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for Aptiom (eslicarbazepine acetate) as monotherapy treatment of partial-onset seizures.

Dysport sBLA Under Review for Upper Limb Spasticity

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Dysport (abobotulinumtoxinA; Ipsen) for the treatment of upper limb spasticity in adults.

Investigational Empyema Treatment Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to its lead drug candidate, LTI-01 (Lung Therapeutics) for the treatment of empyema.

Sebelipase Alfa BLA Submitted for LAL Deficiency

Synageva BioPharma announced the completion of a rolling submission of the Biologics License Application (BLA) to the FDA for sebelipase alfa as a treatment for patients with lysosomal acid lipase deficiency (LAL Deficiency).

Complete Response Letter Issued for Daclatasvir in Hepatitis C

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for its New Drug Application (NDA) for daclatasvir (DCV; Bristol-Myers Squibb), a NS5A complex inhibitor, in combination with other agents for the treatment of hepatitis C virus (HCV).

FDA Issues Complete Response Letter for Acute Migraine Treatment

The Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to its New Drug Application (NDA) for AVP-825 (Avanir Pharmaceuticals), its Breath Powered investigational drug-device combination product for the acute treatment of migraine.

Ixaomib Designated Breakthrough Therapy for AL Amyloidosis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to ixazomib (Takeda), an investigational oral proteasome inhibitor for the treatment of relapsed or refractory systemic light-chain (AL) amyloidosis.

Investigational Hemophilia A Therapy BLA Submitted by Baxter

Investigational Hemophilia A Therapy BLA Submitted by Baxter

Baxter announced that it has submitted a Biologics License Application to the Food and Drug Administration (FDA) for the approval of BAX 855, an investigational, extended half-life recombinant factor VIII (rFVIII) treatment for hemophilia A based on Advate [Antihemophilic Factor (Recombinant).

FDA to Review Eylea for Diabetic Retinopathy

The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea (afilbercept; Regeneron) injection for the treatment of diabetic retinopathy in patients with diabetic macular edema (DME).

Brodalumab Meets Primary Endpoint in Plaque Psoriasis Trial

Amgen and AstraZeneca announced results from the Phase 3 AMAGINE-2 study evaluating two doses of brodalumab in patients with moderate-to-severe plaque psoriasis.

FDA Grants QDIP Status to Two Inhalation Products

The Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) to two Bayer Healthcare products, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).

Duchenne Muscular Dystrophy Therapy Designated Orphan Drug

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CAT-1004 (Catabasis) for the treatment of Duchenne Muscular Dystrophy (DMD).

Acute Lymphoblastic Leukemia Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to JCAR015 for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia.

Pediatric Ulcerative Colitis Therapy Granted Orphan Drug Status

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Avaxia Biologics' investigational therapy, AVX-470 for the treatment of pediatric ulcerative colitis.

Alirocumab Meets Primary Endpoint in Six Hypercholesterolemia Trials

Sanofi and Regeneron announced positive results from six Phase 3 ODYSSEY trials that showed alirocumab significantly reduced LDL-C in hypercholesterolemic patients.

Dupilumab Designated Breakthrough Therapy for Atopic Dermatitis

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to dupilumab (Regeneron and Sanofi) for the treatment of adults with moderate-to-severe atopic dermatitis who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

FDA Grants Orphan Drug Status to Investigational Acute Myeloid Leukemia Treatment

The FDA has granted Orphan Drug designation to BGB324 (BerGenBio AS) for the treatment of acute myeloid leukemia (AML).

NDA Submitted for Three-Month Paliperidone Palmitate

Janssen R&D announced that it has submitted a New Drug Application (NDA) to the FDA, for three-month paliperidone palmitate as treatment for schizophrenia in adults.

LCZ696 Cuts Sudden Death, ER Visits in Large HF Study

Novartis announced new data from the Phase 3 PARADIGM-HF study, in patients who received LCZ696 for heart failure with reduced ejection fraction (HFrEF).

Secukinumab Demonstrates Efficacy in Psoriatic Arthritis Trials

Novartis announced results from the Phase 3 FUTURE 1 and FUTURE 2 studies with secukinumab in patients with psoriatic arthritis (PsA).

Lesinurad Demonstrates Efficacy in Phase 3 Gout Trials

AstraZeneca announced top-line results for two pivotal Phase 3 trials investigating lesinurad, when used in combination with xanthine oxidare (XO) inhibitor allopurinol in patients with symptomatic gout not achieving target sUA levels on current allopurinol dose.

Opdivo Achieves Primary Endpoint in Melanoma Trial

Bristol-Myers Squibb Company announced results from the Phase 3 CheckMate-066 study comparing Opdivo, an investigational PD-1 immune checkpoint inhibitor, to dacarbazine (DTIC) in patients with treatment naïve BRAF wild-type advanced melanoma.

