Cerebral Edema Treatment Gains Orphan Drug Status

By January 17, 2017

Remedy announced that their investigational treatment for severe cerebral edema in patients with acute ischemic stroke, Cirara, has been granted Orphan Drug Designation.

Oral Therapy for Uterine Fibroids Demonstrates Efficacy in Study

By January 17, 2017

Allergan and Gedeon Richter announced positive results from the second Phase 3 trial of ulipristal acetate, evaluating its efficacy and safety for the treatment of abnormal bleeding due to uterine fibroids in women.

Novel Cephalosporin Demonstrates Superiority in Complicated UTI

By January 13, 2017

Shionogi has announced positive results from the APEKs-cUTI* study which evaluated their novel antibiotic, cefiderocol (S-649266), for the treatment of patients with serious complicated urinary tract infection (cUTI) by Gram-negative bacteria.

Cinvanti NDA Submitted for CINV Prevention

By January 12, 2017

Heron Therapeutics announced the submission of the New Drug Application (NDA) for Cinvanti (HTX-019) to the Food and Drug Administration (FDA) for the prevention of chemotherapy-induced nausea and vomiting (CINV).

FDA Accepts BLA for Trastuzumab Biosimilar

By January 11, 2017

Mylan announced that the Food and Drug Administration (FDA) has accepted the biologics license application (BLA) for their biosimilar to trastuzumab, MYL-1401O

Female Sexual Disorder Drug Appears Effective in Two Phase 3 Studies

By January 10, 2017

AMAG pharmaceuticals and Palatin Technologies have entered into an agreement for the exclusive North American rights to develop and commercialize Rekynda (bremelanotide), an investigational drug to treat hypoactive sexual desire disorder (HSDD).

Viralym-C Granted Fast Track Status for Refractory CMV Infection

By January 10, 2017

ViraCyte announced that the FDA has granted Fast Track designation to its T cell immunotherapy, Viralym-C, for the treatment of refractory cytomegalovirus (CMV) infections in patients following a stem cell transplant.

Fixed-Dose Pan-Genotypic HCV Regimen Shows Promise at Week 8

By January 10, 2017

AbbVie announced positive data from its Phase 3 study of glecaprevir (ABT-493)/pibrentasvir (ABT-530) (G/P) in Japanese patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection without cirrhosis.

Tecentriq Granted Priority Review for mUC Indication

By January 09, 2017

Genentech announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) and granted Priority Review for Tecentriq (atezolizumab)

Soliris Application Seeks Ultra-Rare Neuromuscular Disease Indication

By January 09, 2017

Alexion has submitted a marketing application to the Food and Drug Administration (FDA) to extend the indication for Soliris (eculizumab) to be a treatment for patients with refractory generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive.

Life-Threatening Blood Disorder Treatment Gets Orphan Drug Status

By January 06, 2017

Alexion has announced that the Food and Drug Administration (FDA) has granted orphan drug designation to ALXN1210, their candidate treatment for paroxysmal nocturnal hemoglobinuria (PNH).

FDA Review Underway for Eptacog Beta in Hemophilia

By January 06, 2017

LFB S.A. announced that the FDA has accepted for review the Biologic License Application (BLA) of its recombinant Coagulation Factor VIIa (eptacog beta, activated) for the potential treatment of congenital hemophilia A or B in adolescents and adults with inhibitors.

Potential Treatment for Levodopa-Induced Dyskinesia Under Review

By January 06, 2017

The FDA has accepted for review the New Drug Application (NDA) for ADS-5102 (amantadine extended-release capsules; Adamas) for the treatment of levodopa-induced dyskinesia (LID) in patients with Parkinson's disease.

Stargardt Disease Drug Candidate Receives Orphan Drug Status

By January 06, 2017

Acucela has announced that the Food and Drug Administration (FDA) has granted orphan drug designation to their candidate, emixustat (emixustat hydrochloride), for the treatment of Stargardt disease.

Gene Therapy Fast Tracked for Rare Congenital Skin Disorder

By January 05, 2017

Fibrocell Science announced that the Food and Drug Administration (FDA) has granted Fast Track designation to FCX-007 for the treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB).

