Novartis Seeks New Indication for CAR-T Therapy Kymriah

By October 31, 2017

The latest sBLA is intended for patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant (ASCT).

Influenza Oral Tablet Vaccine Shows Promise in Phase 2 Trial

By October 27, 2017

Results showed that the tablet group had a 39% reduction in clinical disease compared to placebo and a 27% reduction compared to the injectable QIV.

FDA Grants Alzheimer's Disease Drug Candidate Fast Track Status

By October 25, 2017

The company said in a press release that their pivotal Phase 3 program for ALZ-801 will focus on approval in the genetically-defined subpopulation of high risk patients who are at the Mild stage of AD.

Valbenazine Granted Orphan Drug Designation for Tourette Syndrome

By October 25, 2017

Valbenazine is already approved and marketed as Ingrezza in the US to treat adults with tardive dyskinesia

Disease-Modifying Osteoarthritis Tx Granted Fast Track Status

By October 25, 2017

There are currently no DMOADs approved for use in OA. MIV-711 is a selective inhibitor of cathepsin K, which is the principal protease involved in breaking down collagen in bones and cartilage.

Treatment for Fistulizing Crohn's Disease Gets Orphan Drug Status

By October 24, 2017

Cx601 is a first-in-class allogeneic cell therapy intended for patients who have had an inadequate response to at least one conventional or biologic therapy.

First-in-Class, Oral Agent Gets Orphan Drug Status for Pancreatic Cancer

By October 20, 2017

Mesupron is a first-in-class, orally-administered protease inhibitor.

BLA Submitted for Migraine Prevention Drug Fremanezumab

By October 17, 2017

The studies looked at the safety, tolerability, and efficacy of 4 dose regimens of subcutaneous fremanezumab vs. placebo over 16 weeks.

First-in-Class Alzheimer's Drug Gets Fast-Tracked by FDA

By October 16, 2017

CT1812 is a first-in-class, orally-administered small molecule that targets the sigma-2 receptor complex on neuronal synapses, displacing beta amyloid oligomers from their binding sites on brain cells and clearing them in to the cerebrospinal fluid.

Investigational Hyperhidrosis Therapy Found to Be Safe, Effective

By October 13, 2017

Daily treatment with glycopyrronium tosylate in the Phase 3, open-label ARIDO trial was generally well-tolerated during 44 weeks of treatment.

First Gene Tx for Inherited Retinal Disease Gets Thumbs Up from FDA Committee

By October 13, 2017

The recommendation was based on data from the Luxturna clinical development program which included a Phase 3 trial in patients 4-44 years of age.

Merck Decides to Put the Brakes on CETP Inhibitor Anacetrapib

By October 13, 2017

The decision follows a review of the clinical profile and discussions with external experts

Combo Antibiotic Gets Priority Review for New Pneumonia Indication

By October 13, 2017

Avycaz is a combination antibiotic consisting of ceftazidime, a cephalosporin, and avibactam, a beta-lactamase inhibitor.

Leprosy Vaccine Candidate to Be Tested in Humans

By October 12, 2017

Leprosy (also known as Hansen's disease) is caused by the Mycobacterium leprae bacteria and results in disfiguration of the skin and mucous membranes as well as incurable nerve damage.

NDA Submitted for Novel Non-Metastatic CRPC Treatment

By October 11, 2017

Apalutamide, an investigational, next generation oral androgen receptor inhibitor, was assessed for safety and efficacy in the Phase 3 pivotal trial, ARN-509-003 (SPARTAN), which the NDA is based on.

PLK1 Inhibitor Granted Orphan Drug Designation for AML

By October 10, 2017

A Phase 1b/2 open-label study is being planned to assess the safety and efficacy of PCM-075.

First-in-Class Oral Tx for Uterine Fibroids One Step Closer to Approval

By October 10, 2017

Ulipristal acetate is a selective progesterone receptor modulator which acts directly on the progesterone receptors in the endometrium, uterine fibroids, and the pituitary gland.

Lixivaptan Gets Orphan Drug Status for Autosomal Dominant PKD

By October 05, 2017

Lixivaptan is a potent, selective vasopressin V2 receptor antagonist which has been found to delay the progression of an autosomal dominant form of polycystic kidney disease.

Merck Discontinues Clinical Program for Two HCV Treatments

By September 29, 2017

The MK-3682B trial evaluated a triple-combination therapy.

