FDA to Review Rexulti as Maintenance Therapy for Schizophrenia

The Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for the proposed labeling update of Rexulti (brexpiprazole; Otsuka and Lundbeck) for the maintenance treatment of adults with schizophrenia.

Tazemetostat Granted Orphan Drug Status for Rare, Aggressive Cancers

The Food and Drug Administration (FDA) has granted Orphan Drug designation to tazemetostat (Epizyme) for the treatment of malignant rhabdoid tumors (MRTs).

Complete Response Letter Issued for Expanded Kalydeco Indication

Complete Response Letter Issued for Expanded Kalydeco Indication

The Food and Drug Administration (FDA) has issued a Complete Response Letter for the supplemental New Drug Application (sNDA) of Kalydeco (ivacaftor; Vertex) in patients with cystic fibrosis (CF) ≥2 years old who have one of 23 residual function mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Top-line Results Announced for Repatha in Patients Who Are Statin-Intolerant

Top-line Results Announced for Repatha in Patients Who Are Statin-Intolerant

Amgen announced positive top-line data from the Phase 3 GAUSS-3 study evaluating Repatha (evolocumab) in statin-intolerant patients with high cholesterol.

Complete Response Letter Issued for MCNA in Bladder CA

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the Biologics License Application (BLA) for MCNA (Telesta Therapeutics) in the treatment of non-muscle invasive bladder cancer (NMIBC).

Ovarian Cancer Vaccine Granted Fast Track Status

Ovarian Cancer Vaccine Granted Fast Track Status

TapImmune announced that the Food & Drug Administration (FDA) has granted Fast Track designation for its cancer vaccine TPIV 200 in the treatment of ovarian cancer.

Investigational NASH Tx Fast Tracked by FDA

Investigational NASH Tx Fast Tracked by FDA

The Food and Drug Administration (FDA) has granted Fast Track designation to NDI-010976 (Nimbus Therapeutics) for the treatment of non-alcoholic steatohepatitis (NASH)

NDA Submitted for Chronic Idiopathic Constipation Drug Plecanatide

Synergy Pharmaceuticals announced the submission of its first New Drug Application (NDA) to the Food and Drug Administration (FDA) for plecanatide for the treatment of chronic idiopathic constipation (CIC).

Ryanodex Fast Tracked for Exertional Heat Stroke

Ryanodex Fast Tracked for Exertional Heat Stroke

The Food and Drug Administration (FDA) has granted Fast Track designation to Ryanodex (dantrolene sodium; Eagle) injectable suspension for the treatment of exertional heat stroke (EHS).

Positive Data for Investigational Hepatic VOD Tx Announced

Positive Data for Investigational Hepatic VOD Tx Announced

Jazz Pharmaceuticals announced positive data from the Phase 3 pivotal study of defibrotide in patients with hepatic veno-occlusive disease (VOD) with multi-organ failure (MOF) post-hematopoietic stem-cell transplantation (HSCT). Findings were published online in Blood, the Journal of the American Society of Hematology (ASH).

Combo Tx Fast Tracked for Fibromyalgia

The Food and Drug Administration (FDA) has granted Fast Track designation to IMC-1 (Innovative Med Concepts) for the treatment of fibromyalgia.

FDA Grants Breakthrough Tx Designation to Novel Antidepressant

FDA Grants Breakthrough Tx Designation to Novel Antidepressant

The Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to the investigational drug rapastinel (GLYX-13; Allergan) for the adjunctive treatment of Major Depressive Disorder (MDD).

Study on Opdivo for Head, Neck CA Halted Early

Study on Opdivo for Head, Neck CA Halted Early

Bristol-Myers Squibb announced that the CheckMate -141 trial evaluating Opdivo (nivolumab) vs. investigator's choice in patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck (SCCHN) was stopped early due to the study meeting its primary endpoint.

