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.

Alexion Seeks Eculizumab Approval for Ultra-Rare Neuromuscular Disease

By March 08, 2017

The submission is supported by data from the Phase 3 REGAIN study, a randomized, double-blind, placebo-controlled trial which enrolled a total of 125 patients with anti-AChR Abs.

FDA to Review Vraylar for Maintenance Treatment of Schizophrenia

By March 08, 2017

Allergan announced that the Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) for Vraylar (cariprazine) for the addition of new data evaluating Vraylar for the maintenance of efficacy in adults with schizophrenia.

FDA Grants Orphan Drug Status to Plague Vaccine

By March 08, 2017

The Food and Drug Administration (FDA) has granted Orphan Drug designation to the recombinant rF1V plague vaccine (CSRA/DynPort) for pre-exposure prophylaxis of Yersinia pestis infection, also known as, the plague.

Volanesorsen Demonstrates Efficacy in Rare, Severe Hypertriglyceridemia

By March 06, 2017

Akcea and Ionis announced positive findings from the APPROACH study, a Phase 3 trial of volanesorsen for the reduction of triglycerides in patients with familial chylomicronemia syndrome (FCS).

Guselkumab Shows Superiority in Plaque Psoriasis Phase 3 Studies

By March 03, 2017

Janssen announced new findings from VOYAGE 2 and NAVIGATE, two pivotal Phase 3 studies evaluating guselkumab for the treatment of moderate to severe plaque psoriasis.

Breckenridge Launches Generic Pristiq

By March 01, 2017

Desvenlafaxine Succinate is available as 50mg and 100mg extended-release tablets.

FDA Grants Orphan Drug Status to Rare Lysosomal Storage Disorder Treatment

March 01, 2017

The FDA has granted Orphan Drug designation to Sangamo's genome editing product candidate, SB-913, for the treatment of Mucopolysaccharidosis Type II (MPS II).

Avelumab Gets Priority Review for Urothelial Carcinoma Indication

By March 01, 2017

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) for avelumab (Merck and Pfizer) for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) with disease progression on or after platinum-based therapy.

VZV Vaccine for Immunocompromised Patients Shows Promise in Phase 3 Trial

By February 28, 2017

Merck has announced positive results from a Phase 3 trial of V212, an investigational varicella zoster virus vaccine (VZV) for the prevention of herpes zoster (HZ) in immunocompromised patients.

FDA to Review Ready-to-Dilute Pemetrexed Formulation

By February 28, 2017

The FDA has accepted for review the New Drug Application (NDA) for Eagle's ready-to-dilute (RTD) Pemetrexed Injection 25mg/mL for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer and mesothelioma (in combination with cisplatin).

Resolaris Granted Orphan Drug Status for Rare Genetic Myopathy

By February 28, 2017

The Food and Drug Administration (FDA) has granted Orphan Drug designation to Resolaris (aTyr Pharma) for the treatment of limb girdle muscular dystrophy (LGMD).

Drug for Catecholamine Resistant Hypotension Shows Promise in Phase 3 Study

By February 27, 2017

La Jolla announced positive data from the ATHOS-3 study which evaluated LJPC-501 (angiotensin II) for the treatment of catecholamine resistant hypotension (CRH).

NDA Re-Submitted for Novel Glaucoma Drug

By February 27, 2017

Valeant have re-submitted their NDA for latanoprostene bunod ophthalmic solution after receiving a Complete Response Letter from the FDA last summer.

Lurasidone Effective in Phase 3 Pediatric Bipolar Depression Study

By February 27, 2017

Sunovion announced that its Phase 3 study of Latuda (lurasidone HCI) in children aged 10 to 17 years with bipolar depression met its primary and secondary endpoints.

Dsuvia for Acute Pain Under FDA Review

By February 27, 2017

The FDA has accepted for review the New Drug Application (NDA) for Dsuvia (sufentanil sublingual tablet; AcelRx) for the treatment of moderate-to-severe acute pain in a medically supervised setting.

Fusidic Acid Looks Promising as Oral Therapy for ABSSSI

By February 24, 2017

The study achieved its primary endpoint, demonstrating that treatment with oral fusidic acid is non-inferior to oral linezolid.