Priority Review Granted to Potential Liver Cancer Treatment

By January 04, 2017

Bayer has announced that their supplemental New Drug Application (sNDA) for Stivarga (regorafenib tablets) has been granted priority review status by the Food and Drug Administration (FDA).

FDA Fast Tracks Intranasal Diazepam for Acute Repetitive or Cluster Seizures

By January 04, 2017

Neurelis has announced that its intranasal diazepam candidate, NRL-1, has received Fast Track designation by the Food and Drug Administration (FDA).

Positive Phase 3 Results for Dry Eye Disease Candidate

By January 04, 2017

Sun Pharma announced successful Phase 3 results for Seciera (cyclosporine A, 0.09% ophthalmic solution), for the treatment of dry eye disease. Seciera is a preservative-free, aqueous solution with a proprietary nanomicellar formulation of cyclosporine A 0.09%.

NASH Drug Candidate Receives Fast Track Designation

By January 04, 2017

Enanta has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to their drug candidate EDP-305, a farnesoid X receptor (FXR) agonist.

Dual-Mechanism Gout Treatment Under FDA Review

By January 04, 2017

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Duzallo (lesinurad/allopurinol fixed-dose combination; Ironwood) for the treatment of hyperuricemia in patients with uncontrolled gout.

Ganaxolone Designated Orphan Drug for Fragile X Syndrome

By January 03, 2017

FXS, caused by a mutation in the FMR1 gene, is the most common genetic cause of autism.

New Pemetrexed Formulation to Be Reviewed by FDA

By January 03, 2017

The NDA proposes the use of ready-to-dilute pemetrexed injection for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) and mesothelioma (in combination with cisplatin).

New Oral Anticoagulant NDA Granted Priority Review

By December 28, 2016

Betrixaban has the potential to be the first anticoagulant approved for in-hospital and extended-duration VTE in high-risk acute medically ill patients.

Emicizumab Prophylaxis Reduced Number of Bleeds in Hemophilia A Trial

By December 22, 2016

The primary endpoint was the number of bleeds over time among patients with emicizumab prophylaxis or no prophylaxis.

Company Hopes to Deliver 'Virtually Painless Treatment Experience' with QuickShot Testosterone

By December 21, 2016

Antares Pharma announced the submission of a New Drug Application (NDA) for QuickShot Testosterone (testosterone enanthate auto-injector) to the Food and Drug Administration (FDA) to treat males with low testosterone associated with hypogonadism.

Breakthrough Designation Granted for Lymphoma Drug

By December 20, 2016

Juno and Celgene announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational drug JCAR017

FDA Fast Tracks Rare Hematological Disorder Treatment

By December 20, 2016

Apellis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to APL-2, a novel drug candidate studied for the treatment of paroxysmal nocturnal hemoglobinuria (PNH)

Novel DNA Vaccine for Peanut Allergy Gets Fast Tracked

By December 20, 2016

Astellas and Immunomic announced that the Food and Drug Administration (FDA) has granted Fast Track designation to its candidate ASP0892 for the mitigation of severe hypersensitivity reactions due to peanut allergy.

Glecaprevir/Pibrentasvir NDA Submitted for Pan-Genotypic HCV

By December 19, 2016

AbbVie announced the submission of a New Drug Application (NDA) for the pan-genotypic regimen of glecaprevir/pibrentasvir being developed for the treatment of chronic hepatitis C virus (HCV).

PTSD Drug Candidate Granted Breakthrough Therapy Designation

By December 19, 2016

Tonix announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to TNX-102 SL (cyclobenzaprine HCl sublingual tablets) for the treatment of posttraumatic stress disorder (PTSD).

Impavido Designated Orphan Drug for Amebic Meningoencephalitis

December 16, 2016

Profounda announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for Impavido (miltefosine) to treat primary amebic meningoencephalitis (PAM), also known as the "Brain Eating Amoeba".

FDA to Review Stelara for Adolescent Psoriasis

By December 16, 2016

Janssen Biotech announced the submission of a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) for Stelara (ustekinumab) to treat adolescents (12-17 years old) with moderate to severe plaque psoriasis.

Novel Pancreatic Cancer Treatment Granted Orphan Drug Status

By December 14, 2016

Ability Pharmaceuticals has announced that the Food and Drug Administration has granted orphan drug designation to ABTL0812, an investigational candidate for pancreatic cancer.