FDA Grants Priority Review to Expanded Cabozantinib Indication

The Food & Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for cabozantinib as a treatment for patients with advanced renal cell carcinoma (RCC) who have received one prior therapy.

Novel Antitoxin Granted Priority Review for CDI

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the Biologics License Application (BLA) for bezlotoxumab (Merck) for the prevention of Clostridium difficile (C. difficile) infection recurrence.

BLA for Adalimumab Biosimilar Accepted for Review

BLA for Adalimumab Biosimilar Accepted for Review

Amgen announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for ABP 501, a biosimilar candidate to Humira (adalimumab).

FDA Accepts IVIG-SN BLA for Primary Immunodeficiency

Green Cross announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for IVIG-SN (human normal immunoglobulin G), for the treatment of primary immunodeficiency diseases (PID).

BLA for New Plaque Psoriasis Tx Under FDA Review

Valeant, in partnership with AstraZeneca, announced that the Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for brodalumab injection for patients with moderate-to-severe plaque psoriasis.

Preliminary Results for Investigational MDD Tx Announced

Preliminary Results for Investigational MDD Tx Announced

Alkermes announced preliminary topline results from two Phase 3 trials, FORWARD-3 and FORWARD-4, for ALKS 5461, for the adjunctive treatment of major depressive disorder (MDD) in patients who have inadequate response to standard therapies.

Combination CLL Tx Designated Breakthrough Therapy Status

AbbVie announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for venetoclax in combination with rituximab for the treatment of patients with relapsed/refractory chronic lymphocytic leukemia (R/R CLL).

Isunakinra: Top-Line Phase 3 Results Announced

Eleven Biotherapeutics announced top-line results from the Phase 3 clinical trial of isunakinra (EBI-005) for the treatment of severe allergic conjunctivitis (AC).

FDA to Review Once-Daily Oral RA Tx

FDA to Review Once-Daily Oral RA Tx

Eli Lilly and Incyte announced that the New Drug Application (NDA) for once-daily oral baricitinib has been submitted to the Food and Drug Administration (FDA) for the treatment of moderately-to-severely active rheumatoid arthritis (RA).

FDA Issues Complete Response Letter to Kyndrisa

The Food and Drug Administration (FDA) has issued a Complete Response Letter to the New Drug Application (NDA) for Kyndrisa (drisapersen; Biomarin), for the treatment of Duchenne Muscular Dystrophy (DMD) amenable to exon 51 skipping.

FDA Committee in Favor of Subdermal Implant for Opioid Addiction

FDA Committee in Favor of Subdermal Implant for Opioid Addiction

Titan and Braeburn announced that the Psychopharmacologic Drugs Advisory Committee (PDAC) of the Food and Drug Administration (FDA) has recommended the approval of Probuphine, the first long-acting subdermal buprenorphine implant.

FDA Grants Venetoclax NDA Priority Review for CLL

The Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) for venetoclax (Genentech and AbbVie) for the treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, including those with 17p deletion.

FDA to Review TAF NDA for Chronic HBV Infection

Gilead announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for tenofovir alafenamide (TAF) 25mg for the treatment of adults with chronic hepatitis B virus (HBV) infection.

Cancer, RA Biosimilars Demonstrated Efficacy in Phase 3 Trials

Sorrento Therapeutics announced that its partner, MabTech, has successfully completed Phase 3 clinical trials in China for STI-001, a biosimilar antibody for cetuximab (Erbitux).

Cancer Vaccine Granted Orphan Drug Status for AML

Cancer Vaccine Granted Orphan Drug Status for AML

The Food and Drug Administration has granted Orphan Drug designation to WT1 cancer vaccine (Sellas) for the treatment of patients with acute myeloid leukemia (AML).

FDA Fast Tracks Tx for Metastatic Castrate-resistant Prostate CA

FDA Fast Tracks Tx for Metastatic Castrate-resistant Prostate CA

Innocrin announced that the Food and Drug Administration (FDA) has granted Fast Track designation to seviteronel (VT-464) for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC).

