Estel Grace Masangkay

Estel Grace Masangkay is a contributing writer for Life Science Connect who writes regular life sciences news features for several markets. She has a Bachelor’s degree from Gordon College.

ARTICLES BY ESTEL GRACE MASANGKAY

  • Roche Buys Biotech Firm Dutalys And Bina Technologies

    Roche announced that it has entered into agreement to acquire Vienna-based, private biotech firm Dutalys and its proprietary DutaMab technology for the discovery and development of fully human, bi-specific antibodies.

  • Novartis Links With BiolineRX To Develop Israel-Made Drugs

    Israeli clinical-stage biopharmaceutical company BioLineRX announced that it has signed up Swiss pharma giant Novartis in a multi-year strategic collaboration to develop and commercialize Israeli-sourced drug candidates.

  • Merck Acquires OncoEthix, Cancer Drug Lead

    Merck announced that it has acquired Swiss-based oncology firm OncoEthix through a subsidiary. The acquisition gives Merck access to an investigational drug in development for the treatment of blood malignancies and late-stage solid tumors.

  • GSK’s Phase 3 Study For Shingles Vaccine Hits Endpoint

    GlaxoSmithKline announced positive results from its pivotal Phase 3 study investigating its vaccine HZ/su for the prevention of shingles.

  • TxCell Wins EU Orphan Designation For Col-Treg In Uveitis

    Biotech firm TxCell announced that it has received orphan drug designation from the European Commission for its investigational immunotherapy Col-Treg intended for eye disease autoimmune uveitis.

  • Alcon’s Xtoro For “Swimmer’s Ear” Gets FDA Green Light

    Novartis company, Alcon Laboratories, has received approval from the U.S. Food and Drug Administration (FDA) for its drug Xtoro (finafloxacin otic suspension) as treatment for acute otitis externa, also known as “swimmer’s ear.”

  • CMC Biologics, OncoSynergy To Co-Develop Ebola Drug Lead

    CMC Biologics announced that it has entered into agreement with OncoSynergy for accelerated process development and Good Manufacturing Practices (GMP) production for the investigational drug OS2966 targeting the Ebola virus.

  • AstraZeneca Posts Positive Data For Faslodex In Breast Cancer

    AstraZeneca presented new data for its investigational drug Faslodex (fulvestrant) as treatment for hormone-receptor positive breast cancer compared to Arimidex (anastrozole) at the recent 2014 San Antonio Breast Cancer Symposium (SABCS).

  • Alkermes Begins Phase 1 Trial For Schizophrenia Drug

    Alkermes announced that it has started a Phase 1 study to investigate extended dosing intervals of aripiprazole lauroxil as treatment for schizophrenia.

  • Pfizer To Develop GHD Drug With OPKO Health

    Pfizer announced it has partnered with Miami-based OPKO Health to develop the latter's long-acting hGH-CTP as treatment for growth hormone deficiency (GHD) syndrome in both adults and children, as well as for growth failure in children born small for gestational age (SGA) who fall short of catch-up growth standard by 2 years old.

  • EMA Backs MorphoSys' Orphan Application For MOR208 In DLCBL

    MorphoSys, a company specializing in developing therapeutic antibodies, announced that it has received the positive opinion of the European Medicines Agency for the Orphan Medicinal Product Designation application of its drug MOR208 as a treatment for diffuse large B-cell lymphoma (DLBCL).

  • X-Chem, Alexion To Develop Drugs For Ultra-Rare Disorders

    X-Chem, a private biotech firm developing novel small molecule drugs via its DNA-encoded library platform, announced that it has entered into a drug discovery partnership with Alexion to jointly develop treatments for severe and ultra-rare disorders.

  • Sanofi Opens New Production Facility In KAEC Saudi Arabia

    French pharma giant Sanofi has formally inaugurated its new production facility at King Abdullah Economic City in Saudi Arabia.

  • Jazz Pharma Begins Rolling NDA For Defibrotide In Hepatic VOD

    Jazz Pharmaceuticals announced that it has started the rolling submission of a New Drug Application (NDA) for defibrotide as treatment for severe hepatic veno-occlusive disease (VOD) in patients undergoing hematopoietic stem-cell transplantation (HSCT) therapy.