Combination Therapy Effective in Rheumatoid Arthritis Study

Bristol-Myers Squibb Company announced results of several new sub-analyses of the Phase 3b AVERT trial investigating the use of Orencia (abatacept) plus methotrexate (MTX) in biologic and MTX-naïve CCP-positive early moderate to severe rheumatoid arthritis (RA) patients.

Development of Brilinta Reversal Agent Initiated by AstraZeneca

AstraZeneca announced that it has initiated a pre-clinical development program to evaluate the ability of investigational antibody, MEDI2452 to rapidly and specifically reverse the antiplatelet effects of Brilinta (ticagrelor) in rare emergencies, such as urgent surgery or major bleeding.

Positive Phase 3 Data of Sebelipase Alfa for LAL Deficiency

Synageva BioPharma announced positive data on sebelipase alfa in a clinical study of patients with lysosomal acid lipase (LAL) deficiency at the American Association for the Study of Liver Diseases' AASLD Liver Meeting.

Brodalumab Demonstrates Efficacy in Plaque Psoriasis Study

Amgen and AstraZeneca announced results from AMAGINE-3, a Phase 3 trial evaluating brodalumab in patients with moderate-to-severe plaque psoriasis.

Sustained Virologic Responses Achieved with Combination Chronic HCV Therapy

Gilead Sciences announced results from three Phase 2 open-label studies investigating the efficacy and safety of an all-oral pan-genotypic regimen containing Sovaldi (sofosbuvir) and GS-5816 for the treatment of chronic hepatitis C virus (HCV) infection.

Interferon-Free Investigational Treatment for Chronic HCV: New Study Results

Enanta Pharmaceuticals announced results from AbbVie's Phase 2b PEARL-I study with ABT-450/ritonavir and ombitasvir, an all-oral, interferon-free investigational treatment combining two direct-acting antivirals with or without ribavirin in patients with genotype 4 (GT4) chronic hepatitis C virus (HCV) infection.

Results Announced for Harvoni in Chronic Hepatitis C Virus Trials

Gilead Sciences announced results from several Phase 2 and Phase 3 studies evaluating the use of Harvoni (ledipasvir/sofosbuvir) for the treatment of chronic hepatitis C virus (HCV) infection.

Investigational Triple Therapy for Chronic HCV Shows Sustained Virologic Response

Merck announced interim data from the C-SWIFT study investigating the triple-therapy regimen consisting of the fixed-dose combination of grazoprevir/elbasvir in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection.

Sustained Virologic Response with Daclatasvir + Sofosbuvir in Trial

Bristol-Myers Squibb announced late-breaking data from ALLY Trial evaluating a ribavirin-free 12-week regimen of daclatasvir (DCV) in combination with sofosbuvir (SOF) in genotype 3 hepatitis C virus (HCV) patients.

Hepatitis C Virus Combination Therapy Shows Potential in Trials

Bristol-Myers Squibb announced late-breaking results from the UNITY Trial program with all-oral daclatasvir (DCV) TRIO regimen, a fixed-dose combination of daclatasvir with asunaprevir (ASV) and beclabuvir (BCV) in patients with genotype 1 hepatitis C virus (HCV).

Evolocumab BLA Under Review for High Cholesterol

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for evolocumab for the treatment of high cholesterol.

Tivantinib Improves Progression-Free Survival in Prostate Cancer Trial

ArQule announced positive results from a Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer.

Investigational Night Blindness Drug Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to SPK-RPE65 (Spark Therapeutics) for the treatment of nyctalopis, or night blindness, in patients with Leber's congenital amaurosis due to mutations in the RPE65 gene.

NDA Submitted for Single Tablet HIV-1 Infection Regimen

Gilead Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for a once-daily single tablet regimen containing elvitegravir 150mg, cobicistat 150mg, emtricitabine 200mg, and tenofovir alafenamide 10mg (E/C/F/TAF) for the treatment of HIV-1 infection in adults.

Lumacaftor + Ivacaftor NDA Submitted for Cystic Fibrosis

Vertex announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for the combination product lumacaftor and ivacaftor for people with cystic fibrosis (CF) ages ≥12 who have two copies of the F508del mutation in the cystic fibrosis transmembrance conductance regulator (CFTR) gene.

Isavuconazole Designated Orphan Drug for Invasive Candidiasis

The Food and Drug Administration (FDA) has granted Orphan Drug designation to isavuconazole for the treatment of invasive candidiasis.

Investigational Myelofibrosis Therapy Designated Fast Track Status

The Food and Drug Administration (FDA) has granted Fast Track designation to PRM-151 (Promedior) for the treatment of myelofibrosis.

NBI-98854 Designated Breakthrough Therapy for Tardive Dyskinesia

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for NBI-98854 (Neurocrine Biosciences) for tardive dyskinesia.

Investigational Gene Therapy Designated Orphan Drug for Eye Disorder

The Food and Drug Administration (FDA) has granted Orphan Drug designation to RST-001 for the treatment of retinitis pigmentosa (RP).