NDA for First-in-Class DMD Tx Submitted to FDA

NDA for First-in-Class DMD Tx Submitted to FDA

PTC Therapeutics announced the completion of its rolling submission of a New Drug Application (NDA) to the Food and Drug Administration (FDA) for Translarna (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD).

FDA to Review Sarilumab for Moderate-to-Severe RA

The Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for sarilumab (Regeneron and Sanofi) for the treatment of patients with active, moderate-to-severe rheumatoid arthritis (RA).

FDA to Review Novel Topical Treatment for Atopic Dermatitis

FDA to Review Novel Topical Treatment for Atopic Dermatitis

Anacor announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.

Breakthrough Tx Status Granted to Treatment for Rare Obesity Disorder

Breakthrough Tx Status Granted to Treatment for Rare Obesity Disorder

The Food and Drug Administration (FDA) has granted setmelanotide (Rhythm) Breakthrough Therapy designation for the treatment of pro-opiomelanocortin (POMC) deficiency obesity and Orphan Drug designation for the treatment of Prader-Willi Syndrome (PWS).

FDA Grants Priority Review to Expanded Viekira Pak Indication

Enanta Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted and granted Priority Review to AbbVie's supplemental New Drug Application (sNDA) for Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) without ribavirin (RBV) in patients with genotype 1b (GT1b) chronic hepatitis C virus (HCV) and compensated cirrhosis (Child-Pugh A).

Positive Results Announced for Emricasan in Liver Cirrhosis Trial

Conatus Pharmaceuticals announced positive results from the initial stage of the Phase 2 Liver Cirrhosis clinical trial which evaluated emricasan compared to placebo in patients with liver cirrhosis.

Orphan Drug Status Granted to Huntington's First Target-Directed Tx

The Food and Drug Administration has granted Orphan Drug designation to IONIS-HTT (Ionis) for the treatment of Huntington's disease (HD)

Breakthrough Tx Status Granted to Drug for Debilitating Genetic Disease

The FDA has granted VTS-270 (Vtesse) Breakthrough Therapy designation for the treatment of Niemann-Pick Type C1 Disease (NPC), a progressive, irreversible, chronically debilitating, and ultimately lethal genetic disease.

Soft Tissue Sarcoma Tx Receives Orphan Drug Designation

Soft Tissue Sarcoma Tx Receives Orphan Drug Designation

Gem Pharmaceuticals announced that the Food and Drug Administration has granted Orphan Drug designation to GPX-150 for the treatment of soft tissue sarcoma (STS).

Priority Review Granted for Investigational Chronic Hep C Combo Tx

Priority Review Granted for Investigational Chronic Hep C Combo Tx

Gilead Sciences announced that the FDA has granted priority review to the company's New Drug Application (NDA) for an investigational, once-daily fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Gilead Announces Tenofovir Alafenamide Phase 3 Study Results

Gilead Announces Tenofovir Alafenamide Phase 3 Study Results

Gilead Sciences announced that Studies 108 and 110 evaluating the use of once-daily tenofovir alafenamide (TAF) 25mg have met their primary objectives.

FDA to Review Expanded Indication for Cabozantinib

FDA to Review Expanded Indication for Cabozantinib

Exelixis announced that it has completed the submission of its rolling NDA with the FDA and requested Priority Review for cabozantinib (tablet formulation) as a treatment for patients with advanced renal cell carcinoma who have received one prior therapy.

Human Rabies IgG Demonstrates Efficacy in Phase 2/3 Study

Kamada announced that the pivotal Phase 2/3 clinical trial of its human rabies immune globulin (IgG, KamRAB/KedRAB) as a post-exposure treatment for rabies successfully met its primary endpoint of non-inferiority when measured against an IgG reference product.

FDA to Review Single Daily Injection Combo Drug for T2DM

FDA to Review Single Daily Injection Combo Drug for T2DM

Sanofi announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for its investigational fixed-ratio combination of insulin glargine 100 Units/mL and lixisenatide as a single daily injection for the treatment of adults with type 2 diabetes.

