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.
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 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.
GlaxoSmithKline announced positive results from its pivotal Phase 3 study investigating its vaccine HZ/su for the prevention of shingles.
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.
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 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 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 announced that it has started a Phase 1 study to investigate extended dosing intervals of aripiprazole lauroxil as treatment for schizophrenia.
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.
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, 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.
French pharma giant Sanofi has formally inaugurated its new production facility at King Abdullah Economic City in Saudi Arabia.
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.
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 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).
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 reported that its blood cancer drug Jakavi (ruxolitinib) was safe and effective in treating patients with myelofibrosis in a Phase 3B trial.
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 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 reported new Phase 2 data for Imbruvica (ibrutunib) as treatment for relapsed or relapsed/refractory multiple myeloma (MM).
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 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).
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).
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.
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 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.
Sanofi company Genzyme announced it has launched its newly approved drug Lemtrada (alemtuzumab) as treatment for multiple sclerosis in the U.S.
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.
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 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 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).
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 announced that it has partnered with NewLink Genetics in an exclusive global license agreement to develop NewLink’s rVSV-EBOV (Ebola) vaccine candidate.
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.
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.
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).
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).
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.
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 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 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).
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).
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, 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, 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 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 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).
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.
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.
Oxford University reported that an investigational hepatitis C vaccine has demonstrated positive results in a Phase 1 clinical trial conducted at the University.
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.
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 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.
International biotech firm Genmab announced that it has agreed to transfer its ofatumumab collaboration with GlaxoSmithKline to Novartis.
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 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.
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.
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 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).
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).
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.
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.
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.
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.
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 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.
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).
Clinical stage biopharmaceutical company Immunomedics announced that it has received Orphan Drug status for isactuzumab govitecan (IMMU-132) for the treatment of pancreatic cancer.
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 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.
Eli Lilly announced its plans to close one of its three manufacturing plants in Puerto Rico by the end of next year.
Janssen Biotech and Aduro BioTech announced their second agreement to develop treatments for lung cancer using Aduro’s LADD immunotherapy platform.
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’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.
Clinical stage biotech Pfenex announced that it has partnered with international nonprofit organization PATH in a multi-product research initiative to improve vaccine production.
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.
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.
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.
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.
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).
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, 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.
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.
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).
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.
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.
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.
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.
Johnson & Johnson and its company Janssen announced the acquisition of privately held clinical stage Alios BioPharma for an estimated $1.75 billion.
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.
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 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.
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.
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.
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.
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.
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).
Germany-based Merck KGaA announced that it will acquire St. Louis-based chemical firm Sigma-Aldrich to strengthen its laboratory supplies business.