FDA Grants Fast Track Status to Novel Therapy for Hearing Loss

By February 24, 2017

AM-111 is currently under investigation in two Phase 3 trials for patients with severe to profound idiopathic sudden sensorineural hearing loss.

Combination Biologic Granted Breakthrough Status for High Grade Glioma

By February 23, 2017

The Breakthrough Therapy designation was supported by safety, efficacy (durable, complete or partial tumor shrinkage) and patient survival data from three Phase 1 studies involving 126 patients with recurrent brain cancer.

Dextenza NDA Resubmission Accepted for Post-Surgical Ocular Pain

By February 23, 2017

The NDA for Dextenza was resubmitted in January 2017 following a Complete Response Letter that was issued in July 2016 due to concerns with deficiencies in manufacturing processes and controls.

Oliceridine as Effective as Morphine in Phase 3 Studies of Acute Post-Op Pain

By February 22, 2017

Oliceridine is a next generation injectable analgesic specifically designed to deliver the pain-reducing potential of an opioid but with fewer associated adverse effects.

Novel Oral MS Drug Effective, Safe in Phase 3 Study

By February 21, 2017

The primary endpoint was the reduction of annualized relapse rate (ARR) during the treatment period.

Unique Therapy for Advanced Heart Failure Granted Fast Track Status

By February 21, 2017

Ixmyelocel-T is an investigational autologous expanded multicellular therapy administered via transendocardial catheter-based injections.

Carbavance Gets Priority Review for Complicated UTI

By February 21, 2017

The study met the pre-specified primary endpoints and showed that treatment with Carbavance is associated with an overall success rate of 98.4%.

FDA Grants Priority Review to Antibody-Drug Conjugate for ALL

By February 21, 2017

The BLA submission is based on positive data from the INO-VATE 1022 study, a Phase 3 trial evaluating inotuzumab ozogamicin vs. standard of care chemotherapy in 326 adults with relapsed or refractory B-cell ALL.

FDA to Review Potential Neulasta Biosimilar

February 16, 2017

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for MYL-1401H (Mylan and Biocon), a proposed biosimilar candidate to Amgen's Neulasta (pegfilgrastim).

Doravirine Demonstrates Non-Inferiority in Phase 3 HIV Study

By February 15, 2017

Merck announced positive results from the pivotal Phase 3 study of doravirine (MK-1439), evaluating its efficacy and safety for the treatment of HIV-1 infection.vvvv

FDA to Review New Indication for Privigen

By February 14, 2017

Data from the Phase 3 PRIMA study suggests that Privigen may help decrease weakness and loss of motor function in people with CIDP.

FDA Fast Tracks Novel Combo Drug for Treatment Resistant Depression

By February 14, 2017

The FDA has granted Fast Track designation to the investigational drug AXS-05 (Axsome Therapeutics) for patients with treatment resistant depression (TRD).

Two-Drug HIV Combo as Effective as Three-, Four-Drug Regimen in Phase 3 Studies

By February 14, 2017

Janssen announced positive data from the SWORD Clinical Trial Program of the two-drug regimen dolutegravir (ViiV Healthcare) and rilpivirine (Janssen) for the maintenance treatment of HIV-1 infection in patients who have already achieved viral suppression.

Amgen Submits sBLA for Full Blincyto Approval

By February 14, 2017

Amgen has announced the submission of a supplemental Biologics License Application (BLA) for Blincyto (blinatumomab) to the Food and Drug Administration (FDA), to include overall survival data from the TOWER Phase 3 study.

Amgen Submits sBLA for Full Blincyto Approval

By February 14, 2017

Amgen has announced the submission of a supplemental Biologics License Application (BLA) for Blincyto (blinatumomab) to the Food and Drug Administration (FDA), to include overall survival data from the TOWER Phase 3 study.

Rescue Tx for Post-Op Nausea/Vomiting Effective in Pivotal Trial

By February 13, 2017

Acacia has announced positive results from its final pivotal Phase 3 study investigating BAREMSIS (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea and vomiting (PONV), despite having received prior antiemetic prophylaxis.

Positive Results Announced for Novel Microneedle Migraine Patch

By February 13, 2017

Zosano has announced positive results from their Phase 3 clinical trial of M207, the companies lead candidate for the treatment of migraine attacks.