New Hemophilia A Tx Studied for Peds Indication

Baxalta announced initial results from a Phase 3 clinical trial of Adynovate [Antihemophilic Factor (Recombinant), PEGylated] for the treatment of hemophilia A in patients <12 years old.

Top Line Results for Pristiq in Pediatric MDD Announced

Pfizer announced top line results from a Phase 3 study evaluating Pristiq (desvenlafaxine succinate sustained-release formulation) in pediatric patients ages 7-17 with Major Depressive Disorder (MDD).

FDA Grants Orphan Drug Designation to Investigational Epilepsy Tx

FDA Grants Orphan Drug Designation to Investigational Epilepsy Tx

Neurelis announced that the Food and Drug Administration (FDA) has granted Orphan Drug designation to NRL-1 (intranasal diazepam) for the treatment of epilepsy in pediatric, adolescent, and adult patients who experience acute repetitive seizures.

Breakthrough Tx Status Granted for Mutation-positive NSCLC

Breakthrough Tx Status Granted for Mutation-positive NSCLC

The FDA has granted Breakthrough Therapy designation to BI 1482694 (HM61713; Boehringer Ingelheim). BI 1482694 is for the treatment of T790M mutation-positive NSCLC in patients whose tumors have stopped responding to currently available EGFR-directed therapies.

First-in-Class Oral Cholera Vaccine is Granted Priority Review

First-in-Class Oral Cholera Vaccine is Granted Priority Review

The Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for Vaxchora (PaxVax), a single-dose oral cholera vaccine.

Results for First-in-Class Oral Mucositis Tx are Announced

Results for First-in-Class Oral Mucositis Tx are Announced

Soligenix announced positive results from the Phase 2 clinical trial of SGX942, for the treatment of oral mucositis in patients treated with chemoradiation therapy (CRT) for head and neck cancer.

Results Announced for Abdominal Bulge Injection Treatment

Results Announced for Abdominal Bulge Injection Treatment

Neothetics announced results from its AbCONTOUR1 and AbCONTOUR2 Phase 3 trials which evaluated the safety and efficacy of LIPO-202 for the reduction of central abdominal bulging due to subcutaneous fat.

Promising Data for New Combination Antihypertensive

Promising Data for New Combination Antihypertensive

Kitov Pharmaceuticals announced that the Phase 3 study for KIT-302 successfully met its primary efficacy endpoint. KIT-302 was more efficacious at reducing hypertension than amlodipine besylate.

FDA to Review NDA for New Extended-Release Morphine

FDA to Review NDA for New Extended-Release Morphine

Egalet announced that it has submitted to the Food and Drug Administration (FDA) a New Drug Application (NDA) for Arymo ER (morphine sulfate).

Triple Combination Tx for Liver Disease Fast Tracked by FDA

Triple Combination Tx for Liver Disease Fast Tracked by FDA

The FDA has granted Fast Track designation for the development program involving the combination of leucine, metformin and sildenafil for the treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Positive Topline Data for Antifungal Tx Published

Astellas announced that topline data from the pivotal Phase 3 trial, SECURE, which evaluated Cresemba (isavuconazonium sulfate) in adult patients with invasive aspergillosis were published in The Lancet.

New Tx Granted Priority Review for Expanded Breast CA Indication

New Tx Granted Priority Review for Expanded Breast CA Indication

The Food and Drug Administration (FDA) has accepted for filing and granted Priority Review to the supplemental New Drug Application (sNDA) for Ibrance (palbociclib), a Tx for breast cancer.

FDA Grants Ovarian Cancer Vaccine Orphan Drug Designation

FDA Grants Ovarian Cancer Vaccine Orphan Drug Designation

The Food & Drug Administration (FDA) has granted Orphan Drug designation to the cancer vaccine, TPIV 200 (TapImmune), in the treatment of ovarian cancer.

