Company |
Product |
Description |
Indication |
Status |
Date |
AUTOIMMUNE | |||||
Anthera Pharmaceuticals Inc. (Hayward, Calif.) |
Blisibimod |
A selective peptibody antagonist of the B-cell activating factor cytokine |
Systemic lupus erythematosus |
Failed in a phase III trial; data suggested a positive trend on proteinuria |
12/8/16 |
Catalyst Pharmaceuticals Inc. (Coral Gables, Fla.) |
Firdapse |
Amifampridine phosphate |
Lambert-Eaton myasthenic syndrome |
Enrolled the first patient into the second phase III trial |
12/16/16 |
Genentech (unit of Roche Holding AG; Basel, Switzerland) |
Ocrevus |
Ocrelizumab; a humanized monoclonal antibody designed to selectively target CD20-positive B cells |
Relapsing multiple sclerosis |
Positive data from three phase III studies – the OPERA I and OPERA II studies and the ORATORIO study – showed consistent and clinically meaningful reductions in major markers of disease activity and progression compared with Rebif (interferon beta-1a, EMD Serono Inc.) in RMS and with placebo in PPMS; the primary endpoint was met in all three studies, which includes relative reduction of annualized relapse rate in the RMS studies and relative reduction in the progression of clinical disability sustained for at least 12 weeks in the PPMS study |
12/23/16 |
Redhill Biopharma Ltd. (Tel Aviv, Israel) |
RHB-104 |
Targets a specific pathogen |
Crohn's disease |
Received a unanimous recommendation from the independent data and safety monitoring board to continue without any modification its ongoing phase III study |
12/14/16 |
UCB SA (Brussels) and Dermira Inc. (Menlo Park, Calif.) |
Cimzia |
Certolizumab pegol |
Moderate-to-severe chronic plaque psoriasis |
Top-line results from CIMPASI-1, a placebo-controlled phase III trial, demonstrated statistically significant improvements for both co-primary endpoints compared to placebo at both treatment doses |
12/9/16 |
Valeant Pharmaceuticals International Inc. (Laval, Quebec) |
IDP-118 |
Halobetasol propionate and tazarotene lotion |
Plaque psoriasis |
A multicenter, double-blind, randomized, vehicle-controlled phase III study showed statistical significance, with a treatment success rate of 45.33% (p<0.001) compared to vehicle |
12/9/16 |
CANCER | |||||
Astrazeneca plc (London) |
Tagrisso |
Osimertinib |
EGFR T790M mutation-positive locally-advanced or metastatic non-small-cell lung cancer |
Data from the AURA3 trial showed that Tagrisso second-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy |
12/7/16 |
Astrazeneca plc (London) |
Tagrisso |
EGFR inhibitor; osimertinib |
Lung cancer |
AURA3 phase III trial showed Tagrisso second-line therapy improved progression-free survival (PFS) by 5.7 months compared with standard platinum-based doublet chemotherapy (HR=0.3) |
12/12/16 |
Celgene Corp. (Summit, N.J.) |
Abraxane |
Paclitaxel protein-bound particles for injectable suspension |
Non-small-cell lung cancer |
Interim results from the ABOUND clinical trial program evaluating the use of Abraxane found that 91 (73%) patients experienced grade ≥2 peripheral neuropathy (PN) or grade ≥3 myelosuppression; the median overall survival was 14.6 months and the median progression-free survival was 6.2 months |
12/7/16 |
Celgene Corp. (Summit, N.J.)and Takeda Oncology Co. (Cambridge, Mass.) |
VRd |
Revlimid (lenalidomide) and Velcade (bortezomib) and dexamethasone |
Myeloma |
Phase III data showed that a three-drug combination delays recurrence and lengthens life; one regimen used Revlimid and dexamethasone; the other regimen also included Velcade; the addition of Velcade earlier gave patients about another year of remission and another year of life compared to the standard two-drug regimen; patients receiving all three in their first six months of treatment had a median remission time of 43 months compared to a median remission of 30 months for patients who received lenalidomide and dexamethasone alone |
12/27/16 |
Cel-Sci Corp. (Vienna, Va.) |
Multikine |
Leukocyte interleukin, injection |
Squamous cell carcinoma of the head and neck |
FDA issued an incomplete response to the hold letter; the company said it is reviewing all of its options and plans to send the FDA a request to discuss all matters relating to the partial clinical hold |
