Company (location)

Product

Description

Indication

Status

Date

Cancer

Amgen Inc. (Thousand Oaks, Calif.)

Xgeva

Denosumab

Multiple myeloma

Phase III '482 study showed it met the primary endpoint, demonstrating noninferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma (HR=0.98, 95% CI: 0.85-1.14); the median time to first on-study skeletal-related event was 22.8 months for it and 24 months for zoledronic acid; overall survival, a secondary endpoint, was similar between the two arms, with a hazard ratio of 0.90 (95% CI: 0.70-1.16)

2/12/18

Array Biopharma Inc. (Boulder, Colo.) and Pierre Fabre SA (Castres, France)

COMBO-450

Encorafenib plus binimetinib

BRAF-mutant melanoma

Phase III COLUMBUS showed it produced a median overall survival of 33.6 months compared to 16.9 months for patients treated with Zelboraf, resulting in a hazard ratio of 0.61

2/7/18

Astellas Pharma Inc. (Tokyo) and Pfizer Inc. (New York)

Xtandi

Enzalutamide

Non-metastatic castration-resistant prostate cancer

Results from the phase III PROSPER trial testing it plus androgen deprivation therapy (ADT) showed the combination reduced the risk of developing metastases or death by 71% compared to ADT alone and resulted in a median metastasis-free survival of 36.6 months compared to 14.7 months for patients treated with ADT alone

2/7/18

Athenex Inc. (Buffalo, N.Y.)

Oraxol

Oral formulation of paclitaxel plus P-glycoprotein pump inhibitor HM30181A

Metastatic breast cancer

Enrolled more than 180 patients in its phase III KX-ORAX-001 trial

2/16/18

Beigene Ltd. (Beijing)

Tislelizumab

Anti-PD-1 antibody

Advanced unresectable or metastatic esophageal squamous cell carcinoma

Dosed the first patient in a phase III trial

2/1/18

Bristol-Myers Squibb Co. (Princeton, N.J.)

Opdivo and Yervoy

Nivolumab and ipilimumab

Advanced non-small-cell lung cancer (NSCLC)

The ongoing phase III Checkmate-227 study met its co-primary endpoint of progression-free survival with the combo vs. chemotherapy in patients whose tumors have high (≥10 mutations/megabase) tumor mutation burden (TMB), regardless of PD-L1 expression; the safety profile was consistent with previously reported findings in first-line NSCLC for the combination schedule of Opdivo 3 mg/kg every two weeks and low-dose Yervoy (1 mg/kg) every six weeks

2/6/18

Celgene Corp. (Summit, N.J.)

Pomalyst/Imnovid 

Pomalidomide

Relapsed or refractory multiple myeloma

Its phase III OPTIMISMM trial testing it in combination with Velcade and dexamethasone met its primary endpoint, with the triple combination extending progression-free survival compared to Velcade and low-dose dexamethasone alone

2/7/18

Eisai Co. Ltd. (Tokyo)

Halaven

Eribulin mesylate

Advanced liposarcoma (LPS) or leiomyosarcoma

Data from a subgroup analysis of the phase III Study 309 trial showed that in previously treated patients with LPS, it produced a statistically significant improvement in median overall survival of 15.6 months compared to 8.4 months for patients treated with dacarbazine; progression-free survival of 2.9 months vs. 1.7 months was also better for patients treated with it compared to dacarbazine, respectively

2/6/18

Eisai Co. Ltd. (Tokyo)

Lenvima/Kisplyx

Lenvatinib

Hepatocellular carcinoma

Phase III REFLECT showed it was deemed non-inferior to Nexavar and produced statistically significant improvements in the secondary endpoints of progression-free survival, time to progression and objective response rate

2/13/18

Eisai Inc. (Woodcliff Lake, N.J.; U.S. subsidiary of Toyko-based Eisai Co. Ltd.)