FDA to Review NDA for Faster-Acting Insulin Aspart

FDA to Review NDA for Faster-Acting Insulin Aspart

Novo Nordisk announced the submission to the Food and Drug Administration (FDA) of a New Drug Application (NDA) for faster-acting insulin aspart for the treatment of type 1 and type 2 diabetes.

FDA to Review Dextenza NDA for Post-Surgical Ocular Pain

FDA to Review Dextenza NDA for Post-Surgical Ocular Pain

The FDA is to review the New Drug Application (NDA) for Dextenza (sustained-release dexamethasone), an intracanalicular depot for the treatment of ocular pain following ophthalmic surgery.

First Results of Rivaroxaban for VTE Treatment in Active Cancer

First Results of Rivaroxaban for VTE Treatment in Active Cancer

Janssen and Bayer presented the first results from their comprehensive research program, CALLISTO, which evaluated rivaroxaban for the treatment and prevention of venous thromboembolism (VTE) in patients with active cancer, at the 2015 American Society of Hematology (ASH) Annual Meeting.

FDA Grants Orphan Drug Designation to new Treatment for Duchenne Muscular Dysptrophy (DMD)

Food and Drug Administration (FDA) has granted Orphan Drug designation and Rare Pediatric Disease designation to ARM210 (also known as S48168) for the treatment of Duchenne Muscular Dystrophy (DMD)

Xarelto Safety, Efficacy for DVT Confirmed in Real-World Data

Xarelto Safety, Efficacy for DVT Confirmed in Real-World Data

Janssen and Bayer announced the results from their real-world study XALIA, showing that the rates of major bleeding and recurrent blood clots for Xarelto (rivaroxaban) in routine clinical practice were generally consistent with Phase 3 data in patients with deep vein thrombosis (DVT), with shorter hospital stays than standard anticoagulation.

Promising Results in Phase 3 Trial for Novel Estradiol Softgel

A Phase 3 Rejoice Trial of TX-004HR (estradiol) to treat moderate to severe dyspareunia (vaginal pain during sexual intercourse), has had positive top-line results.

FDA Grants Xalkori Priority Review for Non-Small Cell Lung Cancer

FDA Grants Xalkori Priority Review for Non-Small Cell Lung Cancer

The FDA has accepted and granted Priority Review for a supplemental New Drug Application (sNDA) for Xalkori (crizotinib; Pfizer).

Positive Results for Investigational Alzheimer's Aggression Tx

Positive Results for Investigational Alzheimer's Aggression Tx

Amarantus Bioscience announced positive data for eltoprazine in a Phase 2 clinical trial of elderly patients with aggression associated with Alzheimer's dementia.

Oliceridine Being Investigated as Possible IV Opioid Analgesic Replacement

Oliceridine Being Investigated as Possible IV Opioid Analgesic Replacement

The Food and Drug Administration (FDA) has granted Fast Track designation to oliceridine (TRV130; Trevena) for the management of moderate-to-severe acute pain.

FDA to Review New Once Daily Viekira Pak Formulation

The FDA has accepted the New Drug Application (NDA) for a once-daily, fixed-dose formulation of the components of Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir tablets; AbbVie) for patients with genotype 1 (GT1) chronic hepatitis C virus (HCV) infection, including those with compensated cirrhosis.

Study: Trulicity Effective as Add-on to Sulfonylurea

Lilly presented new data from a completed Phase 3 trial, AWARD-8, showing that once-weekly Trulicity (dulaglutide) 1.5mg plus a sulfonylurea was significantly more effective than a sulfonylurea alone in lowering hemoglobin A1c (A1C) from baseline after 24 weeks of treatment.

Ubenimex Granted Orphan Drug Status for PAH

The Food and Drug Administration (FDA) has granted Orphan Drug designation to ubenimex (Eiger) for the treatment of pulmonary arterial hypertension (PAH).

