Dr Mulkerrin has more than 20 years of industry experience in biologics manufacturing, most recently as Vice President, Process Development and Manufacturing at OncoMed and has had prior senior roles at Abgenix, Amgen and Genentech. Dr Simon Chivers joins as Head of Toxicology. Dr. Chivers has more than 15 years of industry experience, most recentl
In the interview posted online since September 15, Pharma IQ asked Dr. Sherley to respond to several questions on the current state of technologies for evaluating stem cell toxicity, challenges to evaluating stem cell toxicity, and future trends in the use of stem cells for toxicological drug evaluations. Dr. Sherley was invited to lead the session
Akorn, Inc., a niche pharmaceutical company, today announced that it has signed a definitive agreement to acquire certain rights to short-acting bronchodilator Xopenex Inhalation Solution from Sunovion Pharmaceuticals Inc. for $45 million, paid in cash at closing, net of certain liabilities. "We are excited to announce this transaction which
Alimera Sciences, Inc., a pharmaceutical company that specializes in the research, development and commercialization of prescription ophthalmic pharmaceuticals, announced today that it has received a $25 million advance from Hercules Technology Growth Capital, Inc.. The payment is the second and final advance under the Loan and Security Agreement
On September 29, 2014, Amarantus Bioscience Holdings, Inc., a Nevada corporation issued a press release announcing that it has submitted a request to the FDA for a review and written feedback of the Phase IIb clinical trial design for Eltoprazine in levodopa-induced dyskinesia. A copy of the press release is attached hereto as Exhibit 99.1.
BioTime reported that its subsidiary Asterias Biotherapeutics has reached an agreement with Cancer Research UK and Cancer Research Technology, the charity's development and commercialization arm, to conduct a clinical trial of Asterias' novel immunotherapy treatment AST-VAC2 in subjects with non-small cell lung cancer. We are delighted to partner..
Avedro Inc., a Boston- based ophthalmic medical device and pharmaceutical company announces today that it resubmitted its New Drug Application for riboflavin ophthalmic solution/ KXL System to the U.S. The proposed indications of treatment of progressive keratoconus or corneal ectasia following refractive surgery were both granted orphan status
By a News Reporter-Staff News Editor at Cancer Weekly Treatment with endocrine therapy and radiation therapy as part of breast conservation is the current standard of care for women with hormone-receptor positive invasive breast cancer. A new study by researchers at Fox Chase Cancer Center, however, shows that combination may not be necessary for
Brainsway Ltd. is pleased to report substantial improvement in OCD patients following Brainsway Deep TMS treatment in a clinical study held in Sheba Medical center, Tel Ha'Shomer, Israel. Joseph Zohar, who was the chairperson of the anxiety and OCD section of the World Psychiatric Association, included 41 OCD patients who did not respond adequate
Celgene said that the U.S. Food and Drug Administration has approved OTEZLA, the Company's oral, selective inhibitor of phosphodiesterase 4, for the treatment of patients with moderate to severe plaque psoriasis for whom phototherapy or systemic therapy is appropriate. "OTEZLA offers a valuable treatment option for a spectrum of plaque psoriasis p
Celldex Therapeutics, Inc. announced today the publication of two papers highlighting early studies of glembatumumab vedotin in breast cancer and metastatic melanoma in the Journal of Clinical Oncology. The papers, " A Phase 1/ 2 Study of the Antibody-Drug Conjugate Glembatumumab Vedotin in Patients with Advanced Melanoma" and " A Phase 1/ 2 Stud
CSP-1103 has undergone Phase 2 testing in people with Mild Cognitive Impairment, and CereSpir is integrating the findings to finalize the Phase 3 clinical protocol in consultation with key opinion leaders in AD research and the U.S. Food and Drug Administration. He retired from Myrexis in 2011. Hobden earned his Bachelor's and Master's degrees in..
