FDA to Review New Generation Topical Quinolone for Impetigo

By August 31, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ozenoxacin 1% cream (Medimetriks) for the treatment of impetigo.

Fostamatinib Demonstrates Efficacy for Chronic, Persistent ITP

By August 30, 2016

Rigel Pharmaceuticals announced positive data from the Phase 3 study of fostamatinib for the treatment of chronic or persistent immune thrombocytopenia (ITP) in adults.

Potential ALS Treatment Under FDA Review

By August 30, 2016

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for edaravone (MCI-186; Mitsubishi Tanabe) for the treatment of amyotrophic lateral sclerosis (ALS).

Skin Substitute Granted Orphan Drug Status for Burn Patients

By August 30, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Regenicin's cultured skin substitute, NovaDerm, for the treatment of burns requiring skin grafting.

Study Highlights Added Benefit of Alirocumab in HeFH Patients Requiring Apheresis

By August 29, 2016

Regeneron and Sanofi announced positive data from ODYSSEY ESCAPE, a Phase 3 study which evaluated Praluent (alirocumab) in patients with heterozygous familial hypercholesterolemia (HeFH) requiring regular apheresis therapy.

Fexapotide vs. Conventional BPH Treatments Evaluated in Crossover Study

By August 26, 2016

Nymox announced positive data from the Phase 3 study of fexapotide for the treatment of benign prostatic hyperplasia (BPH) and localized prostate cancer.

Orphan Drug Status Granted to Ublituximab for Two Neuromyelitis Disorders

By August 26, 2016

The FDA has granted Orphan Drug designation to TG-1101 (ublituximab; TG Therapeutics) for the treatment of neuromyelitis optica (NMO) and neuromyelitis optica spectrum disorder (NMOSD).

IV-to-Oral Solithromycin vs. Moxifloxacin in Head-to-Head CABP Study

By August 26, 2016

Cempra announced published results from the Phase 3 study of solithromycin, evaluating an intravenous-to-oral switch for the treatment of community-acquired bacterial pneumonia (CABP) in the journal Clinical Infectious Diseases.

Synacthen Depot Fast-Tracked for Duchenne Muscular Dystrophy

By August 25, 2016

Mallinckrodt announced that the FDA has granted Fast Track designation to the Investigational New Drug (IND) application of Synacthen Depot (tetracosactide) for the treatment of Duchenne muscular dystrophy (DMD).

FDA to Review Additional Data for iGlarLixi, Approval Process Extended

By August 22, 2016

Zealand Pharma announced that Sanofi has submitted to the FDA updated data for iGlarLixi (insulin glargine and lixisenatide) as part of its New Drug Application (NDA) for the treatment of adults with type 2 diabetes.

FDA Fast Tracks Investigational Alzheimer's Drug

By August 22, 2016

The FDA has granted Fast Track designation to the investigational drug AZD3293 (Eli Lilly and AstraZeneca) for the treatment of Alzheimer's disease.

Inhaled Antifungal Granted Orphan Drug Status for Cystic Fibrosis

By August 22, 2016

The Food & Drug Administration has granted Orphan Drug designation to PUR1900 (Pulmatrix) for the treatment of pulmonary fungal infections in patients with cystic fibrosis (CF).

FDA Designates Dusquetide Orphan Drug for Life-Threatening Immune Disorder

By August 19, 2016

The FDA has granted Orphan Drug designation to dusquetide (SGX942; Soligenix) for the treatment of macrophage activation syndrome (MAS), a life-threatening complication of rheumatic disease.

Darzalex Combination Tx for Multiple Myeloma Under FDA Review

By August 18, 2016

Janssen Biotech announced the submission to the Food and Drug Administration (FDA) of a supplemental Biologics License Application (sBLA), with a request for Priority Review, for Darzalex (daratumumab), seeking to expand its current indication for the treatment of patients with multiple myeloma who have received at least one prior therapy.

