Regulatory Recon: Brexit Fallout: How Will MHRA and EMA Handle the Split?

Headlines: US

• Medivation Sanofi slams 'deceptive' coup says the saga continues fusion (fierce) (Medivation)
• Why US consumers are of two minds when it comes to pharmaceutical companies (Forbes)
• FDA defends response to the final data of Medtronic Infuse (MassDevice)
• FDA committee vote whether reductions in medication for diabetes cardiac death (Reuters)
• White House veto threat Zika Republicans plan funding (Reuters) (STAT)
• A new report urges the FDA to clarify the use of real-world testing (Focus)
• What is the composition of the private sector to help fight Zika? (Blog of Health Affairs)
• Vote "possible cures Senate in July, President HELP Says (Bloomberg)
• Senator renews its opinion Pharma Ties on federal commission (ABC)
• asks the defective filter leukocyte reduction device Recall (Focus)
• Why we inherit mitochondrial DNA only our mothers? (New York Times)
• They are scientists fraudsters deserve a second chance? (STAT)
• PwC medical cost trend: Behind the figures of 2017 (PwC)
• Four ways to address ethical tensions around accelerated approval of new prescription drugs (Health Affairs blog)

Headlines: International

• Brexit Conundrum: How MHRA Working with EMA Moving Forward (Focus) (Reuters) (ferocious) (Political)
• Statements Brexit (EFPIA) (ABPI) (leaders of EU states) (EP Vantage)
• full coverage of the referendum on the EU (The Telegraph) (BBC)
• EMA warns that tablets and oral suspension NOXAFIL have different doses and are not interchangeable (EMA)
• Adempas not for use in patients with pulmonary hypertension caused by idiopathic interstitial pneumonia (EMA)
• EMA recommends six new drugs, including cell therapy for approval (EMA)
• Gavi committed $ 27.5 million for the Pilot Program candidate against malaria WHO as more funds (focus) vaccine
• ISO pharmaceutical sector gets new tool for drug identification (ISO)
• Soon regulatory reform in Thailand? ($ PharmAsiaNews-)

USA .: Pharmacy and Biotechnology

• Biogen in negotiations to sell the stainless steel plant in 2,000L MA (BioPharma-Reporter)
• BIO opposes HB to reduce Biological Exclusivity From 12 to 7 years (Focus)
• Fill a prescription? You might be better to pay cash (KHN)
• FDA extends comment period hepatitis C Guidance for Development (FDA)
• FDA extends comment period for the guide special protocol assessment (FDA)
• Warning Letters FDA: Warning signs are still there (Compliance Monitoring Pharmaceutical)
• AstraZeneca expects to save FluMist in the United States with foreign data (Pink information- $)
• precious sets late stage pipelines in 2017 for some major events (EP Vantage)
• "Shop" CBER Role: Mounting In the Oncology Center of Excellence ($ RPM Report)
• Ocaliva ICER report is an important step forward, but too expensive ($ PharmaLetter-)
• Bye, Bye exenatide Teva to take GLP-1 agonist generic two years before AstraZeneca (Pink detailed $)
• FDA life of influenza vaccine Flublok (DSN) extends
• Why Amgen biotechnology Goliath is strong long-term investment (Street)
• Diabetes medications are expensive worth? (MedPage)
• FDA approves changes (vigabatrin) Sabril® REMS Program (Press)
• Vibrant and flourishing of Life Sciences Ecosystem Home North Carolina Wilmington (Forbes)
• Focus Therapy - product amyloidosis is still Alnylam answers (EP Vantage)
• Agreement to combat Zika virus stimulates NIH, CDC's efforts, but offers no FDA Review Dollars ($ Detailed Gray)
• Epizyme NABS agreement with Genentech combined tests for the candidate of the NHL (fierce)
• biosimilar rituximab in patients naive biological rheumatoid arthritis (GABI)
• Q & A with rare mom and CEO of biotechnology Karen Aiach (Boston Biz Journal)
• Pharma veteran Stephen Friend Bites health data supply Apple (Xconomy)