Novel Buprenorphine Sublingual Spray NDA Submitted

By September 29, 2017

Buprenorphine is a partial agonist of the mu-receptor and an antagonist of the kappa receptor, which contributes to its analgesic effects.

FDA: More Data Needed for Sirukumab for Active RA

By September 27, 2017

The CRL indicated a request for additional clinical data in order to evaluate the safety of sirukumab in the treatment of RA.

No Significant Improvement with Intepirdine in Alzheimer's Disease Study

By September 26, 2017

The study included patients with mild to moderate Alzheimer's disease on donepezil therapy (n= 1315) and compared once-daily oral doses of intepirdine 35mg to placebo over 24 weeks.

Linhaliq NDA Granted Priority Review

By September 25, 2017

Linhaliq was previously granted Qualified Infectious Disease Product (QIDP) Designation and Fast Track designation for NCFBE with lung infections with P. aeruginosa.

Pompe Disease Treatment Granted Orphan Drug Designation

By September 25, 2017

ATB200 is a unique recombinant human acid alpha-glucosidase (rhGAA) enzyme with optimized carbohydrate structures while AT2221 is a pharmacological chaperone.

Phase 3 Results Announced for Lusutrombopag for Thrombocytopenia

By September 25, 2017

The trial, L-PLUS2, included 215 patients who were randomized 1:1 to either 3mg of lusutrombopag or placebo for up to 7 days.

FDA Rejects Vraylar sNDA for Negative Symptoms of Schizophrenia

By September 25, 2017

In the letter the FDA stated that their preliminary appraisal found that the sNDA was not sufficiently complete to permit a substantive review.

NDA for First Darunavir-Based Single-Tab HIV Regimen Submitted

By September 25, 2017

The treatment will become the first darunavir-based, single-tablet HIV treatment, if approved.

NDA Submitted for Thrombocytopenia Treatment

By September 22, 2017

The results from Phase 3 trials demonstrated efficacy and safety in patients with severe thrombocytopenia and with CLD.

UTI Treatment Gains Qualified Infectious Disease Product Designation

By September 21, 2017

"We expect to begin enrolling patients as early as December in a proof-of-concept Phase 2 study of omadacycline in uUTI, and an indication in this type of infection would broaden the opportunities for oral omadacycline in community-acquired infections," said Evan Loh, MD, COO and CMO of Paratek.

Treatment for Subtype of T-Cell Lymphoma Granted Breakthrough Designation

By September 20, 2017

The study enrolled a total of 372 patients with MF and SS who were randomized to either receive mogamulizumab or vorinostat.

Orphan Drug Designation Granted to ALS Treatment

By September 19, 2017

A Phase 2 randomized, double-blind, placebo-controlled trial of AMX0035 titled CENTAUR (nct03127514) has begun with 132 ALS participants enrolled.

Phase 3 Results of Novel CABP Treatment Announced

By September 18, 2017

A second 'LEAP 2' trial is currently in the midst of enrolling patients and expected to have topline results in the spring of 2018.

Investigational Migraine Tx Shows Promise in Phase 3 Trial

By September 14, 2017

Results demonstrated that at 12 weeks after the first dose of fremanezumab, the CM group had reductions of monthly headaches; -4.6 days for the monthly dose, -4.3 days for the quarterly dose and -2.5 for the placebo group (P<0.0001).

FDA Committee Gives Thumbs Up to New Shingles Vaccine Shingrix

By September 13, 2017

While not bound by the Advisory Committee's recommendation, the FDA takes its guidance into consideration.

Cabometyx sNDA Submitted for Expanded Renal Cell Carcinoma Indication

By September 13, 2017

"If [the sNDA is] approved, Cabometyx will offer an important new alternative for the treatment of patients with previously untreated advanced RCC," said Michael M. Morrissey, PhD, President and CEO of Exelixis.

Romosozumab Followed by Alendronate Superior in Reducing Fracture Risk

By September 12, 2017

ARCH (Active-contRolled FraCture Study in Postmenopausal Women with Osteoporosis at High Risk of Fracture) was a multicenter, international, randomized, double-blind, alendronate-controlled study (n=4,093) in postmenopausal women with osteoporosis at high risk for fracture based on previous fracture history.