12/27/16 |
Celsion Corp. (Lawrenceville, N.J.) |
Thermodox |
Heat-activated liposomal encapsulation of doxorubicin |
Primary liver cancer |
The study's data monitoring committee unanimously recommended that the phase III trial continue enrollment; about 40% of patients are currently enrolled in the trial |
12/1/16 |
Celsion Corp. (Lawrenceville, N.J.) |
Thermodox |
Heat-activated liposomal encapsulation of doxorubicin |
Primary liver cancer |
Met with CFDA officials to discuss the ongoing phase III OPTIMA program and regulatory pathway, and presented a survival benefit in patients treated with Thermodox plus optimized radiofrequency ablation (RFA) compared with optimized RFA alone; the CFDA agreed that OPTIMA, if successful, could serve as the basis for a direct regulatory filing in China without the need to file for prior approval in the U.S. or EU. |
12/19/16 |
Mylan NV (Hertfordshire, U.K.) and Biocon Ltd. (Bangalore, India) |
MYL-1401O |
Proposed biosimilar trastuzumab (Herceptin, Roche Holding AG) |
HER2-positive breast and gastric cancers |
Results of the HERITAGE study confirm the efficacy, safety and immunogenicity of MYL-1401O in comparison to branded trastuzumab |
12/28/16 |
Northwest Biotherapeutics Inc. (Bethesda, Md.) |
Dcvax-L |
N/A |
Glioblastoma multiforme |
331 of the planned 348 patients were enrolled in its phase III trial, with data events accumulating toward the trial endpoints; the trial has been under a partial clinical hold on recruitment that has not been lifted by regulators, and the company said it will no longer seek to enroll the final 17 patients |
12/9/16 |
Novartis AG (Basel, Switzerland) |
Zykadia |
Ceritinib; first-line ALK inhibitor |
Anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer |
Results from its phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study found that patients with anaplastic lymphoma kinase-positive advanced non-small-cell lung cancer treated with Zykadia had a median progression-free survival of 16.6 months compared to 8.1 months in patients treated with standard first-line chemotherapy with maintenance |
12/7/16 |
Novartis AG (Basel, Switzerland) |
LEE011 |
Ribociclib |
Hormone receptor positive, human epidermal growth factor receptor-2 negative advanced or metastatic breast cancer |
Phase III MONALEESA-2 data show LEE011 plus letrozole significantly prolonged progression-free survival (PFS) across pre-planned patient subgroups |
12/12/16 |
Novartis AG (Basel, Switzerland) |
LEE011 and Femara |
Cyclin-dependent kinase 4/6 pathway inhibitor in combination with letrozole |
HR-positive/HER2-negative locally advanced breast cancer |
The MONALEESA-2 pivotal trial of ribociclib in combination with letrozole vs. letrozole alone in postmenopausal women who had received no prior therapy showed the combination treatment significantly improved progression-free survival |
12/28/16 |
Pfizer Inc. (New York) |
PF-05280014 |
Biosimilar to Herceptin |
HER2-positive metastatic breast cancer |
The pivotal REFLECTIONS B3271002 study, of PF-05280014 vs. Herceptin (trastuzumab, Roche Holding AG), met its primary endpoint, demonstrating equivalence in the primary endpoint of objective response rate when taken in combination with paclitaxel |
12/1/16 |
Pfizer Inc. (New York) |
Palbociclib |
Cyclin-dependent kinase inhibitor Ibrance |
Estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer |
Positive results from a sub-analysis studying Asian patients in the phase III PALOMA-2 trial of Ibrance, in combination with letrozole, as first-line therapy extended progression-free survival (PFS) by more than 11 months compared to letrozole plus placebo, and demonstrated that the median PFS exceeded two years |
12/22/16 |
Pfizer Inc. (New York) |
Ibrance |
Palbociclib |
Estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer |
A subanalysis from the Paloma-2 trial studying Asian postmenopausal women showed that when treated with Ibrance and letrozole it significantly extended progression-free survival by more than 11 months compared with letrozole plus placebo; PFS exceeded two years in those patients, a benefit consistent with Ibrance in the overall global population. |
12/23/16 |
Pfizer Inc. (New York) and Avillion LLP (London) |
Bosulif |