United States: pharmaceutical and biotechnology products: results of clinical studies, documents and Designations

• FDA Approves Expanded Label for Avycaz (Pharmafile) Allergan
• A new study shows Baxter telemedicine to increase access to care and reduce hospitalizations (Press) Perception

Medical devices in the US:

• GI Dynamics data reveals EndoBarrier final completion of the test (fierce)
• Returns the table FDA MDUFA high and low resolutions ($ detailed Gray)
• rheumatoid arthritis market approach 400m test $ 2,022 (BioSpectrum)
• A new blood test is Epic Sciences patients with PARP inhibitors (MedCityNews)
• The future of the devices devices (as we know them today) (MassDevice)
• Odors are the last frontier of intelligent sensors (MassDevice)
• The evaluation of rapid tests commercially rage reveals serious problems with the accuracy (RGT)
• The first step to navigate Regulatory combination products Road: pmoa (GxP Lifeline)
• Roche receives FDA approval for procalcitonin (PCT) analysis to help physicians to effectively assess the risk of sepsis and treat patients with sepsis (Press)

United States: Assortment and government

• Appeals court confirms the victory over Thermomedic Exergen (MassDevice)
• Apotex litigation Drops counterclaims Sham Litigation Neupogen and Neulasta biosimilar (Biological Blog)
• Barred experts, he says patients have Bayer IUD cases ($ Law360-)
• Florida Physician pleads guilty to fraud - years after complaints about their prescription (ProPublica)
• Janssen accuses media provider HyClone Celltrion patent violation (BioPharma-Reporter)
• scheduled for wrongful death in the bone cement Norian XR judgment (MassDevice)
• Pharma accuses payers use money to influence the monitoring of expenditure of the United States (fierce)

Upcoming Meetings and Events

• Calendar of the Advisory Committee of the FDA
• Webinar for final FDA guidance: Use of existing clinical data for extrapolation to pediatric uses of medical devices - August 8, 2016
• EMA: Workshop on testing of one arm (SAT) in Oncology - June 30, 2016

Europe

• France plans to invest € 670 million in genomics, personalized medicine (GenomeWeb)
• CLL drugs Genmab receives negative opinion from the EMA Commission (Pharmafile)
• Astellas UK ABPI suspended for "deception" and other cultural defects (Pharmafile)
• Belle rejects Celgene drugs to treat cancer of the blood (Pharmafile)
• EC grants marketing authorization for HIV Odefsey (EPR)
• AstraZeneca rejects Belle Tagrisso for lung cancer in the preliminary recommendation (Pharmafile)
• Most Borderline / Combo products to escape the high risk rating in the EU ($ detailed Gray)
• St. Jude wins the CE mark, launches algorithm SyncAV CRT (MassDevice)
• Trulicity gets the seal of approval for Welsh NHS (PharmaTimes)

Asia

• Takeda (TKPYY) Returns some molecules, the products of Amgen (AMGN) (Biospace)
• Zhejiang Hisun anti-influenza drug market Fujifilm China ($ PharmaLetter-)
• Turkey Price Pressure hits profits and market growth ($ PharmAsiaNews-)

India

• Glenmark FDA approval for new generic bags (BioSpectrum)
• Ranbaxy Dinesh Thakur Whistle Blower prosecution suggests strict laws to fix the pharmaceutical industry (Economic Times)
• FDI in the pharmaceutical industry: drug supply NLEM to keep for 5 years (Economic Times)
• pharmaceutical sector grow 20 percent in the relaxed FDI rules: Ananth Kumar (Economic Times)

Australia

• Centinel Spine Australia wins the game STALIF The implant (MassDevice)

Zika

• Without federal funding, counties are prepared to face alone Zika (Washington Post)

Other international organizations

• The reasons for the success of a company in the generic drug market Sudan (GABI)