Astellas Seeks Approval for Overactive Bladder Combo Therapy

By June 30, 2017

"We look forward to FDA's review of our application for a potential new treatment option for the millions of people living with OAB," said Bernhardt Zeiher, MD, president of Development at Astellas.

Emicizumab Beneficial in Hemophilia A Patients With Inhibitors to FVIII

By June 29, 2017

The primary analysis of the study arm showed a statistically and clinically significant reduction in bleeding by 87% (risk rate [RR] 0.13; P<0.0001] with emicizumab prophylaxis.

Rituxan Biosimilar BLA Accepted for FDA Review

By June 29, 2017

The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.

New Antibiotic Designated QIDP for Two Indications

By June 29, 2017

The gel is hormone-free and can be used with other forms of contraception or used alone. The gel, supplied in a pre-filled applicator, can be self-applied.

NDA Resubmitted for Twirla Contraceptive Patch

By June 28, 2017

In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.

NDA Resubmitted for Twirla Contraceptive Patch

By June 28, 2017

In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.

Miltefosine Gains Orphan Drug Status for Serious CNS Infections

By June 28, 2017

Miltefosine is an alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. It is already approved to treat visceral, mucosal and cutaneous leishmaniasis in patients aged ≥12 years; it is the first oral treatment for this rare tropical parasitic disease.

FDA to Review Lower Dose Xarelto for Recurrent VTE Risk Reduction

By June 28, 2017

Both doses of Xarelto (10mg and 20mg) were superior to aspirin (100mg) in lowering the risk of recurrent VTE after ≥6 months of standard anticoagulation.

Novel CETP Inhibitor Shows Coronary Improvements in Phase 3 Study

By June 27, 2017

The full results of the REVEAL trial will be announced at the European Society of Cardiology meeting on August 29.

NDA Accepted for Anti-Inflammatory Inj Post-Cataract Surgery

By June 26, 2017

Dexycu injection was developed to help compliance—especially among elderly patients—and avoid dosing errors associated with conventional treatments that depend on self-administered eye drops multiple times a day.

Novel Synthetic Bio Drug for Hyperammonemia Granted Fast Track

By June 26, 2017

Synthetic Biotic medicines utilize synthetic biology to reprogram probiotic bacteria to perform critical functions that compensate for those missing or damaged due to a particular disease.

Novel Liquid Soln for Lennox Gastaut Syndrome Gets Orphan Drug Status

By June 22, 2017

The Company is awaiting top-line results of the current trial before initiating the LGS study.

Investigational Opioid Use Disorder Injectable Tx Shows Promise

By June 21, 2017

Results showed that at Month 6, the RBP-6000 groups demonstrated abstinence rates of 41.3% (300/300mg dose) and 42.7% (300/100mg dose) vs. 5% for placebo (P<0.0001), a statistically significant difference.

First-in-Class Pancreatic Cancer Drug Gains Orphan Drug Status

By June 21, 2017

Clinical trials of pamrevlumab are currently ongoing for conditions such as idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy.

Shingrix Proves Noninferior to Current Zoster Vaccine in Study

By June 21, 2017

"[These results] indicate that Shingrix can be an option for adults over 50 years of age, who previously received the currently available vaccine and are seeking to benefit from revaccination with Shingrix, if recommended," said Dr. Thomas Breuer, SVP and CMO of GSK Vaccines.

FDA Fast Tracks Drug for Hallucinations Disorder in Lewy Body Dementia

By June 19, 2017

Nelotanserin is a novel once-daily oral 5HT2A inverse agonist. The 5HT2A receptor has been associated with neuropsychiatric effects, including visual hallucinations.

NDA Filed for Tavalisse for Immune Thrombocytopenia Treatment

By June 19, 2017

Tavalisse is an oral treatment designed to inhibit SYK kinase, a key signaling member in the immune process that leads to platelet destruction in ITP.

First-in-Class Drug Candidate Fast Tracked for Chronic Pain

By June 14, 2017

Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies.

Triple-Therapy, Single Tablet HIV Regimen Submitted to FDA for Review

By June 12, 2017

Three of the ongoing studies are evaluating the safety and efficacy of BIC/FTC/TAF vs. triple-therapy regimens containing dolutegravir 50mg among treatment-naive patients and among virologically-suppressed patients who are switching from an existing antiretroviral regimen with dolutegravir.

