Stivarga Improves Overall Survival in Hepatocellular Carcinoma Study

By May 05, 2016

Bayer announced that the Phase 3 study, RESORCE, evaluating Stivarga (regorafenib) tablets for the treatment of patients with unresectable hepatocellular carcinoma (HCC) has met its primary endpoint of a statistically significant improvement in overall survival.

FDA Grants Priority Review to Advanced Soft Tissue Sarcoma Tx

By May 04, 2016

The FDA has granted Priority Review for the Biologics License Application (BLA) for olaratumab (Lilly), in combination with doxorubicin, for the potential treatment of advanced soft tissue sarcoma (STS) not amenable to curative treatment with radiotherapy or surgery.

Recombinant Human Alkaline Phosphatase Fast Tracked for AKI

By May 04, 2016

AM-Pharma announced that the Food and Drug Administration (FDA) has granted Fast Track designation to recAP (recombinant human Alkaline Phosphatase) for the treatment of acute kidney injury (AKI).

Intravenous Carbamazepine Under FDA Review

By May 04, 2016

The FDA has accepted for review the re-submission of the New Drug Application (NDA) for intravenous carbamazepine (Lundbeck), for use as replacement therapy in adults who are on a stable maintenance oral dose of carbamazepine to control certain seizure types, when oral carbamazepine administration is temporarily not feasible.

Ilaris Granted 3 Breakthrough Designations for Rare Types of Periodic Fever Syndromes

By April 27, 2016

Novartis announced that the Food and Drug Administration (FDA) have granted Ilaris (canakinumab) three Breakthrough Therapy Designations, to treat three types of rare Periodic Fever Syndromes (also known as Hereditary Periodic Fevers).

Promising Results in Phase 3 Trials for Nebulized Glycopyrrolate in COPD

By April 27, 2016

Sunovion Pharmaceuticals announced positive data from its Phase 3 study of SUN-101 (glycopyrrolate), to treat people with moderate-to-very severe chronic obstructive pulmonary disease (COPD).

FDA Grants Opdivo New Breakthrough Therapy Status

By April 25, 2016

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo (nivolumab), to potentially treat recurrent or metastic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy.

Nplate Demonstrates Efficacy in Pediatric ITP

By April 20, 2016

Amgen announced published results from a Phase 3 study of Nplate (romiplostim) for the treatment of symptomatic immune thrombocytopenia (ITP) in children. Study data were published in The Lancet.

Novel Chronic Idiopathic Constipation Drug Under FDA Review

By April 19, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for plecanatide (Synergy) for the treatment of chronic idiopathic constipation (CIC).

First Long-Acting Buprenorphine Implant Shows Promise for Opioid Addiction

By April 19, 2016

Braeburn Pharmaceuticals announced positive data from the Phase 3 study of Probuphine (buprenorphine subdermal implant) for the long-term maintenance treatment of opioid addiction. Findings were presented at the 47th Annual American Society of Addiction Medicine (ASAM) Conference.

New Formulation of Vyvanse Submitted to FDA for Review

By April 18, 2016

Shire announced that it has submitted to the Food and Drug Administration (FDA) a New Drug Application (NDA) for a new, alternate formulation of Vyvanse (lisdexamfetamine dimesylate) as a chewable tablet for patients who may have difficulty swallowing or opening a capsule.

FDA Grants Keytruda Fourth Breakthrough Therapy Status

April 18, 2016

The FDA has granted Keytruda (pembrolizumab) its fourth Breakthrough Therapy designation for the treatment of patients with relapsed or refractory classical Hodgkin lymphoma (cHL).

Pan-Genotypic HCV Regimen Shows Promise in Trial

By April 15, 2016

AbbVie announced positive results from the ongoing MAGELLAN-1 study, evaluating the efficacy, safety, and pharmacokinetics of ABT-493 and ABT-530, with and without RBV, for the treatment of genotype 1 (GT1) and genotypes 4-6 chronic hepatitis C virus (HCV) infection in non-cirrhotic adults who failed previous therapy with direct-acting antivirals (DAA).

