July 2016

Merrimack Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted seribantumab, also known as MM-121, Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy.

Merrimack is conducting the SHERLOC trial, a global clinical study of seribantumab in combination with docetaxel or pemetrexed in heregulin-positive patients with NSCLC that is designed to support a Biologics License Application to the FDA. Seribantumab is Merrimack's wholly owned, fully human monoclonal antibody that targets ErbB3.

"We are pleased that the FDA recognizes the importance of investigating a novel, biomarker-directed agent such as seribantumab for patients with locally advanced or metastatic NSCLC who have been previously treated with an immunotherapy," said Dr. Akos Czibere, Vice President, Clinical Development at Merrimack. "Heregulin-positive cancer cells are characterized by their ability to escape the effects of a broad range of cancer therapies and potentially contribute to accelerated disease progression. The SHERLOC trial is designed to advance the development of a much-needed treatment option for patients with heregulin-positive NSCLC after they progress on immunotherapies. This is important because we find that more than 50% of patients with NSCLC are heregulin-positive."

Seribantumab is designed to block heregulin-driven signaling and enhance the anti-tumor effect of the chemotherapy. Data from Merrimack's prior clinical studies have shown that standard-of-care therapy may be more effective and result in improved patient outcomes when combined with seribantumab. Merrimack is investigating the efficacy and safety of seribantumab plus standard-of-care therapy in the SHERLOC trial.

The SHERLOC trial is a randomized, open-label, multi-center, Phase 2 study in patients with heregulin-positive, locally advanced or metastatic NSCLC. Merrimack expects to enroll approximately 280 heregulin-positive patients who will be randomized (2:1) to receive seribantumab in combination with either docetaxel or pemetrexed versus docetaxel or pemetrexed alone. The study's primary endpoint is overall survival with secondary endpoints including progression free survival, objective response rate, safety and quality of life measures. The study is designed to support a Biologics License Application to the FDA with data expected in 2018.

<< Pharma News

Subscribe to PharmaTutor News Alerts by Email

Read more about Roche cobas HPV Test for use with SurePath Preservative Fluid approved by FDA

The U.S. Food and Drug Administration approved the Roche cobas HPV Test as the first test for Human Papilloma Virus (HPV) that can be used with cervical cells obtained for a Pap test and collected in SurePath Preservative Fluid.

10 July 2016

Recruitment of Pharmacists (40 posts) for Mobile Healh Teams Under RBSK

Applications are invited from eligible candidates for recruitment of Medical Officer, ANMs and Pharmacist to work in Mobile Health Teams on contract basis. Applications may be sent to the District Medical and Health Officer, Near District Collectrate, Chittoor, Chittoor District for which application is made. The last date of receiving applications is 12-07-2016 upto 5:00 PM.

Post : Pharmacist - 40 Posts

10 July 2016

Vacancy for M.Pharm, B.Pharm in ICMR Project as Senior Research Fellows and Project Assistant in Shoolini University

The School of Pharmacy of the faculty is approved by the AICTE and committed to produce high quality pharmacist's workforce tailor-made to suit the requirements of the industry and community. We aim to develop latest skills among students by imparting current knowledge about research-centered clinical pharmacy and medicine management.

10 July 2016

Require Assistant Director in Directorate, Medical and Health Services - B.Pharm can apply

Directorate, Medical & Health Services, Dadra and Nagar Haveli, invites applications from eligible candidates for below mentioned posts to be filled on Short Term Contract Basis under UT Administration, National Health Mission and State AIDS Control Society. The applications should reach the undersigned on or before 20/07/2016.

Post : Assistant Director (CST)

10 July 2016

Career as Senior Pharmacist in National Institute of Technology Durgapur

National Institute of Technology Durgapur was set up as Regional Engineering College (REC) in 1960 funded jointly by the Government of India and the Government of West Bengal and was registered under the Registrar of Societies Act. Initially the Chief Minister of West Bengal and subsequently the Minister of Higher Education, the Government of West Bengal was the Chairman of the Board of Governors. It was affiliated to the University of Burdwan. In REC system national integration was considered to be a part and parcel of education, with half the se at allocated to the students from the state while the rest reserved for the students from the other states, which ensured excellent interaction and camaraderie among the students from all corners of the country.

NIT Durgapur invites applications from Indian Nationals for recruitment to Non-teaching posts.

Post : Senior Pharmacist - 1(GN)

10 July 2016

Opening for Scientist / Senior Scientist in Central Salt & Marine Chemicals Research Institute

CSIR-Central Salt & Marine Chemicals Research Institute is a premier national laboratory under Council of Scientific & Industrial Research (CSIR), New Delhi. The Institute undertakes a wide range of basic and applied R&D projects spanning the areas of chemistry, biology and engineering. The Institute has excellent infrastructure by way of sophisticated analytical instruments, modem laboratories, pilot plants, library, local area network and workshop.

Applications are invited in the prescribed form from talented and result-oriented Indian Nationals for 1 post Scientist/Senior Scientist, as per the following details:

Post : Scientist / Senior Scientist 01 [PwD - HH]

9 July 2016

Vacancy for Pharmacist(12 posts) in Central Government Health Scheme | Govt. Job

The “Central Government Health Scheme” (CGHS) provides comprehensive health care facilities for the Central Govt. employees and pensioners and their dependents residing in CGHS covered cities.The Central Govt. Health Scheme provides comprehensive health care to the CGHS Beneficiaries in India. The medical facilities are provided through Wellness Centres(previously referred to as CGHS Dispensaries) /polyclinics under Allopathic, Ayurveda, Yoga, Unani, Sidha and Homeopathic systems of medicines.

Post : Pharmacist

8 July 2016

Required Manager Remediation - Internal Audit in Pfizer

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post : Manager Remediation - Internal Audit

8 July 2016

Vacancy in Clinical data Management at Accenture

Accenture is a global management consulting, technology services and outsourcing company, with approximately 275,000 people serving clients in more than 120 countries. Combining unparalleled experience, comprehensive capabilities across all industries and business functions, and extensive research on the world’s most successful companies, Accenture collaborates with clients to help them become high-performance businesses and governments. The company generated net revenues of US$28.6 billion for the fiscal year ended Aug. 31, 2013.

Post: Clinical data Management