Galcanezumab Shown to Significantly Cut Monthly Migraine Days

By June 10, 2017

Patients in the galcanezumab group had statistically significant greater reduction in monthly migraine headache days with acute medication use compared to placebo.

FDA to Review Trulance for IBS-C Indication in Adults

By June 07, 2017

Results from both studies showed Trulance was statistically superior to placebo in achieving the primary endpoint (Study 1: 30.2%, P<0.001 in 3mg and 29.5% in 6mg vs. 17.8% in placebo; Study 2: 21.5% in 3mg and 24.0% in 6mg vs. 14.2% in placebo).

JZP-110 Effective for Excessive Sleepiness in OSA Patients

By June 06, 2017

Significant overall improvements were also noted on the key secondary endpoint of improved Patient Global Impression of Change (PGIc) scale, with 90% of patients in the 150mg and 300mg arms reporting overall improvement at Week 12.

Tafamidis Gets Fast Track Status for Rare Disease Linked to Progressive HF

By June 06, 2017

Vyndaqel is approved in Europe and a number of other countries to treat transthyretin familial amyloid polyneuropathy (TTR-FAP) but not in the U.S.

FDA to Review New Evolocumab Cardiovascular Outcomes Data

By June 05, 2017

Results showed that the Repatha plus statin group had a statistically significant 20% (P<0.001) reduction in hard major adverse cardiovascular events.

Inhaled L-dopa Meets Endpoints in Parkinson's Disease Study

By June 05, 2017

The study's primary endpoint was meaningful improvement in motor function as defined by the Unified Parkinson's Disease Rating Scale—Part III.

FDA to Review Opdivo for Hepatocellular Carcinoma Indication

By June 02, 2017

The sBLA submission was based on results from the Phase 1/2 CheckMate -040 study.

Vyxeos Granted Priority Review by FDA

By May 31, 2017

Vyxeos, or CPX-351, combines cytarabine and daunorubicin in a nano-scale liposome at a 5:1 molar ratio using the CombiPlex platform.

CGRP Targeted Drug Looks Promising for Migraine Prevention

By May 31, 2017

The HALO Clinical Research Program consists of two 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies that compared fremanezumab to placebo in adults with episodic and chronic migraine.

Acute Hepatic Porphyria Therapy Gets Breakthrough Designation

By May 31, 2017

Currently, the only approved treatment for AHP attacks is hemin for injection (Panhematin or Normosang).

Priority Review Granted for Axicabtagene Ciloleucal in NHL

By May 26, 2017

In the ZUMA-1 trial 42% of patients demonstrated ongoing response at the 8.7-month follow-up, of which 39% achieved complete response.

Lurasidone Benefits Younger Patients with Bipolar Depression in Phase 3 Study

By May 24, 2017

Results showed a statistically significant change from baseline to Week 6 in favor of Latuda vs. placebo in the Clinical Global Impression-Bipolar Version, Severity of Illness (CBI-BP-S) score and the Children's Depression Rating Scale, Revised (CDRS-R) score.

New CRAC Channel Inhibitor for Acute Pancreatitis Fast-Tracked

By May 24, 2017

In Phase 1 safety studies, CM4620 showed positive activity in vivo in several animal models. CalciMedica plans to begin the first of its patient studies early in 2018.

Tildrakizumab to Be Reviewed for Moderate-to-Severe Plaque Psoriasis

By May 24, 2017

Ongoing data from two Phase 3 trials, ReSurface 1 and ReSurface 2, which enrolled over 1,800 patients, is included in the BLA.

Novel HIV Vaccine Shows High Immune Response Rate in Study

By May 24, 2017

Overall, 71 of 76 participants (93%) showed detectable CD4+ or CD8+ responses to at least one of the vaccine's four antigens.

P2X3 Receptor Antagonist Investigated for Chronic Cough

By May 24, 2017

Results, measured by a recording device, found that those in the 50mg MK-7264 group had a statistically significant reduction in cough frequency of 37% when compared with placebo.