Glassia Designated Orphan Drug for Graft-Versus-Host Disease

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Glassia (alpha1-proteinase inhibitor [human]) for the treatment of Graft-versus-host disease (GVHD).

Sarcoidosis-Associated Small Fiber Neuropathy Therapy Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track status to ARA290 (Araim Pharmaceuticals) for the treatment of Sarcoidosis-associated Small Fiber Neuropathy (SFN).

Rare Skin Disorder Therapy Granted Orphan Drug Designation

The FDA has granted Orphan Drug designation to AC-201 for the treatment of epidermolysis bullosa (EB).

FDA to Review Aripiprazole Lauroxil NDA for Schizophrenia

The FDA has accepted for filing the New Drug Application (NDA) for aripiprazole lauroxil, a once-monthly injectable atypical antipsychotic for the treatment of schizophrenia.

FDA Accepts NDA for Type 2 Diabetes Combo Drug for Filing

The FDA has accepted for filing the NDA for empagliflozin plus immediate-release metformin HCl fixed-dose combination for the treatment of adults with type 2 diabetes.

Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures

Fycompa sNDA Under Review for Primary Generalized Tonic-Clonic Seizures

The FDA has accepted for review the Supplemental New Drug Application (sNDA) for Fycompa (perampanel; Eisai) for the treatment of primary generalized tonic-clonic (PGTC) seizures.

FDA Fast Tracks Combination Metastatic Colorectal Cancer Drug

The FDA has granted Fast Track designation for trifluridine and tipiracil hydrochloride (TAS-102), an oral combination anticancer drug for the treatment of refractory metastatic colorectal cancer (mCRC).

Eylea Shows Greater Visual Acuity Gain in DME Trial

Regeneron announced results from an effectiveness study sponsored by the National Institutes of Health (NIH) in patients with diabetic macular edema (DME) treated with Eylea (aflibercept) Injection compared to Avastin (bevacizumab; Genentech) and Lucentis (ranibizumab; Genentech).

Investigational Radiotracer Designated Orphan Drug for Neuroendocrine Tumors

The Food and Drug Administration (FDA) has granted Orphan Drug designation to OPS202 (OctreoPharm Sciences), an investigational radiotracer, based on a next generation antagonistic somatostatin analog for the management of neuroendocrine tumors.

Lenvatinib NDA Under Review for RAI-Refractory Differentiated Thyroid Cancer

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for lenvatinib mesylate (Eisai) for the treatment of progressive radioactive iodine-refractory differentiated thyroid cancer (RAI-refractory DTC) and granted the NDA Priority Review status.

Orexo Seeks to Expand Zubsolv Labeling

Orexo AB announced that it has submitted an application to the Food and Drug Administration (FDA) for an expanded label of Zubsolv (buprenorphine/naloxone) sublingual tablet CIII to include initiation of treatment for opioid dependence.

Palbociclib + Letrozole NDA Under Review for Advanced Breast Cancer

The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the NDA for palbociclib in combination with letrozole, as a first-line treatment of postmenopausal women with ER+, HER- advanced breast cancer who have not received previous systemic treatment for their advanced disease.

Blinatumomab BLA to be Reviewed for Acute Lymphoblastic Leukemia

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for blinatumomab for the treatment of adults with Philadelphia-negative (PH-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL).

Lefamulin Designated QIDP and Fast Track Status for Bacterial Infections

The Food and Drug Administration (FDA) has designated lefamulin (Nabriva) as a Qualified Infectious Disease Product (QIDP) and has been granted Fast Track status for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and skin structure infections (ABSSSI).

Adalimumab Biosimilar Meets Endpoint in Plaque Psoriasis Study

Amgen announced that its Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 501 compared to Humira (adalimumab) in patients with moderate-to-severe plaque psoriasis met its primary endpoint.

NurOwn Granted Fast Track Status for ALS

The Food and Drug Administration (FDA) has granted Fast Track status to NurOwn (BrainStorm Cell Therapeutics) for the treatment of Amyotrophic Lateral Sclerosis (ALS, or Lou Gehrig's Disease).

Oncolytic Adenovirus Designated Orphan Drug for Malignant Glioma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to DNX-2401 (DNAtrix), a conditionally-replicative oncolytic adenovirus for malignant glioma.

PEGPH20 Designated Orphan Drug for Pancreatic Cancer

Halozyme Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to PEGPH20 (PEGylated recombinant human hyaluronidase) for the treatment of pancreatic cancer.

Investigational Pump Efficacious in Type 2 Diabetes Trials

Intarcia Therapeutics announced top-line results from two of its four Phase 3 clinical trials for ITCA 650 (continuously subcutaneous delivery of exenatide) for patients with type 2 diabetes.

ALK+ Metastatic NSCLC Therapy Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AP26113 (ARIAD Pharmaceuticals) for the treatment of anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

Investigational Sickle Cell Disease Agent Fast Tracked

The Food and Drug Administration (FDA) has granted Fast Track designation to NKTT120 for the treatment of sickle cell disease.

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