ARTICLES BY ESTEL GRACE MASANGKAY
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CHMP Backs Italian Firm Newron’s Xadago For Parkinson’s In EU12/26/2014
Newron Pharmaceuticals, an Italian R&D pharma firm focused on novel CNS and pain treatments, announced together with its partner Zambon that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Xadago (safinamide) for the treatment of mid- to late- stage Parkinson’s disease.
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Pfizer Begins Duchenne Muscular Dystrophy Drug Phase 2 Trial12/23/2014
Pfizer announced that its Phase 2 clinical trial for the investigational compound PF-06252616 in boys with Duchenne muscular dystrophy (DMD) has kicked off with the enrollment of the first patient.
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AstraZeneca’s Lynparza Approved For Ovarian Cancer In EU12/23/2014
British pharma giant AstraZeneca reported that it has received the approval of the European Commission (EC) for its drug Lynparza (olaparib) as a first-in-class therapy for the maintenance treatment of adult patients with advanced BRCA-mutated ovarian cancer.
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Pfizer Posts Positive Phase 3 Data For Pregabalin In PHN12/22/2014
Pfizer reported top-line results from the Phase 3 study assessing its drug pregabalin controlled-release (CR) formulation as treatment for adult patients with postherpetic neuralgia (PHN).
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Auspex Pharma Posts Phase 3 Data For HD-Linked Chorea Drug12/22/2014
Auspex Pharmaceuticals announced positive topline results from the Phase 3 registration study investigating its drug candidate SD-809 for chorea in patients suffering from Huntington's Disease (HD).
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FDA Approves Novartis’ Signifor LAR For Acromegaly12/18/2014
Novartis announced the approval of the U.S. Food and Drug Administration (FDA) for its drug Signifor (pasireotide) long-acting release (LAR) as treatment for endocrine disorder acromegaly.
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Novartis Posts Afinitor Results In HER2+ Breast Cancer12/18/2014
Novartis reported results from the BOLERO-1 trial of its drug Afinitor (everolimus) as combination therapy with Herceptin (trastuzumab) and paclitaxel as first-line treatment in HER2+ advanced breast cancer at the 2014 San Antonio Breast Cancer Symposium (SABCS).
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Genentech Files NDA For Two-Pill Combo In Melanoma In U.S.12/18/2014
Roche Group member Genentech announced that it has filed the New Drug Application (NDA) for its two-pill combo therapy cobimetinib and Zelboraf (vemurafenib) with the U.S. Food and Drug Administration (FDA) as treatment for BRAF V600 mutation-positive advanced melanoma.
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FDA Accepts Relypsa's NDA For Patiromer In Hyperkalemia12/18/2014
Relypsa reported that its New Drug Application (NDA) for its drug Patiromer for Oral Suspension (Patiromer FOS) as treatment for hyperkalemia has been accepted by the U.S. Food and Drug Administration (FDA).
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Merck Posts Keytruda Data In Triple Negative Breast Cancer12/17/2014
Merck presented early-study data for Keytruda (pembrolizumab) in the treatment of advanced triple-negative breast cancer at the 2014 San Antonio Breast Cancer Symposium (SABCS) held this week.
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Lilly’s Cyramza Approved By FDA For Aggressive NSCLC12/17/2014
The U.S. Food and Drug Administration (FDA) announced that it has approved the expanded use of Eli Lilly’s drug Cyramza (ramucirumab) as treatment for metastatic non-small cell lung cancer (NSCLC).
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Sanofi Pasteur MSD’s Gardasil 9 For HPV Approved By FDA12/15/2014
The U.S. Food and Drug Administration (FDA) has approved Sanofi Pasteur MSD’s Gardasil 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) to prevent diseases caused by nine types of Human Papillomavirus (HPV).
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Alexion Posts Data For Soliris In aHUS At ASH 201412/15/2014
Alexion presented findings for its drug Soliris (eculizumab) in the treatment of atypical hemolytic uremic syndrome (aHUS), as well as new data regarding medical care for patients with aHUS and paroxysmal nocturnal hemoglobinuria (PNH) at the 56th Annual Meeting of the American Society of Hematology (ASH) held in San Francisco this month.