FDA to Review Sublingual Pain Drug Used in Medically Supervised Settings

By December 13, 2016

AcelRx announced the submission of a New Drug Application (NDA) for ARX-04 (sufentanil sublingual tablet) to the Food and Drug Administration (FDA).

Positive Results for Plazomicin for cUTI, CRE Infections

By December 12, 2016

Achaogen has announced positive results from the Phase 3 trials ('EPIC' and 'CARE') of plazomicin, a lead candidate for potential treatment of complicated urinary tract infections (cUTI) and acute pyelonephritis (AP).

Plecanatide Shows Promise for Treating IBS With Constipation

By December 09, 2016

Synergy has announced results from the first two pivotal Phase 3 trials evaluating plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).

Investigational Alzheimer's Drug Shows Efficacy for Specific Gene Carriers

By December 09, 2016

Alzheon has presented new analyses of a Phase 3 trial of tramiprosate, a potential Alzheimer's disease (AD) treatment.

FDA to Review Combo Drug Considered a Salvage Therapy for HCV Patients

By December 08, 2016

Gilead Sciences announced the submission of a New Drug Application (NDA) for a once-daily single tablet regimen containing sofosbuvir 400mg, velpatasvir 100mg, and voxilaprevir 100mg (SOF/VEL/VOX) for the treatment of patients with direct-acting antiviral (DAA)-experienced chronic hepatitis C virus (HCV) infection.

Study Shows Direct Switch to Ultibro Breezhaler Improves COPD Symptoms

By December 08, 2016

Novartis announced positive data from the CRYSTAL study evaluating the effects of directly switching symptomatic, non-frequently exacerbating patients with moderate chronic obstructive pulmonary disease (COPD) from their current treatments to Ultibro Breezhaler (indacaterol/glycopyrronium) 110mcg/50mcg.

Cimzia Effectiveness Assessed for Chronic Plaque Psoriasis

By December 08, 2016

UCB and Dermira have announced topline results from their Phase 3 trial (CIMPASI-1) evaluating the safety and efficacy of Cimzia (certolizumab pegol) in adult patients with moderate-to-severe chronic plaque psoriasis.

Efficacy Results Announced for Combo Psoriasis Therapy

By December 08, 2016

Valeant announced positive results from a Phase 3 study of IDP-118 (halobetasol propionate and tazarotene lotion) in the treatment of plaque psoriasis.

Fast Track Designation Granted to Novel Gastroparesis Therapy

By December 06, 2016

Theravance announced that the Food and Drug Administration (FDA) has granted Fast Track designation to to velusetrag (TD-5108) for the treatment of symptoms associated with idiopathic and diabetic gastroparesis.

T2DM Drug Semaglutide Gets Closer to Approval with NDA Submission

By December 05, 2016

Novo Nordisk has announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for semaglutide, for the treatment of adults with type 2 diabetes.

FDA Accepts Keytruda sBLA for Hodgkin Lymphoma Indication

By December 01, 2016

Merck announced that the Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab) for review.

Drug to Prevent S. aureus Pneumonia Gets Fast Track Designation

By December 01, 2016

Arsanis has announced that the Food and Drug Administration (FDA) has granted Fast Track designation to ASN100, a novel combination of two fully human monoclonal antibodies to potentially prevent Staphylococcus aureus pneumonia.

DS-8201 Fast-Tracked for HER2+ Metastatic Breast Cancer

By December 01, 2016

Daiichi Sankyo announced that the Food and Drug Administration (FDA) has granted Fast Track designation for DS-8201 for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine (T-DM1).

Significant Seizure Reduction with Pregabalin in Pediatric Study

By December 01, 2016

Pfizer announced positive Phase 3 study data that evaluated Lyrica (pregabalin) capsules and oral solution as adjunctive therapy for pediatric epilepsy patients aged 4-16 years with partial onset seizures.

Pediatric Crohn's Disease Therapy Granted Orphan Drug Designation

By November 30, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to risankizumab (ABBV-066) for the investigational treatment of Crohn's disease in pediatric patients.

Priority Review Given to Metastatic Merkel Cell Carcinoma Agent

By November 30, 2016

Merck and Pfizer announced that the Food and Drug Administration (FDA) has accepted for Priority Review the Biologics License Application (BLA) for avelumab to treat metastatic Merkel cell carcinoma.

