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.

FDA Wants More Info Before Approving Exparel for Post-Op Nerve Block

The FDA has issued a Complete Response Letter (CRL) for the supplemental New Drug Application (sNDA) for the use of Exparel (bupivacaine liposome injectable suspension) in nerve block to provide postsurgical analgesia.

First-In-Class Enzyme Replacement Therapy for Hypophosphatasia Under Review

The FDA has accepted for Priority Review the Biologics License Application (BLA) for asfotase alfa in the treatment of patients with infantile-and juvenile-onset hypophosphatasia (HPP).

FDA to Review Lifitegrast for Dry Eye Disease

Shire has submitted a New Drug Application (NDA) to the FDA for lifitegrast for the treatment of signs and symptoms of dry eye disease in adults.

BI Requesting Accelerated Approval for Pradaxa Reversal Agent

Boehringer Ingelheim announced that it has submitted a Biologics License Application (BLA) to the FDA, requesting accelerated approval for the use of idarucizumab to reverse the anticoagulant effect of Pradaxa (dabigatran etexilate mesylate).

Harvoni for HCV Genotype 4, HIV Co-Infection Assessed in New Research

Gilead Sciences announced results from ION-4, a Phase 3 study evaluating Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of genotypes 1 or 4 chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.

Combo Therapy for HCV, HIV Co-Infection: New Data on Sustained Virologic Response

Bristol-Myers Squibb Company announced results from ALLY-2, a Phase 3 trial evaluating the use of daclatasvir and sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) co-infected with HIV.

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eribulin vs. Dacarbazine for Soft Tissue Sarcoma: New Data Released

Eisai announced results from a Phase 3 trial investigating the use of eribulin vs. dacarbazine in patients with advanced soft tissue sarcomas.

New Data on Once-Daily Baricitinib for RA From Phase 3 Trial

Eli Lilly and Company and Incyte announced results from a second Phase 3 trial with baricitinib in patients with rheumatoid arthritis.

Breakthrough Therapy for Rare Enzyme Disorder Could Be Approved Even Sooner

The Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for Kanuma (sebelipase alfa; Synageva BioPharma) for the treatment of lysosomal acid lipase deficiency (LAL Deficiency).

Shorter FDA Review for Tx of Rare Lung Disorder

The Food and Drug Administration (FDA) has accepted for Priority Review a supplemental New Drug Application (sNDA) for Rapamune (sirolimus; Pfizer) for the treatment of lymphangioleiomyomatosis (LAM).

New Oral Combo for Metastatic Colorectal Cancer To Get FDA Review

The Food and Drug Administration (FDA) has accepted Taiho's New Drug Application (NDA) for review for TAS-102 (nonproprietary names: trifluridine and tipiracil HCl) for the treatment of refractory metastatic colorectal cancer (mCRC).

FDA to Review Belbuca for Pain Management

The Food and Drug Administration (FDA) has accepted the NDA for review for Belbuca (buprenorphine HCl; Endo and BioDelivery Sciences) buccal film 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.

FDA to Review Combination Therapy for Advanced Melanoma

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advanced melanoma.

Adcetris sBLA Submitted for Post-Transplant Hodgkin Lymphoma

Seattle Genetics has submitted a supplemental Biologics License Application (BLA) to the Food and Drug Administration (FDA) for Adcetris (brentuximab vedotin) as consolidation therapy immediately following an autologous stem cell transplant (ASCT) in Hodgkin lymphoma patients at high risk of relapse.

Entrectinib Designated Orphan Drug for Colorectal Cancer

The Food and Drug Administration (FDA) has granted Orphan Drug designation to entrectinib (Ignyta) for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive or ALK-positive colorectal cancer.

Hypoactive Sexual Desire Disorder Drug for Women Gets Closer to Approval

Sprout Pharmaceuticals has resubmitted its New Drug Application (NDA) to the FDA for flibanserin for Hypoactive Sexual Desire Disorder (HSDD) in premenopausal women.

