Industry News

Arena Pharmaceuticals appoints Kevin R. Lind as chief financial officer

Centerwatch - Mon, 2016-06-20 08:10

Arena Pharmaceuticals has announced that Kevin R. Lind will join its management team as executive vice president and chief financial officer, effective June 15, 2016. Lind will report to Amit D. Munshi, Arena’s president and chief executive officer.    “Kevin is an accomplished executive with significant financial expertise and will be an exceptional addition to our team,” said Munshi. “Kevin’s broad […]

The post Arena Pharmaceuticals appoints Kevin R. Lind as chief financial officer appeared first on CenterWatch News Online.

Categories: Industry News

Survey: 75% clinical trials collection processes are paperless

Centerwatch - Mon, 2016-06-20 08:05

SCORR Marketing, a global health science marketing and communications firm, in partnership with Applied Clinical Trials, has released the results of a comprehensive survey on the use of paperless processes in clinical trials. The report describes current levels of paperless data collection, perspectives on the importance of paperless clinical trials and the processes that have already been […]

The post Survey: 75% clinical trials collection processes are paperless appeared first on CenterWatch News Online.

Categories: Industry News

Don’t be hasty in clinical research decisions

Centerwatch - Mon, 2016-06-20 08:00

The ability to use good judgment and make sound decisions in clinical research is based on experience, communication and execution. Decision making is influenced by such factors as the familiarization with regulations that govern clinical research, successful management of investigational site relationships and corrective and preventative action with issues that affect patient safety and credible […]

The post Don’t be hasty in clinical research decisions appeared first on CenterWatch News Online.

Categories: Industry News

Takeda, M2Gen to generate broad genomic data from consenting cancer patients

Centerwatch - Mon, 2016-06-20 08:00

Takeda Pharmaceutical and M2Gen, a healthcare informatics solutions company, have established a new collaboration to generate broad genomic data from consenting cancer patients. Under the agreement, Takeda will help build the Oncology Research Information Exchange Network (ORIEN) Avatar Research Program based on the Total Cancer Care Protocol, a prospective observational study enrolling patients with various cancers, and access […]

The post Takeda, M2Gen to generate broad genomic data from consenting cancer patients appeared first on CenterWatch News Online.

Categories: Industry News

Cell Medica, Baylor partner on cancer treatments

Centerwatch - Mon, 2016-06-20 08:00

Cell Medica, a leader in developing, marketing and manufacturing cellular therapeutics for cancer and infections, has announced a co-development partnership with Baylor College of Medicine to develop next-generation technologies for engineering immune cells with enhanced functions for the treatment of solid tumors. The collaboration provides Cell Medica with an exclusive license over several Baylor cell […]

The post Cell Medica, Baylor partner on cancer treatments appeared first on CenterWatch News Online.

Categories: Industry News

California Life Sciences Association expands advocacy team

Centerwatch - Mon, 2016-06-20 08:00

The California Life Sciences Association (CLSA) has announced a new hire and several staff promotions in its advocacy team, further bolstering the organization’s government relations and communications efforts at the federal, state and local levels on behalf of California’s world-leading life sciences sector. CLSA is the nation’s largest statewide life sciences public policy and business solutions organization […]

The post California Life Sciences Association expands advocacy team appeared first on CenterWatch News Online.

Categories: Industry News

The CenterWatch Weekly, June 20, 2016

Centerwatch - Mon, 2016-06-20 08:00

Does industry need a preclinical database? Robert Califf says yes FDA Commissioner Robert M. Califf, M.D., has suggested that establishing a government-sponsored database of preclinical studies could improve transparency in drug development and the ability of researchers to reproduce study results. Califf, who made his comments at an event co-sponsored by the National Library of Medicine, said […]

The post The CenterWatch Weekly, June 20, 2016 appeared first on CenterWatch News Online.

Categories: Industry News

Shire, Kamada announce FDA Emphysema treatment GLASSIA

Centerwatch - Fri, 2016-06-17 14:18

Shire and Kamada, a plasma-derived protein therapeutics company focused on orphan indications, has announced that the FDA has approved an expanded label for GLASSIA [Alpha-1 Proteinase Inhibitor (Human)], marking the first treatment for adult patients with emphysema due to severe Alpha-1 Antitrypsin (AAT) Deficiency that can be self-infused at home after appropriate training. Patients with […]

The post Shire, Kamada announce FDA Emphysema treatment GLASSIA appeared first on CenterWatch News Online.

Categories: Industry News

Veristat adds Mark Chang as SVP of Strategic Statistical Consulting

Centerwatch - Fri, 2016-06-17 13:27

Veristat, a full service CRO, has strengthened its statistical consulting and adaptive design expertise with the appointment of Mark Chang, Ph.D., to the newly created position of senior vice president of Strategic Statistical Consulting. Dr. Chang will help clients evaluate and implement strategic, operational and technical efficiencies to advance products through the clinical trial and […]

The post Veristat adds Mark Chang as SVP of Strategic Statistical Consulting appeared first on CenterWatch News Online.

