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ReViral begins Phase I trial of RV521 to treat respiratory syncytial virus
Anti-viral drug discovery and development company ReViral has commenced a Phase 1 clinical trial for RV521, an orally active, small-molecule inhibitor of RSV fusion. (Source: Drug Development Technology)
Source: Drug Development Technology - November 1, 2016 Category: Pharmaceuticals Source Type: news

Theranexus begins enrolment for Phase II trial of THN102 to treat narcolepsy-caused sleepiness
Theranexus has enrolled the first patient for its Phase II clinical study of THN102 to treat excessive daytime sleepiness associated with narcolepsy in adult patients. (Source: Drug Development Technology)
Source: Drug Development Technology - October 31, 2016 Category: Pharmaceuticals Source Type: news

Sunovion reports positive results for LATUDA clinical study in adolescents with Schizophrenia
Sunovion Pharmaceuticals has reported positive results from a study evaluating LATUDA (lurasidone HCI) to treat schizophrenia in adolescents aged 13 to 17 years. (Source: Drug Development Technology)
Source: Drug Development Technology - October 31, 2016 Category: Pharmaceuticals Source Type: news

Shire reports positive Phase II study results of maribavir to treat cytomegalovirus infection
Shire has reported positive data results from a Phase 2 study analysing maribavir (SHP620), an investigational anti-viral agent studied in patients with cytomegalovirus (CMV) infection undergoing hematopoietic stem cell transplant or solid organ tran … (Source: Drug Development Technology)
Source: Drug Development Technology - October 31, 2016 Category: Pharmaceuticals Source Type: news

Lartruvo (olaratumab) for the Treatment of Soft Tissue Sarcoma
Developed by Eli Lilly and Company, Lartruvo (olaratumab) in combination with doxorubicin is indicated for the treatment of soft tissue sarcoma in adult patients. (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

M & As this week: I ’rom Group, Walgreens Boots Alliance
I ’rom Group Co plans to acquire a 61% stake in CMAX from IDT Australia for a purchase consideration of A$10m ($7.61m). (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

Entasis Theraputics begins Phase I study of ETX2514
Entasis Therapeutics has initiated its Phase 1 clinical study of ETX2514 to evaluate the safety, tolerability and pharmacokinetics of ETX2514 in healthy volunteers. (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

Apitope enrols first patient in Phase I trial of ATX-GD-59 to treat Graves ’ disease
Drug discovery and development company Apitope has enrolled the first patient in the Phase I clinical trial of its peptide therapy, ATX-GD-59, to treat Graves ’ disease. (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: Kerecis, PharmaJet, Fimbrion Therapeutics
Kerecis and the US Department of Defence have entered an agreement to develop fish skin burn treatment. (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

Report: US market for depression drugs to grow strongly through to 2025
Drug sales for major depressive disorders (MDD) in the US are expected to grow at a compound annual growth rate (CAGR) of 6.6% to reach $4.6bn by 2025, compared to $2.4bn in 2015, according to a report by GlobalData. (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

Micromeritics Introduces Envelope Density Analyser GeoPyc 1365
Micromeritics has announced the introduction of its newest product, GeoPyc 1365. (Source: Drug Development Technology)
Source: Drug Development Technology - October 27, 2016 Category: Pharmaceuticals Source Type: news

OncoGenex reports positive survival results from Apatorsen Phase 2 Borealis-2 trial in metastatic bladder cancer
OncoGenex Pharmaceuticals has reported positive survival results from the final analysis of the Phase 2 Borealis-2 trial of apatorsen in combination with docetaxel treatment in 200 patients suffering from metastatic bladder cancer, whose disease had … (Source: Drug Development Technology)
Source: Drug Development Technology - October 26, 2016 Category: Pharmaceuticals Source Type: news