Dupilumab Beneficial in Patients with Uncontrolled, Persistent Asthma

By September 12, 2017

Results found that at 52 weeks severe asthma attacks were reduced by 46% in the overall population for the 300mg dose group and by 60% and 67% among those patients with ≥150 eosinophilic cells/microliter or greater and ≥300 eosinophilic cells/microliter, respectively (P<0.001).

Cemiplimab Gains Breakthrough Tx Designation for Advanced Skin Cancer

By September 08, 2017

A Phase 2, single-arm, open-label clinical trial, EMPOWER-CSCC 1, is now enrolling patients with metastatic CSCC and locally advanced and unresectable CSCC.

Pediatric Ulcerative Colitis Tx Granted Orphan Drug Designation

By September 08, 2017

Early Phase 1 data has indicated that the treatment drug can be more efficacious than mesalamine/5-ASA treatments alone.

Oral Tx for Acute Suicidal Ideation and Behavior Gets Fast Track Status

By September 06, 2017

Results from two previously Phase 2 trials of NeuroRx's sequential treatment have shown a 50% reduction in symptoms of depression and a 75% reduction in suicidal ideation in bipolar patients.

Elagolix NDA Submitted for Treating Endometriosis-Associated Pain

By September 06, 2017

Elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist, was evaluated in two Phase 3 clinical studies in about 1,700 women with moderate-to-severe endometriosis-associated pain.

Familial Chylomicronemia Syndrome Treatment to Get FDA Review

By August 31, 2017

A total of 66 patients with FCS were enrolled in the year-long APPROACH which met its primary endpoint of reduction in triglycerides at 3 months, with a 77% mean reduction in triglycerides for volanesorsen-treated patients.

FDA Greenlights MDMA Studies for Posttraumatic Stress Disorder

By August 31, 2017

"Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly," said Amy Emerson, Executive Director of the MAPS Public Benefit Corporation.

FDA to Review Novel ADHD Treatment Dasotraline

By August 31, 2017

Two year-long studies assessing safety of dasotraline in children, adolescent and adult ADHD patients found the treatment to be generally well tolerated.

Tezacaftor/Ivacaftor Gets Priority Review for Cystic Fibrosis

By August 25, 2017

The FDA has granted Priority Review to the New Drug Application (NDA) of tezacaftor/ivacaftor (Vertex) for the treatment of patients ≥12yrs old with cystic fibrosis (CF) who have two copies of the F508del mutation or one F508del mutation and one residual function mutation.

BLA for Novel Hemophilia A Therapy Granted Priority Review

By August 24, 2017

The FDA has accepted and granted Priority Review to the Biologics License Application (BLA) of emicizumab (Genentech) for the prophylactic treatment of hemophilia A in adults, adolescents and children with factor VIII inhibitors.

BLA Submitted for Novel X-Linked Hypophosphatemia Tx

By August 24, 2017

Burosumab is being developed in a collaboration between Ultragenyx and Kyowa Hakko Kirin Pharmaceuticals, based on a license agreement between both companies.

Adcetris sBLA Granted Priority Review for Cutaneous T-Cell Lymphoma

By August 17, 2017

Key secondary endpoints included complete response rate, progression-free survival (PFS), and reduction in the burden of symptoms during treatment.

Novel Reversal Agent for Factor Xa Inhibitors Under FDA Review

By August 17, 2017

The FDA has accepted for review the BLA resubmission for AndexXa (andexanet alfa; Portola) for the reversal of the anticoagulant effects of Factor Xa inhibitors in patients experiencing uncontrolled or life-threatening bleeding.

First-in-Class Dual SGLT1/2 Inhibitor Shows Sustained HbA1c Reduction

By August 16, 2017

The overall mean placebo-adjusted A1C reduction at week 24 was 0.37% in the 200mg dose arm (P<0.001) and 0.35% in the 400mg dose arm (P<0.001), this was sustained over the 52-week duration of the study.

Fixed-Dose, Single-Tablet HIV Regimen Granted Priority Review

By August 14, 2017

The investigational fixed-dose treatment combines bictegravir (BIC) 50mg, a novel integrase strand transfer inhibitor (INSTI), with emtricitabine (FTC) 200mg and tenofovir alafenamide (TAF) 25mg, a dual-NRTI backbone.

Regeneron to Discontinue Development of RSV Treatment

By August 14, 2017

The primary endpoint of RSV prevention - assessed through day 150 of treatment - was not significantly reached.