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Merck, Amgen Begin Combo Immunotherapy Trial In Melanoma12/12/2014
Merck and its partner Amgen announced the initiation of the clinical trial investigating the combination immunotherapy of Amgen’s talimogene laherparepvec with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab), in patients with regionally or distantly metastatic melanoma.
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Lilly, Incyte Post Top-Line Phase 3 Data For Baricitinib In RA12/12/2014
Eli Lilly & Co. and its partner Incyte announced positive top-line results from the late-stage trial of baricitinib in moderately-to-severely active rheumatoid arthritis (RA).
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MorphoSys Posts Positive Phase 2 Data For MOR208 In NHL12/11/2014
Therapeutic antibody specialist MorphoSys announced positive mid-stage results for its proprietary drug lead MOR208 as treatment for relapsed or refractory Non-Hodgkin's Lymphoma (NHL).
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Roche To Present Data For Gazyvaro And MabThera At ASH 201412/10/2014
Roche announced that it will present new data for two of its approved hematology drugs Gazyvaro (obinutuzumab) and MabThera/Rituxan (rituximab), along with other medicines at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco.
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Merck Reports Strong Phase 1B Data For Keytruda In r/r cHL12/10/2014
Merck announced strong early study results for Keytruda (pembrolizumab) as treatment for relapsed/refractory classical Hodgkin Lymphoma (cHL) patients who have failed or are ineligible for transplant and whose disease has developed following treatment with brentuximab vedotin.
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Incyte’s Jakafi OK’d By FDA For Blood Cancer PV12/9/2014
Delaware-based biopharmaceutical firm Incyte announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for Jakafi (ruxolitinib) as treatment for patients with uncontrolled polycythemia vera (PV) who are intolerant to or have had an inadequate response to hydroxyurea.
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EMA Accepts Pharmacyclics’ Application For Imbruvica In WM12/8/2014
Pharmacyclics reported that its Type II variation application for Imbruvica (ibrutinib) as treatment for Waldenstrom's Macroglobulinemia (WM) has been accepted by the European Medicines Agency (EMA) for review.
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Novartis To Present Oncology Data At ASH 201412/5/2014
Novartis announced that it will present the latest data on its oncology, hematology, and cell and gene therapy research pipeline at the upcoming American Society of Hematology (ASH) annual meeting.
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Lung Therapeutics Gets FDA Orphan Status For Lead Drug12/5/2014
Lung Therapeutics, a pharma firm specializing on niche, orphan drugs for lung disease and injury, announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate LTI-01 as treatment for empyema, a usual complication of pneumonia.
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Novartis’ Heart Failure Drug Awarded Speedy Review By CHMP12/4/2014
Basel-based Novartis reported that it has received accelerated assessment from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for its investigational drug LCZ696 in patients with heart failure with reduced ejection fraction (HFrEF).
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Lilly, AstraZeneca Kick Off Phase 2/3 Trial Of Alzheimer’s Drug12/4/2014
AstraZeneca and its partner Eli Lilly & Co. announced that the companies’ Phase 2/3 trial of their drug candidate for the treatment of Alzheimer’s disease has begun with the enrollment of the first patient.
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Janssen’s HIV Pill Rezolsta Approved In EU12/4/2014
Johnson & Johnson company Janssen-Cilag announced the approval of the European Commission for Rezolsta (darunavir/cobicistat) as treatment for human immunodeficiency virus-1 (HIV-1) infection in patients 18 years and above in the EU.
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J&J Files U.S. NDA For Yondelis In Sarcoma12/3/2014
Janssen R&D announced that it has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for Yondelis (trabectedin) as treatment for patients with advanced soft tissue sarcoma (STS), including liposarcoma and leiomyosarcoma subtypes, and who have undergone prior chemotherapy including an anthracycline.
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Apitope’s Hemophilia A Drug Awarded Orphan Status In EU12/3/2014
Pharmaceutical firm and immunotherapy developer Apitop announced that the European Medicines Agency’s Committee for Orphan Medicinal Products (EMA COMP) has awarded orphan medicinal product designation to the company’s ATX-F8-117 for the treatment of bleeding disorder hemophilia A.