Triple-Bead Mixed Amphetamine Salts Shows Promise in ADHD Study

By April 14, 2016

Shire announced positive topline results from the Phase 3 study, SHP465-305, evaluating SHP465 (triple-bead mixed amphetamine salts - MAS) in children and adolescents aged 6-17 years with Attention-Deficit/Hyperactivity Disorder (ADHD).

Positive Results Announced for Dupilumab in Atopic Dermatitis Studies

By April 14, 2016

Regeneron and Sanofi announced that the two Phase 3 studies, LIBERTY AD SOLO 1 and SOLO 2, evaluating dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD), met their primary endpoints.

FDA to Review Remoxy NDA for Pain Management

By April 13, 2016

Durect and its licensee, Pain Therapeutics, announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Remoxy (extended-release oxycodone).

Orphan Drug Status Granted to Inhaled Antimicrobial Agent Mul-1867

By April 13, 2016

The FDA has granted Orphan Drug designation to Mul-1867 (TGV-Inhalonix) for the treatment of antibiotic-resistant bacterial lung infections in patients with cystic fibrosis.

Reformulated Metronidazole Granted Orphan Drug for CDI in Children

By April 12, 2016

Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.

Palatable CDI Tx for Children Designated Orphan Drug Status

By April 12, 2016

Appili Therapeutics announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for ATI-1501 (metronidazole) for the potential treatment of Clostridium difficile infection (CDI) in children.

FDA Granted Priority Review for Atezolizumab BLA in NSCLC Indication

By April 12, 2016

Genentech announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for atezolizumab (anti-PDL1; MPDL3280A

Potential Tx for CRE Infections Fast Tracked by the FDA

By April 11, 2016

The FDA has granted Fast Track designation to Carbavance (meropenem-vaborbactam; The Medicines Company) for the treatment of complicated urinary tract infections (cUTI).

Study Halted After Mixed Results with Investigational Cholesterol Drug

By April 04, 2016

Researchers from the Cleveland Clinic have found that treatment with evacetrapib in the ACCELERATE study failed to reduce the rates of major cardiovascular events, including heart attack, stroke, angina or cardiovascular death, despite a reduction in the levels of low-density lipoprotein (LDL) by 37% and an increase in the levels of high-density lipoprotein (HDL) by 130%.

Aplidin Shows Significant Risk Reduction in Multiple Myeloma Study

By April 01, 2016

PharmaMar announced top-line data from its Phase 3 ADMYRE clinical trial with Aplidin (plitidepsin) in combination with dexamethasone vs. dexamethasone alone in patients with relapsed/refractory multiple myeloma (MM).

Radius Submits NDA for New Osteoporosis Tx in Postmenopausal Women

By April 01, 2016

Radius Health announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for abaloparatide-subcutaneous (SC) 80mg, a once daily treatment for postmenopausal women with osteoporosis.

Investigational PCSK9 Inhibitor Shows Positive Results in Phase 3 Study

By April 01, 2016

Pfizer announced topline data for the Phase 3 SPIRE-AI (AutoInjector) trial where bococizumab given as a prefilled pen met its co-primary endpoints.

Novel Vaccine Adjuvant Found to Enhance Flu Vaccine Efficacy

By March 31, 2016

Kineta announced new data showing that KIN 1148 enhanced the efficacy of existing flu vaccines in animal models through a balanced immune response.

Brinavess Superior to Ibutilide in Conversion to Sinus Rhythm

By March 31, 2016

Conversion to sinus rhythm (SR) in patients with recent-onset atrial fibrillation (AF) (<48 hours duration) was significantly shorter with Brinavess (vernakalant) than ibutilide.

FDA Wants Data Regarding Abuse Potential for Xadago

By March 30, 2016

Newron Pharmaceuticals and its partners, Zambon and US WorldMeds, announced that the Food and Drug Administration has issued a Complete Response Letter for Xadago (safinamide) as an adjunctive treatment for Parkinson's disease (PD).

Naldemedine NDA Submitted for Opioid-Induced Constipation

By March 30, 2016

Shionogi announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for naldemedine 0.2mg once daily tablet for the treatment of opioid-induced constipation (OIC).