Orphan Drug Designation Granted to Glioblastoma Multiforme Therapy

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Saposin C, the active ingredient in BXQ-350 (Bexion) for the potential treatment of glioblastoma multiforme.

ALO-02 NDA Under Review for Pain Management

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ALO-02 (oxycodone HCl and naltrexone HCl; Pfizer) extended-release capsules 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.

Investigational Heart Failure Therapy Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for LCZ696 (Novartis) for the treatment of heart failure with reduced ejection fraction (HFrEF).

FDA Fast Tracks Intranasal Naloxone

Lightlake Therapeutics and Adapt Pharma Limited announced that the Food and Drug Administration (FDA) has granted Fast Track designation to its intranasal naloxone, an opioid antagonist for opioid overdose reversal treatment.

Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

Lenvatinib Delays Progression of Advanced Thyroid Cancer in Clinical Trial

Oral lenvatinib delayed progression of advanced thyroid cancer by 18 months, compared with four months for patients treated with a placebo, according to results from a new clinical trial.

Mesothelioma Treatment Granted Orphan Drug Designation

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VS-5584 (Verastem) for the treatment of mesothelioma.

ANA-Conjugated Liposomal Doxorubicin Designated Orphan Drug for Ewing's Sarcoma

The Food and Drug Administration (FDA) has granted Orphan Drug designation to its antinuclear antibody (ANA) conjugated liposomal doxorubicin (NanoSmart Pharmaceuticals) intended to treat Ewing's sarcoma, with potential expansion to other indications.

New Data Released on Investigational Hemophilia A Therapy

Baxter announced additional safety and efficacy data from its Phase 3 study of BAX 855, an extended half-life recombinant factor VIII (rFVIII) for the treatment of hemophilia A based on Advate [Antihemophilic Factor (Recombinant)].

FDA to Review NDA for Investigational Abuse-Deterrent Opioid

The Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for MorphaBond ER (morphine sulfate extended-release; Inspirion Delivery Technologies and Trygg Pharma Group), 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.

Investigational Cystic Fibrosis Therapy Designated Orphan Drug

Advanced Inhalation Therapies announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to AIT-CF, a high dose formulation of nitric oxide for adjunctive treatment of cystic fibrosis (CF).

Entrectinib Designated Orphan Drug for NSCLC

The Food and Drug Administration (FDA) has granted Orphan Drug designation to entrectinib (Ignyta) for the treatment of TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small cell lung cancer (NSCLC).

Xeljanz sNDA Accepted for Review for Plaque Psoriasis

The Food and Drug Administration (FDA) has accepted for review the sNDA for Xeljanz (tofacitinib citrate; Pfizer) 5mg and 10mg tablets for the treatment of adults with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

BLA for Investigational Hemophilia B Drug Accepted for Review

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for rIX-FP (Coagulation Factor IX [Recombinant], Albumin Fusion Protein; CSL Behring), for patients with hemophilia B.

Adalimumab Biosimilar Effective in Rheumatoid Arthritis Trial

Adalimumab Biosimilar Effective in Rheumatoid Arthritis Trial

Amgen announced results for its Phase 3 study evaluating the safety and efficacy of biosimilar candidate ABP 501 compared to adalimumab (Humira; AbbVie) in patients with moderate-to-severe rheumatoid arthritis.

Yondelis NDA Granted Priority Review for Soft Tissue Sarcoma

Janssen R&D and PharmaMar announced that the Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for Yondelis (trabectedin).

Beta-Thalassemia Major Treatment Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to LentiGlobin BB305 Drug Product for the treatment of transfusion-dependent patients with beta-thalassemia major.

PD-L1 Positive NSCLC Therapy Designated Breakthrough Therapy

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to MPDL3280A (anti-PDL1 and RG7446; Genentech) for the treatment of patients with PD-L1 positive non-small cell lung cancer (NSCLC) whose disease has progressed during or after platinum-based chemotherapy.

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).

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