Orexigen announced that it has resubmitted an NDA to the FDA for Contrave (naltrexone sustained release [SR]/bupropion SR), an investigational drug for weight loss and maintenance of weight loss.
The FDA has granted a 6-month Priority Review designation to Genzyme's New Drug Application (NDA) for Cerdelga (eliglustat), an investigational oral therapy for adults with Gaucher disease type 1.
AbbVie announced Phase 3 results for its investigational three direct-acting antiviral (3D) regimen plus ribavirin in patients with chronic, genotype 1 (GT1) hepatitis C virus (HCV) infection.
Seattle Genetics has announced updated results from a Phase 2 clinical trial of Adcetris (brentuximab vedotin) in diffuse large B-cell lymphoma (DLBCL) and other B-cell non-Hodgkin's lymphoma.
Baxter announced that it has submitted a Biologics License Application (BLA) to the FDA for OBI-1 in patients with acquired hemophilia A.
Daiichi Sankyo Company announced results from a prespecified subgroup analysis of 771 cancer patients enrolled in its Phase 3 Hokusai-VTW study evaluating the use of edoxaban.
Interim results announced from Gilead's Phase 2 study evaluating GS-9973 for the treatment of patients with relapsed or refractory hematologic malignancies.
Results have been announced from Study 101-09, Gilead's Phase 2 study evaluating idelalisib for the treatment of patients with indolent non-Hodgkin's lymphoma (iNHL) that is refractory (non-responsive) to rituximab and to alkylating-agent-containing chemotherapy.
Baxter has announced that it has submitted an application to the FDA for a pediatric indication of Rixubis (coagulation factor IX [recombinant]) for the treatment of hemophilia B.
Positive interim results announced for Emergent BioSolutions' Phase 2 study evaluating the combination of otlertuzumab (TRU-016) and bendamustine vs. bendamustine alone in patients with relapsed chronic lymphocytic leukemia (CLL) (Study 16201).
Shire announced top-line results from OPUS-2, a Phase 3 efficacy and safety study of 5.0% lifitegrast ophthalmic solution for dry eyes.
Eli Lilly and Company announced that the primary study objective from three studies of edivoxetine for superior efficacy was not met in depression after eight weeks of treatment.
Sanofi announced full results for EDITION II (basal insulin + oral therapy) and additional results from its EDITION Phase 3 program for EDITION III, EDITION IV, and EDITION JP I for the investigational new insulin U300 in patients with type 1 or type 2 diabetes.
The FDA has designated isavuconazole (Astellas Pharma) a Qualified Infectious Disease Product (QDIP) for the treatment of invasive aspergillosis.
The FDA has accepted the New Drug Application (NDA) for Zalviso (sufentanil sublingual microtablet system; AcelRx) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
FibroGen announced interim results from an ongoing Phase 2 study evaluating FG-3019 for the treatment of idiopathic pulmonary fibrosis (IPF).
The FDA has accepted for review a New Drug Application (NDA) for Targiniq ER (oxycodone HCl/naloxone HCl controlled-release; Purdue Pharma) Tablets (CII) for the management of chronic pain.
The FDA has granted Fast Track designation to its lead clinical product candidate, CERC-301 (Cerecor ) for major depressive disorder (MDD).
Sanofi and Regeneron announced that in the SARIL-RA-MOBILITY Phase 3 clinical trial, sarilumab in combination with methotrexate (MTX) improved disease signs and symptoms as well as physical function, and inhibited progression of joint damage in adult patients with active rheumatoid arthritis (RA) who were inadequate responders to MTX therapy.
The FDA has issued a Complete Response Letter regarding the New Drug Application (NDA) for cariprazine (Forest Laboratories and Gedeon Richter Plc), an atypical antipsychotic for the treatment of schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults.
Daiichi Sankyo announced positive results from the Phase 3 ENGAGE AF-TIMI 48 study comparing once-daily edoxaban with warfarin in patients with non-valvular atrial fibrillation (NVAF) at moderate-to-high risk of thromboembolic events.
The FDA has accepted the New Drug Application (NDA) for naloxegol (Nektar Therapeutics and AstraZeneca), in opioid-induced constipation (OIC) for adult patients with chronic non-cancer pain.
Amgen announced interim overall survival (OS) results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC, or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Boehringer Ingelheim announced results demonstrating that its investigational fully humanized antibody fragment (Fab) rapidly reversed the anticoagulation effect of dabigatran in healthy male volunteers.
BioSpecifics Technologies has announced positive results from its Phase 3b MULTICORD study evaluating Xiaflex (collagenase clostridium histolyticum) for the concurrent treatment of adult Dupuytren's contracture patients with multiple palpable cords.