Novel Drug for Major Depressive Disorder Gets Breakthrough Tx Designation

By August 18, 2016

The FDA has granted Breakthrough Therapy designation to the investigational compound esketamine (Janssen) for the treatment of major depressive disorder (MDD) with imminent risk for suicide.

FDA Wants More Data for Anticoagulant Antidote AndexXa

By August 18, 2016

The FDA has issued a Complete Response Letter (CRL) to the Biologics License Application (BLA) of AndexXa (andexanet alfa; Portola) as a reversal agent for life-threatening or uncontrolled bleeding due to Factor Xa inhibitors.

Long-Acting Buprenorphine Formulation Shows Promise for Opioid Dependence

By August 17, 2016

Indivior announced positive top-line results from the Phase 3 clinical trial of RBP-6000 (buprenorphine monthly depot) for the treatment of opioid use disorder as part of a complete treatment plan to include counseling and psychosocial support.

Sublingual Sufentanil Demonstrates Efficacy for Acute Pain in ER Patients

By August 15, 2016

AcelRx announced topline results from the Phase 3 SAP302 study of ARX-04 (sufentanil sublingual tablet) for the treatment of moderate-to-severe acute pain associated with trauma or injury in patients presenting to the emergency department.

Investigational Muscle Protein Designated Orphan Drug for DMD

By August 15, 2016

The FDA has granted Orphan Drug designation to TVN-102 (Tivorsan), previously referred to as recombinant human Biglycan, for the treatment of Duchenne Muscular Dystrophy (DMD).

Duodenal Mucosal Resurfacing Shows Promise as Type 2 Diabetes Treatment

By August 12, 2016

Fractyl Laboratories announced publication of data from its first-in-human study of Revita DMR (duodenal mucosal resurfacing) for the treatment of patients with Type 2 diabetes.

Baremsis Demonstrates Efficacy for Post-Op Nausea and Vomiting

By August 12, 2016

Acacia Pharma announced positive data from the Phase 3 study of Baremsis (amisulpride) for the potential treatment of post-operative nausea & vomiting (PONV).

Novel Glucokinase Activator Shown Effective, Safe for Type 2 Diabetes

By August 11, 2016

vTv Therapeutics announced positive topline results from the Phase 2b AGATA study of the glucokinase activator, TTP399, for the treatment of Type 2 diabetes.

FDA Grants Priority Review to Deflazacort for Duchenne Muscular Dystrophy

By August 10, 2016

The FDA has accepted for filing and granted Priority Review to the New Drug Applications (NDA) of deflazacort immediate-release tablet and oral suspension formulations for the treatment of Duchenne Muscular Dystrophy (DMD).

Positive Results Announced for Adalimumab Biosimilar in Psoriasis Study

By August 09, 2016

Coherus BioSciences announced topline results from an ongoing Phase 3 clinical study of CHS-1420, an adalimumab (Humira) biosimilar candidate, for the treatment of patients with psoriasis.

Expanded Dosing Interval for Aristada Under FDA Review

By August 08, 2016

Alkermes announced that it has submitted a supplemental New Drug Application (sNDA) to the Food and Drug Administration (FDA) for a two-month dosing interval of Aristada (aripiprazole lauroxil), providing a third dosing option for the treatment of schizophrenia.

Anti-Cocaine Vaccine To Be Tested in Humans Soon

By August 08, 2016

Weill Cornell Medicine and NewYork-Presbyterian have developed a vaccine for cocaine addiction to be studied in a Phase 1 clinical trial.

FDA to Review Follow-on Biologic Insulin Glargine Candidate

By August 05, 2016

The FDA has accepted for review the New Drug Application (NDA) for MK-1293 (Merck), a follow-on biologic insulin glargine candidate, for the treatment of type 1 and type 2 diabetes.

Stem Cell Tx Evaluated for Perianal Fistulas in Crohn's Disease

By August 02, 2016

Takeda and TiGenix announced positive results from the Phase 3 ADMIRE-CD trial of Cx601 for the treatment of complex perianal fistulas in patients with Crohn's disease. Study findings were published in The Lancet.