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Merck Files Omarigliptin Application For T2D In Japan12/2/2014
Merck reported that it has filed a New Drug Application (NDA) for its investigational drug omarigliptin as treatment for patients with Type 2 diabetes in Japan.
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EC Approves Novartis’ Signifor For Acromegaly In EU12/2/2014
Novartis announced that it has received the approval of the European Commission for Signifor (pasireotide) as treatment for adult patients with acromegaly in the EU.
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EMA Grants Orphan Status To Clementia Pharma’s Lead Drug11/26/2014
Privately-held, clinical stage biopharmaceutical firm Clementia Pharmaceuticals announced that it has received Orphan Medicinal Product Designation from the European Medicines Agency (EMA) for its lead drug palovarotene as treatment for fibrodysplasia ossificans progressiva (FOP).
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Bayer Wins 2 FDA QIDP Designations For Inhaled Drugs11/26/2014
Bayer announced that it has received two Qualified Infectious Disease Product (QIDP) designations from the U.S. Food and Drug Administration (FDA) for two of its inhaled investigational drugs, Amikacin Inhale and Ciprofloxacin Dry Powder for Inhalation (DPI).
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Sanofi, Regeneron Present Alirocumab Data At AHA11/25/2014
Pharma partners Sanofi and Regeneron announced results from six late-stage trials of alirocumab, an investigational drug being developed for its potential to lower down low-density lipoprotein (LDL) cholesterol.
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Novartis’ Cosentyx For Plaque Psoriasis Backed By CHMP11/25/2014
Novartis announced that it has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Cosentyx (secukinumab) as first-line systemic therapy for the treatment of moderate-to-severe plaque psoriasis in adults in the EU.
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Lilly Posts New Jardiance Data In Diabetes At AHA 201411/25/2014
Eli Lilly & Co. on behalf of its partner Boehringer Ingelheim presented new data from a retrospective analysis of clinical trials showing that Jardiance (empagliflozin) reduced average blood sugar, body weight, and several markers of abdominal fat in adults with Type 2 diabetes.
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Synergy Posts Topline Phase 2 Data For OIC Drug11/24/2014
Synergy Pharmaceuticals reported positive data from its Phase 2 trial investigating SP-333 in patients with opioid-induced constipation (OIC).
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Pfizer Launches Trumenba Vaccine For Meningitis B In U.S.11/24/2014
Pfizer announced the launch of Trumenba (meningococcal group B vaccine) for those 10 to 25 years of age infected with meningitis caused by Neisseria meningitidis serogroup B.
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Janssen Files New Application For Simponi For Nr-AxSpA In EU11/24/2014
Johnson & Johnson company Janssen Biologics announced that it has filed a Type II Variation application with the European Medicines Agency (EMA) for the approval of Simponi (golimumab) as treatment for severe, active, non-radiographic axial spondyloarthritis (nr-AxSpA).
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Roche’s Avastin Given Green Light For Ovarian Cancer By FDA11/21/2014
Women with platinum-resistant recurrent ovarian cancer have another treatment option available in the form of Avastin plus chemotherapy, Roche announced earlier this week following the combination’s approval from the U.S. Food and Drug Administration (FDA).
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Clovis Links With GSK For Cancer Drug Combo Trial11/21/2014
Biopharmaceutical firm Clovis Oncology announced that it has signed up with GlaxoSmithKline to conduct a clinical trial that will investigate the combination of rociletinib and trametinib as treatment for patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC).
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The Medicines Co. Posts Positive Phase 1 Data For CAD Drug11/20/2014
The Medicines Company presented positive data from a new Phase 1 study investigating its lipid-modifying agent MDCO-216 as treatment for reducing atherosclerotic disease.
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Merck’s Keytruda Improves Melanoma PFS In Phase 2 Study11/20/2014
Merck reported positive results from a pivotal Phase 2 study of anti-PD-1 therapy Keytruda (pembrolizumab) as treatment for ipilimumab-refractory advanced melanoma.
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AstraZeneca Presents Phase 3 Results For Lesinurad Combo In Gout11/20/2014
AstraZeneca presented top-line results from two pivotal Phase 3 trials assessing lesinurad in combination with xanthine oxidase (XO) inhibitor allopurinol in patients with gout.
