Europe- New Regulatory guidelines!

From my B. pharmacy days i used to follow FDA and their guidelines but America has to learn many things from the Europeans in terms of regulatory guidelines recently for which there is lot of discussion happening in NICE front for new regulatory development, where in Macro level involvement of specific groups have been initiated for decision making for approval of drugs, there is lot to learn from NHS (National health services) and NICE UK. Will it be possible in India to implement these all regulations?

Generics?????

Generics have been eating our pie of revenue is the buzz following everywhere in Social media by the big players, whether its BMS and Astra, Astra at this point is in pretty bad shape as a giant which BMS was there 10 years back, BMS recovered with strategic partnership and alliances but what about Astra will it be able to cope?

These Big Pharma knew that generics will one or the other day will eat their pie of revenue and the best way to stop them is by making stringent regulations for sales and promotion.......

Astra should have thought beforehand about all this when it was making strategic blunders over the last three years ??????

After the generics and counterfeits ......it’s time for biosimilars to eat the revenue of big players  

Merck-Will this strategy help???

Today one of the top line news is that Merck and company is expanding in HIV arena, by signing two licensing agreements for investigational drug candidates. One deal is with Chimerix, based in Research Triangle Park, NC, and the other is with Yamasa of Choshi, Japan. With respect to its own portfolio Merck is also planning to advance an internally developed HIV candidate, MK-1439, which is into a Phase IIb trial. The question which is bugging my mind is that will Merck be able to penetrate the market which is majorly monopolized by Gilead for more than decade and if it is thinking of penetrating to the emerging markets, then will it be able to displace the stiff competition from companies like Cipla who have been playing the low price game for more than 3 decades? Food for thought ………..

Regulatory issues!

For past many months there has been issues related GMP production whether it’s Roche, Sanofi and Hospira and the issue was cGMP compliance in manufacturing. For Roche the issue was API production in their API manufacturing in North carolina, US and later Sanofi with their TB drug production in Canada. Why is that developed nations facing the CGMP issues as their regulatory bodies are the most stringent ones in the world?What should be the next steps for this company, third party manufacturing of active API's and products ?

Social Media Bug in Pharma!

Social media in some years has become a hot topic or rather then talk of the town, In FMCG scenario it has worked wonders and made some old products come back into shelf after consumer's persuasion. But I feel for Pharma there is an overall different story. Pfizer had closely watched effort for patient recruitment for clinical trials, One year after launching its so-called clinical-trial-in-a-box.

Pfizer is planning to discontinue enrollment in the first such study that was designed to allow the patients to participate from home by using computers and smart phones rather going back to hospital or doctor's office for medicines and after check-ups. While this effort created lot of Buzz in the virtual world but the drug maker was not able to pursue the patients to come up front to participate in trial, which was for testing the Detrol overactive bladder drug.

Time will say Social media success in Pharma and biopharma sector?

Pharma consolidation!

Good Morning Bangalore!.....India.......i have started loving Bangalore because of many things but majorly because of its climate and good Volvo services :)

Last to last week when Astra zenaca CEO stepped down after series of failures in strategic decisions...there were humors that GSK in eyeing on Astra, Both of then are Europe based companies and if this merger happens, it will help GSK to penetrate Europe and access to R&D in APAC region.......I assume that after 10 years all the Top 20 to 30 companies will be subsidiary of the Top 10 and i am just here to watch the consolidation of the Pharma industry......Might be case that Novartis mights increse its stakes in Roche and might even make it as its Biological subsidiary.......We never know what will be the consequences......but the shrinkage and consolidation of Pharma across the globe has started........

Turkey the next land of oppurtunity!

From the beginning of this year my life has been a roller coaster ride, leaving the hectic life, what I found is Bangalore is better compared to my life in Delhi. From last month I have been looking at a different trend, I started reading about Big pharma investment in emerging markets, what i am looking at is many of the big pharma's in the last 2-3 years have started collaboration with the Turkish companies or rather buying them out,  and some for instance like out of the major top 20, Novartis last month announced that it is going to start its R&D in Turkey and today’s latest news is Amgen bought 95% stakes Turkish Drug maker Mustafa Nevzat for $700 Million. After china being the favorite destination in Asia for big pharma’s emerging market strategy, I feel that likewise Turkey is becoming key destination for penetration into North Africa and middle east emerging market strategy for Big pharma. Amgen of course with this deal has become part of large pharma with generic arm and what I believe that in coming 6-7 years will promote its biosimilar arm through the generic divisions which it will perhaps expand from turkey to other parts of Europe, as from olden days (Biblical era) Turkey was gateway to both Europe, Africa and Asia…………

Reverse merger of Pfizer and Sanofi????

One year back while I was traveling with my boss for a small conference in Delhi. Aditya my boss started telling me about reverse merger of Merck by Schering-Plough, I was surprised to know that as I had a always known that Merck had acquired Schering-plough.....leaving that story apart, in the current scenario if I look into world’s largest pharma Pfizer's current pipeline, it is somewhat dry with its major block buster getting off patented last month,  there are not many revolutionary drugs in its somewhat dry pipeline which will give it a huge ROI in next 10 years and it also do not have a strong biopharma presence .....on the other hand the company which is making mark and has been into lot action in biological for a while is Sanofi Aventis of france.........with Sanofi's strong biological pipeline and Pfizer's strength in world class chemical synthesis...in future can we think of a reverse merger of Pfizer by Sanofi ???