Combo Tx for AML Patients Unfit for Intensive Chemotherapy Gets FDA Breakthrough Status

By August 01, 2016

The FDA has granted Breakthrough Therapy designation for pracinostat (MEI Pharma) in combination with azacitidine for the treatment of acute myeloid leukemia (AML) in newly diagnosed patients who are ≥75 years old or ineligible for intensive chemotherapy.

FDA Grants VX15 Fast Track Status for Huntington's Disease

By August 01, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation for VX15 (Vaccinex) as a potential treatment for Huntington's disease (HD).

Treatment for Rare, Pediatric Neurodegenerative Disease Granted Priority Review

By August 01, 2016

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of cerliponase alfa (BioMarin) for the treatment of children with CLN2 disease, a form of Batten disease.

FDA to Review Novel Steroid-Releasing Implant for Chronic Sinus Disease

By August 01, 2016

Intersect ENT announced the submission of a supplemental premarket approval (PMA-s) to the Food and Drug Administration for its novel, bioabsorbable steroid-releasing implant, NOVA, for patients with chronic sinus disease.

Xeljanz Demonstrates Efficacy in Third Phase 3 Ulcerative Colitis Study

By July 29, 2016

Pfizer announced top-line results from OCTAVE Sustain, the third Phase 3 study of Xeljanz (tofacitinib citrate) for the potential treatment of patients with moderately to severely active ulcerative colitis (UC).

Investigational Drug Fast Tracked for NASH with Liver Fibrosis

By July 29, 2016

The FDA has granted Fast Track designation to SHP626 (volixibat; Shire) for the potential treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis

Positive Results for Postoperative IV Meloxicam Announced

By July 29, 2016

Recro Pharma announced positive results from the Phase 3 study for intravenous (IV) meloxicam (N1539) for the treatment of acute postoperative pain in patients following bunionectomy surgery.

FDA Fast Tracks Personalized Treatment for Type 1 Diabetes

By July 29, 2016

The FDA has granted Fast Track designation to Caladrius Biosciences' product candidate CLBS03 (autologous expanded polyclonal regulatory T cells, or Tregs) for the treatment of Type 1 diabetes mellitus (T1DM).

Second Breakthrough Therapy Designation Granted for Darzalex

By July 27, 2016

The FDA has granted Breakthrough Therapy designation to Darzalex (daratumumab; Janssen Biotech) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of multiple myeloma in patients who have received at least one prior therapy.

Novel Alzheimer's Disease Therapy Demonstrates Efficacy as Monotherapy

July 27, 2016

TauRx Therapeutics announced findings from the Phase 3 trial of LMTX for the treatment of mild or moderate Alzheimer's disease (AD). Results were presented at the 2016 Alzheimer's Association International Conference (AAIC) in Toronto, Canada.

Complete Response Letter Issued for Dextenza for Post-Surgical Ocular Pain

By July 25, 2016

The FDA has issued a Complete Response Letter (CRL) to the New Drug Application (NDA) of Dextenza (dexamethasone insert; Ocular Therapeutix) 0.4mg for the intracanalicular treatment of ocular pain after ophthalmic surgery.

Investigational Ebola Vaccine Granted Breakthrough Therapy Status

By July 25, 2016

Merck announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational vaccine V920 (rVSV-ZEBOV-GP, live attenuated) for the Ebola Zaire virus.

Safety of Glycopyrrolate Via eFlow Nebulizer Closed System Evaluated in COPD

By July 22, 2016

Sunovion announced positive findings from the GOLDEN-5 safety study evaluating SUN-101 (glycopyrrolate) delivered via an investigational nebulizer system (SUN-101/eFlow) for the treatment of moderate-to-very severe chronic obstructive pulmonary disease (COPD).