Roclatan Meets Primary Endpoint in Phase 3 Glaucoma Study

By May 24, 2017

The evaluation of Roclatan has been ongoing in two distinct trials.

Sinuva Implant for Chronic Sinusitis to Be FDA Reviewed

By May 23, 2017

The Sinuva implant releases mometasone furoate to the ethmoid sinus lining and is intended to treat chronic sinusitis patients who have recurrent sinus obstruction.

Novel Oral Therapy Looks Promising for Relapsing MS

By May 22, 2017

The Radiance trial included 1,313 relapsing multiple sclerosis (RMS) patients who were administered either 0.5mg or 1mg of oral ozanimod, or weekly intramuscular interferon beta-1a (Avonex) over a 2 year treatment period.

Benralizumab Use Cuts Need for Oral Steroids in Severe Asthma

By May 22, 2017

The primary endpoint was met with 75% of the benralizumab group reducing their OCS doses compared to 25% in the placebo group. Additionally, 52% of the benralizumab group who had optimized baseline OCS doses of ≤12.5mg/d were able to completely stop OCS use.

Aptiom sNDA for Pediatric Indication Accepted for Review

By May 22, 2017

The sNDA submission includes data from five controlled clinical trials in adults with POS and three clinical studies demonstrating safety and tolerability in pediatric patients.

Biologic for Migraine Prevention Submitted to FDA

By May 18, 2017

Amgen announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for erenumab for the prevention of migraines.

Neuroactive Steroid Gets Fast Tracked for Major Depressive Disorder

By May 18, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SAGE-217 (Sage Therapeutics) for the potential treatment of major depressive disorder (MDD).

Copanlisib Granted Priority Review for Follicular Lymphoma

By May 17, 2017

Orphan designation has also been granted to copanlisib for the treatment of splenic, nodal, and extranoldal subtypes of marginal zone lymphoma.

AML Drug Candidate Granted Breakthrough Therapy Designation

By May 17, 2017

Data from an ongoing multicenter, open-label Phase 1/2 trial was presented at the American Society of Hematology in 2016 that evaluated GMI-1271 as adjunct to chemotherapy to patients with relapsed/refractory AML in addition to patients aged ≥60 years with newly diagnosed disease.

Fast Track Status Granted to Tideglusib for Myotonic Dystrophy

By May 17, 2017

In preclinical studies, AMO-02 has shown efficacy in transgenic models and reversal of muscle cell differentiation deficits in ex vivo tissue samples.

Novel Hemophilia A Gene Therapy Gets Fast Track Status

By May 16, 2017

The Food and Drug Administration (FDA) has granted Fast Track designation to SB-525 (Sangamo Therapeutics) for the treatment of hemophilia A.

Inotersen Shows Promise in Phase 3 Familial Amyloid Polyneuropathy Study

By May 15, 2017

Ionis announced positive results from the Phase 3 study of inotersen (IONIS-TTRRx) for the treatment of familial amyloid polyneuropathy (FAP), now referred to as hereditary transthyretin amyloidosis with polyneuropathy (hATTR-PN).

FDA Accepts NDA for Glaucoma Drug Rhopressa

By May 15, 2017

The FDA has completed its initial 60-day review of the New Drug Application (NDA) for Rhopressa (netarsudil; Aerie) 0.02% and determined that it's sufficiently complete to permit a substantive review.

Trigriluzole Fast Tracked for Rare Neurodegenerative Disorder

By May 15, 2017

The FDA has granted Fast Track designation to trigriluzole (BHV-4157; Biohaven) for the potential treatment of Spinocerebellar Ataxia (SCA), a rare and debilitating neurodegenerative disorder.

Tenapanor Achieves Primary Endpoint in IBS-C Trial

By May 12, 2017

Results showed that the endpoint was met with 27% in the tenapanor arm compared to 18.7% in the placebo arm (P=0.02) having at least 30% reduction in abdominal pain and an increase of 1 or more complete spontaneous bowel movements.

Novel Treatment for IgG4-Related Disease Gains Orphan Drug Status

By May 12, 2017

There is currently no approved treatment for lgG4-RD, which is a newly recognized disorder and is estimated to affect 40,000 individuals in the U.S.