  • Bayer, DNDi To Develop Drug For Human River Blindness

    German pharma firm Bayer announced that it has signed an agreement with Drugs for Neglected Diseases initiative (DNDi) to develop the company’s emodepside as a new oral treatment for river blindness, also known as onchocerciasis.

  • Ariad Posts Phase 2 Data For Iclusig In CML And Ph+ ALL

    Ariad Pharmaceuticals reported long-term data from its pivotal Phase 2 trial of Iclusig (ponatinib) in chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).

  • Insys Receives FDA Orphan Status For Gastric Cancer Drug

    Specialty pharmaceutical firm Insys Therapeutics announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its Liposome Entrapped Paclitaxel Easy to Use (LEP-ETU) drug lead for gastric cancer.

  • Novartis' Jakavi Safe And Effective In Phase 3B Myelofibrosis Trial

    Novartis reported that its blood cancer drug Jakavi (ruxolitinib) was safe and effective in treating patients with myelofibrosis in a Phase 3B trial.

  • Pfizer Inks Gene Therapy Partnership With Spark Therapeutics

    Pfizer announced two major moves that will expand its rare disease R&D activities. First, the company said it will establish a gene therapy platform through its newly inked agreement with Spark Therapeutics. Secondly, it has appointed Dr. Michael Linden, Director of the University College London Gene Therapy Consortium, as head of Pfizer’s gene therapy research in rare diseases area.

  • Sunovion Files sNDA With FDA For Aptiom In Seizures

    Sunovion Pharmaceuticals announced its filing of a Supplemental New Drug Application (sNDA) with the U.S. Food and Drug Administration (FDA) for its drug Aptiom (eslicarbazepine acetate) as monotherapy for partial-onset seizures.

  • Pharmacyclics’ Imbruvica Shows Potential In Multiple Myeloma

    Pharmacyclics reported new Phase 2 data for Imbruvica (ibrutunib) as treatment for relapsed or relapsed/refractory multiple myeloma (MM).

  • Novartis Posts Positive CTL019 Data In r/r ALL

    Novartis revealed strong clinical data for its investigational chimeric antigen receptor (CAR) therapy CTL019 as treatment for relapsed/refractory acute lymphoblastic leukemia (r/r ALL).

  • Genmab, Janssen To Study Daratumumab In 3 NHL Types

    Genmab announced that its partner Janssen Biotech is preparing to launch a Phase 2 trial for daratumumab as treatment for three different types of non-Hodgkin’s lymphomas (NHL), namely diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), and mantle cell lymphoma (MCL).

  • ChemoCentryx Drug Wins EU Orphan Status In Rare Vasculitis

    Clinical stage biopharmaceutical firm ChemoCentryx announced it has received Orphan Medicinal Product designation from the European Commission for CCX168 as treatment for two forms of anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV).

  • Tesaro, AnaptysBio Expand Immuno-Oncology Partnership

    Oncology-focused biopharma firm Tesaro and privately-held therapeutic antibody firm AnaptysBio announced that the companies are expanding their immuno-oncology partnership and exclusive license agreement with the development of a new bispecific antibody lead targeting two unnamed immune checkpoints.

  • FDA OKs Sanofi’s Priftin For Latent TB Infection

    Sanofi announced that the U.S. Food and Drug Administration (FDA) has approved Priftin (rifapentine) in combination with isoniazid (INH) as treatment for latent tuberculosis infection (LTBI) in patients two years old and above who are also at high risk of developing tuberculosis (TB).

  • Novartis Posts Phase 3 Data For Gilenya In MS

    Novartis reported the latest findings from the Phase 3 trial of its drug Gilenya (fingolimod) in primary progressive multiple sclerosis (PPMS), a difficult form of multiple sclerosis.

  • Genzyme Launches Lemtrada For MS In U.S.

    Sanofi company Genzyme announced it has launched its newly approved drug Lemtrada (alemtuzumab) as treatment for multiple sclerosis in the U.S.

