In this episode, I cover the latest on Obamacare repeal (where the Republicans have pulled their repeal & replace plan), BPCIA lawsuits between Amgen v Genentech as well as Janssen v Celltrion, FDA approval of 23AndMe's first genentic test product, FDA approval times, and the general introduction to the current US Opioid Epidemic.
In this episode, I review the Trumpcare, or American Health Care Act, which is set to modify the PPACA established by Obama. After outlining the proposed changes, I review what incentives remain for market players to act upon when the new system is enacted.
In this episode, I cover the recent issue with Marathon's pricing of a steriod drug for DMD, updates to Amgen v Sanofi and the new biosimilar lawsuit between Genentech v Amgen as well as the recent patent lawsuit around CRISPR technology between UC Berkeley and the Broad Institute. We close the episode around the introduction of the new book, Human Genome Editing, and how authorities have provided green lights in different countries to alter baby-genes for therapeutic purposes.
Episode 8 - Trump’s FDA deregulation proposal, 21st Century Cures Act, and Value-based Reimbursement Model
In this episode, I open with the latest #GOBOLDY (read: Go Boldy, not GOB OLDY) campaign by the industry trade association, PhRMA, then move onto Trump's latest request to Pharma companies to lower prices, one solution of which is his proposal on lessening FDA regulations so drugs will enter into the market faster. I then move onto the 21st Century Cures Act to clear up any potential confusion on where this Act modifies FDA approvals process as well as a high-level overview of the Act. Then, I move onto what the pharma companies have proposed on lowering prices, which is through value-based reimbursement models.
In this episode, I discuss the new Pfizer campaign around scientists as well as Martin Shkreli's response to the Davos comments. Then we discuss J&J's move to acquire Actelion and more importantly, their decision to spin off the R&D unit to be independent. Near the end, discussion around scientific discoveries in the area of CAR-T treatment of two babies and new findings in breast cancer including drug resistance and passive/backseat genes that manipulate the cancer progression.
In this episode, I recap briefly heresay around the pharmaceutical industry from the new POTUS and a Pharma CEO then move onto updates around the repeal of PPACA then onto the solutions around R&D productivity in Pharma.
In this very long 30+min episode, I discuss the race between Amgen and Sanofi to launch the first PCSK9 drug into the market space. Try to keep up with who files first, who is approved first, and then who sues first. Case on-going and results pending due to an appeal that has already been scheduled. Permanent injunction granted this week against Sanofi/Regeneron. Looks like they should have reserved money for the courts as well as for buying their voucher. After that, I look into the attempts by the Republican party to repeal Obamacare and looking at the health insurance market to address its innate issues, flaws in the system, as well as challenges congress may run into as they try to put a better working system in place.
Episode 4 - Trends in 2017: Power to Patients, Payers, Changes in Regulation and Lower R&D Productivity
In this episode, I take a look at the Magic 8 Ball to determine the trends to watch out for in Pharma for 2017. Patient consumerism continues to increase while payers grow influence over which drugs to reimburse & how. Changes in regulations are expected across the board to allow novel therapies where the unspoken race to become the powerhouse for gene and cell therapy center continues around the globe. New insights are provided to whether current level of technology is viable in the area of gene and cell therapy as well as impact of biosimilars in the market. Last but not least, R&D productivity continues to wither as newer incremental jumps are not incorporated to make R&D in pharma more productive - regulation changes may help resolve some of these challenges.
In this special Christmas/Holiday episode, I cover the drug promotions you hear on radio and TV. Why are drugs promoted? How are they regulated? Where is the future in drug promotions and how does this affect the general patient? High level introduction to the regulations as well as healthcare consumerism. Two snippets of drug promos in the beginning of the episode. Happy Holidays!
In this episode, I discuss what it means now that Tamiflu generic has been approved and introduced in several markets. Generics and biosimilars are explained within the context of drug development and commercialization. Pricing discussion continues around original v generic/biosimilar drugs and what policy may help more effective pricing. 15 min.