Once-Monthly Biologic Looks Promising for Migraine Prophylaxis

By May 12, 2017

Lilly announced encouraging results from three Phase 3 studies of galcanezumab, EVOLVE-1, EVOLVE-2 and REGAIN, evaluating its efficacy and safety for the prevention of episodic and chronic migraine.

First-in-Class Oral Enzyme Designated Breakthrough Therapy for CDI Prevention

By May 11, 2017

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for ribaxamase (SYN-004; Synthetic Biologics) for the prevention of Clostridium difficile infection (CDI).

Gimoti Shows Benefit in Moderate to Severe Diabetic Gastroparesis

By May 11, 2017

Results showed that the primary efficacy endpoint of change from baseline to week 4 was not statistically met (P=0.881), although a significant treatment benefit was seen in patients with moderate to severe symptoms (P<0.05).

FDA Grants Vonapanitase Breakthrough Therapy Status for Hemodialysis Use

By May 10, 2017

A second Phase 3 trial for vonapanitase in hemodialysis patients, PATENCY-2, is currently ongoing and is expected to complete enrollment in the first quarter of 2018.

FDA Issues Complete Response Letter for Dyspareunia Drug

By May 09, 2017

The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of TX-004HR (TherapeuticsMD) for the treatment of moderate-to-severe vaginal pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA) due to menopause.

FDA Fast Tracks Gene Therapy for Chronic Angina Patients

By May 08, 2017

XC001 is an investigational cardiovascular angiogenic gene therapy that promotes angiogenesis to provide arterial blood flow to myocardial regions with inadequate blood supply.

FDA Fast Tracks Metastatic Breast Cancer Combo Treatment

By May 08, 2017

The only adverse event that was grade 3 or higher was fatigue with 16.3% incidence in the treatment group and 13.2% in the control group.

Xeljanz Under FDA Review for Psoriatic Arthritis

By May 05, 2017

An anticipated Prescription Drug User Fee Act (PDUFA) action date of December 2017 has been set by the FDA for both Xeljanz sNDAs.

Brexpiprazole Evaluated for Agitation in Alzheimer's Dementia

May 03, 2017

Otsuka and Lundbeck announced top-line results from two Phase 3 trials of brexpiprazole for the treatment of agitation in patients with dementia of the Alzheimer's type.

Xarelto sNDA Looks to Add New Dosing Option to Reduce Recurrent VTE Risk

By May 02, 2017

The new sNDA submission is supported by the 'Einstein Choice' study, which included 3,365 patients in a Phase 3 randomized, double-blind study that compared Xarelto once daily to aspirin.

Intranasal Midazolam Evaluated as Rescue Therapy for Seizure Clusters

By May 02, 2017

Proximagen announced promising data from the pivotal Phase 3 trial of USL261 (intranasal midazolam) for the rescue treatment of seizure clusters. The primary efficacy endpoint was treatment success, defined as achieving 1) termination of seizure(s) and 2) no recurrence of seizure(s)

FDA Grants Lorlatinib Breakthrough Therapy Designation for NSCLC

By April 28, 2017

Pfizer has begun enrolling patients in a Phase 3 study of lorlatinib, called 'CROWN'. The trial will be an open-label randomized, two-arm study comparing lorlatinib to crizotinib in the first-line treatment of patients with metastatic ALK-positive NSCLC.

FDA to Review BLA Resubmission of Rheumatoid Arthritis Biologic

By April 28, 2017

The FDA has accepted for review the resubmission of the Biologics License Application (BLA) for Kevzara (sarilumab; Regeneron and Sanofi) for the treatment of adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to one or more disease modifying antirheumatic drugs.

Promising Results for Novel IV Migraine Therapy

By April 28, 2017

Results met the primary endpoint of a significant reduction in migraine days for the eptinezumab groups, as measured by 75% responder rates.

Novel DNRI Agent Improves ADHD Symptoms in Study

By April 21, 2017

Study data revealed children taking dasotraline 4mg daily had statistically significant and clinically meaningful improvement vs. placebo on the primary endpoint.

New Findings for Novel Pan-Genotypic HCV Regimen in Phase 3 Study

By April 20, 2017

New findings from EXPEDITION-1 showed that 99% of HCV infected patients with GT 1, 2, 4, 5 or 6 and compensated cirrhosis achieved SVR12 after 12 weeks of G/P treatment.