  • Actinium Wins FDA Orphan Status For AML Drug

    Biopharma firm Actinium Pharmaceuticals announced it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for Actimab-A as treatment for newly diagnosed AML patients older than 60 years old.

  • AstraZeneca, CRUK Link Arms To Screen For New Cancer Drugs
    AstraZeneca, CRUK Link Arms To Screen For New Cancer Drugs

    British drug maker AstraZeneca and Cancer Research UK have expanded their ongoing collaborative relationship with their latest agreement to screen new cancer drug leads at the AstraZeneca MRC UK Centre for Lead Discovery, a new center to be built in Cambridge.

  • Janssen Links With Transposagen To Develop CAR-T Therapies
    Janssen Links With Transposagen To Develop CAR-T Therapies

    Janssen Biotech and private biotech firm Transposagen Biopharmaceuticals announced that the companies have entered into a research collaboration and global license agreement to jointly develop allogeneic Chimeric Antigen Receptor T-cells (CAR-T) therapies against cancer.

  • Alexion’s Soliris Awarded Orphan Status In Japan For Neuromyelitis Optica
    Alexion’s Soliris Awarded Orphan Status In Japan For Neuromyelitis Optica

    Alexion announced that it has received Orphan Drug Designation from Japan's Ministry of Health, Labor, and Welfare (MHLW) for Soliris (eculizumab) as treatment for patients with neurological disorder neuromyelitis optica (NMO).

  • Researchers Discover Potential New Treatment Method For ALS
    Researchers Discover Potential New Treatment Method For ALS

    A team of scientists at Thomas Jefferson University reported their discovery of a new approach to help enhance the efficacy of drugs that target Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease.

  • Merck And NewLink Join Forces For Ebola Vaccine Lead
    Merck And NewLink Join Forces For Ebola Vaccine Lead

    Merck announced that it has partnered with NewLink Genetics in an exclusive global license agreement to develop NewLink’s rVSV-EBOV (Ebola) vaccine candidate.

  • CHMP Backs Genzyme’s Cerdelga For Gaucher Disease
    CHMP Backs Genzyme’s Cerdelga For Gaucher Disease

    Sanofi firm Genzyme announced that it has received a positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the approval of Cerdelga (eliglustat) for the treatment of Gaucher disease type 1.

  • AstraZeneca Expands Maryland Biologics Manufacturing Site For $200M
    AstraZeneca Expands Maryland Biologics Manufacturing Site For $200M

    British drug maker giant AstraZeneca announced its plans to expand its Frederick, Maryland biologics manufacturing center in order to support its maturing pipeline, 50 percent of which is comprised of biologics.

  • ChemoCentryx Gets FDA Orphan Status For Kidney Disease Drug
    ChemoCentryx Gets FDA Orphan Status For Kidney Disease Drug

    Clinical stage biopharmaceutical company ChemoCentryx announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for CCX168 as an investigational treatment for atypical Hemolytic Uremic Syndrome (aHUS).

  • BerGenBio’s AML Drug Granted FDA Orphan Status
    BerGenBio’s AML Drug Granted FDA Orphan Status

    Oncology biopharmaceutical company BerGenBio announced that it has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its investigational drug BGB324 as treatment for acute myeloid leukemia (AML).

  • Roche, Inovio End Pact On Prostate Cancer Drug
    Roche, Inovio End Pact On Prostate Cancer Drug

    Inovio Pharmaceuticals announced that it has ended its agreement with biotech giant Roche to jointly develop Inovio’s INO-5150 as immunotherapy for prostate cancer.

  • Researchers Convert Skin Cells To Replace HD-Damaged Brain Cells
    Researchers Convert Skin Cells To Replace HD-Damaged Brain Cells

    A team of researchers at the Washington University School of Medicine in St. Louis reported that they have discovered a way to directly convert human skin cells into a type of brain cell that has been damaged by Huntington’s disease.

  • Pfizer Links With Merck KGaA In Immuno-Oncology Mega Deal
    Pfizer Links With Merck KGaA In Immuno-Oncology Mega Deal

    Pfizer announced that it has signed up with German firm Merck KGaA to co-develop and market an investigational anti-PD-L1 treatment for several types of cancer.