Bosutinib |
Chronic phase Philadelphia chromosome positive chronic myeloid leukemia |
Results from the phase III BFORE trial demonstrated superiority of Bosulif over imatinib (Gleevec, Novartis AG) as a first-line treatment; the study met its primary endpoint of major molecular response (MMR) at 12 months |
12/6/16 |
Progenics Pharmaceuticals Inc. (New York) |
99mTc-MIP-1404 |
PSMA-targeted SPECT/CT imaging agent candidate |
Newly diagnosed or low-grade prostate cancer |
The independent data monitoring committee completed review of an interim analysis of the phase III trial, and recommended that the trial continue |
12/27/16 |
Sandoz (unit of Novartis AG; Basel, Switzerland) |
GP2013 |
Biosimilar of Mabthera (rituximab, Roche AG), a monoclonal antibody that targets CD20 |
Advanced follicular lymphoma |
The ASSIST-FL trial shows GP2013 met its primary endpoint of overall response rate (87.1%), demonstrating equivalence with the reference product, Mabthera, in 629 patients |
12/6/16 |
Sanofi Genzyme (unit of Sanofi SA; Cambridge, Mass.) |
Isatuximab |
Anti-CD38 monoclonal antibody |
Relapsed and refractory multiple myeloma |
Initiated the ICARIA-MM phase III trial |
12/6/16 |
TG Therapeutics Inc. (New York) |
TG-1101 |
Glycoengineered anti-CD20 monoclonal antibody |
High-risk relapsed or refractory chronic lymphocytic leukemia |
The target enrollment of 120 patients in the GENUINE phase III study has been met and enrollment will be closed shortly |
12/7/16 |
VBL Therapeutics Inc. (Tel Aviv, Israel) |
VB-111 |
Ofranergene obadenovec |
Recurrent glioblastoma |
The independent data safety monitoring committee (DSMC) met to conduct its first safety review of the phase III GLOBE Study and did not find any adverse events that would be cause for concern |
12/6/16 |
Xbiotech Inc. (Austin, Texas) |
Xilonix |
IgG1k monoclonal antibody immunotherapy |
Advanced colorectal cancer |
Enrollment has been completed in its randomized, double-blind, placebo-controlled phase III study |
12/8/16 |
CARDIOVASCULAR | |||||
Akcea Therapeutics Inc. |
Volanesorsen |
Designed to reduce apolipoprotein C-III (apoC-III) production and lower triglycerides |
Cardiometabolic lipid disorders |
COMPASS, the first phase III study, met its primary endpoint, with patients who received the drug (n=75) achieving a statistically significant (p<0.0001) mean reduction in triglycerides of 71.2% from baseline following 13 weeks of treatment compared with a mean reduction of 0.9% in placebo-treated patients (n=38) |
12/20/16 |
Biocardia Inc. (San Carlos, Calif.) |
CardiAMP |
Autologous, minimally processed bone marrow cell therapy |
Heart failure |
Initiated a randomized, controlled pivotal trial |
12/30/16 |
Cytokinetics Inc. (South San Francisco) |
Omecamtiv mecarbil |
A cardiac myosin activator |
Heart failure |
Started the GALACTIC-HF phase III cardiovascular outcomes trial |
12/2/16 |
Eagle Pharmaceuticals Inc. (Woodcliff Lake, N.J.) |
Ryanodex |
Dantrolene sodium |
Exertional heat stroke |
In its pivotal animal study conducted under the Animal Rule, for Ryanodex, significantly more animals treated with Ryanodex in addition to the standard of care (SOC) achieved the primary efficacy endpoint, which was reversal of the induced heat stroke/hypermetabolic crisis, compared to animals treated with SOC alone |
12/14/16 |
Genentech (unit of Roche Holding AG; Basel, Switzerland) |
ACE910 |
Emicizumab; bispecific monoclonal antibody |
Hemophilia A |
Top-line data from the phase III HAVEN1 study showed a statistically significant reduction in the number of bleeds over time for emicizumab patients vs. those with no prophylactic treatment; the study also met all secondary endpoints, including a statistically significant reduction in the number of bleeds with emicizumab in an intra-patient comparison that brought aboard people who had received prior bypassing-agent prophylaxis |
12/23/16 |
Shire plc (Dublin) |
Vonvendi |
Von Willebrand factor (recombinant) |
Severe von Willebrand disease |
Top-line results from a phase III trial of Vonvendi to treat bleeds in elective surgical settings for adults with severe von Willebrand disease showed it met its primary endpoint, finding that overall hemostatic efficacy was "excellent" or "good" for the 15 treated subjects |