Rayaldee Approval Process Halted Due to Third-Party Manufacturer Issues

By March 30, 2016

The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Rayaldee (calcifediol; Opko) as a treatment for secondary hyperparathyroidism (SHPT) in patients with Stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

Encenicline Phase 3 Results in Schizophrenia Announced

By March 28, 2016

Forum Pharmaceuticals announced topline results from two Phase 3 clinical trials evaluating encenicline (FRM-6124) in patients with cognitive impairment in schizophrenia (CIS).

Positive Results for Oral Tofacitinib in Ulcerative Colitis Presented

By March 24, 2016

Pfizer announced detailed results from the first 2 pivotal Phase 3 trials of the OCTAVE program evaluating oral tofacitinib 10mg twice daily in inducing remission in adults with moderately to severely active ulcerative colitis (UC). Findings were orally presented at the 11th Congress of ECCO Scientific Session.

FDA to Review Novel Non-Steroidal Tx for Atopic Dermatitis

By March 22, 2016

Anacor Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) of crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Promising Results for Romosozumab in Men with Osteoporosis

March 22, 2016

Amgen and UCB announced positive top-line results from the pivotal Phase 3 study, BRIDGE, evaluating romosozumab for the treatment of osteoporosis in men.

Pegvaliase Demonstrates Efficacy in Phase 3 PKU Study

By March 21, 2016

BioMarin announced positive preliminary results from the pivotal Phase 3 PRISM-2 study of pegvaliase for the reduction of blood phenylalanine (Phe) in patients with phenylketonuria (PKU).

FDA Denies NDA Application for Kangio

By March 18, 2016

The FDA has issued a Complete Response Letter for the New Drug Application (NDA) of Kangio (bivalirudin injection; Eagle) for use as an anticoagulant in patients: (1) undergoing percutaneous coronary intervention (PCI) with use of glycoprotein IIb/IIIa inhibitor, (2) undergoing PCI with, or at risk of, heparin-induced thrombocytopenia (HIT) and thrombosis syndrome (HITTS), and/or (3) with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA).

BLA for Advanced Bladder CA Tx Granted Priority Review

By March 15, 2016

Genentech announced that the FDA has accepted and granted Priority Review to the Biologics License Application (BLA) for atezolizumab

First-in-Class ChemoTx Granted Orphan Drug Status for Pediatric Brain CA

By March 15, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation for VAL-083 (DelMar) in the treatment of medulloblastoma, the most common malignant pediatric brain cancer.

FDA to Review Enbrel for Pediatric Plaque Psoriasis

By March 11, 2016

Amgen has announced that the U.S. Food and Drug Administration (FDA) has accepted for review their supplemental Biologics License Application (sBLA) for the expanded use of Enbrel (etanercept).

Investigational Treatment Shows Superiority in RA Study

By March 11, 2016

Regeneron and Sanofi announced their Phase 3 study for sarilumab has met its primary endpoint, demonstrating superiority over adalimumab in improving symptoms in patients with active rheumatoid arthritis (RA) at Week 24, in the SARIL-RA-MONARCH trials.

Top-Line Results for Ixmyelocel-T in Dilated Cardiomyopathy Announced

By March 10, 2016

Vericel announced top-line results from the Phase 2b ixCELL-DCM clinical trial of ixmyelocel-T in patients with advanced heart failure due to ischemic dilated cardiomyopathy (DCM).

Ixekizumab Demonstrates Efficacy in Two Phase 3 Psoriasis Studies

By March 07, 2016

Lilly announced positive results from two Phase 3 studies, UNCOVER-2 and UNCOVER-3, of ixekizumab for the treatment of moderate-to-severe plaque psoriasis compared to etanercept or placebo. Study findings were recently presented at the American Academy of Dermatology (AAD) Annual Meeting in Washington, D.C.

Orphan Drug Status Granted to BHV-0223 for Spinocerebellar Ataxia

By March 04, 2016

Portage Biotech and Biohaven Pharmaceutical announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to BHV-0223 for the treatment of spinocerebellar ataxia (SCA)

Amgen Submits New sBLA for Blincyto Pediatric Indication

By March 02, 2016

Amgen announced that it has submitted to the FDA a supplemental Biologics License Application (sBLA) for Blincyto (blinatumomab), to include new data supporting the treatment of pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).