  • Sarepta Kickstarts Eteplirsen Study In Muscular Dystrophy
    Sarepta Kickstarts Eteplirsen Study In Muscular Dystrophy

    Sarepta Therapeutics announced that it has begun the clinical study of its lead exon-skipping therapeutic candidate eteplirsen for the treatment of Duchenne muscular dystrophy (DMD).

  • Xeris’ Hypoglycemia Drug Awarded FDA And EMA Orphan Status
    Xeris’ Hypoglycemia Drug Awarded FDA And EMA Orphan Status

    Clinical stage, specialty biopharmaceutical company Xeris Pharmaceuticals announced that it has received Orphan Drug Designation from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for its investigational soluble glucagons as preventive treatment for severe, persistent hypoglycemia in patients with congenital hyperinsulinism (HI).

  • Encycle Therapeutics Advances Macrocycle Drug For IBD
    Encycle Therapeutics Advances Macrocycle Drug For IBD

    Biotech startup Encycle Therapeutics announced that it has entered into multi-stakeholder collaboration for the development of its lead macrocycle drug for the treatment of inflammatory bowel disease (IBD).

  • RedHill BioPharma’s H. Pylori Drug Snags FDA QIDP Status
    RedHill BioPharma’s H. Pylori Drug Snags FDA QIDP Status

    RedHill BioPharma, an Israeli firm specializing on late clinical-stage drugs for gastrointestinal and inflammatory diseases, announced that the U.S. Food and Drug Administration (FDA) has granted Qualified Infectious Disease Product (QIDP) status for RHB-105, its Phase 3 Helicobacter pylori (H. pylori) eradication therapy.

  • GliaCure’s Lead Drug For Alzheimer’s Fast Tracked By FDA
    GliaCure’s Lead Drug For Alzheimer’s Fast Tracked By FDA

    GliaCure, a privately-held biotech firm that develops treatments for neurological and neuropsychiatric disorders based on glial targets, announced that the U.S. Food and Drug Administration (FDA) has awarded Fast Track status to its lead drug GC021109 as treatment for Alzheimer’s disease.

  • The Medicines Company Launches Carbavance Phase 3 Study
    The Medicines Company Launches Carbavance Phase 3 Study

    The Medicines Company announced that it has launched the Phase 3 trial of its investigational antibiotic Carbavance as treatment for serious bacterial infections due to gram-negative bacteria following the recent enrollment of the trial’s first patient.

  • Merck Posts Data For Triple-Drug HCV Regimen
    Merck Posts Data For Triple-Drug HCV Regimen

    Merck announced that it will present interim data from the proof-of-concept study investigating the company’s triple-therapy comprised of grazoprevir and elbasvir together with the nucleotide inhibitor sofosbuvir for the Hepatitis C virus (HCV).

  • Merck And BIND To Develop Nanomeds For Cancer
    Merck And BIND To Develop Nanomeds For Cancer

    Clinical stage nanomedicine platform company BIND Therapeutics announced that it has signed a joint R&D agreement with Merck to develop novel nanomedicines for oncology.

  • Janssen To Present Data On Imbruvica At ASH 2014
    Janssen To Present Data On Imbruvica At ASH 2014

    Johnson & Johnson company Janssen R&D reported that it will present new data from its oncology portfolio in over eight diseases at the 56th American Society of Hematology (ASH) Annual Meeting to be held next month in San Francisco, California.

  • GSK’s Hepatitis C Vaccine Shows Positive Phase 1 Trial Results
    GSK’s Hepatitis C Vaccine Shows Positive Phase 1 Trial Results

    Oxford University reported that an investigational hepatitis C vaccine has demonstrated positive results in a Phase 1 clinical trial conducted at the University.

  • FDA Approves Lilly’s Cyramza + Paclitaxel For Advanced Gastric Cancer
    FDA Approves Lilly’s Cyramza + Paclitaxel For Advanced Gastric Cancer

    Eli Lilly & Co. announced the U.S. Food and Drug Administration (FDA) granted approval to its drug Cyramza (ramucirumab) in combination with chemotherapy paclitaxel as treatment for advanced or metastatic gastric (stomach) or gastroesophageal junction (GEJ) adenocarcinoma, which has become progressive while being treated or after being treated with fluoropyrimidine- or platinum-containing chemotherapy.