Lenvima

Lenvatinib mesylate

Unresectable hepatocellular carcinoma

Phase III REFLECT data showed it produced a median overall survival of 13.6 months compared to 12.3 months for Nexavar; the median progression-free survival was 7.4 months for patients treated with it compared to 3.7 months for Nexavar; it also improved median time to progression and objective response rate

2/16/18

Endocyte Inc. (West Lafayette, Ind.)

177Lu-PSMA-617

Radioligand therapy

Prostate cancer

Launched the Vision trial, a phase III registration study

2/27/18

Genentech (South San Francisco, unit of the Roche Group)

Tecentriq and Avastin

Atezolizumab and bevacizumab

Advanced or metastatic renal cell carcinoma

The phase III IMmotion151 study met its co-primary endpoint of investigator-assessed progression-free survival (PFS) in people whose disease expressed the PD-L1 protein; those who received the combination had a 26% reduced risk of disease worsening or death compared to people treated with Sutent (median PFS of 11.2 months vs. 7.7 months; p=0.02)

2/7/18

Hutchison China Meditech Ltd. (London)

Fruquintinib

Inhibitor of vascular endothelial growth factor receptors 1, 2 and 3

Non-small-cell lung cancer

Completed enrollment of the phase III FALUCA trial

2/14/18

Janssen Pharmaceutical Cos. (Raritan, N.J., unit of Johnson & Johnson)

Erleada

Apalutamide

Nonmetastatic castration-resistant prostate cancer

Phase III SPARTAN data showed it decreased risk of metastasis or death by 72% and improved median metastasis-free survival (MFS) by more than two years (difference of 24.3 months) in patients whose prostate-specific antigen is rapidly rising, compared to placebo

2/12/18

Merck KGaA (Darmstadt, Germany) and Pfizer Inc. (New York)

Bavencio

Avelumab

Non-small-cell lung cancer

Javelin Lung 200, a phase III trial comparing it to docetaxel found that overall survival failed to improve in patients with unresectable, recurrent or metastatic PD-L1-positive tumors that progressed after treatment with a platinum-containing doublet therapy

2/16/18

OSE Immuno-therapeutics SA (Nantes, France)

Tedopi

10 combined neoepitopes

Non-small-cell lung cancer (NSCLC)

Received approval by U.S. institutional review boards to resume enrollment in its phase III trial, using the revised protocol that will focus on patients with NSCLC who have failed a previous treatment with a PD-1/PD-L1 immune checkpoint inhibitor

2/28/18

Cardiovascular

Astrazeneca plc (London)

Brilinta

Ticagrelor

Heart attack and stenosis

Phase III PEGASUS-TIMI 54 subanalyses showed a risk reduction of 19% in MACE (the composite of CV death, myocardial infarction or stroke) (HR 0.81; 95% CI, 0.7–0.95) and of 36% in coronary death (HR 0.64; 95% CI, 0.45–0.89) from treatment with 60 mg, in combination with low-dose aspirin

2/8/18

La Jolla Pharmaceutical Co. (San Diego)

Giapreza

Angiotensin II

Vasodilatory Shock

Phase III ATHOS-3 (Angiotensin II for the Treatment of High Output Shock) data showed a lower 28-day mortality rate in patients with baseline APACHE II scores >30 in the Giapreza group vs. the placebo group: 28-day mortality was 51.8% (n=58) for the Giapreza group compared to 70.8% (n=65) for the placebo group (hazard ratio [HR]=0.62 [95% CI: 0.39, 0.98; p=0.037])

2/27/18

Dermatologic

Abbvie Inc. (North Chicago)

Risankizumab

IL-23 inhibitor

Psoriasis

Additional ranked secondary endpoints of phase III ultIMMa-1 and ultIMMa-2 replicate trials showed significantly higher rates of skin clearance at week 16 and at one year of treatment, compared with ustekinumab, as measured by static Physician Global Assessment (sPGA 0); skin clearance rates (sPGA 0) were consistent with the previously reported PASI 100 rates at one year

2/21/18

Athenex Inc. (Buffalo, N.Y.)

