- China Resilient: New Pharma Survey Offers Highly Positive Outlook (pharmexec.com)
..survey of the Chinese pharmaceutical market based on an opinion poll conducted with domestic and foreign suppliers attending CPhI’s annual China expo in Shanghai…Despite some structural concerns in the context of slowing macro-economic growth overall, the report offers a very positive outlook…China is the world’s largest producer of active pharmaceutical ingredients. Its massive pharmaceutical market is projected to be worth $158 billion worldwide in 2016, while domestic sales alone will account for $63 billion…China sales will double over the next five years.
- Behavioral Patterns that Contribute to a Patient’s Propensity to Be More or Less Adherent (pharmacytimes.com)
Bruce Berger, PhD, president of Berger Consulting LLC, discusses the behavioral patterns that contribute to a patient’s propensity to be more or less adherent to their medications. (video)
- 5 Big FDA Decisions Expected in September (247wallst.com)
Pharmaceutical companies usually are involved in a lengthy process in getting their drug candidates to market through clinical trials. There is a fair amount of risk involved,..should a study come back negative or should a candidate not be approved. Conversely, if a drug is approved or passes a clinical trial, there can be big upside. Food and Drug Administration rulings can make or break these companies…. big FDA decisions coming up on the calendar for the month of September..
- Opko Health - expecting a rolapitant PDUFA (Prescription Drug User Fee Act ) action date on September 5. (prevention of chemotherapy induced nausea and vomiting)
- Tesaro - tag along with Opko, has a New Drug Application for oral rolapitant under review by the FDA with the same PDUFA goal date.
- Zosano Pharma - completed its enrollment for the Phase 2 trial for ZP-Glucagon. (significant improvement over the currently marketed products for treatment of severe hypoglycemia)
- Xenoport - completed enrollment in its Phase 2 clinical trial of XP23829 as a potential treatment for moderate-to-severe chronic plaque-type psoriasis..
- Apricus Biosciences - enrolled its last patient in its RayVa Phase 2a proof-of-concept study, (Raynaud’s phenomenon secondary to scleroderma)
- Pharmacists write in, Part 2: Why mistakes happen (drugtopics.modernmedicine.com)Pharmacists write in: Worst mistakes, Part 1 (drugtopics.modernmedicine.com)Pharmacy mistakes, Part 3: State BOPs and public safety (drugtopics.modernmedicine.com)
Do pharmacists feel that discipline by the state board of pharmacy is effective in deterring future errors? Should the pharmacist’s name be published in the state board of pharmacy newsletter for all the pharmacists in the state to see? Readers were vocal on this subject and plenty more.
- Official actions
- The public
- Script volume
- Working conditions
- E-stuff
- Next-gen pharms
- The right stuff
- Moody’s upgrades financial outlook for biopharma industry (biopharmadive.com)
Citing the success of product launches, the ratings firm Moody's has raised the outlook for the pharmaceutical sector from "neutral" to "positive."...Projected annual EBIDTA for the global biopharma industry is 4% to 5% over the next 12 to 18 months…One of the industry's biggest areas of growth is oncology, driven largely by the emergence of immuno-oncologic drugs, such as Bristol-Myers Squibb's Opdivo and Merck's Keytruda.
- Examining drug issues in depth (bostonglobe.com)
Open your medicine chest and you’ll find bottles and vials that contain so much more than a needed remedy…Each container actually holds a fascinating tale about the drawn-out process it took to develop the drug, the delicate dance required to win regulatory approval, the sometimes controversial steps taken to persuade doctors to prescribe the medicine, or the complicated calculus that was used to set pricing
- You can have sex or you can drink, but you can’t do both.
- Drug makers have free speech rights, too. Seriously, they do.
- My medicine costs how much?
- Is the sky the limit . . . or is the sky falling?
- No, Virginia, we don’t yet have a cure for cancer, but . . .
- You’re dying, but getting access to experimental medicine may be nearly impossible.
- The High Cost of Delays in Biosimilars Hitting the US Market (specialtypharmacytimes.com)
“Biosimilars will do for the biotech market, primarily made up of very expensive injectable drugs, what generic drugs did for traditional oral solid pills a decade ago: lower the cost for safe, effective treatments that improve and save lives,”… “They will revolutionize the category of spending that is among the fastest-growing and most worrisome for payers who want to continue providing sustainable, high-quality benefits for their members.”
- Biosimilars Council chief answers 6 key questions about biosims in the US (biopharmadive.com)
At the beginning of the year, there was a great deal of anticipation about when the first biosimilar would be approved in the U.S…And then it happened…On March 6, the FDA has approved Novartis/Sandoz's Zarxio (filgrastim-sndz), a biosimilar of Amgen's Neupogen…And as of Thursday, September 3, Zarxio officially hit the U.S. market at a 15% discount to Neupogen… to gain clarification around several key issues concerning biosimilars, we spoke with Dr. Bert Liang, Chair of the Biosimilars Council…
- Last month, you responded to the decision from the Federal Circuit Court of Appeals that recognized the ‘patent dance’ as optional by applauding the decision. Can you explain your reaction?
- When would it be beneficial for a biosimilar company to provide a complete copy of its biosimilar application to the reference manufacturer upon filing?
- You have indicated that the proposed biosimilar naming convention put forth by the FDA in which originator products and biosimilars share the same core name and have different suffixes. Please tell us why you disagree with that.
- What type of approach to naming would work in your opinion?
- How do you see the public hearing hosted by the FDA playing out? Who are your allies in this issue?
- Can the U.S. look to Europe as a model for the evolving role of biosimilars?
- Precision medicine, linked to DNA, still too often misses (bostonglobe.com)
precision medicine is more complicated than portrayed by politicians and even some top health officials. Contrary to its name, precision medicine is often inexact, which means that for some patients, it will offer false hope rather than a cure…
- Sepsis: 4 things formulary managers can do to save lives, resources (formularyjournal.modernmedicine.com)
Everyone is a potential victim of the dangerous condition known as sepsis, which kills more than 258,000 Americans each year…. Early recognition and immediate treatment can reduce the morbidity and mortality of sepsis. In other words, healthcare professionals need to be fast and loud to beat sepsis.
The following are 4 specific things formulary managers can do in the battle against sepsis:
- Increase consumer and patient awareness
- Act fast: Treat sepsis as a medical emergency
- Know and screen for risk factors
- Participate in continuing education about sepsis