Louise Zornoza from raps.org produced a very informational article on the impact of the reclassification deadline for hip, shoulder, and knee implants. Australia’s Therapeutics Goods Administration (TGA) has warned implant companies that they have only a few more months to complete the reclassification for their products. Implants are being reclassified by the TGA from a medium risk to a high risk July 1st. The TGA has tried to help companies by giving them a 2 year grace period to complete the reclassification of their products. To read the full article click here.
Deanna Pogorelc from medcitynews.com wrote an interesting article on the impact middle market pharma companies are having on mergers and acquisitions in the pharmaceutical industry. PwC reported in their yearend report on the industry that 2013 was up 46% in transactions versus 2012. In the same report PwC stated that a major difference shown in 2013 than was the lack of mega deals. Pogorelc goes on to explain that middle market companies are being picked up for their products to help major players increase their portfolio value. An example of this occurring is the acquisition of Bard EP by to help their electrophysiology sector. Read more here about how these mid-market companies are helping the pharma giants diversify their companies.
Kevin Mccaffery from mmm-online.com brings to light a very interesting topic on mergers and acquisitions (M&A) in the pharmaceutical industry. In the article, Mccaffery reviews the big slump in M&A activity with 2012 being the worst in recent history. While it looked like the trend would continue, things changed dramatically in 2013 with increases in every category. The biggest change came in deal value with an increase by 45 billion which is a 45.8% increase from 2012. To read the full article click here.
Arzezu Sarvestani from massdevice.com wrote an intriguing article on FDA’s Center for Devices and Radiological Health’s (CDRH) outlined priorities for the upcoming 2014 year. One of their main priorities will be in streamlining its clinical trial program with hopes of becoming more efficient, consistent, and predictable. To accomplish this they will have fewer applications that require multiple cycles before approval. Going along with this view the CDRH will consider moving some of the pre-data requirements to post market. FDA will soon start looking for public remarks on the framework on which pre-data requirements can be moved to post market. To read the full article click here.
Alexander Gaffney of raps.org provides a very interesting article on FDA’s move to have a more specialized program to deal with scientific advances and regulatory complexity. Gaffney introduces the article by discussing the cryptic message from FDA saying there was a need for the agency to realign the programs. When FDA announced the Program Alignment Group (PAG) they sent out a memo outlining some of the areas the PAG will focus on.
- specialization across FDA’s inspection and compliance functions based on specialization within FDA’s regulated industries and the demands of new legislation
- training that is developed collaboratively by ORA and the Centers and leads to the development of competency and training requirements to enhance and maintain FDA’s workforce
These are just a few of the focus areas provided in the article. Gaffney goes on to talk about how the PAG will impact FDA centers all over the country whether it be in the specialization of some employees or trying to “de-layer” to allow FDA to take timely and appropriate action. To determine whether this new program helps or hurts FDA, we will have to wait and see. To read the full article click here.
Richard Knox of NPR introduces to us a fascinating article about the power of the mind in thinking that a pill works when trying to cure an illness. Knox uses two specific illnesses to help show the impact of a placebo in migraines and asthma attacks. With each study you see the impact of people using the real medicine and people using the placebo. The interesting result was that people didn’t really notice the difference between the two. But as they delve in deeper they began to see that the placebo helped dull the pain for a short time but the people who took the real medicine felt better in the long run. One of the doctors interviewed states that the information provided was not made to undermine certain drugs but to encourage doctors to make their talks with patients positive. To read the full article click here.
Genengnews published an interesting article on the Top 25 mergers and acquisitions (M&A) that occurred in the pharmaceutical world this year. There was a wide variety of purchases ranging in price, technology and geography. What makes this article stand out is the detail it goes into on each M&A, sharing detailed payment financials and deal status. It is also important also to know that the list does not include M&A where the values were not disclosed to the public. To see the full list and the rest of the article click here.
Save the Date: Gretchen Bowker, Pearl COO to speak at MAGI’s Clinical Research Conference, Boston, May 4-7
This year’s MAGI Clinical Research Conference will take place May 4-7 in Boston, Massachusetts. Pearl’s Gretchen Bowker will serve on a panel discussing “Regulatory Myths: ‘common’ wisdom about what the rules don’t actually say” during the Regulatory Compliance session on Monday, May 5, 2014 from 3:45-4:30. Pearl will also be exhibiting so please stop by and visit us. To learn more, check out the MAGI conference website.
With China’s economy continuing to develop many people in their population will begin to receive advanced healthcare for the first time. Now it’s time to look to see how China can learn from the healthcare insurance systems from around the world and what opportunities will foreign firms have there.
Join the Indina Life Sciences Collaboration Center to discuss:
The current opportunities in China.
Developing and expanding US and Chinese Business Relationships.
Cultural and regulatory lessons learned from entering the Chinese market.
Pearl Pathways is a proud sponsor of the Kelley School Life Sciences series. If interested click here to register.
Lindsey Alexander from medcitynews.com introduces a very interesting article on the importance of venture capitalists in the medical device industry. To help support her theory she brings in TherOX’s CEO Kevin Larkin, to share his views on how to gain and maintain a relationship with a venture capitalist firm. Larkin stresses the importance of five key tidbits that will help medtech startups increase their attractiveness to outside investors. With each bullet point Larkin gives helpful advice and allows startups a view of what they might run into on the course to make a key medical breakthrough
1. “Don’t fall in love with your initial animal research data and benchtop testing.”
2. Expect that you need to iterate.
3. Collect data on a very targeted patient population.
4. Work hand-in-hand with regulatory experts. Know your regulatory path inside and out.
5. Make devices that accommodate a large array of skill sets.
To read the full article click here.