KX2-391

Topical dual Src kinase and tubulin polymerization inhibitor

Actinic keratosis

Completed patient enrollment for both phase III studies ahead of schedule

2/15/18

Cara Therapeutics Inc. (Stamford, Conn.)

Korsuva

CR-845/difelikefalin injection

Moderate to severe chronic kidney disease-associated pruritis

Started a phase III trial

2/1/18

Celgene Corp. (Summit, N.J.)

Otezla

Apremila

Behçet's disease with oral ulcers

Phase III RELIEF data showed that after 12 weeks of treatment, the area under the curve for the number of oral ulcers was 129.5 for patients treated with it, a statically significant improvement over 222.1 seen for patients treated with placebo; it also improved multiple secondary endpoints, including oral ulcer pain and overall disease activity as measured by the Behçet's Syndrome Activity Score and the Behçet's Disease Current Activity Index, as well as quality of life

2/21/18

Dermira Inc. (Menlo Park, Calif.)

Glycopyrronium tosylate

Once-daily anticholinergic wipe

Primary axillary hyperhidrosis

Phase III data showed that when applied topically, it improved disease severity, reduced sweat production and was associated with improved quality-of-life outcomes for pediatric patients (ages 9 to 16) compared to vehicle-treated patients

2/21/18

Eli Lilly and Co. (Indianapolis)

Taltz

Ixekizumab

Moderate to severe genital psoriasis

Phase IIIb data showed that patients treated with it reported a greater decrease in the impact of their condition on sexual activity compared to placebo after 12 weeks of treatment; 92% of patients treated with it compared to 56.8% of patients treated with placebo (p<0.001) reported no or little sexual difficulties caused by skin symptoms, as measured by the Dermatology Life Quality Index

2/21/18

Evolus Inc. (Irvine, Calif.)

Prabotulinum-toxinA

900-kilodalton botulinum toxin type A complex

Glabellar frown lines

Phase III EVB-003 data showed it was noninferior to onabotulinumtoxinA with 87.2% of patients treated with it achieving no or mild lines on the Glabellar Line Scale at day 30 compared to 82.8% of patients treated with onabotulinumtoxinA and 4.2% of placebo-treated patients

2/21/18

Janssen-Cilag International NV (Beerse, Belgium; part of Janssen Pharmaceutical Cos. of Johnson & Johnson)

Tremfya

Guselkumab

Moderate to severe plaque psoriasis

Phase III VOYAGE 2 data showed that of the patients with at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90) at week 28 who continued receiving it, 86% maintained a PASI 90 response through week 72, while only 11.5% of patients who were withdrawn from treatment maintained a PASI 90 response; of the patients who were withdrawn, 87.6% achieved a PASI 90 response within six months of commencing retreatment

2/21/18

Leo Pharma A/S (Ballerup, Denmark)

Kyntheum

Brodalumab

Psoriasis on the nail

Results from two phase III studies – AMAGINE-2 and -3 – showed that it decreased the Nail Psoriasis Severity Index (NAPSI) score in the most affected nail at week 52 and was associated with a lower NAPSI score than ustekinumab and placebo; patients continuously receiving 210 mg changed from a mean NAPSI score of 9.6 at baseline to 1.6 at week 52; patients receiving ustekinumab changed from a mean NAPSI score of 9.9 at baseline to 2.4 at week 52

2/21/18

Novartis AG (Basel, Switzerland)

Cosentyx

Secukinumab

Moderate to severe plaque psoriasis

Data from the SCULPTURE study showed that two-thirds of patients treated with it reported no impact of skin disease on their quality of life through five years, as described by the Dermatology Life Quality Index (DLQI) 0/1 response (72.7% at year one and 65.5% at year five)

2/21/18

Endocrine/Metabolic

Diurnal Group plc (Cardif, U.K.)