Enanta announced results from the SAPPHIRE-I study, for a regimen containing Enanta's protease inhibitor ABT-450 for the treatment of hepatitis C virus (HCV) genotype 1(GT1) infection.
The FDA has accepted for Priority Review Merck's New Drug Application (NDA) for an investigational intravenous solution of Noxafil (posaconazole).
The FDA has granted Epidiolex (GW Pharmaceuticals) Orphan Drug designation for the treatment of children with Dravet syndrome, a rare and severe form of form of infantile-onset, genetic, drug-resistant epilepsy syndrome.
The FDA has accepted for review NPS Pharmaceuticals' supplemental New Drug Application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
Merck announced data for its investigational Timothy grass sublingual allergy immunotherapy tablet (MK-7243) to treat the underlying cause of allergic rhinitis.
The FDA has granted Fast Track designation to Alnylam's patisiran (ALN-TTR02) for the treatment of transthyretin (TTR)-familial amyloid polyneuropathy (FAP).
Advaxis has announced the final 18-month survival data from Lm-LLO-E7-15, a Phase 2 study evaluating the safety and efficacy of ADXS-HPV (ADXS11-001) with and without cisplatin in patients with recurrent cervical cancer.
Genentech has announced positive data from a Stage 2, Phase 3 CLL11 study comparing Gazyva (obinutuzumab) to Rituxan (rituximab), both in combination with chlormabucil for people with previously untreated chronic lymphocytic leukemia (CLL) and co-existing medical conditions.
Statistically significant results were observed in Agenus's Phase 2 study for HerpV, a recombinant therapeutic vaccine for the treatment of genital herpes caused by the herpes simplex virus-2 (HSV-2).
The FDA has granted ADXS-HPV (Advaxis) Orphan Drug Designation for the treatment of human papillomavirus (HPV)-associated head and neck cancer.
Top-line results were announced from two Phase 3 studies evaluating the efficacy and safety of Vyvanse (lisdexamfetamine dimesylate; Shire) Capsules (CII) vs. placebo in adults with binge eating disordsers (BED).
Gilead Sciences has announced results from PHOTON-1, a Phase 3 study evaluating the investigational once daily nucleotide analogue sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infection among patients co-infected with HIV.
The FDA has accepted for filing a supplemental New Drug Application (sNDA) for Vimpat (lacosamide; UCB) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy ≥17 years of age.
In a Phase 3 efficacy study, Merck's investigational 9-valent HPV vaccine (V503) prevented about 97% of cervical, vaginal, and vulvar pre-cancers caused by HPV types 31, 33, 45, 52, and 58.
Boehringer Ingelheim has announced new data from its Phase 3 clinical trial program, STARTVerso evaluating faldaprevir in combination with pegylated interferon and ribavirin (PegIFN/RBV) in genotype 1 (GT1) patients with hepatitis C (HCV).
Acadia has announced results from its Phase 3 -020 Study with pimavanserin in patients with Parkinson's disease psychosis (PDP).
The FDA has granted KB001-A (KaloBios) Orphan Drug designation for the treatment of cystic fibrosis (CF) patients with Pseudomonas aeruginosa.
The FDA has designated Busulipo (MZH-2; Pharmalink) Orphan Drug status for use in cancer patients prior to hematopoietic stem cell transplantation (HSCT).
NPS Pharmaceuticals has submitted a Biologic License Application (BLA) to the FDA for Natpara (recombinant human parathyroid hormone 1-84, rhPTH [1-84]) for the treatment of hypoparathyroidism.
The FDA has granted MK-5172/MK-8742 (Merck) Breakthrough Therapy designation for treatment of chronic hepatitis C virus infection.
The FDA has granted Priority Review to the Biologics License Application for ramucirumab (IMC-1121B) as a single-agent treatment for advanced gastric cancer following disease progression after initial chemotherapy.
Cubist has submitted a New Drug Application (NDA) to the FDA for its investigational antibiotic tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
Regeneron announced positive top-line results for Eylea (afilbercept) Injection from its Phase 3 VIBRANT study in patients with macular edema following branch retinal vein occlusion (BRVO).
Pfizer announced top-line results from two Phase 3b studies with Lyrica (pregabalin) capsules in patients with fibromyalgia and painful diabetic peripheral neuropathy.
Sanofi and Regeneron announced that the Phase 3 ODYSSEY MONO trial with alirocumab for the reduction in low-density lipoprotein-cholesterol (LDL-C) met its primary efficacy endpoint.