Categories: Industry News

FDA approves Vaxchora, PaxVax’s single-dose oral cholera vaccine

Centerwatch - Fri, 2016-06-17 12:34

PaxVax has received marketing approval from the FDA for Vaxchora, a single-dose oral, live attenuated cholera vaccine indicated for use in adults 18 to 64 years of age. Vaxchora is the only vaccine available in the U.S. for protection against cholera and the only single-dose vaccine for cholera currently licensed anywhere in the world. “FDA […]

The post FDA approves Vaxchora, PaxVax’s single-dose oral cholera vaccine appeared first on CenterWatch News Online.

Categories: Industry News

La FDA refuerza las advertencias relacionadas con el riñón para los medicamentos para la diabetes canagliflozina (Invokana, Invokamet) y dapagliflozina (Farxiga, Xigduo XR)

FDA News - Fri, 2016-06-17 12:26
[6-14-2016] La Administración de Alimentos y Medicamentos de EE. UU. (FDA) ha reforzado la advertencia existente acerca del riesgo de lesión renal aguda para los medicamentos para la diabetes tipo 2 canagliflozina (Invokana, Invokamet) y dapagliflozina (Farxiga, Xigduo XR).
Categories: Industry News

FDA Drug Safety Communication: FDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)

FDA News - Fri, 2016-06-17 11:36
[6-14-2016] The U.S. Food and Drug Administration (FDA) has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).
Categories: Industry News

BIND Therapeutics announces resignation of directors affiliated with Polaris Partners

Centerwatch - Fri, 2016-06-17 11:13

BIND Therapeutics, a biotechnology company developing targeted and programmable therapeutics called ACCURINS, has announced the resignations of Amir Nashat, managing partner at Polaris Partners, and Amy Schulman, venture partner at Polaris Partners and chief executive officer at Arsia Therapeutics and Lyndra Therapeutics, from BIND’s board of directors. The resignations of Nashat and Schulman are not […]

The post BIND Therapeutics announces resignation of directors affiliated with Polaris Partners appeared first on CenterWatch News Online.

Categories: Industry News

FDA Drug Safety Communication: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin

FDA News - Fri, 2016-06-17 08:55
[06-06-2016] The U.S. Food and Drug Administration (FDA) is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach.
Categories: Industry News

Study: Support for ‘Bring Your Own Device’ approach in clinical trials

Centerwatch - Fri, 2016-06-17 08:41

Icon, a global provider of drug development solutions and services to the pharmaceutical, biotechnology and medical device industries, has announced research showing many pharmaceutical and CROs support the use of a ‘Bring Your Own Device’ (BYOD) approach in clinical studies, enabling patients to use their own mobile devices to collect patient-reported outcomes (PRO) data. The research highlights […]

The post Study: Support for ‘Bring Your Own Device’ approach in clinical trials appeared first on CenterWatch News Online.

Categories: Industry News

PSR Orphan Experts, Raremark partner for rare disease

Centerwatch - Fri, 2016-06-17 08:37

PSR Orphan Experts, a specialty orphan drug consulting and clinical research company, and Raremark, a new online service for families affected by rare disease, have announced a strategic partnership to accelerate the development of new treatments. The collaboration will leverage the companies’ complementary experience and capabilities, addressing the unique challenges involved in clinical research in […]

The post PSR Orphan Experts, Raremark partner for rare disease appeared first on CenterWatch News Online.

Categories: Industry News

Bioclinica to launch patient engagement divisions

Centerwatch - Fri, 2016-06-17 08:33

Bioclinica, a specialty clinical trials technology and services provider, has announced two new divisions, creating an integrated offering focused on patient engagement. With the announcement comes the combination of Bioclinica’s extensive global clinical research site network and patient recruitment-retention engine under the Global Clinical Research business segment. Bioclinica President and CEO John Hubbard, Ph.D., said, “Our combined […]

The post Bioclinica to launch patient engagement divisions appeared first on CenterWatch News Online.

Categories: Industry News

Wilson Therapeutics appoints Rick Lilley chief regulatory officer

Centerwatch - Fri, 2016-06-17 08:27

Wilson Therapeutics has appointed Rick Lilley as chief regulatory officer. Lilley will report to CEO Jonas Hansson and will join the company’s management team. Lilley is a senior global regulatory executive with more than 30 years of experience in the pharmaceutical and biotech industries with a strong track record of achievements and leadership in regulatory […]

The post Wilson Therapeutics appoints Rick Lilley chief regulatory officer appeared first on CenterWatch News Online.

Categories: Industry News

Pfizer inks service agreements with Icon, Parexel

Centerwatch - Fri, 2016-06-17 08:25

Icon, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, has signed a three-year agreement with Pfizer. Under the terms of the agreement, Pfizer has the right to extend the term for up to an additional two years. Financial details of the agreement were not disclosed. The new agreement […]

The post Pfizer inks service agreements with Icon, Parexel appeared first on CenterWatch News Online.

Categories: Industry News
Syndicate content