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Novartis Posts Phase 3 Results For Secukinumab In AS11/19/2014
Novartis reported positive results from two pivotal Phase 3 studies of secukinumab AIN457) investigating the drug in ankylosing spondylitis (AS).
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Genzyme’s Lemtrada For MS Approved By The FDA11/19/2014
Sanofi’s subsidiary Genzyme announced that Lemtrada (alemtuzumab) has been approved by the U.S. Food and Drug Administration (FDA) as a treatment for patients with relapsing forms of multiple sclerosis (MS).
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Janssen’s Invega Sustenna sNDA Approved By FDA11/18/2014
Johnson & Johnson company Janssen Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval to the company’s Supplemental New Drug Application (sNDA) for Invega Sustenna as a monotherapy or adjunct treatment for schizoaffective disorder.
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FDA Clears Roche’s Strep A Infection Test11/18/2014
Roche announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its cobas Strep A test for the detection of group A streptococcus bacterial (Strep A) DNA.
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GSK Files EU Marketing Authorization Application For Eltrombopag In Anemia11/17/2014
GlaxoSmithKline announced that it has submitted a marketing authorization application to the European Medicines Agency (EMA) for eltrombopag to include an additional indication for the treatment of severe aplastic anemia (SAA).
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AstraZeneca Begins Pre-Clinical Program For Brilinta Reversal Agent11/17/2014
British drug maker AstraZeneca announced that it has initiated pre-clinical development of an investigational antibody MEDI2452 as a reversal agent for heart drug Brilinta in patients who need urgent surgery or are experiencing a major bleeding event.
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QIAGEN And Novartis Partner For Companion Diagnostics11/14/2014
QIAGEN, a Netherlands-based company specializing in assays and technologies, announced that it has signed into a master collaboration agreement with Swiss pharmaceutical firm Novartis to develop companion diagnostics for Novartis’ products.
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MedImmune To Present New Data On Autoimmune Drugs At ACR 201411/14/2014
AstraZeneca’s global biologics R&D arm MedImmune announced that it will be presenting new data for five of its drugs being developed for inflammation and autoimmune diseases at the upcoming American College of Rheumatology (ACR) 2014 Annual Meeting in Boston, Massachusetts.
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AstraZeneca, Amgen Trumpet Positive Phase 3 Results For Brodalumab11/14/2014
AstraZeneca and its partner Amgen announced positive results from the second pivotal Phase 3 trial of brodalumab in moderate-to-severe plaque psoriasis.
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Sanofi Posts Positive Results For Asthma Drug Dupilumab11/13/2014
Sanofi and its partner Regeneron Pharmaceuticals reported positive results from the Phase 2B trial of dupilumab in patients with unmanaged moderate-to-severe asthma.
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Merck Posts Phase 2 Data For Grazoprevir/Elbasvir In HCV11/13/2014
Merck announced that it presented results from the Phase 2 trial of combo therapy grazoprevir/elbasvir with or without ribavirin (RBV) in patients with Hepatitis C virus (HCV) genotype 1 infection.
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Lilly Launches Trulicity For Diabetes In U.S.11/13/2014
Eli Lilly & Co.announced that its recently approved diabetes drug Trulicity (dulaglutide) is now available in pharmacies across the U.S.
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Novartis To Present Phase 3 Data For Secukinumab At ACR11/12/2014
Novartis reported that it will present data from four Phase 3 trials of secukinumab (AIN457) investigating the drug in psoriatic arthritis (PsA) and ankylosing spondylitis (AS) at the American College of Rheumatology (ACR) Congress taking place this month.
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Merck Presents Anti-PD-1 Keytruda Data In 3 Cancers11/12/2014
Merck announced that it will present new data for its anti-PD-1 therapy Keytruda (pembrolizumab) in advanced melanoma versus chemotherapy, in relapsed/refractory classical Hodgkin Lymphoma (cHL), and advanced triple negative breast cancer (TNBC).