Chronocort

Modified release hydrocortisone

Congenital adrenal hyperplasia

Completed enrollment of a phase III trial

2/13/18

Eli Lilly and Co. (Indianapolis)

Trulicity

Dulaglutide

Type 2 diabetes

Phase III Award-9 data showed that 1.5 mg plus insulin glargine significantly reduced A1C from baseline (1.44%) compared to placebo with insulin glargine (0.67%); participants treated with 1.5 mg also lost an average 1.91 kg as compared to participants treated with placebo plus insulin glargine, who gained an average 0.50 kg

2/27/18

The Medicines Co. (Parsippany, N.J.)

Inclisiran

GalNAc-conjugated RNA interference therapeutic

Heterozygous familial hypercholesterolemia

Target of 400 patients randomized in the ORION-9 Phase III trial has been exceeded in 10 weeks, ahead of its anticipated recruitment goal of 24 weeks

2/21/18

Novo Nordisk A/S (Bagsværd, Denmark)

Oral semaglutide

Glucagon-like peptide 1 (GLP-1) receptor agonist

Type 2 diabetes

The Pioneer 1 phase IIIa trial achieved its primary objective by demonstrating improvements in long-term blood sugar for all three doses of oral semaglutide compared to placebo; patients in the active treatment arm given 3-mg, 7-mg and 14-mg doses achieved reductions in HbA1c of 0.8%, 1.3% and 1.5%, respectively, compared to a reduction of 0.1% in people treated with placebo, from a mean baseline of 8%; only the 14-mg dose demonstrated statistically significant weight loss vs. placebo

2/26/18

Xeris Pharmaceuticals Inc. (Chicago)

Glucagon rescue pen

Metabolic hormone

Severe hypoglycemia associated with diabetes

Completed two phase III studies and initiated a phase IIIb study; the usability and reliability study showed 99% of participants were able to successfully administer a full dose with the rescue pen

2/20/18

Zealand Pharma A/S (Copenhagen)

Dasiglucagon

Glucagon analogue

Type 1 diabetes

Completed its phase III trial

2/22/18

Gastrointestinal

Anthera Pharmaceuticals Inc. (Hayward, Calif.)

Sollpura

Non-pig pancreatic enzyme replacement therapy

Exocrine pancreatic insufficiency due to cystic fibrosis

The final patient completed the last visit in the primary treatment phase of RESULT, a phase III study

2/6/18

Takeda Pharmaceutical Co. Ltd. (Osaka, Japan)

Entyvio

Vedolizumab

Crohn's disease (CD)

Phase IIIb results at week 26 found it induced complete mucosal healing (15%), endoscopic remission (12%) and endoscopic response (25%) in the overall population of CD patients

2/20/18

Wilson Therapeutics AB (Stockholm, Sweden)

WTX-101

Bis-choline tetrathiomolybdate

Wilson disease

The first patient has been enrolled in its pivotal phase III trial, called Focus

2/20/18

Genitourinary/Sexual Health

Abbvie Inc. (North Chicago)

Elagolix

Gonadotropin-releasing hormone receptor antagonist

Heavy menstrual bleeding associated with uterine fibroids

The phase III Elaris UF-I study met its primary endpoint showing that at month six, when combined with low-dose hormone (add-back) therapy, it reduced heavy menstrual bleeding, with 68.5 % (p<0.001) of women with uterine fibroids achieving clinical response compared to placebo (8.7%), as measured by the alkaline hematin method; the study also met all ranked secondary endpoints (p<0.001) at month six

2/22/18

Aquinox Pharmaceuticals Inc. (New York)

AQX-1125

Rosiptor

Interstitial cystitis/bladder pain syndrome

Aquinox Pharmaceuticals Inc., of New York, said it met its enrollment threshold of 300 women in its LEADERSHIP 301 trial of rosiptor (AQX-1125), its SHIP1 activator, in interstitial cystitis/bladder pain syndrome and remains on track for top-line data in the third quarter of 2018. The study, which has enrolled a total of 322 women and 88 men, is testing the change from baseline at week 12 in maximum daily bladder pain based on an 11-point numeric rating scale compared to placebo, recorded by electronic diary, as the primary endpoint.