MannKind Corp. has resubmitted the New Drug Application (NDA) to the FDA for Afrezza (insulin human [rDNA origin]) Inhalation Powder to improve glycemic control in adults with type 1 or type 2 diabetes.
Novoteris announced that the FDA has granted Orphan Drug Designation for inhaled nitric oxide gas for the treatment of cystic fibrosis.
BioDelivery Sciences International announced that its New Drug Application (NDA) for Bunavail (buprenorphine and naloxone buccal film) has been accepted for the maintenance treatment of opioid dependence.
Vertex has submitted a supplemental New Drug Application (sNDA) to the FDA for the approval of Kalydeco (ivacaftor) monotherapy for people with cystic fibrosis (CF) ages 6 and older who have at least one non-G551D gating mutation in the CFTR gene.
AcelRx has submitted a New Drug Application (NDA) to the FDA for Zalviso (sufentanil sublingual microtablet system) for the management of moderate-to-severe acute pain in adult patients in the hospital setting.
The FDA has granted OMS824 (Omeros) Orphan Drug Designation for the treatment of Huntington's disease.
Amgen announced results from the Phase 3 ASPECCT ('763) trial comparing Vectibix (panitumumab) to Erbitux (cetuximab; Bristol-Myers Squibb) for the treatment of wild-type KRAS metastatic colorectal cancer in patients who have not responded to chemotherapy.
Additional results announced from a pivotal Phase 3 trial evaluating talimogene laherparepvec (Amgen) in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF).
Eli Lilly and Company announced positive patient-reported health outcomes from a Phase 3 clinical trial of dulaglutide as a once-weekly treatment for type 2 diabetes.
Results were presented from two global Phase 3 studies of ramucirumab (IMC-1121B; Eli Lilly and Company), in advanced gastric cancer and metastatic breast cancer.
The FDA has granted Orphan Drug designation to LUM001 (Lumena) in four rare cholestatic liver diseases: Alagille syndrome, progressive familial intrahepatic cholestasis, primary biliary cirrhosis, and primary sclerosing cholangitis.
The FDA has granted Orphan Drug Designation to riociguat (Bayer HealthCare), proposed trade name Adempas, for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH).
Phase 2 results announced for retaspimycin HCl (Infinity Pharmaceuticals) in combination with docetaxel in patients with non-small cell lung cancer (NSCLC) who had a history of smoking.
AstraZeneca and Bristol-Myers Squibb Company announced results from a Phase 3 study evaluating dapagliflozin in adult patients with type 2 diabetes who were inadequately controlled on combination treatment with metformin plus sulfonylurea.
The FDA has issued a Complete Response Letter (CRL) to Merck's New Drug Application (NDA) for sugammadex sodium injection.
The FDA has accepted for review a New Drug Application (NDA) for Epanova (AstraZeneca), an investigational compound for the treatment of patients with severe hypertriglyceridemia (triglycerides ≥500mg/dL).
The use of Prophage Series G-100 (HSPPC-96; Agenus) in combination with current standard of care (radiation and temozolomide) demonstrates improvement in progression free survival in patients with newly diagnosed glioblastoma multiforme (GBM).
The FDA has granted Breakthrough Therapy designation to volasertib (Boehringer Ingelheim) for the treatment of patients ≥65 years old with previously untreated acute myeloid leukemia (AML), ineligible for intensive remission induction therapy.
The FDA has granted Orphan Drug designation to Soligenix's active ingredient SGX94 for the treatment of acute radiation syndrome (ARS).
The FDA has designated Forest Labs' investigational drug, ceftazidime/avibactam, a Qualified Infectious Disease Product (QDIP) for complicated intra-abdominal infections (cIAI), complicated urinary tract infections (cUTI) and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).
Bristol-Myers Squibb announced results from Study 043 comparing Yervoy (ipilimumab) 10mg/kg to placebo following radiation in patients with advanced metastatic castration-resistant prostate cancer (mCRPC) who have received prior treatment with docetaxel.
The FDA has granted Fast Track designation to ganetespib (Synta Pharmaceuticals) to use combination with docetaxel for the treatment of patients with metastatic non-small lung adenocarcinoma who have progressed following one prior chemotherapy regimen.
United Therapeutics announced that the FDA has accepted for review its resubmission of a New Drug Application (NDA) for treprostinil diolamine extended release tablets (oral treprostinil) for the treatment of pulmonary arterial hypertension.
Gilead Sciences has submitted a New Drug Application (NDA) to the FDA for idelalisib for the treatment of indolent non-Hodgkin's lymphoma (iNHL).