12/5/16 |
Vifor Pharma Ltd. |
Ferinject |
Ferric carboxymaltose |
Chronic heart failure and iron deficiency |
An open label study found a "significantly beneficial effect" for Ferinject on exercise capacity, confirming the findings of previous studies |
12/8/16 |
CENTRAL NERVOUS SYSTEM | |||||
Alzheon Inc. (Framingham, Mass.) |
Tramiprosate |
Amyloid anti-aggregation agent and the active molecule |
APOE4/4 homozygous Alzheimer's disease |
Additional analyses of phase III data showed tramiprosate's largest efficacy signals occurred on cognition and function in individuals who carry two e4 alleles of apolipoprotein E gene (APOE4/4 homozygotes) and are diagnosed with mild AD, defined as MMSE of 22 and higher |
12/12/16 |
Flamel Technologies SA (Lyon, France) |
FT218 |
A once-nightly formulation |
Excessive daytime sleepiness and cataplexy in narcolepsy |
The first patient was dosed in its Rest-On phase III trial |
12/19/16 |
Otsuka Pharmaceutical Development & Commercialization Inc. (part of Otsuka Pharmaceuticals Co. Ltd.; Tokyo) and H. Lundbeck A/S (Valby, Denmark) |
Abilify Maintena |
An extended-release injectable formulation of aripiprazole |
Bipolar I disorder |
Phase III data showed it significantly delayed time to recurrence of any mood episode during a 52-week treatment study compared with placebo (p<0.0001) |
12/8/16 |
Pfizer Inc. (New York) |
Lyrica |
Pregabalin capsules CV and oral solution CV |
Pediatric epilepsy |
Top-line results showed that adjunctive treatment with Lyrica 10 mg/kg/day resulted in a statistically significant reduction in seizure frequency vs. placebo |
12/2/16 |
Pharnext SA (Paris) |
PXT3003 |
Pleodrug |
Charcot-Marie-Tooth disease type 1A |
Completed patient enrollment in its pivotal, phase III PLEO-CMT trial |
12/21/16 |
Scilex Pharmaceuticals Inc. (San Diego) |
Ztlido |
Lidocaine patch 1.8% |
Post-herpetic neuralgia |
Pivotal study for Ztlido met a primary endpoint establishing comparative pharmacokinetics and a secondary endpoint of bioequivalence for Ztlido as compared to the reference product, Lidoderm (lidocaine patch 5%, Endo Pharmaceuticals Inc.) |
12/6/16 |
TherapeuticsMD Inc. (Boca Raton, Fla.) |
TX-001HR |
A bio-identical hormone therapy combination 17ß-estradiol and progesterone in a single, oral softgel |
Moderate to severe vasomotor symptoms due to menopause |
Pivotal phase III data showed that TX-001HR estradiol 1 mg/progesterone 100 mg and TX-001HR estradiol 0.5 mg/progesterone 100 mg both achieved all four of the co-primary efficacy endpoints and the primary safety endpoint; they both demonstrated a statistically significant and clinically meaningful reduction from baseline in both the frequency and severity of hot flashes |
12/7/16 |
DIABETES | |||||
Novo Nordisk A/S (Bagsvaerd, Denmark) |
Xultophy |
Once-daily single injection fixed combination of long-acting insulin degludec |
Type 2 diabetes |
Phase IIIb trial in combination with insulin aspart at all main meals, showed that after 26 weeks, the trial successfully demonstrated it is non-inferior to insulin glargine U100 in combination with insulin aspart with regards to lowering of HbA1c; from a mean baseline HbA1c of 8.2%, both patient groups reached a similar HbA1c level of 6.7% after 26 weeks of treatment |
12/5/16 |
GASTROINTESTINAL | |||||
Ironwood Pharmaceuticals Inc. (Cambridge, Mass.) and Allergan plc (Dublin) |
Linzess |
A peptide agonist of guanylate cyclase 2C |
Irritable bowel syndrome with constipation |
Disclosed positive top-line data from a phase IIb trial that showed numerically greater abdominal pain improvement with 300 mcg compared to placebo and to the 290 mcg immediate-release (IR) formulation of linaclotide |
12/23/16 |
Synergy Pharmaceuticals Inc. (New York) |
Plecanatide |
A guanylate cyclase C receptor agonist |
Irritable bowel syndrome with constipation |
Phase III trials showed that plecanatide 3 mg and 6 mg, administered orally once daily, met the primary endpoint and showed statistical significance in the percentage of overall responders compared to placebo during 12 weeks of treatment; the second pivotal trial indicated that both doses met the primary endpoint and showed statistical significance in the percentage of overall responders |