Stealth begins Phase II IDDEA-HF study of elamipretide to treat congestive heart failure
Stealth BioTherapeutics has initiated IDDEA-HF, a Phase 2 study evaluating elamipretide in patients hospitalised due to congestive heart failure. (Source: Drug Development Technology)
Source: Drug Development Technology - October 26, 2016 Category: Pharmaceuticals Source Type: news

Faron begins enrolment for Phase III trial of Traumakine to treat respiratory disease in Japan
Faron Pharmaceuticals has reported that its Japanese licensing partner Maruishi Pharmaceutical has recruited the first patient in the Phase III pivotal clinical trial for the treatment of acute respiratory distress syndrome (ARDS) with FP-1201-lyo (a … (Source: Drug Development Technology)
Source: Drug Development Technology - October 25, 2016 Category: Pharmaceuticals Source Type: news

Gilead reports results from Phase 3 studies of switching to Descovy-based regimens from Truvada-based regimens
Gilead Sciences has reported 96-week data from a Phase 3 study and 48-week data from two Phase 3b studies analysing the safety and efficacy of switching virologically suppressed HIV-1 infected patients from regimens containing Truvada to regimens con … (Source: Drug Development Technology)
Source: Drug Development Technology - October 25, 2016 Category: Pharmaceuticals Source Type: news

Eurocine Vaccines begins Phase I/II study of influenza vaccine Immunose FLU
Eurocine Vaccines has commenced a phase I/II clinical study of the quadrivalent influenza vaccine candidate Immunose FLU, a novel nose drop formulation based on the company's technology Endocine and inactivated split antigens. (Source: Drug Development Technology)
Source: Drug Development Technology - October 25, 2016 Category: Pharmaceuticals Source Type: news

Two studies confirm positive benefit-risk profile of XARELTO in treating VTE
Janssen Pharmaceuticals and its development partner Bayer announced results of two new real-world studies, which confirmed the positive benefit-risk profile of XARELTO (rivaroxaban) in treating venous thromboembolism (VTE), or blood clots, and minimi … (Source: Drug Development Technology)
Source: Drug Development Technology - October 24, 2016 Category: Pharmaceuticals Source Type: news

Boston Biomedical begins Phase III CanStem303C study of napabucasin to treat colorectal cancer
Boston Biomedical has dosed the first patient in CanStem303C, a new global Phase III study investigating napabucasin in combination with standard of care (FOLFIRI) in patients with previously treated metastatic colorectal carcinoma (mCRC). (Source: Drug Development Technology)
Source: Drug Development Technology - October 24, 2016 Category: Pharmaceuticals Source Type: news

MicuRx begins Phase III trial of MRX-I in China to treat skin infections
MicuRx Pharmaceuticals has begun patient enrolment in a Phase 3 study of MRX-I in China for the treatment of complicated skin and skin structure infections (cSSSI). (Source: Drug Development Technology)
Source: Drug Development Technology - October 23, 2016 Category: Pharmaceuticals Source Type: news

Theravance Biopharma and Mylan report positive results from two Phase III studies of revefenacin to treat COPD
Theravance Biopharma and Mylan have reported positive results from two replicate Phase 3 efficacy studies of revefenacin (TD-4208), an investigational, long-acting muscarinic antagonist (LAMA) and the first once-daily, nebulised bronchodilator in dev … (Source: Drug Development Technology)
Source: Drug Development Technology - October 23, 2016 Category: Pharmaceuticals Source Type: news

Amgen reports positive top-line results from XGEVA (Denosumab) Phase 3 trial for delay of bone complications in multiple myeloma patients
Amgen has announced that a Phase 3 study evaluating XGEVA (denosumab) versus zoledronic acid met the primary endpoint of non-inferiority in delaying the time to first on-study skeletal-related event (SRE) in patients suffering with multiple myeloma. (Source: Drug Development Technology)
Source: Drug Development Technology - October 23, 2016 Category: Pharmaceuticals Source Type: news