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Merrimack Pharma Begins Phase 1 Trial Of Brain Cancer Drug11/10/2014
Biopharmaceutical company Merrimack Pharma announced that its Phase 1 clinical study of MM-398 (nanoliposomal irinotecan injection) has begun with the enrollment of the first patient for the trial.
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MedImmune Acquires Definiens, Biomarker Tool Technology11/7/2014
AstraZeneca announced that its global biologics R&D arm MedImmune has acquired the Germany-based firm Definiens, which specializes in imaging and data analysis technology.
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Genzyme Launches Phase 2 Vatelizumab Trial In RRMS11/7/2014
Sanofi company Genzyme announced that it has kicked off the Phase 2 clinical trial of its investigational infusion therapy vatelizumab in patients with relapsing remitting multiple sclerosis (RRMS).
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D-Pharm Posts Phase 2 Trial Results For THR-18 In Stroke11/6/2014
D-Pharm, a clinical stage biopharmaceutical company focused on developing treatments for CNS disorders, posted the first safety results from its Phase 2 clinical study of its drug THR-18 in acute ischemic stroke (AIS) patients treated with tissue plasminogen activator (tPA).
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AstraZeneca, Pharmacyclics, And J&J Join Forces On Immuno-Oncology Trials11/6/2014
AstraZeneca, Pharmacyclics, and Johnson & Johnson company Janssen Research & Development announced that the companies have inked a clinical trial partnership deal to investigate the safety and efficacy of AZ’s MEDI4736 in combination with Imbruvica (ibrutinib), co-developed by Janssen and Pharmacyclics.
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Ultragenyx Snags EU Orphan Status For XLH Drug KRN2311/4/2014
Biopharmaceutical company Ultragenyx Pharmaceutical announced that it has received Orphan Medicinal Product Designation from the European Commission for its investigational drug KRN23 (or UX023) for the treatment of rare metabolic bone disease, X-linked hypophosphatemia (XLH).
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FDA Approves AstraZeneca’s Xigduo For T2D11/4/2014
AstraZeneca announced that it has secured approval from the U.S. Food and Drug Administration (FDA) for its once-daily Xigduo XR for the treatment of adult patients with Type 2 diabetes.
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U.K.’s NICE Backs J&J And Bayer’s Blood Thinner Xarelto11/3/2014
In a draft guidance published for consultation, UK’s National Institute for Health and Care Excellence (NICE) announced that it has given a positive opinion for coverage of Xarelto (rivaroxaban) for patients who have had a heart attack.
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Pfizer’s Vaccine For Meningitis B Gets FDA Accelerated Approval11/3/2014
Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Trumenba as the first licensed vaccine in the U.S. for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals from 10 through 25 years old.
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3rd Potential Ebola Vaccine To Enter Human Trials11/3/2014
An Ebola vaccine candidate developed by the Public Health Agency of Canada is set to enter human clinical trials, The Guardian reports.
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Ariad’s Cancer Drug Iclusig Backed By CHMP10/31/2014
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Merck Scores 2nd FDA Breakthrough Status For Keytruda10/30/2014
Merck announced that it has received a second Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for Keytruda (pembrolizumab) — this time as a treatment for advanced non-small cell lung cancer (NSCLC).
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AstraZeneca’s Lynparza For Ovarian Cancer Backed By CHMP10/30/2014
AstraZeneca reported that it has received the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the marketing authorization of Lynparza (olaparib) as monotherapy and maintenance treatment of advanced ovarian cancer in adult patients.
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Akebia Posts Topline Phase 2B Trial Results Of CKD Drug10/30/2014
Akebia Therapeutics, a biopharmaceutical company developing treatments for kidney disease based on hypoxia inducible factor (HIF) biology, reported positive topline results from the Phase 2B trial of AKB-6548 in non-dialysis patients with anemia caused by chronic kidney disease (CKD).
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Novartis’ Secukinumab Excels In 2 Phase 3 Trials In AS10/28/2014
Novartis posted positive results from two Phase 3 trials investigating its drug AIN457 (secukinumab) in ankylosing spondylitis, a debilitating spine disorder.
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NIH Starts Phase 1 Trial Of NewLink Ebola Vaccine10/28/2014
The National Institutes of Health (NIH) announced that it has begun the Phase 1 trial of its second investigational Ebola vaccine VSV-ZEBOV.