2/12/18

Evofem Biosciences Inc. (San Diego)

Amphora

L-lactic acid, citric acid, and potassium bitartrate vaginal gel

Pregnancy prevention

Completed enrollment of its phase III trial

2/16/18

Ferring Pharmaceuticals Inc. (Parsippany, N.J.) and Merck & Co. Inc. (Kenilworth, N.J.)

Carbetocin

Analogue of oxytocin

Postpartum hemorrhage

Completed the CHAMPION (Carbetocin Haemorrhage Prevention) trial

2/23/18

Obseva SA (Geneva)

Nolasiban

Oxytocin antagonist

In vitro fertilization

The phase III met its primary endpoint with an absolute increase in ongoing pregnancy rate at 10 weeks of 7.1%, reflecting a 28.5% success rate on placebo vs. a 35.6% rate on nolasiban (p = 0.031); in a subgroup of women undergoing embryo transfer (ET) five days after oocyte retrieval, the absolute increase in ongoing pregnancy rate at 10 weeks was 11.2% in favor of nolasiban (p = 0.034); it was well-tolerated, with low rates of discontinuation

2/27/18

Tetraphase Pharmaceuticals Inc. (Watertown, Mass.)

Eravacycline

Fluorocycline antibiotic

Complicated urinary tract infections

Statistical non-inferiority to ertapenem was not established in the Ignite 3 trial, failing to meet the co-primary efficacy endpoints of responder rate (a combination of clinical cure and microbiological success) in the microbiological intent-to-treat population at the end-of-I.V. treatment visit and at the test-of-cure visit, which were evaluated using a 10% non-inferiority margin; it was well tolerated, with a safety profile consistent with prior studies

2/15/18

Hematologic

Shield Therapeutics plc (London)

Feraccru

Ferric maltol

Iron deficiency anemia

Phase III data of 168 chronic kidney disease patients showed that while the drug improved hemoglobin from baseline compared to placebo at eight weeks, the result wasn't sustained and the trial didn't meet the primary endpoint with hemoglobin improvement of 0.45 g/dL in patients treated with it compared to 0.15 g/dL for placebo at 16 weeks

2/6/18

Shield Therapeutics plc (London)

Feraccru

Oral iron replacement therapy

Anemia in chronic kidney disease

Phase III results showed it failed to demonstrate a statistical difference in hemoglobin levels from baseline compared to placebo, at 0.45 g/dL vs. 0.15 g/dL (p=0.01686)

2/13/18

Spectrum Pharmaceuticals Inc. (Henderson, Nev.)

Rolontis

Eflapegrastim

Chemotherapy-induced neutropenia management

Advance, the first of two phase III trials seeking to prove it noninferior to Neulasta achieved that goal; the second phase III trial, Recover, is fully enrolled

2/6/18

Immune

Aimmune Therapeutics Inc. (Brisbane, Calif.)

AR-101

Oral immunotherapy

Peanut allergy

Phase III data showed that about 67% of evaluable people treated with it tolerated a single highest dose of at least 600 mg of peanut protein with no more than mild symptoms vs. 4% of those given a placebo, meeting its primary and secondary endpoints in its primary target population of patients ages 4 to 17

2/21/18

Cytori Therapeutics Inc. (San Diego)

Habeo

Cell therapy

Scleroderma

Phase III STAR showed treatment with it produced responses that exceeded the minimal clinical important differences for the Cochin Hand Function Scale and for the Health Assessment Questionnaire-Disability Index in 52% of patients with diffuse SSc compared to 16% for placebo

2/16/18

Mesoblast Ltd. (Perth, Australia)

MSC-100-IV

Remestemcel-L

Refractory acute graft-vs.-host disease (aGVHD)

Met the primary endpoint in a phase III trial in children; in 55 children who failed initial steroid therapy, the overall response rate at day 28 of treatment was 69% compared to a historical control rate of 45%