Promising Results for Breast Cancer Drug Biosimilar

By November 30, 2016

Pfizer announced positive results from the REFLECTIONS B3271002 study that compared the safety and efficacy of Herceptin (trastuzumab; Genentech) and PF-05280014, a potential biosimilar to Herceptin.

FDA to Review Abilify Maintena for Bipolar I Disorder

By November 30, 2016

Otsuka and Lundbeck announced that the Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for the expanded labeling of Abilify Maintena (aripiprazole extended-release) for the maintenance treatment of bipolar I disorder in adults.

Biosimilar Candidate Effective in Phase 3 Psoriasis Trial

By November 29, 2016

Momenta has announced their adalimumab biosimilar candidate, M923, has met its Phase 3 primary endpoint of at least 75% reduction in the Psoriasis Area and Severity Index (PASI-75) following 16 weeks of treatment.

Results Released for Investigational Uveitis Therapy

By November 29, 2016

Santen has announced positive results from two Phase 3 trials of sirolimus intravitreal injection 440µg (Opsiria) for patients with non-infectious uveitis of the posterior segment.

Rare Liver Disorder Therapy Designated Orphan Drug

By November 28, 2016

PhaseRx announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for PRX-OTC for the treatment of ornithine transcarbamylase deficiency (OTCD).

Novel Opioid Therapy Emits Blue Dye as Abuse Indicator

By November 28, 2016

Intellipharmaceutics has filed a New Drug Application (NDA) with the Food and Drug Administration (FDA) for Rexista, a formulation of extended-release oxycodone hydrochloride with abuse-deterrent properties.

Results for Solanezumab in Mild Dementia of Alzheimer's Disease Announced

By November 23, 2016

Eli Lilly announced that solanezumab did not meet the primary endpoint in the Phase 3 EXPEDITION3 clinical trial in patients with mild dementia due to Alzheimer's disease.

Unique Diabetes Therapy Moves One Step Closer to Approval

By November 21, 2016

Intarcia has submitted its New Drug Application (NDA) to the Food and Drug Administration (FDA) for ITCA 650, a novel, subcutaneous GLP-1 receptor agonist therapy for the treatment of type 2 diabetes (T2D).

Company Halts Development of Post-Stroke Walking Difficulty Therapy

By November 21, 2016

Acorda has stopped development of dalfampridine to treat post-stroke walking difficulties (PSWD), due to an overall lack of clinically meaningful efficacy.

FDA to Review Closed Triple Combo Tx for COPD

By November 21, 2016

GlaxoSmithKline (GSK) and Innoviva have announced GSK's New Drug Application submission to the Food and Drug Administration (FDA) for the once-daily, closed triple combo therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25mcg), for the treatment of patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

FDA to Review Investigational Plaque Psoriasis Treatment

By November 17, 2016

Janssen has announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA), seeking approval of guselkumab for the treatment of adults with moderate to severe plaque psoriasis.

FDA Grants Orphan Drug Status to Novel PAH Treatment

By November 17, 2016

Reviva announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for RP5063, its lead development product for the treatment of pulmonary arterial hypertension (PAH).

Novel BACE Inhibitor in Development for Alzheimer's Disease

By November 17, 2016

Eisai announced that the Food and Drug Administration (FDA) has granted Fast Track designation for E2609 (Eisai and Biogen) in development for early Alzheimer's disease.

Positive Results Announced for Seborrheic Keratosis Treatment

By November 16, 2016

Aclaris has announced positive results from its two pivotal Phase 3 trials of A-101 40% Topical Solution (A-101), a novel treatment for seborrheic keratosis (SK).

Treatment for Painful Foot Nerve Disorder Gets Fast Track Designation

By November 15, 2016

Centrexion announced that the Food and Drug Administration (FDA) has granted Fast Track designation to CNTX-4975, a novel therapy intended to treat Morton's neuroma.

Phase 3 Trial Shows Promise in Treating Multi-Drug Resistant HIV-1

By November 10, 2016

TaiMed Biologics have released positive preliminary results of the Phase 3 trial of ibalizumab in patients with multi-drug resistant (MDR) HIV-1 (TMB-301).

