Hypertension, Pain Combo Drug Shown Beneficial on Kidney Function

By June 24, 2016

Kitov Pharmaceuticals announced new study data from the Phase 3 study for KIT-302 (amlodipine besylate/celecoxib) in the treatment of osteoarthritis pain and hypertension, suggesting beneficial effects on renal function.

FDA Grants Napabucasin Orphan Drug Status for Gastric Cancer

By June 24, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation for the investigational compound, napabucasin (Boston Biomedical), for the treatment of gastric cancer, including gastroesophageal junction (GEJ) cancer.

Jakafi Granted Breakthrough Therapy Status for Graft-Versus-Host Disease

By June 23, 2016

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Jakafi (ruxolitinib; Incyte) for the treatment of patients with acute graft-versus-host disease (GVHD).

Investigational Drug for Huntington's Disease Granted Orphan Drug Status

By June 22, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to the investigational drug WVE-120101 (Wave Life Sciences) for the treatment of Huntington's disease (HD).

NDA for Potential ALS Treatment Submitted to FDA

By June 21, 2016

Mitsubishi Tanabe Pharma announced that a New Drug Application has been submitted to the Food and Drug Administration (FDA) for edaravone (MCI-186) for the treatment of amyotrophic lateral sclerosis (ALS).

Initial NDA for Investigational ALK Inhibitor Submitted to FDA

By June 17, 2016

Ariad Pharmaceuticals announced the initiation of the first part of a rolling New Drug Application (NDA) submission to the Food and Drug Administration (FDA) for its investigational agent, brigatinib, for the treatment of patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) who are resistant to crizotinib.

Company Halts Clinical Program for Ganaxolone in Adult Seizures

By June 15, 2016

Marinus Pharmaceuticals announced top-line results from the Phase 3 clinical trial of ganaxolone in adults with drug-resistant focal onset seizures.

Follow-on Biologic Insulin Glargine Candidate Similar to Lantus in Two Studies

June 15, 2016

Merck announced that two Phase 3 studies evaluating MK-1293, an investigational, follow-on biologic insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes, achieved their primary endpoints. Study data was presented for the first time at the 76th Scientific Sessions of the American Diabetes Association.

FDA Rejects Approval of Pain Drug Apadaz

By June 15, 2016

KemPharm announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of Apadaz (benzhydrocodone and acetaminophen) for the treatment of moderate to moderately severe acute pain.

Ertugliflozin Monotherapy, Combo Tx Evaluated in T2DM Studies

By June 14, 2016

Merck and Pfizer announced that VERTIS Mono and VERTIS Factorial, two Phase 3 studies evaluating the investigational oral SGLT-2 inhibitor, ertugliflozin, for the treatment of patients with type 2 diabetes, met their primary endpoints. Study results were presented for the first time at the 76th Scientific Sessions of the American Diabetes Association.

FDA to Review Deflazacort for Duchenne Muscular Dystrophy

By June 14, 2016

Marathon Pharmaceuticals announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for deflazacort for the treatment of patients with Duchenne Muscular Dystrophy (DMD).

Canagliflozin/Phentermine Combo Evaluated in Weight Loss Study

By June 13, 2016

Janssen announced findings of a Phase 2 proof-of-concept clinical trial demonstrating that combination therapy of canagliflozin and phentermine was effective for weight loss in overweight or obese non-diabetic adult patients. Data were presented as a late-breaking poster presentation at the 76th Annual Scientific Sessions of the American Diabetes Association (ADA).

FDA to Review New Narcotic Analgesic Combo for Pain

By June 13, 2016

The FDA has accepted for review the New Drug Application (NDA) for CL-108 (Charleston Laboratories and Daiichi Sankyo) for the relief of moderate to severe pain while preventing or reducing the associated opioid-induced nausea and vomiting (OINV).

Two Investigational Drugs Granted Breakthrough Therapy Status for Rare GI Disorders

By June 13, 2016

Shire announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for two investigational drugs for rare diseases: SHP621 (budesonide oral suspension, or BOS) for eosinophilic esophagitis (EoE), and SHP625 (maralixibat) for progressive familial intrahepatic cholestasis type 2 (PFIC2).

Complete Response Letter Issued to First Deuterated Drug Under FDA Review

By June 13, 2016

Teva announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) of SD-809 (deutetrabenazine) tablets for the treatment of chorea associated with Huntington's disease (HD).

Lower Dosage of Chronic Idiopathic Constipation Drug Under Review

By June 09, 2016

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the 72mcg dose of linaclotide (Ironwood and Allergan) for the treatment of adults with chronic idiopathic constipation (CIC).

Oral Baricitinib Evaluated in RA Unresponsive to Conventional DMARDs

By June 09, 2016

Eli Lilly and Incyte announced positive data from the pivotal study, RA-BEYOND, evaluating baricitinib vs. placebo for the treatment of rheumatoid arthritis (RA). Study findings were presented at the Annual European Congress of Rheumatology (EULAR 2016) in London.

Sirukumab Inhibits Joint Destruction, Improves RA Symptoms, Study Shows

By June 08, 2016

Janssen announced positive results from the SIRROUND-D study, a pivotal Phase 3 trial evaluating subcutaneous sirukumab (CNTO 136) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA).

