Answers: CROs Market Quiz

A few weeks back, Partnerships Guest Blogger Rashmi Pant presented us with a quiz about the CROs market. Here are the answers! Corrected answers appear in red.

1. Which is the larger deal? Please mention approx deal size in billions.
• The Abbot-NCH takeover
• the Daichi-Ranbaxy Takeover

2. How many NME’s have been approved by the FDA in 2009?
• 30
• 27
• 29
• 32

3. How many Clinical trials are registered at the Indian Clinical Trial registry till date?
• 800
• 950
• 1000
• 1193

4. Which is the recent guidance published on the DCGI website which could act as a major barrier to BA BE studies?
• Change in Format of Ethics committee submission
• Change in Format of medical devices
• Change in timelines for submission
• CoE for export

5. Which is the recent Guidance ( august 2010 ) which applies to those clinical trials under moderate or severe published on the DCGI website:
• Anti hypertensive drugs
• Diabetes drugs
• Cancer trials
• Medical Device trials

6. How many years has Indian Pharma spent in Active R &D?
• 10
• 12
• 14
• 16

7. Which is the Indian company which has entered into a licensing deal for its 41 generic drug products with Pfizer?
• Ranbaxy
• Orchid
• Cipla
• Intas


8. Which is the Indian company which has entered into a licensing deal with MNC, Astra for generic drug products?
• Intas
• Nicholas Piramal
• Abbot
• Torrent

9. Which is the Indian Life science company which has r been issued a warning letter on its antibiotic products in May 2010?
• Cipla
• Ranbaxy
• Claris
• Core Pharma

10. Which of the following companies are into CT supply Outsourcing business in Ahmedabad:
• Synchron
• Lambda
• Thermofisher
• None of the above

11. Which is the NYSE listed CRO which has recently expanded operations in India?
• Parexel
• PPD
• CRV
• Kendle

12. Which is the Indian Pharma Company which has declared its IPO plans of greater than 500crs?
• Glenmark
• Glenmark Generics
• Intas
• Venus Remedies
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Q & A- Direct questions:

13. Which is the drug and the company which has been warned by the FDA to withdraw their product on account of safety issues in the last 6 months?
Avandia ( Rosiglitazone) by Glaxo

14. Which Global CRO came into limelight after their Phase I trial for an mAB brought 6 volunteers to serious ADR’s?
Parexel in 2006

15. Also name the Hospital and countries involved in the trial. What is the code name of the molecule involved in the trial?
Northwick Park Hospital, UK & Germany, TGN1412

16. Which is the Indian CRO which faced heavy penalties when a volunteer expired during felodipine trial last year?
GVK Biosciences

17. Which company came under the DCGI scanner for vaccine trial on neonates AIMMS hospital on informed consent issues? Also this resulted in the death of one of the infants as well. Name the CRO Involved.
Wyeth, GVK BIO

18. Which Canadian CRO has recently merged with an Indian CRO? Name the PE involved in the deal.
Lambda took over Bioavail Contract research in Canada; Avendus Capital

19. Who is the president of the OPPI? When was the OPPI established?
Organisation of Pharmaceutical producers of India president is Mr Ranjit Sahni of Novartis; 1965

20. Which the only cancer vaccine approved in 2010? What as the company’s name? What is the indication for the vaccine?
Provenge by Dendreon; Prostrate Cancer