FDA to Review Novel Sickle Cell Disease Therapy

By November 09, 2016

Emmaus Life Sciences has announced that the Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for its orally administered pharmaceutical grade L-glutamine (PGLG) treatment for sickle cell disease.

Trastuzumab Biosimilar BLA Submitted to FDA

By November 08, 2016

Mylan and Biocon announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for MYL-141O, the proposed biosimilar to trastuzumab.

Novel Mucopolysaccharidosis Tx Designated Orphan Drug

By November 07, 2016

Eloxx announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to ELX-02, its propriety drug candidate for the treatment of mucopolysaccharidosis type 1 (MPS I).

Spinraza Improves Motor Function in Spinal Muscular Atrophy Study

By November 07, 2016

Biogen and Ionis have announced positive results from the Phase 3 study of Spinraza (nusinersen), an investigational treatment for spinal muscular atrophy (SMA) in children.

PARP Inhibitor Veliparib Gets Orphan Drug Status from FDA

By November 04, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation to veliparib, an investigational combination with chemotherapies or radiation for the treatment of advanced squamous non-small cell lung cancer (NSCLC).

Investigational Insomnia Treatment Improves Sleep in Pediatric Patients

By November 02, 2016

Neurim announced positive top-line results from its NEU_CH_7911 Phase 3 study evaluating the efficacy and safety of PedPRM, a novel treatment for pediatric insomnia, designed for those with swallowing difficulties.

Positive Results for On-Demand Hypoactive Sexual Desire Disorder Drug

By November 02, 2016

Palatin has announced positive top-line results from the Phase 3 clinical trial of bremelanotide (a melanocortin 4 receptor agonist), an investigational treatment for hypoactive sexual desire disorder (HSDD).

Brigatinib NDA Accepted for FDA Review

By October 31, 2016

ARIAD announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for brigatinib to treat patients with metastatic ALK+ non-small cell lung cancer (NSCLC) who have progressed on crizotinib.

FDA to Review Treatment for Levodopa-Induced Dyskinesia

By October 27, 2016

Adamas announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for ADS-5102 (amantadine hydrochloride) extended-release capsules, to potentially treat levodopa-induced dyskinesia (LID) in patients with Parkinson's disease (PD).

NDA Submitted for Extended-Duration VTE Prophylaxis Drug Betrixaban

October 25, 2016

Portola has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval to market the investigational treatment betrixaban for extended-duration prophylaxis of venous thromboembolism (VTE).

New DMD Drug Candidate Designated Orphan Drug

By October 25, 2016

Solid Biosciences and Solid GT announced that the Food and Drug Administration (FDA) has granted Orphan Drug Designation for SGT-001 for the treatment of patients with Duchenne muscular dystrophy (DMD).

New Antibiotic for Serious Skin Infections Submitted for FDA Review

By October 24, 2016

Melinta Therapeutics announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for approval of intravenous (IV) and oral Baxdela (delafloxacin) for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).

FDA to Review Opdivo for Urothelial Carcinoma Use

By October 24, 2016

Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for Priority Review.

Positive Efficacy Results for Novel Depression Treatment

By October 21, 2016

Positive topline results have been announced for ALKS 5461, a once-daily, oral investigational drug for the adjunctive treatment of major depressive disorder.

Positive Results for HCV Combo Drug in Patients with Prior DAA Failure

By October 20, 2016

Gilead has announced positive results from four Phase 3 clinical studies of once-daily, fixed-dose combination of sofosbuvir (SOF), velpatasvir (VEL), and voxilaprevir (VOX; GS-9857), for the treatment of genotype 1-6 chronic hepatitis C infection.

Novel COPD Treatment Shows Benefits in Phase 3 Studies

By October 20, 2016

Theravance Biopharma and Mylan have announced positive results from two replicate Phase 3 studies of revefenacin (TD-4208) for the treatment of chronic obstructive pulmonary disease (COPD).

Letermovir Meets Primary Endpoint in CMV Infection Study

By October 19, 2016

Merck announced that the Phase 3 clinical study of letermovir for the prevention of clinically significant cytomegalovirus (CMV) infection in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant (HSCT) patients met its primary endpoint.

Positive Results for Elagolix in Two Endometriosis Studies

By October 19, 2016

AbbVie has announced positive results from two replicate Phase 3 clinical trials of Elagolix in premenopausal women with endometriosis.