NDA Submitted for Non-Cystic Fibrosis Bronchiectasis Treatment

By August 11, 2017

Linhaliq (previously known as 'Pulmaquin') consists of a mixture of liposome encapsulated and unencapsulated ciprofloxacin. Linhaliq has previously been granted Orphan Drug status for the management of bronchiectasis.

Novel lgA Nephropathy Tx Gains Orphan Drug Status

By August 11, 2017

Phase 2 trials have shown to be associated with reductions in urine protein levels following treatment with OMS721 in patients with lgA nephropathy.

FDA Grants Zelboraf Priority Review for Rare Blood Disease

By August 07, 2017

The application includes data from the open-label, Phase 2 VE-BASKET study; non-randomized, basket study investigating the use of Zelboraf in patients with BRAF V600 mutation-positive cancers and other diseases, including 22 patients with ECD.

Mytesi Granted Orphan Drug Designation for Short Bowel Syndrome

By August 07, 2017

Clinical studies of Mytesi have shown that the most common adverse reactions were upper respiratory tract infection (5.7%), bronchitis (3.9%), cough, and flatulence (3.1%).

Tesevatinib Gains Orphan Drug Status for EGFR-Mutation Positive NSCLC

By August 07, 2017

In March 2016, tesevatinib was designated Orphan Drug status for the treatment of autosomal recessive polycystic kidney disease (ARPKD).

Investigational PNH Treatment Granted Orphan Drug Status

By August 04, 2017

"We have designed RA101495 for once-daily, subcutaneous self-administration, an approach which has the potential to ease this burden, improve convenience, and provide much-needed dosing flexibility," said Doug Treco, PhD, President and CEO of Ra Pharma.

Investigational PNH Treatment Granted Orphan Drug Status

By August 04, 2017

"We have designed RA101495 for once-daily, subcutaneous self-administration, an approach which has the potential to ease this burden, improve convenience, and provide much-needed dosing flexibility," said Doug Treco, PhD, President and CEO of Ra Pharma.

Investigational Migraine Drug Lasmiditan Effective in Phase 3 Study

By August 04, 2017

Results showed that a statistically significant number of those participants who received lasmiditan (in all doses) were pain-free at 2-hours post dosage compared to those who received placebo (the primary endpoint).

Obeticholic Acid + Statin Shows Rapid Reversal of LDL Rise in NASH Patients

By August 02, 2017

The mean LDL change from baseline to Week 16 were as follows: placebo: -48 mg/dL, OCA 5mg: -40mg/dL, OCA 10mg: -40mg/dL, and OCA 25mg: -45mg/dL.

Two BLAs for Herceptin Biosimilars Submitted to FDA

By July 31, 2017

Two separate Biologics License Applications (BLAs) for biosimilar candidates to Herceptin (trastuzumab) have been submitted to the Food and Drug Administration (FDA).

Imfinzi Designated Breakthrough Therapy for NSCLC

By July 31, 2017

Imfinzi, an anti-PD-L1 monoclonal antibody, was previously granted accelerated approval from the FDA for locally advanced or metastatic urothelial carcinoma in patients who have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Repatha sBLA Under Priority Review for MACE Risk Reduction

By July 28, 2017

Results showed that the evolocumab group had a statistically significant 15% reduction (P<0.001) in the risk of extended MACE composite (primary) endpoint - which included hospitalization for unstable angina, coronary revascularization, heart attack, stroke or cardiovascular death - compared to placebo group.

Epinephrine Auto-Injector for Infants, Small Children Gets Priority Review

By July 27, 2017

The company has indicated that if the new auto-injector is approved they expect it to be available for patients in the first half of 2018.

Caplacizumab Fast-Tracked for Acquired Thrombotic Thrombocytopenic Purpura

By July 26, 2017

The Phase 2 TITAN study (n=75) evaluated the safety and efficacy of caplacizumab with standard of care of plasma exchange and immunosuppression.

Vaccine for Recurrent UTI Granted Fast Track Designation

By July 26, 2017

The vaccine consists of the FimH bacterial adhesion protein as well as a new adjuvant designed to induce an immune response to prevent bacterial colonization of the urinary tract.