Inhaled Levodopa Shows Promise for OFF Periods in PD Patients

By February 09, 2017

Acorda Therapeutics announced statistically significant results from the Phase 3 study of CVT-301, an investigational inhaled formulation of levodopa, for the treatment of OFF periods in patients with Parkinson's disease (PD) on an oral carbidopa/levodopa regimen.

FDA Accepts Zilretta NDA for Osteoarthritis Knee Pain

By February 07, 2017

The FDA has accepted for review the New Drug Application (NDA) for Zilretta (FX006; Flexion Therapeutics) for the treatment of patients with osteoarthritis (OA) of the knee.

FDA to Review New Film Formulation of Erectile Dysfunction Drug

By February 07, 2017

The FDA has accepted for review the New Drug Application (NDA) for Tadalafil Oral Soluble Film (Tadalafil OSF; MonoSol Rx) for the treatment of erectile dysfunction (ED).

FDA to Review Injection-Free GLP-1 Receptor Agonist Therapy for T2D

By February 06, 2017

The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for ITCA 650 (Intarcia Therapeutics) for the treatment of type 2 diabetes (T2D)

GM1 Gangliosidosis Treatment Gets FDA's Orphan Drug Designation

By February 06, 2017

Lysogene announced that the Food and Drug Administration (FDA) has granted orphan designation to LYS-GM101, their gene therapy drug candidate for the treatment of GM1 Gangliosidosis (GM1).

Priority Review Granted to Fixed-Dose Pan-Genotypic HCV Regimen

By February 02, 2017

The FDA has accepted and granted Priority Review to the New Drug Application (NDA) of glecaprevir/pibrentasvir (G/P; AbbVie) for the treatment of genotypes 1-6 (GT1-6) chronic hepatitis C virus (HCV) infection.

Investigational Hemophilia B Gene Therapy Granted Breakthrough Status

By January 30, 2017

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational gene therapy, AMT-060 (uniQure), for the treatment of severe hemophilia B.

Mixed Results for Acne Gel Candidate in Phase 3 Trials

By January 27, 2017

Novan has announced results from its two Phase 3 trials of SB204 gel 4%, its investigational candidate for the treatment of acne vulgaris.

Encouraging Results for Lenvatinib in HCC Trial

By January 25, 2017

Eisai has announced positive topline results from their Phase 3 trial of lenvatinib (Lenvima), for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC).

Tocilizumab Gets Priority Review for Treatment of Giant Cell Arteritis

By January 24, 2017

Genentech has announced that the Food and Drug Administration (FDA) has accepted the company's Supplmental New Drug Application (sBLA) for Actemra (tocilizumab) to treat giant cell arteritis (GCA).

CMV Treatment Granted Orphan Drug Designation by FDA

By January 24, 2017

ViraCyte has announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to its candidate cytomegalovirus (CMV) treatment, Viralym-C.

FDA to Review Drug for Exertional Heat Stroke

By January 23, 2017

Eagle announced the complete submission to the Food and Drug Administration (FDA) of its New Drug Application (NDA) for Ryanodex for the treatment of exertional heat stroke (EHS).

Dextenza NDA Resubmitted for Post-Surgery Ocular Pain

By January 23, 2017

Ocular has announced that it has resubmitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Dextenza (dexamethasone insert) 0.4mg, to treat ocular pain after ophthalmic surgery.

FDA Grants Deuterated CF Therapy Orphan Drug Designation

By January 20, 2017

The Food and Drug Administration (FDA) has granted Orphan Drug designation for Concert Pharmaceuticals' CTP-656 (deuterated ivacaftor) for the treatment of cystic fibrosis.

FDA to Review Briviact as Monotherapy for Partial-Onset Seizures

By January 19, 2017

UCB has filed a supplemental New Drug Application (sNDA) for Briviact (brivaracetam) as monotherapy to treat partial-onset seizures in patients ≥16 years with epilepsy.

FDA to Review Potential Single-Dose Therapy for Bacterial Vaginosis

By January 19, 2017

Symbiomix announced the submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Solosec (secnidazole oral granules) for the treatment of bacterial vaginosis (BV).

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.