Merck

Merck's Glucophage(R) extended release (XR) can be used for more type 2 diabetes patients

  • Posted on: 7 November 2015
  • By: Shalini.Sharma

Merck a leading science and technology company, announced that the British Medicines and Healthcare products Regulatory Agency (MHRA), has approved on November 2 an updated labeling for Glucophage® XR (extended release metformin) for the treatment of patients with type 2 diabetes. The label change removes moderate renal impairment stage 3a and stable chronic heart failure from the list of the contraindications of Glucophage® XR.

Merck KGaA, Darmstadt, Germany, and Pfizer Announce Initiation of Phase III First-Line Trial of Avelumab in Patients with Recurrent or Stage IV Non-Small Cell Lung Cancer(NSCLC)

  • Posted on: 7 November 2015
  • By: Shalini.Sharma

Merck KGaA, Darmstadt, Germany, and Pfizer announced the initiation of an international Phase III study of the investigational cancer immunotherapy avelumab* in a treatment naïve advanced NSCLC setting. The study, JAVELIN Lung 100, is designed to assess the safety and efficacy of avelumab compared with platinum-based doublet chemotherapy, in patients with late-stage NSCLC who have not previously received any treatment for their systemic lung cancer. Avelumab (previously known as MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody that potentially uses the body’s own immune system to fight cancer.

GSK, Merck to study immunotherapy combination as potential cancer treatment

  • Posted on: 6 November 2015
  • By: Shalini.Sharma

GSK and Merck, known as MSD outside the US and Canada, announced the initiation of a phase I clinical trial designed to evaluate GSK’s investigational immunotherapy GSK3174998 as monotherapy and  in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumour(s) that have progressed after standard treatment.

Work as Senior Therapy Manager Vaccines Asansol in Merck

At Merck, you'll find rewarding opportunities, diverse experiences and an unwavering commitment to ethics and integrity. As part of our global team, you'll collaborate with talented and dedicated colleagues whose sense of purpose complements your own.
Whatever your career path — whether it's research, sales, marketing, manufacturing, supply, IT, policy, or supporting our business in another way — Merck offers opportunities to develop and expand your career while making a true difference in people's lives.

Post: Senior Therapy Manager Vaccines Asansol- 1

Opening for Therapy Manager in Merck | B.Pharm/B.Sc

At Merck, you'll find rewarding opportunities, diverse experiences and an unwavering commitment to ethics and integrity. As part of our global team, you'll collaborate with talented and dedicated colleagues whose sense of purpose complements your own.
Whatever your career path — whether it's research, sales, marketing, manufacturing, supply, IT, policy, or supporting our business in another way — Merck offers opportunities to develop and expand your career while making a true difference in people's lives.

Post: Therapy Manager Gorakhpur DVBRx-DIR012662

DATA INTEGRITY NON-COMPLIANCES – THE GOOD, BAD AND UGLY

ABOUT AUTHORS
Krishnendu Singha
Manager – Quality Assurance
[The author is a Quality Assurance professional of a leading MNC]
Krish_singha2007@yahoo.co.in

DI issues – a cause or effect
“It is only the laboratory where such issues were noted, otherwise, we were good at everything”- heard almost after every USFDA inspection once a 483 or warning letter has been issued. It’s been always the laboratories accused of objectionable GMP findings specifically related to data integrity issues.

The question that remains unanswered is why would someone from one department of a big organization be so unethical, so unprofessional that they tend to cause such damages to their own organization who they receive salaries from? In fact, they had to work hard to earn this job! Neither are the lab professionals happy to have damaged organizational reputations. We perhaps may need to rethink whether we are blaming the corners for holding dust of a big room. It might turn out that we start realizing integrity issues are actually the consequence of an organizational deficiency and a reflection of an operational integrity; it has less to do with data and more to do with integrity. Data integrity non-compliance therefore is not the cause but a real effect.

EMA committee recommends Merck's antibiotic Zerbaxa approval

  • Posted on: 8 August 2015
  • By: Shalini.Sharma

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of Merck's investigational antibiotic Zerbaxa (ceftolozane and tazobactam). This is used for the treatment of the complicated intra-abdominal infections, acute pyelonephritis, and complicated urinary tract infections in adults.

Career opportunity for Senior Manager of Asia Contract Manufacturing in Merck

At Merck, you'll find rewarding opportunities, diverse experiences and an unwavering commitment to ethics and integrity. As part of our global team, you'll collaborate with talented and dedicated colleagues whose sense of purpose complements your own.
Whatever your career path — whether it's research, sales, marketing, manufacturing, supply, IT, policy, or supporting our business in another way — Merck offers opportunities to develop and expand your career while making a true difference in people's lives.

Post: Senior Manager of Asia Contract Manufacturing (91524)

Vacancy as Senior Analyst - Quality Control in Merck

At Merck, you'll find rewarding opportunities, diverse experiences and an unwavering commitment to ethics and integrity. As part of our global team, you'll collaborate with talented and dedicated colleagues whose sense of purpose complements your own.
Whatever your career path — whether it's research, sales, marketing, manufacturing, supply, IT, policy, or supporting our business in another way — Merck offers opportunities to develop and expand your career while making a true difference in people's lives.

Post: Senior Analyst - Quality Control, Animal

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