FDA to Review Xolair Pediatric Indication for Allergic Asthma

By March 01, 2016

The Food and Drug Administration (FDA) has accepted for review the supplemental Biologics License Application (sBLA) for Xolair (omalizumab; Genentech and Novartis) to extend its indication in allergic asthma to pediatric patients.

Top-Line Results for Novel Asthma Tx Announced

By February 29, 2016

Genentech announced top-line results from two Phase 3 studies, LAVOLTA I and II, of lebrikizumab for the treatment of patients with severe asthma.

FDA Accepts Arymo ER NDA for Pain Management

By February 29, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Arymo ER (morphine sulfate; Egalet) extended-release tablets 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.

Encouraging Results for ARX-04 in Trauma, Injury-Related Pain

By February 26, 2016

AcelRx announced positive interim results from an ongoing Phase 3 study of ARX-04 for the treatment of adults with moderate-to-severe acute pain associated with trauma or injury.

Aristada Under Investigation for 2-Month Dosing Interval in PK Study

By February 26, 2016

Alkermes announced positive top-line results from its pharmacokinetics trial of Aristada (aripiprazole lauroxil extended-release injectable suspension).

FDA to Review Adynovate Proposed Peds, Surgery Indications

By February 26, 2016

Baxalta announced that it has submitted to the Food and Drug Administration (FDA) supplemental Biologics License Applications (sBLAs) for Adynovate [Antihemophilic Factor (Recombinant), PEGylated] to expand its indications to treat children <12 years old with hemophilia A and for use in surgical settings.

Clinical Labeling Update for Xtandi Under FDA Review

By February 23, 2016

Astellas and Medivation announced that the Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for Xtandi (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC) to update its labeling within the current indication.

T-cell Tx Granted Orphan Drug Status for Immunodeficiency, GvHD

By February 23, 2016

Bellicum Pharmaceuticals announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation for the combination of BPX-501 and activator agent rimiducid, as a replacement T-cell therapy for the treatment of immunodeficiency and graft versus host disease (GvHD) after allogeneic hematopoietic stem cell transplant.

Positive Results for Once Daily Isentress Formulation Announced

By February 22, 2016

Merck announced top-line results from its Phase 3 pivotal trial, ONCEMRK, evaluating a once daily formulation of Isentress (raltegravir) in adult patients with previously untreated HIV-1 infection.

Top-Line Results for Investigational Osteoporosis Tx Announced

February 22, 2016

Amgen and UCB announced top-line results from the Phase 3 FRAME study evaluating the safety and efficacy of romosozumab for the treatment of osteoporosis in postmenopausal women.

Oliceridine Granted Breakthrough Tx Status for Acute Pain

By February 22, 2016

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to intravenous oliceridine (TRV130) for the management of moderate-to-severe acute pain.

NDA for Inj Combo Diabetes Drug Under FDA Review

By February 22, 2016

Sanofi announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide for the treatment of adults with type 2 diabetes.

Naldemedine Demonstrates Efficacy in Pivotal Phase 3 OIC Study

By February 19, 2016

Shionogi announced positive results from the pivotal Phase 3 COMPOSE I study evaluating naldemedine for opioid-induced constipation (OIC) in patients with chronic non-cancer pain.

Third Orphan Drug Designation Granted to TXA127 in Muscular Dystrophy

By February 17, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to TXA127 (Tarix Orphan) for the treatment of laminin-deficient congenital muscular dystrophy (LAMA2 MD or MDC1A).

Ocrelizumab Designated Breakthrough Tx for Debilitating Form of MS

By February 17, 2016

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for the investigational drug ocrelizumab (Ocrevus; Genentech) for the treatment of primary progressive multiple sclerosis (PPMS).

Positive Data from Aranesp MDS Study Announced

By February 16, 2016

Amgen announced positive results from the Phase 3 ARCADE study evaluating Aranesp (darbepoetin alfa) in anemic patients with low and intermediate-1 risk myelodysplastic syndrome (MDS).

FDA to Review Expanded Teflaro Indication in Pediatrics

By February 16, 2016

Allergan announced that the Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Teflaro (ceftaroline fosamil). The sNDA is intended to expand its label to include children ≥2 months old for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA) and community-acquired bacterial pneumonia (CABP) caused by Staphylococcus pneumoniae and other designated susceptible bacteria.