FDA Issues Complete Response Letter for Opdivo

The FDA has issued a Complete Response Letter to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab; BMS) as a single agent for the treatment of previously untreated patients, specifically those with BRAF V600 mutation positive unresectable or metastatic melanoma.

FDA to Review Extended-Release Formulation of Lorcaserin

The FDA has accepted for filing the New Drug Application (NDA) for extended-release lorcaserin (Eisai and Arena) as once daily dosing option for chronic weight management.

Results for Lyrica in Post-Traumatic Peripheral Neuropathic Pain Announced

Results for Lyrica in Post-Traumatic Peripheral Neuropathic Pain Announced

Pfizer announced that a Phase 3 study evaluating the efficacy and safety of Lyrica (pregabalin) Capsules CV in adults with chronic post-traumatic peripheral neuropathic pain did not meet its primary efficacy endpoint.

New IVIG BLA Submitted for Primary Immunodeficiency

Green Cross announced that it has submitted its Biologics License Application (BLA) to the FDA for IVIG-SN (human normal immunoglobulin G) for the treatment of primary immunodeficiency diseases (PID).

FDA Fast Tracks Investigational Tx for Liver Fibrosis

Nitto Denko announced that the FDA has granted two Fast Track designations to ND-L02-s0201 for the treatment of nonalcoholic steatohepatitis (NASH) liver fibrosis and hepatitis C virus (HCV) liver fibrosis.

FDA to Review New Warfarin Formulation

Accu-Break Pharmaceuticals (ABP) announced that the Food & Drug Administration (FDA) has accepted for filling the New Drug Application (NDA) for Warfarin Potassium.

NDA for Extended-Release Diabetes Tx Submitted

Janssen announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for once-daily Invokamet XR (canagliflozin/metformin extended-release) as a new treatment option for adults with type 2 diabetes mellitus as adjunct to diet and exercise to improve glycemic control.

Novel Tx Granted Orphan Drug Status for Aggressive Brain Cancer

The FDA has granted Orphan Drug designation to marizomib (Triphase Accelerator) for the treatment of malignant glioma, an aggressive form of brain cancer with a significant unmet need due to its poor prognosis.

Avelumab Receives Breakthrough Tx Status for Rare Skin Cancer

The FDA has granted Breakthrough Therapy designation to avelumab (Merck/Pfizer) for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer, who have progressed after at least one previous chemotherapy regimen.

Opdivo Granted Priority Review for Advanced Renal Cancer

The FDA has accepted for filing and granted priority review to the supplemental Biologics License Application (sBLA) for Opdivo (nivolumab; BMS) for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

Novel Synthetic Drug Granted QIDP Designation for Staph Infections

The FDA has granted Qualified Infectious Disease Product (QIDP) designation to XF-73 (exeporfinium chloride; Destiny Pharma) for the prevention of post-surgical infections caused by Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA).

Buprenorphine SC Injections Fast Tracked for Opioid Addiction

The FDA has granted Fast Track designation to CAM2038, buprenorphine subcutaneous injection products (Braeburn/Camurus), for the treatment of opioid addiction.

Sublingual Nitroglycerin Powder NDA Accepted for Review

The FDA has accepted for review the New Drug Application (NDA) for GoNitro (nitroglycerin; Espero) for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease.

FDA Grants Gene Therapy Orphan Drug Status for Rare Genetic Disorder

The FDA has granted Orphan Drug designation to the investigational gene therapy AGIL-AS (Agilis Biotherapeutics) for the treatment of Angelman syndrome (AS).

Promising Results for First Long-Acting All-Injectable HIV Combo Drug

Janssen and Viiv Healthcare announced new Phase 2b data from LATTE 2 for the first investigational, long-acting, all-injectable combination regimen of rilpivirine (Janssen) and cabotegravir (ViiV Healthcare) given together every 4-8 weeks for HIV infection.