  • Sea Sponge Drug Extends Breast Cancer Survival By 5 Months
    Sea Sponge Drug Extends Breast Cancer Survival By 5 Months

    Cancer Research UK reported that a cancer drug derived from a sea sponge demonstrated potential to extend survival of patients with advanced triple negative breast cancer by an average of five months.

  • AstraZeneca, Pharmacyclics Ink 2 Oncology Partnerships
    AstraZeneca, Pharmacyclics Ink 2 Oncology Partnerships

    AstraZeneca and Pharmacyclics announced that they have agreed to enter into multiple clinical trial collaborations to investigate drug combo therapies in solid tumors and several hematological cancers.

  • Genmab To Transfer Ofatumumab From GSK To Novartis
    Genmab To Transfer Ofatumumab From GSK To Novartis

    International biotech firm Genmab announced that it has agreed to transfer its ofatumumab collaboration with GlaxoSmithKline to Novartis.

  • PATH Awarded $156M In Grant For Malaria Vaccine
    PATH Awarded $156M In Grant For Malaria Vaccine

    International nonprofit organization PATH announced that it has received a $156 million grant from the Bill & Melinda Gates Foundation to support the PATH Malaria Vaccine Initiative (MVI).

  • Merck Posts Phase 2B Results Of HIV Drug Doravirine
    Merck Posts Phase 2B Results Of HIV Drug Doravirine

    Merck presented results from the 48-week Phase 2B study of its experimental HIV drug doravirine (MK-1439) in patients who have not undergone therapy for their disease.

  • New Vaccine-Centered Biotech To Target Pneumococcal Disease
    New Vaccine-Centered Biotech To Target Pneumococcal Disease

    Affinivax, a biotech firm dedicated to the development of novel vaccines, announced its launch this week with a $4 million investment from the Bill & Melinda Gates Foundation to support the company’s Multiple Antigen Presenting System (MAPS) technology platform.

  • GPCR Consortium, 3 Pharma Firms To Pool Early Drug Research
    GPCR Consortium, 3 Pharma Firms To Pool Early Drug Research

    The GPCR Consortium launched this week in collaboration with three major pharmaceutical firms and partner research institutes to advance the study of a family of proteins that plays a part in many diseases.

  • Penn’s Drug For Rare Blood Disorder Snags FDA Orphan Status
    Penn’s Drug For Rare Blood Disorder Snags FDA Orphan Status

    Penn Medicine announced that AMY-101, a drug developed at the institute, has been awarded Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) as treatment for the rare and deadly blood disorder, paroxysmal nocturnal hemoglobinuria (PNH).

  • TSRI’s MS Drug Also Shows Promise In Ulcerative Colitis
    TSRI’s MS Drug Also Shows Promise In Ulcerative Colitis

    The Scripps Research Institute (TSRI) reported that results from the Phase 2 study of RPC1063, a drug discovered at the Institute, show RPC1063’s potential in the treatment of ulcerative colitis (UC).

  • Salk Scientists Identify Protein As HIV-1 Therapeutic Target
    Salk Scientists Identify Protein As HIV-1 Therapeutic Target

    A team of scientists from the Salk Institute for Biological Studies reported that they have identified a protein that could be exploited as HIV-1’s Achilles heel.

  • GSK Expands Drug Research Partnership With Five Prime
    GSK Expands Drug Research Partnership With Five Prime

    Five Prime Therapeutics, a clinical stage biotech firm, announced that its partner GlaxoSmithKline has extended their drug research collaboration in respiratory diseases for another year and a half.

  • J&J Joins Race To Develop And Deliver Ebola Vaccine
    J&J Joins Race To Develop And Deliver Ebola Vaccine

    Johnson & Johnson announced that it is committing up to $200 million to speed and expand its production of an Ebola vaccine under development at its subsidiary Janssen Pharmaceuticals.