2/23/18

Infection

Basilea Pharmaceutica Ltd. (Basel, Switzerland)

Ceftobiprole

Antibiotic

Acute bacterial skin and skin structure infection

Started enrollment in a phase III trial

2/26/18

Bavarian Nordic A/S (Copenhagen)

Imvamune

Non-replicating smallpox vaccine

Small pox

The phase III study achieved both of its primary endpoints, demonstrating efficacy in comparison to Acam-2000; the peak neutralizing antibodies induced by it were shown to be twofold higher than those stimulated by Acam-2000, meeting the co-primary endpoint of noninferiority and was shown to be a statistically superior immune response; primary vaccination with it resulted in a highly attenuated take (reduction in lesion size), and prevented the vaccine take in the majority of subjects re-vaccinated with Acam-2000

2/7/18

Citius Pharmaceuticals Inc. (Cranford, N.J.)

Mino-Lok

Antibiotic lock solution

Catheter-related bacteremias

Enrolled the first patient in its phase III trial

2/16/18

Cormedix Inc. (Berkeley Heights, N.J.)

Neutrolin

Non-antibiotic antimicrobial solution

Catheter-related bloodstream infections (CRBSIs)

The clinical adjudication committee reviewed potential cases of CRBSI in the Lock-It-100 study of hemodialysis patients with central venous catheters that occurred through early December 2017, and identified 28 such cases; as previously agreed with the FDA, an interim analysis will be performed when the first 28 CRBSIs case have been identified

2/22/18

Glaxosmithkline plc (London)

Fluarix Quadrivalent

Vaccine

Influenza

Trial data demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity in children 6 months through 35 months of age

2/22/18

Viiv Healthcare Ltd. (London)

Tivicay and Epivir

Dolutegravir and lamivudine

HIV

Launched the eighth phase III study in individuals with HIV who achieved viral suppression on a tenofovir alafenamide fumarate (TAF)-based regimen of at least three drugs

2/9/18

Musculoskeletal

Eli Lilly and Co. (Indianapolis)

Taltz

Ixekizumab

Ankylosing spondylitis

Phase III COAST-V showed it increased the proportion of patients who achieved Assessment of Spondyloarthritis International Society 40 response at 16 weeks, compared to placebo; the trial also met all key secondary endpoints

2/14/18

Neurology/Psychiatric

Adamas Pharmaceuticals Inc. (Emeryville, Calif.)

Gocovri

Amantadine extended-release capsules

Parkinson's disease

Phase III EASE LID 2 subanalyses showed patients experienced a 35% improvement in motor complications at week eight after transitioning from immediate-release amantadine to Gocovri; the effects were maintained for the 64-week period assessed

2/9/18

Allergan plc (Dublin)

Ubrogepant

Oral CGRP receptor antagonist

Acute migraine

It hit the co-primary efficacy endpoints in ACHIEVE I, the first of two pivotal phase III trials; both 50-mg and 100-mg doses showed a statistically significant difference in the percentage of individuals treated with it who achieved pain freedom two hours after the initial dose compared to placebo (50 mg vs. placebo, p=0.0023, 100 mg vs. placebo, p=0.0003) – response rates of about 19% and 21%, respectively, for the treatment arms compared to 12% for placebo

2/7/18

Biogen Inc. (Cambridge, Mass.) and Ionis Pharmaceuticals Inc. (Carlsbad, Calif.)