The FDA has designated entinostat as a Breakthrough Therapy for the treatment of locally recurrent or metastatic estrogen receptor-positive (ER+) breast cancer when added to exemestane in postmenopausal women whose disease has progressed following non-steroidal aromatase inhibitor therapy.
Relypsa announced positive results for Part A of a two-part pivotal Phase 3 clinical trial evaluating patiromer for the treatment of hyperkalemia.
The FDA has accepted for review the New Drug Application (NDA) for corifollitropin alfa for Controlled Ovarian Stimuation (COS) in women participating in in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).
GlaxoSmithKline's DERMA study did not meet the first co-primary endpoint of extending disease-free survival (DFS) with Agenus' QS-21 Stimulon adjuvant, a component of GSK's AS15 adjuvant system when compared to placebo in the MAGE-A3 positive population.
Adynxx has completed patient enrollment in a Phase 2 clinical study for AYX1 for the reduction of acute post-surgical pain and prevention of the transition to persistent or chronic pain with a single administration at the time of surgery.
MNK-795 (Mallinckrodt) achieved the primary endpoint in a Phase 3 efficacy trial for the treatment of moderate to severe acute pain following bunionectomy.
The FDA has accepted for review Endo's Complete Response submission to the New Drug Application (NDA) for AVEED (testosterone undecanoate), a long-acting injection intended for men diagnosed with hypogonadism.
Takeda announced that the FDA has granted Priority Review status to the Biologics License Application (BLA) for vedolizumab for the treatment of adults with moderately to severe active ulcerative colitis.
Amgen and Cytokinetics announced data from ATOMIC-AHF (Acute Treatment with Omecamtiv Mecarbil to Increase Contractility inAcute Heart Failure), a Phase 2 study of omecamtiv mecarbil in patients with acute heart failure (AHF).
Janssen R&D submitted a Biologic License Application (BLA) to the FDA for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.
Treatment with AMG 145 (Amgen) resulted in significant reductions in low-density lipoprotein cholesterol (LDL-C) of up to 59% in an efficacy analysis of pooled data from four 12-week Phase 2 studies.
The FDA issued a Complete Response Letter in response to an NDA filing for tolvaptan (Otsuka) for the treatment of adult patients with rapidly progressing autosomal dominant polycystic kidney disease (ADPKD).
The FDA has accepted for review the sNDA for Pradaxa (dabigatran etexilate mesylate; Boehringer Ingelheim) in patients with deep vein thrombosis (DVT) and pulmonary embolism (PE).
The FDA has granted Priority Review for Nexavar (sorafenib) tablets in the treatment of locally advanced or metastatic radioactive iodine (RAI)-refractory differentiated thyroid cancer.
The FDA has accepted for filing the New Drug Application (NDA) for Pennsaid (diclofenac sodium topical solution; Mallinckrodt) 2% w/w in the treatment for pain associated with osteoarthritis of the knee.
The FDA has granted ALN-AT3 (Alnylam Pharmaceuticals) Orphan Drug designation for the treatment of hemophilia A.
Ampio announced positive results from the SPRING study of Ampion for the treatment of osteoarthritis of the knee (OAK).
The FDA has granted ALN-AT3 (Alnylam Pharmaceuticals) Orphan Drug designation for the treatment of hemophilia B.
Results from Study 171, a Phase 3 trail, were announced for Afezza (insulin human [rDNA origin]; MannKind Corp.) Inhalation Powder in patients with type 1 diabetes.
The FDA has designated ADXS-HPV (Advaxis) Orphan Drug status for the treatment of human papillomoavirus (HPV)-associated anal cancer.
SQUIRE, a Phase 3 study met its primary endpoint of overall survival when necitumumab (IMC-11F8 ; Eli Lilly and Company) in combination with gemcitabine and cisplatin was administered as first-line treatment in patients with stage IV metastatic squamous non-small cell lung cancer (NSCLC).
U.S. researchers announced promising results from a Phase 1 clinical trial of Sanaria's PfSPZ Vaccine to combat malaria.
A New Drug Application (NDA) was submitted to the FDA for Zerenex (ferric citrate coordination complex) for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
Eylea (aflibercept; Regeneron, Bayer Healthcare) Injection for the treatment of diabetic macular edema meets the primary endpoint in two Phase 3 trials, VIVID-DME and VISTA-DME.
A New Drug Application for OMS302, a combination of phenylephrine and ketorolac has been submitted to the FDA by Omeros for patients undergoing intraocular lens replacement surgery.
The FDA has designated CGTG-102 (Oncos Therapeutics) Orphan Drug status for the treatment of soft tissue sarcoma.