  • EMA Grants Orphan Status To GW’s Epidiolex For Epilepsy
    EMA Grants Orphan Status To GW’s Epidiolex For Epilepsy

    Biopharmaceutical company GW Pharmaceuticals announced that it has received Orphan Drug Designation from the European Medicines Agency (EMA) for Epidiolex as treatment for rare form of epilepsy Dravet syndrome.

  • Roche, Pharmacyclics Enter Cancer Combo Therapy Deal
    Roche, Pharmacyclics Enter Cancer Combo Therapy Deal

    Pharmacyclics announced that it has signed into a master clinical drug supply agreement with Roche for an initial Phase 3 study of Pharmacyclics’ Imbruvica and Roche/Genentech’s Gazyva as a combination cancer therapy.

  • Roche Invests $3 Billion In Basel R&D Site
    Roche Invests $3 Billion In Basel R&D Site

    Roche announced its commitment to invest 3 billion Swiss francs ($3.2 billion) over the next 10 years for its development plans that will include the construction of a new R&D site in Basel, Switzerland.

  • Halozyme Gets FDA OK For 2 New Production Sites For Hylenex
    Halozyme Gets FDA OK For 2 New Production Sites For Hylenex

    Biopharmaceutical company Halozyme Therapeutics announced that it has received the approval of the U.S. Food and Drug Administration (FDA) for its new contract manufacturing facilities that will be used to produce Hylenex recombinant (hyaluronidase human injection).

  • Immunomedics Gets EU Orphan Status For Pancreatic Cancer ADC
    Immunomedics Gets EU Orphan Status For Pancreatic Cancer ADC

    Clinical stage biopharmaceutical company Immunomedics announced that it has received Orphan Drug status for isactuzumab govitecan (IMMU-132) for the treatment of pancreatic cancer.

  • Karolinska Institutet Links With Moderna In mRNA Therapeutics
    Karolinska Institutet Links With Moderna In mRNA Therapeutics

    Moderna Therapeutics, Karolinska Institutet (KI), and Karolinska University Hospital (KUH) have joined forces to discover and develop drugs using messenger RNA (mRNA) Therapeutics technology.

  • AstraZeneca Bolsters Partnership With U Of Cambridge
    AstraZeneca Bolsters Partnership With U Of Cambridge

    AstraZeneca and its global biologics R&D arm MedImmune announced four new collaborations with the University of Cambridge, all launched in an attempt to strengthen AZ’s existing partnership with the University as the company sets out to expand its research infrastructure in Cambridge.

  • Lilly To Streamline Manufacturing Operations In 2015
    Lilly To Streamline Manufacturing Operations In 2015

    Eli Lilly announced its plans to close one of its three manufacturing plants in Puerto Rico by the end of next year.

  • Janssen And Aduro Ink New Deal In Lung Cancer Immunotherapy
    Janssen And Aduro Ink New Deal In Lung Cancer Immunotherapy

    Janssen Biotech and Aduro BioTech announced their second agreement to develop treatments for lung cancer using Aduro’s LADD immunotherapy platform.

  • ProMetic Seeks Orphan Status For Lead IPF Drug
    ProMetic Seeks Orphan Status For Lead IPF Drug

    Biopharmaceutical company ProMetic Life Sciences announced its intent to pursue idiopathic pulmonary fibrosis (IPF) as an orphan indication for its lead drug candidate PBI-4050.

  • Sanofi Ally Shantha Begins Rotavirus Vaccine Phase 3 Trial
    Sanofi Ally Shantha Begins Rotavirus Vaccine Phase 3 Trial

    Sanofi’s vaccine division, Sanofi Pasteur, reported that its affiliate Shantha Biotechnics has initiated the Phase 3 clinical trial in India for its investigational vaccine for rotavirus.

  • Pfenex, PATH Link Arms For Vaccine Development Model
    Pfenex, PATH Link Arms For Vaccine Development Model

    Clinical stage biotech Pfenex announced that it has partnered with international nonprofit organization PATH in a multi-product research initiative to improve vaccine production.