12/12/16 |
INFECTION | |||||
Achaogen Inc. (South San Francisco) |
Plazomicin |
A next-generation aminoglycoside antibacterial derived from sisomicin |
Complicated urinary tract infections and acute pyelonephritis |
Phase III EPIC showed non-inferiority compared to meropenem, and superiority in the EMA's primary efficacy endpoints of microbiological eradication at the test-of-cure visit |
12/13/16 |
Cempra Inc. (Chapel Hill, N.C.) and Toyama Chemical Co. Ltd. (Tokyo) |
Solithromycin |
A ketolide antibiotic |
Community-acquired bacterial pneumonia and other respiratory infections |
Has begun phase III clinical trials |
12/6/16 |
Cytodyn Inc. (Vancouver, Wash.) |
PRO 140 |
Fully humanized monoclonal antibody targeting the CCR5 entry receptor |
HIV |
The first patients were treated in its phase III trial with PRO 140 as a single-agent maintenance therapy in virally suppressed subjects |
12/13/16 |
Janssen Sciences Ireland UC (Cork, Ireland) and Viiv Healthcare Ltd. (Brentford, U.K) |
Rilpivirine and dolutegravir |
Antiretrovirals |
HIV |
Two phase III studies to evaluate the safety and efficacy of switching virologically suppressed patients from a three or four drug antiretroviral regimen to the two drug regimen of rilpivirine (Janssen) and dolutegravir (Viiv Healthcare) met the primary endpoint of noninferiority at week 48 |
12/21/16 |
Merck & Co. Inc. (New York) |
VSV-ZEBOV |
Vaccine |
Ebola |
Final results of the phase III ring vaccination study show it to be 100% effective, with no one who received the vaccine contracting the virus |
12/27/16 |
Nabriva Therapeutics AG (Vienna) |
Lefamulin |
A semisynthetic pleuromutilin antibiotic |
Moderate to severe community-acquired bacterial pneumonia |
Achieved 60% of its enrollment target in the lefamulin evaluation against pneumonia (LEAP) 1 trial; LEAP 1 is a global, registrational, phase III trial |
12/21/16 |
Paratek Pharmaceuticals Inc. (Boston) |
Omadacycline |
An aminomethylcycline |
Community-acquired bacterial pneumonia |
Projects its ongoing pivotal phase III study will report top-line data during the second quarter of 2017, compared to the earlier estimate for data as early as the third quarter of 2017, due to faster-than-expected enrollment |
12/14/16 |
MISCELLANEOUS | |||||
Aerie Pharmaceuticals Inc. (Irvine, Calif.) |
Roclatan |
Netarsudil/latanoprost ophthalmic solution |
Glaucoma or intraocular pressure |
Completed patient enrollment in the company's second phase III registration trial (Mercury 2) |
12/8/16 |
Aytu Bioscience Inc. (Englewood, Colo.) |
Natesto |
Nasal testosterone gel |
Hypogonadism |
Demonstrated significant clinical improvements in erectile function and mood in hypogonadal men in the multicenter phase III |
12/1/16 |
Azurrx Biopharma Inc. (Brooklyn, N.Y.) and Mayoly Spindler SAS (Chatou Cedex, France) |
MS1819-SD |
A recombinant enzyme that is derived from the yarrowia lipolytica lipase |
Exocrine pancreatic insufficiency |
Enrolled the first three patients in a phase IIa trial |
12/22/16 |
Biomarin Pharmaceutical Inc. (San Rafael, Calif.) |
Vosoritide |
Analog of C-type natriuretic peptide |
Achondroplasia, the most common form of dwarfism |
Initiated a global phase III study in children |
12/13/16 |
Biotime Inc. (Alameda, Calif.) |
Renevia |
Injectable matrix; designed to mimic the extracellular matrix and provide a 3-D scaffold |
For whole adipose tissue fat transfer procedures |
Has enrolled more than 50 patients in its pivotal trial |
12/15/16 |
Bluebird Bio Inc. (Cambridge, Mass.) |
Lentiglobin |
Gene therapy |
Transfusion-dependent beta-thalassemia and non-beta0/beta0 genotypes |
Treated the first patient in Northstart-2, a phase III trial |
12/15/16 |
Galena Biopharma Inc. (San Ramon, Calif.) |
GALE-401 |
Anagrelide controlled release |
Essential thrombocythemia |
Confirmed the regulatory pathway to advance GALE-401 into a pivotal phase III trial following a meeting with the FDA |
12/29/16 |
GW Pharmaceuticals plc (London) |
Epidiolex |
A formulation of cannabidiol, an anti-convulsant |
Dravet syndrome and Lennox-Gastaut syndrome |
Disclosed additional positive Epidiolex phase III data that reinforce the robust nature of the results achieved in two of the most difficult-to-treat epilepsy patient populations |