PharmaEngine begins Phase Ib/II trial of PEP503 to treat head and neck cancer
PharmaEngine has announced that the first patient has been dosed in a Phase Ib/II trial of PEP503 (NBTXR3) of head and neck squamous cell carcinoma (HNSCC) at Keelung Chang Gung Memorial Hospital (Lovers Lake Branch) in Keelung, Taiwan. (Source: Drug Development Technology)
Source: Drug Development Technology - October 20, 2016 Category: Pharmaceuticals Source Type: news

Report: Penetrating crowded heart failure market could prove difficult for Omecamtiv Mecarbil
Cytokinetics ’ new heart failure drug, Omecamtiv Mecarbil (OM), will have to target patient subgroups in order to succeed in the crowded heart failure market, says GlobalData in its recent report. (Source: Drug Development Technology)
Source: Drug Development Technology - October 20, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: ATCC, Sirenas, Nektar Therapeutics
ATCC and BioAgilytix have entered a partnership to develop assay systems, which can be used for testing drug potency, stability testing and other applications. (Source: Drug Development Technology)
Source: Drug Development Technology - October 20, 2016 Category: Pharmaceuticals Source Type: news

Exondys 51 (eteplirsen) for the Treatment of Duchenne Muscular Dystrophy (DMD)
Exondys 51 (eteplirsen) is an injectable solution developed by Sarepta Therapeutics. (Source: Drug Development Technology)
Source: Drug Development Technology - October 20, 2016 Category: Pharmaceuticals Source Type: news

M & As this week: Chengdu Kanghong Pharmaceutical, Cachet Pharmaceutical, Antegrin Therapeutics
Chinese pharmaceutical company Chengdu Kanghong Pharmaceutical Group has announced its intention to acquire the remaining 7% stake in a pharmaceutical unit based in Chengdu, China. (Source: Drug Development Technology)
Source: Drug Development Technology - October 20, 2016 Category: Pharmaceuticals Source Type: news

AbbVie and Neurocrine Biosciences report positive Phase III trial results of Elagolix to treat endometriosis
AbbVie and Neurocrine Biosciences have reported positive results from two replicate pivotal Phase III clinical trials of Elagolix to treat premenopausal women suffering from endometriosis. (Source: Drug Development Technology)
Source: Drug Development Technology - October 20, 2016 Category: Pharmaceuticals Source Type: news

New study shows IVF increases chances of conceiving baby boy
Researchers at the Colorado Center for Reproductive Medicine (CCRM) have discovered that use of assisted reproductive technology (ART) will increase the chances of conceiving a baby boy. (Source: Drug Development Technology)
Source: Drug Development Technology - October 19, 2016 Category: Pharmaceuticals Source Type: news

MDCO reports positive Phase II trial results of PCSK9si to treat hypercholesterolemia
The Medicines Company (MDCO) has reported positive topline results from its Phase II trial of single or multiple subcutaneous injections of PCSK9 synthesis inhibitor (PCSK9si). (Source: Drug Development Technology)
Source: Drug Development Technology - October 19, 2016 Category: Pharmaceuticals Source Type: news

Biovian to Present at Bio-Europe in Germany
Biovian has announced it will be present at the biotechnology partnering Conference Bio-Europe in Cologne, Germany. (Source: Drug Development Technology)
Source: Drug Development Technology - October 19, 2016 Category: Pharmaceuticals Source Type: news

Soligenix reports positive interim results of Phase II trial of SGX942 to treat severe oral mucositis
Biopharmaceutical company Soligenix has reported positive interim results from its Phase II clinical trial of SGX942 (dusquetide) to treat severe oral mucositis. (Source: Drug Development Technology)
Source: Drug Development Technology - October 18, 2016 Category: Pharmaceuticals Source Type: news

Transgene randomises first patient in Phase I/Ib trial of TG1050 to treat chronic hepatitis B
French biopharmaceutical company Transgene has randomised its first patient in the multiple-dose cohort of its Phase I/Ib trial of TG1050 to treat chronic hepatitis B virus (HBV) infection. (Source: Drug Development Technology)
Source: Drug Development Technology - October 18, 2016 Category: Pharmaceuticals Source Type: news