  • Auspherix, Domainex Join Forces Against Drug-Resistant Infections
    Auspherix, Domainex Join Forces Against Drug-Resistant Infections

    Early-stage anti-infectives firm Auspherix and U.K.-based drug discovery services firm Domainex announced a new collaboration to develop treatments that will combat antibiotic-resistant bacterial infections.

  • Nuvilex Files For Orphan Status For Cell-In-A-Box Therapy
    Nuvilex Files For Orphan Status For Cell-In-A-Box Therapy

    Clinical stage biotech firm Nuvilex announced that it has submitted an application seeking Orphan Drug Designation for its Cell-in-a-Box treatment for pancreatic cancer.

  • GAPVAC Vaccine For Glioblastoma Advances To Clinical Trial
    GAPVAC Vaccine For Glioblastoma Advances To Clinical Trial

    immatics biotechnologies and its partner BioNTech AG reported that they are advancing the Glioma Actively Personalized VAccine Consortium (GAPVAC) into a Phase 1/2 clinical trial to investigate the concept of fully personalized therapeutic vaccines against cancer.

  • FDA Accepts Pfizer’s NDA For Breast Cancer Drug
    FDA Accepts Pfizer’s NDA For Breast Cancer Drug

    Pfizer announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for its breast cancer drug palbociclib. The company is seeking approval for palbociclib in combination with letrozole as a first-line treatment for patients with advanced breast cancer.

  • Texas A&M On Standby For Ebola Drug Mass Production
    Texas A&M On Standby For Ebola Drug Mass Production

    The Texas A&M Health Science Center is one of the three sites on standby for mass production of Z-MAPP, an investigational drug for Ebola awaiting approval from the U.S. Food and Drug Administration (FDA).

  • Natural Molecule Can Reverse Autoimmune Disease Response
    Natural Molecule Can Reverse Autoimmune Disease Response

    Researchers at the Brigham and Women's Hospital (BWH) reported the results of a new study investigating a natural molecule that can be used as a potential treatment to reverse autoimmune response and disease progression.

  • DNAtrix’s Glioma Treatment Granted FDA Orphan Drug Status
    DNAtrix’s Glioma Treatment Granted FDA Orphan Drug Status

    DNAtrix, a company developing modified viruses as treatment against aggressive types of cancer, announced that its DNX-2401has received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of malignant glioma.

  • FDA Clears Vivolux Cancer Drug Phase 1/2 Trial In Myeloma
    FDA Clears Vivolux Cancer Drug Phase 1/2 Trial In Myeloma Vivolux reported that it has received the green light from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 1/2 trial for VLX1570 in relapsed and/or refractory multiple myeloma.
  • EMD Serono Enters Alliance To Develop Anti-Cancer Drugs
    EMD Serono Enters Alliance To Develop Anti-Cancer Drugs

    Merck’s biopharmaceutical division EMD Serono announced that it has entered into an alliance with The Institute of Cancer Research (ICR) and the Wellcome Trust in London to jointly develop and license potential anti-cancer drugs.

  • Ariad’s Lung Cancer Drug Gets FDA Breakthrough Status
    Ariad’s Lung Cancer Drug Gets FDA Breakthrough Status

    Oncology company Ariad Pharmaceuticals announced that its investigational drug AP26113 has been designated Breakthrough Therapy status by the U.S. Food and Drug Administration (FDA) as treatment for crizotinib-resistant patients with anaplastic lymphoma kinase positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

  • NKT’s Sickle Cell Drug Fast Tracked By The FDA
    NKT’s Sickle Cell Drug Fast Tracked By The FDA

    Privately held biotech firm NKT Therapeutics announced that its lead therapeutic NKTT120 has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of sickle cell disease.

  • Neurocrine Kick-Starts Trial For Tourette Syndrome Drug
    Neurocrine Kick-Starts Trial For Tourette Syndrome Drug

    Clinical stage drug discovery company Neurocrine Biosciences reported that it has initiated the clinical trial of its VMAT2 inhibitor NBI-98854 in adult and pediatric patients with Tourette syndrome.