FDA to Review Investigational Bone-Forming Monoclonal Antibody for Osteoporosis

By July 22, 2016

Amgen and UCB announced the submission of a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for romosozumab for the treatment of osteoporosis in postmenopausal women at increased risk of fracture.

Intranasal Metoclopramide Evaluated for Diabetic Gastroparesis in Women

By July 19, 2016

Evoke Pharma announced topline Phase 3 data demonstrating that treatment with EVK-001 for the symptomatic relief of acute and recurrent diabetic gastroparesis in adult women failed to achieve the primary endpoint at Week 4.

FDA Fast Tracks Esketamine Gel for Acute Inner Ear Tinnitus

By July 18, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to Keyzilen (AM-101; Auris Medical) for the treatment of acute peripheral tinnitus following cochlear injury or otitis media in adults.

FDA to Review Device-Based Approach for Tear Production

By July 18, 2016

Allergan announced the submission of a de novo application to the Food and Drug Administration (FDA) for the Oculeve Intranasal Tear Neurostimulator device.

Generic Nilandron Now Available

By July 18, 2016

ANI announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for nilutamide tablets, the generic version of Nilandron (Covis), indicated for use in combination with surgical castration for the treatment of metastatic prostate cancer.

FDA Grants Orphan Drug Status to Narcolepsy Treatment

By July 11, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation for mazindol (NLS Pharma) for the treatment of narcolepsy.

FDA Reviews Aggrastat sNDA, Needs More Information for Expanded Indication

By July 08, 2016

The FDA has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) of Aggrastat (tirofiban; Medicure) for the expanded indication in patients with ST segment elevation myocardial infarction (STEMI).

Idalopirdine Granted Fast Track Designation for Alzheimer's Disease

By July 08, 2016

The Food and Drug Administration (FDA) has granted Fast Track designation to idalopirdine (Lundbeck and Otsuka) for the treatment of mild to moderate Alzheimer's disease.

Humira Evaluated for Fingernail Psoriasis in Phase 3 Study

By July 07, 2016

AbbVie will present positive data from a Phase 3 study evaluating Humira (adalimumab) in patients with moderate to severe fingernail psoriasis at the Psoriasis 2016 - 5th Congress of the Psoriasis International Network in Paris, France.

Next-Generation Macrolide for CABP Under FDA Review

By July 07, 2016

The FDA has accepted for filing the two New Drug Applications (NDAs) for the intravenous and oral formulation of Solithera (solithromycin; Cempra) as a potential treatment for community-acquired bacterial pneumonia (CABP).

Orphan Drug Status Granted to First-in-Class Sarcoidosis Treatment

By July 06, 2016

The Food and Drug Administration (FDA) has granted Orphan Drug designation to the investigational agent, ARA 290, for the treatment of sarcoidosis.

FDA Grants Priority Review to Ocrevus in MS

By June 30, 2016

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for Ocrevus (ocrelizumab; Genentech) for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).

Triple-Bead Mixed Amphetamine Salts Evaluated in Adult ADHD Study

By June 29, 2016

Shire announced positive topline results from the efficacy and safety study of SHP465 (triple-bead mixed amphetamine salts - MAS) for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adults.

FDA Grants Imbruvica Fourth Breakthrough Therapy Designation for cGVHD

By June 29, 2016

AbbVie announced that the Food and Drug Administration (FDA) has granted a fourth Breakthrough Therapy designation for Imbruvica (ibrutinib) and an Orphan Drug designation for the potential treatment of chronic graft-versus-host-disease (cGVHD) after failure of one or more lines of systemic therapy.

FDA to Review Novel Topical Antibiotic for Impetigo

By June 27, 2016

Ozenoxacin belongs to a novel generation of non-fluorinated quinolones

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).

Erenumab Demonstrates Efficacy as Chronic Migraine Prophylaxis Therapy

By June 08, 2016

Amgen announced positive data from the Phase 2 study of erenumab (AMG 334) as a potential therapy for chronic migraine prevention.

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).