PharmaMar enrols patients in Phase III CORAIL study with lurbinectedin to treat ovarian cancer
PharmaMar has announced the completion of patient recruitment for the randomised and key Phase III of CORAIL study with lurbinectedin (PM1183) for the treatment of platinum-resistant ovarian cancer. (Source: Drug Development Technology)
Source: Drug Development Technology - October 18, 2016 Category: Pharmaceuticals Source Type: news

Clementia reports results from Phase 2 trial of palovarotene to treat fibrodysplasia ossificans progressiva
Clementia Pharmaceuticals has announced top-line results from its Phase 2 clinical trial investigating palovarotene for the treatment of fibrodysplasia ossificans progressiva (FOP). (Source: Drug Development Technology)
Source: Drug Development Technology - October 17, 2016 Category: Pharmaceuticals Source Type: news

Hua Medicine reports positive Phase II trial results of HMS5552 to treat diabetes
Chinese clinical stage biotech company Hua Medicine has reported positive results from its Phase II monotherapy trial of HMS5552 to treat diabetes. (Source: Drug Development Technology)
Source: Drug Development Technology - October 17, 2016 Category: Pharmaceuticals Source Type: news

SciFluor initiates Phase I/II trials of SF0166 to treat DME and wet-AMD
US-based clinical-stage biopharmaceutical company SciFluor Life Sciences has initiated both Phase I/II trials of SF0166 to treat diabetic macular edema (DME) and age-related macular degeneration (wet-AMD). (Source: Drug Development Technology)
Source: Drug Development Technology - October 16, 2016 Category: Pharmaceuticals Source Type: news

Tetraphase Pharmaceuticals begins dosing of first patient in IGNITE4 trial of eravacycline to treat cIAI
Tetraphase Pharmaceuticals has announced the dosing of its first patient in IGNITE4, the phase 3 clinical study analysing the efficacy and safety of intravenous (IV) eravacycline compared to meropenem in complicated intra-abdominal infections (cIAI). … (Source: Drug Development Technology)
Source: Drug Development Technology - October 16, 2016 Category: Pharmaceuticals Source Type: news

Celgene reports positive data from Phase Ib study of GED-0301 for Crohn ’s disease
US-based Celgene's Swiss subsidiary Celgene International has reported positive data from its exploratory Phase Ib CD-001 study of GED-0301 (mongersen) to treat active Crohn ’s disease. (Source: Drug Development Technology)
Source: Drug Development Technology - October 16, 2016 Category: Pharmaceuticals Source Type: news

Carnexiv (carbamazepine) for the Treatment of Partial, Generalised Tonic-clonic Seizures in Adults
Carnexiv (carbamazepine) is an injectable formulation developed by Lundbeck for partial, generalised tonic-clonic seizures in adult patients who are unable to temporarily take oral medication. (Source: Drug Development Technology)
Source: Drug Development Technology - October 13, 2016 Category: Pharmaceuticals Source Type: news

M & As this week: RXi Pharmaceuticals, TFS International, Danaher Corporation
RXi Pharmaceuticals plans to expand its product pipeline and enter the immuno-oncology market by acquiring all the outstanding shares of cancer immunotherapies developer MirImmune. (Source: Drug Development Technology)
Source: Drug Development Technology - October 13, 2016 Category: Pharmaceuticals Source Type: news

Eisai announces Phase Ib trial results of lenvatinib with pembrolizumab in selected solid tumours
Eisai has announced the results of a Phase Ib clinical trial of its multiple-receptor, tyrosine kinase inhibitor lenvatinib mesylate (lenvatinib) in combination with the anti-PD-1 antibody pembrolizumab developed by Merck& Co in patients with select … (Source: Drug Development Technology)
Source: Drug Development Technology - October 13, 2016 Category: Pharmaceuticals Source Type: news