Investigational Antibiotic Combo Beats Best Available Tx for CRE

By July 26, 2017

Patient randomization was discontinued early after an independent Data and Safety Monitoring Board (DSMB) determined that a risk-benefit analysis (n=72) of available data no longer necessitated additional patient randomization to the comparator arm (best available therapy).

ALS-Related Muscle Cramp Drug Gains Fast Track Status

By July 25, 2017

Two Phase 2 trials of FLX-787 titled COMMAND and COMMIT are expected to start in the U.S. this quarter in ALS and Charcot-Marie-Tooth (CMT) patient populations, respectively.

Lyme Disease Vaccine Gets Fast Track Status

By July 24, 2017

Additionally, the study will measure immunogenicity against the 6 most prevalent serotypes of Lyme borreliosis present in the vaccine.

Investigational Nebulized LAMA Shows Promise in COPD Trial

By July 19, 2017

Results found that rates of COPD exacerbations were lowest in the 175mcg treatment arm. Also, the adverse events and serious adverse events in the revefenacin group were comparable to the tiotropium group.

FDA Requests More Data for Unique Osteoporosis Drug Candidate

By July 17, 2017

Dr. Pascale Richetta, head of bone and executive vice president, UCB, stated, "With all three pivotal romosozumab Phase 3 studies now included in the clinical evidence package, representing data from more than 11,000 patients, we are committed to bringing this important potential new treatment to those people living at risk of fragility fractures."

First-in-Class Drug for Primary Hyperoxaluria Gets Orphan Drug Designation

By July 13, 2017

The Orphan Drug designation was supported by data from preliminary studies showing that ALLN-177 significantly decreased urinary and plasma oxalate in several rodent and porcine models.

FDA Fast Tracks New Oral Antifungal to Treat Valley Fever

By July 13, 2017

VT-1598, an oral fungal CYP51 inhibitor, has shown high potency against pathogens such as molds, yeasts, and multi-drug resistant fungal pathogens (eg, Candida auris).

Cancer Peptide Vaccine Designated Orphan Drug for MDS

By July 10, 2017

Data from a Phase 1/2 study in patients with MDS who had disease progression on or after first-line azacitidine treatment showed initial signs of clinical activity with DSP-7888, and that it was well tolerated in study patients.

Advanced Breast Cancer Drug Granted Priority Review

By July 10, 2017

The NDA included data from two trials, MONARCH 1 and MONARCH 2, which are a part of the comprehensive MONARCH clinical trial program.

Entrectinib Gains Orphan Drug Status for NTRK Fusion(+) Tumors

By July 10, 2017

Currently, entrectinib is being evaluated in the global, multicenter, open-label, potentially registration-enabling Phase 2 STARTRK-2 trial (Studies of Tumor Alterations Responsive to Targeting Receptor Kinases)

Trevyent NDA Submitted for Pulmonary Arterial Hypertension

By July 06, 2017

Trevyent contain treprostinil, a vasodilatory prostacyclin analogue. It works primarily through vasodilation of pulmonary and systemic arterial vascular beds, and inhibition of platelet aggregation.

SOBI003 Gains Orphan Drug Status for Rare Metabolic Disorder

By July 05, 2017

According to the Company, SOBI003 is currently in the late pre-clinical phase and its first clinical trial is expected to commence in 2018.

Biomarin Submits BLA for New Phenylketonuria Therapy

By July 05, 2017

The investigational drug is intended to substitute the deficient PAH enzyme with a PEGylated phenylalanine lyase enzyme to break down Phe.

Astellas Seeks Approval for Overactive Bladder Combo Therapy

By June 30, 2017

"We look forward to FDA's review of our application for a potential new treatment option for the millions of people living with OAB," said Bernhardt Zeiher, MD, president of Development at Astellas.

Emicizumab Beneficial in Hemophilia A Patients With Inhibitors to FVIII

By June 29, 2017

The primary analysis of the study arm showed a statistically and clinically significant reduction in bleeding by 87% (risk rate [RR] 0.13; P<0.0001] with emicizumab prophylaxis.

Rituxan Biosimilar BLA Accepted for FDA Review

By June 29, 2017

The proposed indications are for the treatment of non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis and microscopic polyangiitis.

New Antibiotic Designated QIDP for Two Indications

By June 29, 2017

The gel is hormone-free and can be used with other forms of contraception or used alone. The gel, supplied in a pre-filled applicator, can be self-applied.