Long-Term Safety Data for Novel Chronic Idiopathic Constipation Drug Announced

By October 17, 2016

At the American College of Gastroenterology (ACG) annual scientific meeting, Synergy presented new long-term safety data of plecanatide for the treatment of chronic idiopathic constipation (CIC).

FDA to Review New Data for Avycaz in Complicated UTI

By October 14, 2016

The Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for Avycaz (ceftazidime and avibactam; Allergen), for the addition of new Phase 3 data to the label.

FDA Grants Orphan Drug Status to ALS Treatment

By October 13, 2016

MediciNova announced that the Food and Drug Administration (FDA) has granted orphan drug designation to MN-166 (ibudilast) for the treatment of amyotrophic lateral sclerosis (ALS).

Novel Treatment for Recurrent Vulvovaginal Candidiasis Gets Fast Track Status

By October 13, 2016

Viamet has announced that the Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) and Fast Track designation to VT-1161, a novel treatment for recurrant vulvovaginal candidiasis (RVVC).

Priority Review Granted to Lucentis for Vision-Threatening Condition

By October 11, 2016

The Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA), and granted Priority Review, for Lucentis (ranibizumab injection; Genentech), to expand its indication for the treatment of myopic choroidal neovascularization (mCNV).

Experimental Drug Shows Promise in Alcohol Use Disorder and Smoking

October 11, 2016

Smokers may also benefit, results of a clinical trial suggest

Neulasta Biosimilar to Be Reviewed by FDA

By October 07, 2016

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies comparing CHS-1701 to Neulasta.

Positive Results for Investigational IL-23p19 Inhibitor in Psoriasis Studies

By October 05, 2016

The reSURFACE 1 and 2 trials were randomized, placebo-controlled, multicenter studies designed to demonstrate the efficacy of tildrakizumab in moderate-to-severe plaque psoriasis vs. placebo and comparative drug, and to assess safety and tolerability.

Actemra Designated Breakthrough Therapy for Giant Cell Arteritis

By October 05, 2016

Giant cell arteritis is a chronic, potentially life-threatening autoimmune condition that is more likely to affect women than men.

Guselkumab Goes Head-to-Head with TNF Blocker in Plaque Psoriasis Study

By October 03, 2016

The trial included an active comparator arm evaluating guselkumab vs. adalimumab, which demonstrated the superiority of guselkumab for major study endpoints and through Week 48 of treatment.

Pan-Genotypic HCV Regimen Gets Breakthrough Status

By September 30, 2016

The clinical development program is designed to investigate a pan-genotypic (genotypes 1 to 6) regimen of glecaprevir/pibrentasvir.

New Data on First-in-Class Schizophrenia Drug Announced

By September 29, 2016

Intra-Cellular Therapies have announced inconclusive results from the second Phase 3 trial of ITI-007 (Study '302), a first-in-class investigational medicine for the treatment of schizophrenia.

Neonatal Herpes Simplex Drug Designated Orphan Drug

By September 29, 2016

Neonatal herpes simplex, a life-threatening infection, often produces severe long-term sequelae in the newborn.

Dupilumab Granted Priority Review for Atopic Dermatitis

By September 27, 2016

Regeneron and Sanofi announced that the Food and Drug Administration (FDA) has accepted for priority review the Biologics License Application (BLA) for dupilumab for the treatment of adults with inadequately controlled moderate-to-severe atopic dermatitis (AD).

NDA Submitted for Spinal Muscular Atrophy Treatment

By September 27, 2016

Biogen and Ionis have completed the rolling submission of a New Drug Application (NDA) to the FDA for the approval of nusinersen, an invesigational treatment for spinal muscular atrophy (SMA), for which there is currently no approved treatment.

FDA to Review Fycompa for Monotherapy Use in Partial-Onset Seizures

By September 27, 2016

Eisai announced the submission of a supplemental application for a proposed label change for Fycompa (perampanel) which would include use as monotherapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy ≥12 years.

Duchenne Muscular Dystrophy Drug Granted Fast Track Status

By September 27, 2016

Summit Therapeutics announced it has received a Fast Track designation from the Food and Drug Administration (FDA) for Ezutromid in the treatment of Duchenne muscular dystrophy (DMD).