Trevi Therapeutics reports positive results from Phase 2 trial for treatment of prurigo nodularis
Trevi Therapeutics, a late-stage clinical development company developing oral Nalbuphine ER for chronic pruritus conditions, has reported positive results from its Phase 2 trial for the treatment of moderate-to-severe prurigo nodularis (PN). (Source: Drug Development Technology)
Source: Drug Development Technology - October 13, 2016 Category: Pharmaceuticals Source Type: news

Deals this week: Nordic Nanovector ASA, Charles River Laboratories International, Transgene SA
Nordic Nanovector ASA and LegoChem Biosciences have entered an agreement to include CD37-targeting antibody drug conjugates to non-radionuclide cancer drugs. (Source: Drug Development Technology)
Source: Drug Development Technology - October 13, 2016 Category: Pharmaceuticals Source Type: news

Report: Major depressive disorder market to grow at CAGR of 6.1% over next ten years
The global market for major depressive disorder (MDD) is anticipated to grow at a substantial compound annual growth rate (CAGR) of 6.1% over the next ten years, according to a report by GlobalData. (Source: Drug Development Technology)
Source: Drug Development Technology - October 13, 2016 Category: Pharmaceuticals Source Type: news

Allegro Ophthalmics announced positive results from DEL MAR Phase 2b trial
Allegro Ophthalmics has announced that the DEL MAR Phase 2b clinical trial analysing Luminate (ALG-1001) in 136 patients with diabetic macular edema (DME) met its primary and secondary endpoints. (Source: Drug Development Technology)
Source: Drug Development Technology - October 12, 2016 Category: Pharmaceuticals Source Type: news

Inivata initiates clinical trial of ctDNA in non-small-cell lung cancer
Global clinical cancer genomics company Inivata has announced the initiation of its US clinical validation study (INI-001) of a new approach to circulating tumour DNA (ctDNA) in non-small-cell lung cancer (NSCLC). (Source: Drug Development Technology)
Source: Drug Development Technology - October 12, 2016 Category: Pharmaceuticals Source Type: news

Delcath Systems adds new clinical sites for FOCUS trial to treat ocular melanoma liver metastases
Delcath Systems has announced that five new clinical trial sites in the US have been added to its global FOCUS Phase 3 clinical trial for patients with hepatic dominant ocular melanoma. (Source: Drug Development Technology)
Source: Drug Development Technology - October 11, 2016 Category: Pharmaceuticals Source Type: news

NAPOLI-1 Phase 3 study confirms benefit for ONIVYDE regimen for pancreatic cancer
Merrimack Pharmaceuticals has announced the final results from the pivotal Phase 3 NAPOLI-1 study validating the use of ONIVYDE (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin to treat metastatic pancreatic canc … (Source: Drug Development Technology)
Source: Drug Development Technology - October 11, 2016 Category: Pharmaceuticals Source Type: news

Daiichi Sankyo enrolls first patient in Phase 3 of QuANTUM-First trial for Quizartinib
Japan-based pharmaceutical company Daiichi Sankyo has enrolled the first patient in its global Phase 3 QuANTUM-First trial to assess quizartinib in patients with newly diagnosed FLT3-ITD-positive (+) acute myeloid leukemia (AML). (Source: Drug Development Technology)
Source: Drug Development Technology - October 11, 2016 Category: Pharmaceuticals Source Type: news

Boehringer Ingelheim announces Phase III nintedanib trial results in patients with metastatic colorectal cancer
Boehringer Ingelheim has announced that its   LUME-Colon 1 study has met   one of the co-primary endpoints of progression-free survival (PFS) in pre-treated patients with metastatic colorectal cancer (mCRC). (Source: Drug Development Technology)
Source: Drug Development Technology - October 10, 2016 Category: Pharmaceuticals Source Type: news