Elagolix Demonstrates Efficacy in 2nd Phase 3 Endometriosis Study

By February 10, 2016

AbbVie and Neurocrine Biosciences announced positive top-line results from the second of two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis-associated pain.

Orphan Drug Designation Granted to Novel Echinocandin

By February 10, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to CD101 IV (Cidara Therapeutics) for the treatment of candidemia and invasive candidiasis.

FDA Designates Eltoprazine Orphan Drug in Parkinson's Disease

By February 10, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation for eltoprazine (Amarantus BioScience) in the treatment of Parkinson's disease levodopa-induced dyskinesia (PD-LID).

FDA to Review Rexulti as Maintenance Therapy for Schizophrenia

By February 08, 2016

The Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update of Rexulti (brexpiprazole; Otsuka and Lundbeck) for the maintenance treatment of adults with schizophrenia.

Tazemetostat Granted Orphan Drug Status for Rare, Aggressive Cancers

By February 08, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to tazemetostat (Epizyme) for the treatment of malignant rhabdoid tumors (MRTs).

Complete Response Letter Issued for Expanded Kalydeco Indication

By February 05, 2016

The Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) of Kalydeco (ivacaftor; Vertex) in patients with cystic fibrosis (CF) ≥2 years old who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Top-line Results Announced for Repatha in Patients Who Are Statin-Intolerant

February 05, 2016

Amgen announced positive top-line data from the Phase 3 GAUSS-3 study evaluating Repatha (evolocumab) in statin-intolerant patients with high cholesterol.

Complete Response Letter Issued for MCNA in Bladder CA

By February 03, 2016

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for MCNA (Telesta Therapeutics) in the treatment of non-muscle invasive bladder cancer (NMIBC).

Ovarian Cancer Vaccine Granted Fast Track Status

By February 03, 2016

TapImmune announced that the Food & Drug Administration (FDA) has granted Fast Track designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.

Investigational NASH Tx Fast Tracked by FDA

By February 02, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to NDI-010976 (Nimbus Therapeutics) for the treatment of non-alcoholic steatohepatitis (NASH)

NDA Submitted for Chronic Idiopathic Constipation Drug Plecanatide

By February 01, 2016

Synergy Pharmaceuticals announced the submission of its first New Drug Application (NDA) to the Food and Drug Administration (FDA) for plecanatide for the treatment of chronic idiopathic constipation (CIC).

Ryanodex Fast Tracked for Exertional Heat Stroke

By February 01, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to Ryanodex (dantrolene sodium; Eagle) injectable suspension for the treatment of exertional heat stroke (EHS).

Positive Data for Investigational Hepatic VOD Tx Announced

By February 01, 2016

Jazz Pharmaceuticals announced positive data from the Phase 3 pivotal study of defibrotide in patients with hepatic veno-occlusive disease (VOD) with multi-organ failure (MOF) post-hematopoietic stem-cell transplantation (HSCT). Findings were published online in Blood, the Journal of the American Society of Hematology (ASH).

Combo Tx Fast Tracked for Fibromyalgia

By January 29, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to IMC-1 (Innovative Med Concepts) for the treatment of fibromyalgia.

FDA Grants Breakthrough Tx Designation to Novel Antidepressant

By January 29, 2016

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational drug rapastinel (GLYX-13; Allergan) for the adjunctive treatment of Major Depressive Disorder (MDD).

Study on Opdivo for Head, Neck CA Halted Early

By January 28, 2016

Bristol-Myers Squibb announced that the CheckMate -141 trial evaluating Opdivo (nivolumab) vs. investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) was stopped early due to the study meeting its primary endpoint.

FDA Grants Priority Review to Expanded Cabozantinib Indication

By January 28, 2016

The Food & Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

Novel Antitoxin Granted Priority Review for CDI

By January 27, 2016

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for bezlotoxumab (Merck) for the prevention of Clostridium difficile (C. difficile) infection recurrence.