12/6/16 |
Horizon Pharma plc (Dublin) |
Actimmune |
Interferon gamma-1b |
Friedreich's ataxia |
Failed in a phase III trial, STEADFAST, which missed its primary and secondary endpoints; company is winding down the program |
12/9/16 |
Ophthotech Corp. (New York) |
Fovista |
Pegpleranib; anti-platelet-derived growth factor therapy |
Wet age-related macular degeneration |
The pre-specified primary endpoint of mean change in visual acuity at 12 months was not achieved in its two pivotal phase III trials |
12/13/16 |
Proteon Therapeutics Inc. (Waltham, Mass.) |
Vonapanitase |
Recombinant human elastase |
Chronic kidney disease |
Phase III PATENCY-1 trial missed its primary endpoint of improved primary unassisted patency compared to placebo; top-line data for the trial's secondary endpoint showed it may improve secondary patency compared to placebo, however, and data from one of three tertiary endpoints suggested the drug may improve fistula use in hemodialysis |
12/14/16 |
Revance Therapeutics Inc. (Newark, Calif.) |
RT002 |
Daxibotulinum-toxinA |
Moderate to severe frown lines |
Started dosing patients enrolled in the company's phase III study of daxibotulinumtoxinA for the treatment of moderate to severe frown lines in adults |
12/8/16 |
Strongbridge Biopharma plc (Trevose, Pa.) |
COR-003 |
Levoketoconazole; a cortisol synthesis inhibitor |
Endogenous Cushing's syndrome |
Plans to initiate a second phase III study, LOGICS, which will supplement the long-term efficacy and safety data from the ongoing SONICS study; LOGICS enrollment is anticipated to begin midyear 2017 and top-line data are expected in the third quarter of 2018 |
12/27/16 |
RESPIRATORY | |||||
Anthera Pharmaceuticals Inc. (Hayward, Calif.) |
Sollpura |
Liprotamase; recombinant pancreatic enzyme replacement therapy |
Cystic fibrosis patients with exocrine pancreatic insufficiency |
Topline phase III SOLUTION clinical study data showed it narrowly missed the coefficient of fat absorption (CFA) non-inferiority margin of the primary modified intent-to-treat analysis; however, by additional pre-specified analyses of CFA, Sollpura met the non-inferiority criterion; the study also confirmed that the ratio of the three enzymes in Sollpura demonstrated an appropriate response in the coefficient of nitrogen absorption |
12/29/16 |
Aradigm Corp. (Hayward, Calif.) |
Pulmaquin |
Formulation of once-daily ciprofloxacin for inhalation |
Non-cystic fibrosis bronchiectasis with chronic lung infections with Pseudomonas aeruginosa |
Top-line results showed that the median time to first mild, moderate or severe pulmonary exacerbation was 230 days in the Pulmaquin group, compared to 163 days in the placebo group (p=0.0462), showing statistical significance in the ORBIT-4 trial; it was 221 days for Pulmaquin and 136 days for placebo in the ORBIT-3 trial, which missed statistical significance (p=0.8488) |
12/2/16 |
Glaxosmithkline plc (London) and Innoviva Inc. (Brisbane, Calif.) |
Fluticasone furoate/umeclidinium/vilanterol |
Inhaled corticosteroid (ICS); long-acting muscarinic antagonist; long-acting beta2-adrenergic agonist |
Asthma |
Started a phase III study investigating the effects when compared to therapy with Relvar/Breo |
12/20/16 |
Lexicon Pharmaceuticals Inc. (The Woodlands, Texas) |
Sotagliflozin |
First-in-class, oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 |
Type 1 diabetes |
The pivotal inTandem1 phase III clinical trial met its primary endpoint, showing a statistically significant reduction in A1C at 24 weeks in patients with type 1 diabetes on a background of optimized insulin; top-line results showed that patients treated with sotagliflozin had a mean A1C reduction from baseline of 0.43% on 200mg once daily sotagliflozin dose (p<0.001) and a reduction of 0.49% on 400mg once daily sotagliflozin dose (p<0.001) as compared to a reduction of 0.08% on placebo after 24 weeks of treatment |
12/22/16 |
Notes Public biopharmaceutical company stock symbols can be found in the stock report located on the last two pages of this issue. The date indicated refers to the BioWorld Today issue in which the news item can be found. For more information about individual companies and/or products, see Thomson Reuters Cortellis. |