  • GSK, NewLink Race To Bring Ebola Vaccines Online By 2015
    GSK, NewLink Race To Bring Ebola Vaccines Online By 2015

    The World Health Organization revealed that pharmaceutical companies GlaxoSmithKline and NewLink Genetics are working double time to ramp up their capacity to produce Ebola vaccine candidates. The companies hope to bring an effective Ebola vaccine online by 2015, reports Reuters.

  • NIH Inks 7 Vaccine Adjuvant Discovery Contracts
    NIH Inks 7 Vaccine Adjuvant Discovery Contracts

    The National Institutes of Health’s (NIH) National Institute of Allergy and Infectious Diseases (NIAID) has signed a total of seven new vaccine adjuvant discovery contracts with different institutions, including five leading universities.

  • J&J Buys Alios BioPharma, Acquires Antiviral Therapies
    J&J Buys Alios BioPharma, Acquires Antiviral Therapies

    Johnson & Johnson and its company Janssen announced the acquisition of privately held clinical stage Alios BioPharma for an estimated $1.75 billion.

  • FDA Awards $19M To 15 Orphan Drug Projects
    FDA Awards $19M To 15 Orphan Drug Projects

    The U.S. Food and Drug Administration (FDA) has given over $19 million in grants to encourage the development of drugs, biologics, and medical devices that address rare diseases. At least a quarter of the funds were allocated towards supporting projects that target pediatrics.

  • Puma Biotech Posts Positive Phase 2 Data For NSCLC Drug
    Puma Biotech Posts Positive Phase 2 Data For NSCLC Drug

    Development stage biopharmaceutical firm Puma Biotechnology reported positive early results from its Phase 2 trial investigating PB272 (neratinib) for the treatment of patients with HER2-mutated non-small cell lung cancer (NSCLC).

  • Pfizer And Kyowa Hakko Kirin To Combine Immuno-Oncology Drugs
    Pfizer And Kyowa Hakko Kirin To Combine Immuno-Oncology Drugs

    Pfizer announced that it has entered an agreement with Kyowa Hakko Kirin to explore the potential of the immuno-oncology combination of Kyowa’s mogamulizumab and Pfizer’s antibody PF-05082566 in patients with solid tumors.

  • Rare Antibodies May Be Key To Future HIV Vaccine
    Rare Antibodies May Be Key To Future HIV Vaccine

    A team of researchers from The Scripps Research Institute (TSRI) reported their findings about a single family of antibodies that could adapt to fight the elusive HIV virus and its different strains. Their discovery may one day provide the key to designing an effective HIV vaccine in the future.

  • MIT Team Hacks Anthrax To Deliver Cancer Drugs
    MIT Team Hacks Anthrax To Deliver Cancer Drugs

    A team of chemists from the Massachusetts Institute of Technology (MIT) reported that they have turned to bacillus anthracis bacteria, the culprit behind anthrax infection, in order to deliver cancer drugs more effectively.

  • FDA Grants Orphan Status To MabVax’s Neuroblastoma Vaccine
    FDA Grants Orphan Status To MabVax’s Neuroblastoma Vaccine

    Clinical stage oncology drug development firm MabVax Therapeutics announced that it has received the coveted Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for its vaccine targeting childhood cancer neuroblastoma.

  • NIH Funds Phase 2 Of ‘Tissue Chip For Drug Screening’ Program
    NIH Funds Phase 2 Of ‘Tissue Chip For Drug Screening’ Program

    The National Institutes of Health (NIH) announced that it will award funds to support the next phase of the Tissue Chip for Drug Screening program, which will attempt to a build a human-like system to test drugs’ safety and efficacy.

  • Genzyme Links With Universities In Gene Therapy Research
    Genzyme Links With Universities In Gene Therapy Research

    Sanofi company Genzyme announced that it has signed a research partnership with the University of Pennsylvania and the University of Florida for the development of a gene therapy that addresses the rare genetic disease Leber congenital amaurosis type 1 (LCA-1).

  • Merck KGaA To Acquire Sigma-Aldrich For $17B
    Merck KGaA To Acquire Sigma-Aldrich For $17B

    Germany-based Merck KGaA announced that it will acquire St. Louis-based chemical firm Sigma-Aldrich to strengthen its laboratory supplies business.

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