BLA for Adalimumab Biosimilar Accepted for Review

By January 26, 2016

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

FDA Accepts IVIG-SN BLA for Primary Immunodeficiency

By January 26, 2016

Green Cross announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for IVIG-SN (human normal immunoglobulin G), for the treatment of primary immunodeficiency diseases (PID).

BLA for New Plaque Psoriasis Tx Under FDA Review

January 25, 2016

Valeant, in partnership with AstraZeneca, announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for brodalumab injection for patients with moderate-to-severe plaque psoriasis.

Preliminary Results for Investigational MDD Tx Announced

By January 21, 2016

Alkermes announced preliminary topline results from two Phase 3 trials, FORWARD-3 and FORWARD-4, for ALKS 5461, for the adjunctive treatment of major depressive disorder (MDD) in patients who have inadequate response to standard therapies.

Combination CLL Tx Designated Breakthrough Therapy Status

By January 20, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL).

Isunakinra: Top-Line Phase 3 Results Announced

By January 19, 2016

Eleven Biotherapeutics announced top-line results from the Phase 3 clinical trial of isunakinra (EBI-005) for the treatment of severe allergic conjunctivitis (AC).

FDA to Review Once-Daily Oral RA Tx

By January 19, 2016

Eli Lilly and Incyte announced that the New Drug Application (NDA) for once-daily oral baricitinib has been submitted to the Food and Drug Administration (FDA) for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

FDA Issues Complete Response Letter to Kyndrisa

By January 15, 2016

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the New Drug Application (NDA) for Kyndrisa (drisapersen; Biomarin), for the treatment of Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping.

FDA Committee in Favor of Subdermal Implant for Opioid Addiction

By January 13, 2016

Titan and Braeburn announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the Food and Drug Administration (FDA) has recommended the approval of Probuphine, the first long-acting subdermal buprenorphine implant.

FDA Grants Venetoclax NDA Priority Review for CLL

By January 12, 2016

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for venetoclax (Genentech and AbbVie) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion.

FDA to Review TAF NDA for Chronic HBV Infection

By January 12, 2016

Gilead announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25mg for the treatment of adults with chronic hepatitis B virus (HBV) infection.

Cancer, RA Biosimilars Demonstrated Efficacy in Phase 3 Trials

By January 11, 2016

Sorrento Therapeutics announced that its partner, MabTech, has successfully completed Phase 3 clinical trials in China for STI-001, a biosimilar antibody for cetuximab (Erbitux).

Cancer Vaccine Granted Orphan Drug Status for AML

By January 11, 2016

The Food and Drug Administration has granted Orphan Drug designation to WT1 cancer vaccine (Sellas) for the treatment of patients with acute myeloid leukemia (AML).

FDA Fast Tracks Tx for Metastatic Castrate-resistant Prostate CA

By January 08, 2016

Innocrin announced that the Food and Drug Administration (FDA) has granted Fast Track designation to seviteronel (VT-464) for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC).

NDA for First-in-Class DMD Tx Submitted to FDA

By January 08, 2016

PTC Therapeutics announced the completion of its rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

FDA to Review Sarilumab for Moderate-to-Severe RA

By January 08, 2016

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab (Regeneron and Sanofi) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA).

FDA to Review Novel Topical Treatment for Atopic Dermatitis

By January 07, 2016

Anacor announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Breakthrough Tx Status Granted to Treatment for Rare Obesity Disorder

By January 07, 2016

The Food and Drug Administration (FDA) has granted setmelanotide (Rhythm) Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and Orphan Drug designation for the treatment of Prader-Willi Syndrome (PWS).

FDA Grants Priority Review to Expanded Viekira Pak Indication

By January 07, 2016

Enanta Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to AbbVie's supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A).

Positive Results Announced for Emricasan in Liver Cirrhosis Trial

By January 06, 2016

Conatus Pharmaceuticals announced positive results from the initial stage of the Phase 2 Liver Cirrhosis clinical trial which evaluated emricasan compared to placebo in patients with liver cirrhosis.

Orphan Drug Status Granted to Huntington's First Target-Directed Tx

By January 06, 2016

The Food and Drug Administration has granted Orphan Drug designation to IONIS-HTT (Ionis) for the treatment of Huntington's disease (HD)