Pexidartinib Designated Breakthrough Therapy for Rare Tumor

The FDA has granted Breakthrough Therapy designation to pexidartinib (formerly PLX3397; Daiichi Sankyo/Plexxikon) for the treatment of tenosynovial giant cell tumor (TGCT) where surgical removal of the tumor would be associated with potentially worsening functional limitation or severe morbidity.

FDA Grants Keytruda Third Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation to Keytruda (pembrolizumab; Merck) for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer.

Novel SSIA Agent Granted Priority Review for Parkinson's Disease Psychosis

Acadia announced that the Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Nuplazid (pimavanserin) for Priority Review.

New Opioid Combo Demonstrates Efficacy for Pain, OINV

Charleston Laboratories and Daiichi Sankyo announced that a third Phase 3 clinical trial of CL-108, a novel opioid-containing formulation, met its primary endpoints for the treatment of moderate to severe pain and the prevention of opioid-induced nausea and vomiting (OINV).

Sofosbuvir/Velpatasvir NDA Submitted for HCV Genotype 1-6

Gilead announced the submission of its New Drug Application (NDA) to the FDA for an investigational, once-daily fixed-dose combination of sofosbuvir (SOF) and velpatasvir (VEL) for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.

Complete Response Letter Issued for Propylene Glycol-Free Melphalan

The FDA has issued a Complete Response Letter to the New Drug Application (NDA) of Evomela (melphalan; Spectrum) for patients with multiple myeloma undergoing autologous stem cell transplantation (ASCT).

Study: Longer Overall Survival for Keytruda vs. Docetaxel

Merck announced that the KEYNOTE-010 study of Keytruda (pembrolizumab) in advanced non-small-cell lung cancer (NSCLC) met its primary endpoint.

Epileptic Encephalopathy Tx Granted Fast Track Designation

The FDA has granted Fast Track designation to the investigational agent TUR-004 (Turing) for the treatment of epileptic encephalopathies.

Long-Acting Tx for Ocular Itching Shows Efficacy in Phase 3 Study

Ocular Therapeutix announced topline efficacy results from a Phase 3 clinical trial evaluating the safety and efficacy of Dextenza (sustained release dexamethasone) 0.4 mg, Intracanalicular Depot for the treatment of allergic conjunctivitis.

Lifitegrast Improves Dry Eye Symptoms, Study Finds

Shire announced positive topline results from OPUS-3, a Phase 3 efficacy and safety study of lifitegrast for the treatment of signs and symptoms for dry eye disease.

Positive Results for New HIV Single Tablet Regimen

Gilead Sciences announced results from two Phase 3 studies evaluating the once daily single tablet regimen, Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide), for the treatment of HIV-1 infection in treatment-naïve adults.

FDA Grants Orphan Drug Status to GLP-1 Replacement Tx for SBS

The FDA has granted Orphan Drug designation to NB1001 (Naia) for the treatment of Short Bowel Syndrome (SBS).

New ALL Drug Granted Breakthrough Therapy Designation

The FDA has granted Breakthrough Therapy designation to the investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin (Pfizer) for the treatment of acute lymphoblastic leukemia (ALL).

NDA for Progressive Eye Conditions Resubmitted to the FDA

The New Drug Application (NDA) for riboflavin ophthalmic solution/KXL System (Avedro) has been resubmitted to the Food and Drug Administration (FDA) for the treatment for progressive keratoconus and corneal ectasia following refractive surgery.

Promising Results for Potential Stelara Expanded Indication

Janssen presented new Phase 3 data showing that treatment with Stelara (ustekinumab) induced clinical response and clinical remission in patients with moderate to severe Crohn's disease who had previously failed conventional therapy.

FDA Issues Complete Response Letter for Dry Eye Tx

The FDA has issued a complete response letter (CRL) requesting an additional clinical study for the New Drug Application (NDA) of lifitegrast (Shire) for the signs and symptoms of dry eye disease in adults.

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