- Biotech Stock Mailbag: Sarepta, Biomarin, Spark, Raptor (thestreet.com)
…I appreciate your prediction of the approval for the DMD drugs but I think you're too optimistic about Sarepta Therapeutics. I believe FDA approves Biomarin but tells Sarepta that another trial must be run…why Biomarin over Sarepta? Because what Biomarin is seeking to do -- make a convincing argument for drisapersen's approval based on messy clinical data…It's something that the FDA has done before with drugs for rare diseases… Sarepta's eteplirsen, by contrast, requires the FDA to set a regulatory precedent which the agency might regret later.
- 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?
- Kim Kardashian Posts Drug Side Effects After FDA Warning (bloomberg.com)Kim Kardashian's FDA run-in shows the challenge of policing drug ads in the Instagram age (vox.com)
Kardashian's #CorrectiveAd came during MTV's Video Music Awards...Kim Kardashian West took to social media…to belatedly acknowledge the side effects of a controversial morning-sickness drug she endorses (Diclegis)… Aug. 7 warning from the U.S. Food and Drug Administration to drugmaker Duchesnay saying that Kardashian's original paid endorsement omitted important safety information.
- The FDA has spoken on biosimilar names. But will its hybrid proposal work? (fiercepharma.com)Naming and Biological Products (blogs.fda.gov)
After much industry lobbying and public debate, the FDA has proposed a system for naming biosimilar drugs. It's a sort of hybrid of the generic name on one hand and the unique brand name on the other. ..it would allow the FDA to make some biosims easy to substitute for the brand-name original--and others not so easy… both branded meds and biosims would share a "core drug substance" name… Each product would also carry a four-letter suffix….individualized product-by-product,..
- FDA Grants Malignant Mesothelioma Treatment Orphan Drug Designation (specialtypharmacytimes.com)
Biologic therapy targets genetic defects found in various cancers… FDA granted Orphan Drug Designation to MTG-201 (MTG Biotherapeutics Inc.) for the treatment malignant mesothelioma…drug targets the Dickkopf-3 genetic defect found in various cancers…There is a…need for new treatment options for…mesothelioma…one of the most aggressive and poorly treated cancers. MTG-201 represents a…novel approach to treating this cancer by selectively inducing apoptosis and inducing an immunologic response against the cancer..
- Eko Core, stethoscope that streams to smartphones, cleared by FDA (healthcarefinancenews.com)
'We've started by pairing the oldest and the newest tools in the medical toolkit – the stethoscope and the smartphone.'…The FDA has cleared Eko Core, a digital stethoscope designed by medical devices startup Eko Devices..."a next-generation" stethoscope – billed as the only one on the market to wirelessly stream heart sounds to a HIPAA-compliant smartphone app. It is also the first to integrate heart sounds directly into the patient's EHR.
- Progress seen In addressing US drug shortages, but challenges remain (in-pharmatechnologist.com)
New US drug shortages this year are running roughly at the same levels as the last two years, and far below the record highs seen earlier this decade,…several significant products remain difficult to find, and hospitals, still shaken by the critical shortages of the recent past, remain concerned that key drugs could once again become scarce..
- In a bad-news first for pharma reps, more than half of doctors now restrict access (fiercepharma.com)
It's no secret that pharma salespeople are barred at the doors of many doctors' offices. Those doors have been closing one by one for several years…barriers are rising at a bad time for drugmakers intent on launching new products to make up for patent-cliff losses. Just as doors are closing, there's been a renaissance in drug approvals, with the FDA blessing record numbers of meds in the past few years…pharma marketers have adopted workarounds--such as digital detailing--face-to-face meetings are still the cornerstone of new drug launches.
- Europe bans drugs tested by GVK; FDA monitors but keeps allowing sales (in-pharmatechnologist.com)
US FDA has found no systemic issues affecting the safety or efficacy of generics clinically tested at GVK BioSciences, but says it supports Europe’s ban of around 700 products…Last week, a European ban took effect on…medicines that were approved based …on what regulators called flawed clinical studies… US Food and Drug Administration isn’t taking any action on products sold here that included data from GVK’s studies in their applications,…
- 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)