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Arbor’s Sotylize For Arrhythmia Approved By The FDA10/28/2014
Arbor Pharmaceuticals, a specialty pharmaceutical company focused on cardiovascular, pediatric, and hospital markets announced the U.S. Food and Drug Administration (FDA) approval of Sotylize (sotalol hydrochloride) oral solution for the treatment of ventricular arrhythmias.
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Research Team Discovers How To Slow Antibiotic Resistance10/27/2014
With the help of computer simulations, a research team from the University of Bristol has found how bacteria destroy antibiotics and how the process can be slowed down.
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FDA Awards Orphan Status To TWi Pharma’s Rare Skin Disease Drug10/27/2014
TWi Pharmaceuticals reported that its subsidiary TWi Biotechnology has been awarded Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) for its drug AC-201 as treatment for rare skin disease epidermolysis bullosa (EB).
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Sanofi, Regeneron Launch Dupilumab Phase 3 Study In Atopic Dermatitis10/24/2014
Sanofi and partner Regeneron Pharmaceuticals announced the launch of the Phase 3 study investigating dupilumab in moderate to severe atopic dermatitis (AD) with the dosing of the first patient.
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Lilly, Boehringer Ingelheim NDA For Diabetes Combo Accepted By FDA10/24/2014
Eli Lilly together with its partner Boehringer Ingelheim announced that the U.S. Food and Drug Administration (FDA) has accepted the filing of a New Drug Application (NDA) for empagliflozin/metformin fixed-dose combination as treatment for Type 2 diabetes.
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FDA Approves Genzyme’s Label Expansion Of MS Drug Aubagio10/24/2014
Sanofi company Genzyme announced the approval of the U.S. Food and Drug Administration (FDA) for the U.S. label of its multiple sclerosis drug Aubagio to include additional safety and efficacy data
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FDA Panel Backs Novartis’ Secukinumab For Psoriasis10/23/2014
Novartis announced that it has received the full support of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) to the U.S. Food and Drug Administration (FDA) for the regulatory approval of its drug secukinumab as treatment for moderate-to-severe plaque psoriasis.
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Janssen, Pharmacyclics File sNDA For Imbruvica In WM10/23/2014
Janssen Research & Development reported that its partner Pharmacyclics has filed a supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for Imbruvica as treatment for a rare type of B-cell lymphoma known as Waldenstrom's macroglobulinemia (WM).
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FDA Allows Abuse Deterrent Label Update For Pfizer’s Embeda10/22/2014
Pfizer reported that the U.S. Food and Drug Administration (FDA) has approved its application to update the label of its oral painkiller, Embeda (morphine sulfate and naltrexone hydrochloride) extended-release (ER) capsules, to include abuse-deterrence studies.
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Alexion Files NDA In Japan For Asfotase Alfa For HPP10/21/2014
Alexion Pharmaceuticals announced that it has filed the New Drug Application (NDA) with the Ministry of Health, Labor, and Welfare (MHLW) in Japan for its asfotase alfa as treatment for hypophosphatasia (HPP).
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Novartis And Penn Post Positive Data For ALL Drug10/20/2014
Novartis and its partner the University of Pennsylvania's Perelman School of Medicine (Penn) announced positive preliminary results from two pilot clinical trials evaluating CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL).
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Prosensa Begins NDA Filing For DMD Drug Lead10/15/2014
Prosensa, a biotech firm focused on RNA-modulating therapeutics for genetic disorders, announced that it has kickstarted the submission process for a New Drug Application (NDA) for its lead drug drisapersen as treatment for Duchenne muscular dystrophy (DMD).
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AstraZeneca, Charles River Partnership Turns Out New Respiratory Drug10/10/2014
Charles River Laboratories announced that its partnership with British drug firm AstraZeneca has led to the advancement of an oral respiratory drug candidate into preclinical development.
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Sorrento, Lee’s Pharma Ink Immuno-Oncology Licensing Agreement10/8/2014
Late-stage clinical oncology firm Sorrento Therapeutics announced its agreement with Lee’s Pharma for the exclusive licensing of Sorrento’s anti-PD-L1 immunotherapy in China.