A clinical study published in the August 23, 2014 issue of The Lancet demonstrated that delivery of AFLURIA with the PharmaJet Needle-Free Injector compared favorably to traditional needle and syringe delivery. In the PharmaJet study, 89 percent of the people receiving the PharmaJet Needle-Free Injection reported they would choose to receive thi
?receiving the Orphan Drug Designation from the U.S. Food and Drug Administration for COTI-2 in the treatment of ovarian cancer; x0D;. ?commencing trading on the OTCQB venture stage marketplace in the United States under the symbol COTQF. x0D;. Wayne Danter, President and CEO.
CSL Behring announced that it is set to commence operations in its newly expanded facility now that the U.S. Food& Drug Administration has granted approval. The new facility will use the same state-of-the-art technology as CSL Behring's long-standing manufacturing center of excellence in Bern, Switzerland. CSL Behring's Executive Vice President G
CytRx Corporation, a biopharmaceutical research and development company specializing in oncology, today announced the initiation of a global Phase 2 b clinical trial evaluating aldoxorubicin compared to topotecan in subjects with extensive-stage small cell lung cancer who have relapsed or were refractory to prior chemotherapy.
DanDrit Biotech A/S, the subsidiary of DanDrit Biotech USA, Inc., a biotechnology company seeking to develop an approved vaccine for the treatment of colorectal cancer, signed a contract of collaboration with the University Hospital IRCCS "San Martino"- IST National Institute for Cancer Research known as the San Martino Hospital of Genoa.
Ambry Genetics and researchers from Memorial Sloan Kettering Cancer Center, Mayo Clinic, Abramson Cancer Center of the University of Pennsylvania, Dana-Farber Cancer Institute and other diagnostic testing laboratories reported a research partnership aimed to recognize the significance of mutations and variants found by multi- gene testing for...
BERKELEY HEIGHTS& PARSIPPANY, N.J. Clinical-stage biotechnology company Edge Therapeutics, Inc. and leading specialty chemicals company Evonik Corporation announced today that they have received a U.S. Patent and Trademark Office has issued this composition of matter patent, which builds upon our existing intellectual property portfolio for EG-
EDP Biotech Corporation,, a global in vitro diagnostic innovator of life-saving, easy-to-use cancer diagnostic tests using ELISA technology, has announced CE Mark approval for ColoMarker , an aid in early detection of Colon Cancer. Herbert Fritsche, retired tenured Professor of Laboratory Medicine& Chief of Clinical Chemistry; MD Anderson Cancer
By a News Reporter-Staff News Editor at Cancer Weekly Nektar Therapeutics reported that partner AstraZeneca announced that the US Food and Drug Administration approved MOVANTIK tablets as the first once-daily oral peripherally-acting mu-opioid receptor antagonist medication for the treatment of opioid-induced constipation, in adult patients...
Fibrocell Science and Intrexon Corp. reported plans to file an investigational new drug application with the U.S. Food and Drug Administration in the first half of 2015 for their drug candidate, GM-HDF-COL7. Fibrocell and Intrexon commenced preclinical activities of GM-HDF-COL7 earlier this year and have since attained certain regulatory and...
Clinical trial report, "Idiopathic Hypertension Global Clinical Trials Review, H2, 2014? provides data on the Idiopathic Hypertension clinical trial scenario. Scope? Data on the number of clinical trials conducted in North America, South and Central America, Europe, Middle-East and Africa and Asia-pacific and top five national contributions in
Helix BioPharma Corp., a biopharmaceutical company developing innovative drug candidates for the prevention and treatment of cancer, today announced it has completed its interim data review of the first eight cohorts of the Company's ongoing Phase I/II clinical safety, tolerability and preliminary efficacy study of L-DOS47 in Poland.
LONDON- Hikma Pharmaceuticals PLC Tuesday said it was granted approval by the US Food and Drug Administration for its colchicine 0.6 mg capsules for prophylaxis of gout flares in adults. According to IMS Health, sales of colchicine in the US market were approximately USD688 million for the 12 months ended August 2014, Hikma said in its statement Tu