Investigational Tx Fast Tracked for Life-Threatening Stroke

By June 08, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to Cirara (Remedy) for the treatment of large hemispheric infarctions (LHI).

FDA Rejects Anaphylaxis Drug Again, Requires More Data

By June 06, 2016

Adamis Pharmaceuticals announced that the Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) for Epinephrine Injection USP 1:1000 0.3mg Pre-filled Single Dose Syringe (PFS) for the emergency treatment of acute anaphylaxis.

Dupilumab + Topical Corticosteroids Beats TCS Alone in Atopic Dermatitis Study

By June 06, 2016

Regeneron and Sanofi announced that the Phase 3 study, LIBERTY AD CHRONOS, met its primary and key secondary endpoints for dupilumab in the treatment of moderate-to-severe atopic dermatitis (AD) in adult patients.

Efficacy of Semaglutide vs. Insulin Glargine Compared in T2DM Study

By June 02, 2016

Semaglutide significantly improved glycemic control vs. insulin glargine U100 in adults with type 2 diabetes, according to findings from the SUSTAIN 4 trial.

First Topical Echinocandin Antifungal Granted QIDP, Fast Track Designation

By June 01, 2016

Cidara announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) status to its CD101 topical, for the proposed treatment for vulvovaginal candidiasis (VVC) and prevention of recurrent VVC (RVVC).

Gazyva Goes Head-to-Head with Rituxan in Follicular Lymphoma Study

By May 27, 2016

Genentech announced positive results from the pivotal Phase 3 GALLIUM study.

FDA Continues Review of Controversial DMD Treatment

By May 26, 2016

Sarepta announced that the Food and Drug Administration (FDA) is continuing the pending New Drug Application (NDA) review for eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

Filgotinib Achieves Clinical Remission in Crohn's Disease Study

By May 26, 2016

Galapagos announced positive study data from the Phase 2 trial, FITZROY, evaluating filgotinib for the treatment of Crohn's Disease. Detailed results were presented at Digestive Disease Week 2016 in San Diego, CA.

Positive Results for Potential Bacterial Vaginosis Treatment Announced

By May 26, 2016

Symbiomix announced positive results from the second pivotal Phase 3 trial of SYM-1219 (secnidazole) for the treatment of bacterial vaginosis (BV).

Investigational Tx Granted Orphan Drug Status for Spinocerebellar Ataxia

By May 25, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Biohaven's investigational agent BHV-4157 for the treatment of Spinocerebellar Ataxia (SCA).

FDA Grants Antifungal Orphan Drug Status for Valley Fever

By May 25, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to VT-1598 (Viamet) for the treatment of coccidioidomycosis or Valley Fever, a common lung infection in the southwestern US.

Maintenance Treatment with Stelara Evaluated in Crohn's Disease Study

By May 24, 2016

Janssen announced new data from the Phase 3 study, IM-UNITI, showing that a significantly greater proportion of adult patients with moderate to severe Crohn's disease receiving maintenance treatment of Stelara (ustekinumab) achieved clinical remission at one year. Study findings were presented for the first time at Digestive Disease Week 2016.

FDA to Review Topical Rosacea Treatment

By May 24, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for oxymetazoline HCl cream 1% (Allergan) for the treatment of persistent facial erythema associated with rosacea in adults.

Positive Phase 3 Results for Chronic Idiopathic Constipation Drug

By May 23, 2016

Synergy announced additional clinical data from two Phase 3 trials, Study-00 and Study-03, evaluating the efficacy and safety of plecanatide for the treatment of chronic idiopathic constipation (CIC). Study findings were presented at Digestive Disease Week (DDW) in San Diego.

Sublingual Cyclobenzaprine Shows Promise in PTSD Study

By May 20, 2016

Tonix Pharmaceuticals announced topline results from the Phase 2 AtEase Study, evaluating TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of military-related Post-Traumatic Stress Disorder (PTSD).

FDA Grants Vyxeos Breakthrough Therapy Status for AML

By May 19, 2016

Celator announced that the FDA has granted Breakthrough Therapy designation to Vyxeos (CPX-351) for the treatment of adults with therapy-related acute myelogenous leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Novel Gene Tx Fast Tracked for ALS

By May 18, 2016

The FDA has granted Fast Track designation for the investigational drug, VM202 (VM BioPharma/ViroMed), for the potential treatment of Amyotrophic Lateral Sclerosis (ALS).

FDA Designates Selumetinib Orphan Drug for Differentiated Thyroid CA

By May 17, 2016

AstraZeneca announced that the FDA has granted Orphan Drug designation to selumetinib for the adjuvant treatment of patients with stage III or IV differentiated thyroid cancer (DTC).

Novel Asthma Biologic Demonstrates Efficacy in Two Phase 3 Studies

By May 17, 2016

AstraZeneca announced that two pivotal Phase 3 registrational trials for benralizumab achieved their primary endpoint, demonstrating significant reductions in the annual asthma exacerbation rate compared to placebo.

Orphan Drug Status Granted to Hyperoxaluria Treatment

By May 09, 2016

The FDA has granted Orphan Drug designation to ALLN-177 (oxalate decarboxylase; Allena) for the treatment of pediatric hyperoxaluria.

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.