Regulatory Recon: Rep. Cummings

Regulatory Recon: Rep. Cummings Wanted to Talk Drug Prices With Trump; ANVISA Developing New Device Regulations

In Focus US:

• Cummings contradicts Trump in meeting the price of medicines (Baltimore Sun)
• Hundreds of Zika tests that test in US laboratories (Reuters) (Forbes)
• Trump said he will introduce health reforms in early to mid-March (Reuters 1, 2)
• Republican House Leaders Describe Replacement Plan for Obama Health Care Act (New York Times) (Reuters)
• Republican disease proposal would shift the rich to poor money (New York Times)
• Trump's election to lead health agency puts EpiPen 'disturbing' issue (Reuters)
• CMS nominated ducks price problems (BioCentury) (The Hill)
• MP links to foreign reviews of Biotechnology opinion (KHN)
• FDA Issues Frequently Asked Questions About Pharmaceutical Product Development and Manufacturing (FDA)
• CDER 2016 Update for Rare Diseases (FDA)
• A Closer DNA Computer "Smart Drugs" (Phys.org)
• MicroRNA Therapeutics: A New Era for Treatment of Cancer and Other Diseases (Nature)
• Biopharma in 2016 (Nature)
• Regulatory clock: The target product profile for the regulatory tool advantageous but underutilized (Nature)
• CTTI provides recommendations for pediatric clinical trials for antibiotics (Focus)
• GAO: FDA's ability to monitor drug shortages remains a concern
• House Bill aims to add mandatory FDA drug recall withdrawal Arsenal (Focus)
• Industry groups FDA petition on revisions to the intended use rule (Focus)
• 'Tsunami' of Alzheimer's cases among Latinos raises concerns about the costs of care (KHN)
• Amgen hide information from biosimilars, Genentech claims says ($ Law360-)
• Cheapest drugs from Canada? Pharma despise the idea, but the best senators grow HHS chief to deal (fierce)
• Xeljanz Pfizer alone can not match Humira for Abbvie in the big Miss RA head-to-head (fierce) (Presse)
• The Alexion million transaction is largely lost (the street)
• Baxalta buys a big jump in sales in the fourth quarter of Shire (PharmaTimes) ($ PharmaLetter-)

In Focus International:

• Regulation of ANVISA Brazil for personalized sanitary products (Emergo)
• Canada tries to apply a biosimilar equilibrium law ($ -pink sheet)
• EC will not provide a timetable for the phasing out of research on non-human primates (Focus)
• EMA weighs a new guideline on quality requirements for combination products (Focus)
• Daiichi, worried lutantinib ArQule fails in liver cancer stage 3 (fierce) (Presse)
• Martina Schüssler-Lenz elected as new chair of the Committee on Advanced Therapies (EMA)
• Uniqure three-pin gene therapy trial program details (fierce)
• Etanercept biosimilar submitted for approval in Japan (Gabi)
• Takeda buys ARIAD purchase (PharmaTimes)
• Takeda and TiGenix announced a successful test of Crohn's disease (Feroz) (Presse)
• The Mali study shows the effectiveness of the new malaria vaccine ($ PharmaLetter-) (NIH)
• Swiss VC launches new fund with the aspirations of orphan drugs ($ scriptures)
•  Health Canada approves HIV drug Odefsey ($ PharmaLetter-)
• Eisai Comtan and Stalevo markets in China ($ PharmaLetter-)