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Prima BioMed Announces Plan To Acquire Immutep For $28M10/8/2014
Australia-based Prima BioMed announced its plan to acquire French biopharmaceutical Immutep for up to $28 million.
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Alcobra Posts Positive Phase 3 Results For ADHD Drug10/8/2014
Alcobra, a pharmaceutical company focused on developing treatments for cognitive disorders, announced positive top line results from the Phase 3 study of Metadoxine Extended Release (MDX) in adult patients with ADHD.
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Novartis, Bristol-Myers Squibb Partner To Test Combo Treatments For NSCLC10/7/2014
Novartis announced that it has linked arms with Bristol-Myers Squibb to jointly conduct clinical trials investigating the combination of three of Novartis’ compounds with Bristol-Myers Squibb’s Opdivo (nivolumab) in patients with non-small cell lung cancer (NSCLC).
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Lilly Halts Phase 3 Trials For Lupus Drug Tabalumab10/7/2014
Eli Lilly & Co. announced that it is pulling the plug on the development of its candidate drug tabalumab under investigation as a potential treatment for systemic lupus erythematosus (SLE). The company said the decision to halt tabalumab’s development is due to a lack of efficacy and not because of safety concerns.
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Novartis Returns HCV Drug Rights, Ends Agreement With Enanta10/6/2014
R&D biotech firm Enanta Pharmaceuticals announced that it will be regaining full rights of investigational hepatitis C treatment EDP-239 from its ex-partner Novartis.
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Novartis’ Zykadia Extended PFS In ALK+ NSCLC10/3/2014
Novartis reported positive new data from its pivotal study showing that Zykadia (ceritinib) extended progression-free survival (PFS) for an average of over 18 months in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who took the drug as their first ALK inhibitor.
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Janssen’s Rezolsta For HIV Backed By CHMP10/3/2014
Janssen-Cilag International announced that it has received the positive opinion of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for Rezolsta (darunavir/cobicistat) for use with other antiretroviral therapies against human immunodeficiency virus-1 (HIV-1) infection in adult patients.
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FDA Grants Triple Orphan Designations To CytRx Lead Drug10/3/2014
Biopharmaceutical R&D firm CytRx announced that its lead drug candidate aldoxorubicin has been awarded multiple Orphan Drug Designations by the U.S. Food and Drug Administration (FDA) in three indications. These indications include glioblastoma multiforme (GBM), small cell lung cancer, and ovarian cancer.
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Bayer Completes Purchase Of Merck’s OTC Business For $14.2B10/3/2014
Bayer announced that it has completed its acquisition of fellow pharma giant Merck’s consumer care business after receiving the necessary antitrust approvals.
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Janssen-Cilag Posts Phase 3 Data For Zytiga In Prostate Cancer10/2/2014
Janssen-Cilag International reported positive data from the final analysis of its Phase 3 trial investigating Zytiga in male patients with metastatic castration-resistant prostate cancer (mCPRPC) who have not yet undergone chemotherapy.
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AstraZeneca Posts Early Data For Anti-Cancer Combo At ESMO10/2/2014
AstraZeneca and its global biologics R&D arm MedImmune reported promising early results from the ongoing Phase 1 study of MEDI4736 (PD-L1) and tremelimumab (CTLA-4) combination in patients with non-small cell lung cancer (NSCLC) who have already undergone prior treatment.
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CHMP Recommends Novartis’ Signifor For Acromegaly10/1/2014
Novartis announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive recommendation for the company’s Signifor (pasireotide) long-acting release (LAR) formulation as treatment for certain adult patients with acromegaly.
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Novartis Posts Positive Phase 3 Data For Afinitor In pNET9/30/2014
Novartis reported positive final results from a Phase 3 trial investigating Afinitor (everolimus) tablets versus placebo in patients with pancreatic neuroendocrine tumors (pNET).
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Merck Posts Early Data For Keytruda In Gastric And Bladder Cancer9/30/2014
Merck reported positive early trial results for its anti-PD-1 therapy pembrolizumab in both advanced gastric cancer and advanced urothelial cancer or bladder cancer.