NDA Resubmitted for Twirla Contraceptive Patch

By June 28, 2017

In the NDA resubmission, the Company included safety and efficacy data from the Phase 3 trial SECURE, the manufacturing information, and a summary response to the CRL.

Miltefosine Gains Orphan Drug Status for Serious CNS Infections

By June 28, 2017

Miltefosine is an alkyllysophospholipid analogue drug with in vitro activity against the promastigote and amastigote stages of Leishmania species. It is already approved to treat visceral, mucosal and cutaneous leishmaniasis in patients aged ≥12 years; it is the first oral treatment for this rare tropical parasitic disease.

FDA to Review Lower Dose Xarelto for Recurrent VTE Risk Reduction

By June 28, 2017

Both doses of Xarelto (10mg and 20mg) were superior to aspirin (100mg) in lowering the risk of recurrent VTE after ≥6 months of standard anticoagulation.

Novel CETP Inhibitor Shows Coronary Improvements in Phase 3 Study

By June 27, 2017

The full results of the REVEAL trial will be announced at the European Society of Cardiology meeting on August 29.

NDA Accepted for Anti-Inflammatory Inj Post-Cataract Surgery

By June 26, 2017

Dexycu injection was developed to help compliance—especially among elderly patients—and avoid dosing errors associated with conventional treatments that depend on self-administered eye drops multiple times a day.

Novel Synthetic Bio Drug for Hyperammonemia Granted Fast Track

By June 26, 2017

Synthetic Biotic medicines utilize synthetic biology to reprogram probiotic bacteria to perform critical functions that compensate for those missing or damaged due to a particular disease.

Upadacitinib Meets Endpoints for Phase 3 Study in RA

By June 23, 2017

The results from the 12-week period show that both arms of upadacitinib treatment were superior in achieving ACR 20 (64% in 15mg arm, 66% in 30mg arm) vs. placebo (36%).

Novel Liquid Soln for Lennox Gastaut Syndrome Gets Orphan Drug Status

By June 22, 2017

The Company is awaiting top-line results of the current trial before initiating the LGS study.

Investigational Opioid Use Disorder Injectable Tx Shows Promise

By June 21, 2017

Results showed that at Month 6, the RBP-6000 groups demonstrated abstinence rates of 41.3% (300/300mg dose) and 42.7% (300/100mg dose) vs. 5% for placebo (P<0.0001), a statistically significant difference.

First-in-Class Pancreatic Cancer Drug Gains Orphan Drug Status

By June 21, 2017

Clinical trials of pamrevlumab are currently ongoing for conditions such as idiopathic pulmonary fibrosis, pancreatic cancer, and Duchenne muscular dystrophy.

Shingrix Proves Noninferior to Current Zoster Vaccine in Study

By June 21, 2017

"[These results] indicate that Shingrix can be an option for adults over 50 years of age, who previously received the currently available vaccine and are seeking to benefit from revaccination with Shingrix, if recommended," said Dr. Thomas Breuer, SVP and CMO of GSK Vaccines.

FDA Fast Tracks Drug for Hallucinations Disorder in Lewy Body Dementia

By June 19, 2017

Nelotanserin is a novel once-daily oral 5HT2A inverse agonist. The 5HT2A receptor has been associated with neuropsychiatric effects, including visual hallucinations.

NDA Filed for Tavalisse for Immune Thrombocytopenia Treatment

By June 19, 2017

Tavalisse is an oral treatment designed to inhibit SYK kinase, a key signaling member in the immune process that leads to platelet destruction in ITP.

First-in-Class Drug Candidate Fast Tracked for Chronic Pain

By June 14, 2017

Currently, there is a global Phase 3 program comprised of 6 studies involving approximately 7,000 patients with OA, CLBP or cancer pain with inadequate treatment of pain with approved therapies.

Triple-Therapy, Single Tablet HIV Regimen Submitted to FDA for Review

By June 12, 2017

Three of the ongoing studies are evaluating the safety and efficacy of BIC/FTC/TAF vs. triple-therapy regimens containing dolutegravir 50mg among treatment-naive patients and among virologically-suppressed patients who are switching from an existing antiretroviral regimen with dolutegravir.

Galcanezumab Shown to Significantly Cut Monthly Migraine Days

By June 10, 2017

Patients in the galcanezumab group had statistically significant greater reduction in monthly migraine headache days with acute medication use compared to placebo.