Tissue-Based Tx Granted Breakthrough Status for Complete DiGeorge Syndrome

By April 19, 2017

The FDA has granted Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations for the investigational tissue-based therapy, RVT-802 (Enzyvant), for the treatment of complete DiGeorge Syndrome (cDGS).

FDA to Review Fostamatinib for Chronic, Persistent ITP

By April 18, 2017

Rigel announced its submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for fostamatinib for the treatment of patients with chronic and persistent immune thrombocytopenic purpura (ITP).

Emicizumab Evaluated in Children with Hemophilia A

By April 17, 2017

The interim results from HAVEN 2, after a median of 12 weeks of treatment, showed that prophylaxis with emicizumab is associated with clinically meaningful reduction in the number of bleeds over time.

FDA Requires More Data Before Baricitinib Approval

By April 14, 2017

The NDA for baricitinib was submitted in January 2016 and a 3-month extension for time to review additional analyses was announced in January 2017.

NDA Submitted for Post-Cataract Surgery Inflammation Treatment

By April 13, 2017

Dexycu is a long-acting, biodegradable extended-release formulation of the anti-inflammatory agent dexamethasone, which is injected into the anterior chamber of the eye following cataract surgery.

FDA Fast Tracks d-Methadone as Adjunct Treatment for Depression

By April 13, 2017

The company has completed a Phase 1 study for REL-1017 and intends to initiate a randomized, double-blind, placebo-controlled Phase 2a trial in patients with major depressive disorder to assess its efficacy, safety, tolerability and pharmacokinetics.

Combo Tx Significantly Improves Lung Function in Cystic Fibrosis Study

By April 11, 2017

Results showed that the ivacaftor/tezacaftor group reached the primary endpoint with a mean absolute improvement in ppFEV1 of 4% points from baseline vs. placebo (P<0.0001).

Alectinib Improves Progression-Free Survival in NSCLC Study

April 10, 2017

The ALEX study is intended to convert Alecensa to full approval as an initial treatment.

Evinacumab Gets Breakthrough Status for Severe Form of Hypercholesterolemia

By April 06, 2017

Regeneron previously reported positive interim Phase 2 results which showed that evinacumab added to current lipid-lowering therapy reduced low-density lipoprotein cholesterol (LDL-C) levels by an additional 55%.

Opdivo Granted Priority Review for Colorectal Cancer Indication

By April 06, 2017

Opdivo, a human programmed death receptor-1 (PD-1)-blocking antibody, is already indicated for various renal and urologic cancers, head and neck cancer, lymphoma, skin cancer, and lung cancer.

First-in-Class Injectable Antibiotic Shows Promise for Complicated UTIs

By April 06, 2017

Zavante Therapeutics announced promising results from the pivotal ZEUS clinical trial, evaluating Zolyd (fosfomycin for injection) for the treatment of complicated urinary tract infections (cUTI), including acute pyelonephritis (AP).

Imbruvica Under Review for Graft-Versus-Host-Disease

By April 05, 2017

Imbruvica is a first-in-class, oral Bruton's tyrosine kinase (BTK) inhibitor.

Amgen Looks to Expand Xgeva Use to Multiple Myeloma Patients

By April 05, 2017

The study met its primary endpoint of Xgeva non-inferiority versus zoledronic acid in delaying the time to first on-study SRE in multiple myeloma patients (HR=0.98, 95% CI: 0.85, 1.14; P=0.01).

Novel Tetracycline Goes Head-to-Head with Moxifloxacin in Pneumonia Study

By April 04, 2017

The study met the primary and secondary endpoints, showing that omadacycline is non-inferior to moxifloxacin for the treatment of CABP.

Bio-Identical Combo Therapy Promising for Vasomotor Symptoms of Menopause

By April 04, 2017

TherapeuticsMD announced positive data for its investigational hormone therapy, TX-001HR, for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. Study findings were presented at the annual meeting of the Endocrine Society, ENDO 2017.

FDA to Review Vyxeos for Acute Myeloid Leukemia

By April 03, 2017

Jazz Pharmaceuticals announced the completion of a rolling submission of the New Drug Application (NDA) for Vyxeos (cytarabine and daunorubicin) liposome to the Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML).