US: Pharmaceuticals & Biotechnology 

• The common final rule: Many keep or eliminate, but not much new added (FDA Blog Law)
• Oncology Practitioner, Doctor Practice Manager and pay $ 1.7 million to settle charges he billed Medicare for illegally-imported drugs (DoJ)
• Flu vaccine protects half of the time, according to the CDC (NBC) (Medscape)
• Amygdala becomes a drug candidate for Gilead (Ferocious) (Presse)
• The future of successful generic and commercial strategies (Pharmafile)
• FDA asks for comments on pediatric and post-marketing pharmacovigilance of drug use Comments (FDA)
• The return of the one-stop shop model is simply an OCM marketing ploy?
• (InPharmaTechnologist)
• Charles River separates and sells activities OPHRDC (OutsourcingPharma)
• The orientation of phospholipase D in cancer, infections and neurodegenerative diseases (Nature)
• Basic results on apoptosis selective inhibitors of the Bcl-2 family (Nature)
• Inhibitors of JNK stimulate antifungal immunity (Nature)
• How Sanofi blew his chance with Actelion (Drug Delivery)
• AmpliPhi advances the clinical phage for the treatment of microbial infections ($ scriptures)
• FDA extends Boehringer asthma approval to include children ($ PharmaLetter-)
• Sage therapeutic supplies and cushions its own rumors of mergers and acquisitions (fierce)
• Insulet opens a factory in Acton, Massachusetts. (Drug Delivery)
• Zoetis reports that the pace gains, so why do stocks that fold? (The street)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations

• The drug giving positive results against chemotherapy for breast cancer AstraZeneca (Pharmafile) (PMLive) (Presse)
• FDA review of Mylan / Biosimilar Biocon Neulasta (BioCentury) (Economic Times)
• Celgene Announces Positive Phase III Oral RAYO Ozanimod Trial in Patients With Recurrent Multiple Sclerosis (Press)
• Perrigo announces FDA approval for the end of hydrocodone bitartrate and oral homatropine methyl bromide solution (press)
• Zydus Cadila receives two FDA approvals (Pharmafile) (Economic Times)
• Aimmune Therapeutics provides an ongoing program update Phase 3 AR101 for peanut allergy based on feedback from FDA (Presse) 

US: Medical Devices:

• Vascular solutions shareholders approve acquisition of Teleflex $ 1M (MassDevice)
• J & J announces the publication of an NEJM study on bariatric surgery for type 5 diabetes mellitus (MassDevice
• FDA Expands Indication for Cryoablation Catheter Freezor Xtra Medtronic (MassDevice) (Presse)
• Medtronic has the Signia stapling system, the innovative surgical stapler for minimally invasive surgery (press) 

US: Assorted & Government:

• UnitedHealth pursued by the United States government on health insurance costs (Reuters)
• The fight against breast implants should remain in court, according to the Brazilian company ($ Law360-)
• Celgene files $ 198.5 million patent application ($ FDANews-)
• Treatment differences persist between low-income workers and high-income workers, even with insurance (KHN)
• Something we can all support: H.R. 985, where Lift Off Left CAFA (Drug Devices Act e)
• Align Technology secures ClearCorrect patent dispute victory

Upcoming Meetings & Events

• FDA Advisory Committee Calendar 

Europe:

• A new framework to stimulate research, innovation and growth? (Dehns)
• Update on the procedure for requesting Conventions and Meetings (AIFA)
• EBITDA and EFPIA supports the ARM initiative on hospital exemptions and require greater transparency in all advanced cell, gene and tissue therapies (EFPIA)

Asia: 

• Difficult to detect, China's bird flu virus may be more common (Reuters)
• Japan supports wireless pacemaker Medtronic Micra (MassDevice) (Presse)
• Medigus wins a nod to the Chinese test of trans-muscular stapler (MassDevice)

 India:

• The support policy needed for the pharmaceutical industry to maintain momentum for growth: FICCI president (PharmaBiz)
• New stents disappear from hospitals to 're-label' (Economic Times)
• Cipla, Serum Institute launches hepatitis B vaccine (Economic Times) 

Australia: 

• MiniMed 640G insulin pumps (TGA) 
• Prima Biomed launches new I-S lead drug test, but needs more money, analysts say (fierce)

 Canada:

 12 arrested in Ottawa for counterfeit prescription drug network (Industry Assurance)