Spinraza

Nusinersen

Later-onset spinal muscular atrophy

Phase III CHERISH data showed treatment resulted in a 1.0 point increase in the mean change from baseline to month 15 in the Hammersmith Functional Motor Scale-Expanded score compared to a 3.9 point decline for untreated patients; revised Upper Limb Module scores also improved with a 4.2 point increase for patients treated with Spinraza compared to a 0.5 point increase in untreated patients

2/16/18

Centrexion Therapeutics Corp. (Boston)

CNTX-4975

Synthetic, ultra-pure injection of trans-capsaicin

Chronic moderate to severe pain due to knee osteoarthritis

The first patient has been dosed in its phase III Victory-1 trial

2/22/18

Hisamitsu Pharmaceutical Co. Ltd. (Tosu City, Japan) and subsidiary Noven Pharmaceuticals Inc. (Miami)

HP-3070

Transdermal patch comprising asenapine maleate

Schizophrenia

It achieved the primary endpoint in a phase III trial in the U.S.; when compared to placebo, it achieved statistically significant improvement from baseline in the change of the total Positive and Negative Syndrome Scale score at six weeks

2/1/18

Ipsen Biopharma-ceuticals Inc. (affiliate of Ipsen SA, of Paris)

Dysport

Abobotulinum-toxinA

Cerebral palsy

Results from three phase III studies showed that 37% of hemiparetic (post-stroke/traumatic brain injury) patients with adult upper limb spasticity, 20% of hemiparetic patients with adult lower limb spasticity (ALLS) and 74% of patients with pediatric (at least 2 years of age) lower limb spasticity did not require reinjection until week 16 or later; a separate phase III study followed by an open-label extension showed improvements in muscle tone after a single injection that were sustained over subsequent treatment

2/16/18

Merck & Co. Inc. (Kenilworth, N.J.)

MK-8931

Verubecestat

Prodromal Alzheimer's disease

The company is stopping its phase III APECS study following a recommendation by the external data monitoring committee, which assessed overall benefit/risk during a recent interim safety analysis and concluded that it was unlikely that positive benefit/risk could be established if the trial continued

2/15/18

Pharma Two B Ltd. (Rehovot, Israel)

P2B-001

Pramipexole and rasagiline

Early Parkinson's disease

The first patients were dosed in the phase III study

2/7/18

Sumitomo Dainippon Pharma Co. Ltd. (Osaka, Japan) and Nitto Denko Corp. (Osaka, Japan)

Blonanserin

Atypical antipsychotic, transdermal patch formulation

Schizophrenia

Its phase III study met its primary endpoint; for change from baseline to week six in the Positive and Negative Syndrome Scale (PANSS) total score, both 40 mg/day and 80 mg/day groups showed statistically significant improvement vs. placebo; the difference in score change vs. placebo was -16.4 [adjusted p=0.007] for the 40 mg/day group and -21.3 [adjusted p<0.001] for the 80 mg/day group; the placebo group's PANSS score declined by 10.8 points

2/15/18

Zogenix Inc. (Emeryville, Calif.)

ZX-008

Low-dose fenfluramine

Dravet syndrome

The last patient was randomized into the treatment period of Study 1504, its second phase III trial evaluating it as an adjunctive treatment for seizures in children and young adults

2/2/18

Ocular

Psivida Corp. (Watertown, Mass.)

Durasert

Three-year microinsert

Posterior segment uveitis

Data from a second phase III trial showed it reduced the recurrence with only 36.6% of patients recurring compared to 71.2% of sham-treated patients

2/9/18

Other/Miscellaneous

Endo International plc (Dublin)

CCH

Collagenase clostridium histolyticum

Cellulite

Started two identical phase III RELEASE trials

2/7/18

Saniona AB, (Copenhagen) and Productos Medix SA de CV (Mexico City)

Tesofensine

Triple monoamine reuptake inhibitor

Obesity

Completed recruitment for its phase III study

2/2/18

Respiratory

Vertex Pharmaceuticals Inc. (Boston)

Symdeko

Tezacaftor/ivacaftor

Cystic fibrosis

Halted phase III trials in France because a deal couldn't be reached there on reimbursement for Orkambi

2/14/18

Vertex Pharmaceuticals Inc. (Boston)

VX-659

Tezacaftor and ivacaftor

Cystic fibrosis

Started the first phase III trial in patients who have one F508del mutation and one minimal function mutation

2/23/18

Notes

The date indicated refers to the BioWorld issue in which the news item can be found.

For more information about individual companies and/or products, see Cortellis.