Coversin Gets Fast Track Status for Paroxysmal Nocturnal Hemoglobinuria

By March 31, 2017

Akari is currently investigating Coversin in two Phase 2 clinical trials in patients with paroxysmal nocturnal hemoglobinuria.

Blincyto Gains Priority Review for sBLA

By March 31, 2017

Blincyto is the first single-agent immunotherapy approved to treat patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

Novel Allergic Rhinitis Nasal Spray Shows Promise in Phase 3 Trial

By March 29, 2017

Results showed that GSP 301 was tied to statistically significant improvements from baseline for the primary endpoint when compared to placebo (P<0.001), olopatadine (P=0.028), and mometasone (P=0.019).

Synergy Seeks IBS-C Indication for Trulance

By March 28, 2017

The new application for an IBS-C indication is supported by data from two placebo-controlled Phase 3 studies that lasted 12 weeks and evaluated plecanatide in 2,100 patients with IBS-C.

Ryanodex Gets Priority Review for Exertional Heat Stroke

By March 27, 2017

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Ryanodex (dantrolene sodium; Eagle) for the treatment of exertional heat stroke (EHS).

Sarecycline Promising for Moderate to Severe Acne

By March 27, 2017

Allergan and Paratek announced positive results from two Phase 3 studies of sarecycline for the treatment of moderate to severe acne.

Rituxan Gets Breakthrough Therapy Status for Rare Autoimmune Skin Disorder

By March 24, 2017

Genentech announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Rituxan (rituximab) for the treatment of pemphigus vulgaris.

Dravet Syndrome Tx Receives Orphan Drug Status

By March 23, 2017

Currently, FDA approved treatments for this disorder are unavailable in the U.S.

Single-Dose Treatment for Bacterial Vaginosis Under Priority Review

By March 23, 2017

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of Solosec (secnidazole oral granules; Symbiomix) for the treatment of bacterial vaginosis (BV).

FDA Fast Tracks Recombinant ADAMTS13 Enzyme Replacement Therapy

By March 22, 2017

Shire announced that the FDA has granted Fast Track designation to SHP655 (historically BAX930) for the treatment of acute episodes of hereditary thrombotic thrombocytopenic purpura (hTTP) in patients with a constitutional ADAMTS13 deficiency.

Orphan Drug Status Granted for C3 Glomerulopathy Treatment

By March 22, 2017

Patients with C3G experience progressive deterioration in renal function, ultimately leading to renal failure requiring dialysis and kidney transplant, if left untreated.

First-in-Class Opioid Analgesic Evaluated for Chronic Back Pain

By March 20, 2017

Nektar Therapeutics announced positive results from the SUMMIT-07 Phase 3 study of NKTR-181, a first-in-class opioid analgesic for the treatment of moderate to severe chronic pain.

Novel Drug Shows Promise for Excessive Sleepiness in OSA

By March 20, 2017

Both demonstrated highly statistically significant improvement in the co-primary endpoints of Maintenance of Wakefulness test and the Epworth Sleepiness scale, for JZP-110 versus placebo.

Sunovion Seeks Pediatric Indication for Aptiom

By March 13, 2017

Aptiom, a dibenzazepine carboxamide antiepileptic, is currently approved for use as monotherapy or adjunctive therapy for partial onset seizures (POS) in adults, the new supplemental NDA aims to extend this indication for the treatment of POS in children aged ≥4 years.

Evolocumab Reduces LDL-C Apheresis Need in Phase 3 Study

By March 13, 2017

Treatment with Repatha reached its primary endpoint of reducing the need for continued apheresis at the end of the randomization period.

FDA Grants Orphan Drug Status to MDS Biologic

By March 09, 2017

Boehringer Ingelheim announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to BI 836858 for the treatment of myelodysplastic syndromes (MDS).

Antibiotic Drug Reservoir Granted QIDP Status for Surgical Infections

By March 08, 2017

The FDA has granted Qualified Infectious Disease Product (QIDP) to D-PLEX (Doxycycline/Polymer-Lipid Encapsulation Matrix; PolyPid), a secured antibiotic drug reservoir for the local prevention and treatment of surgical infections.