Regulatory Reconnaissance: Researchers, Regulators and Roche Battle Over Tamiflu Data (10 April 2014)

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In Focus: US

• FDA is Asked to Reconsider Denial of NCE Exclusivity for STRIBILD; Gilead Says FDA Erred in Not Applying the New (and Old) Interpretation (FDA Law Blog)
• Can States Overturn the FDA's Limits on Compassionate Use? (NCPA)
• Merck's HepC Drug Combo Aces Phase II Trials, 98% Cure Rate (Press) (Fierce) (Reuters)
• Heart docs seek curbs on kidney-zapping hypertension devices (Reuters)

In Focus: International

• Researchers, regulators and Roche row over stockpiled drug Tamiflu (Reuters) (PMLive) (WSJ-$) (In-Pharma) (Pharma Times) (Guardian) (MNT) (AllTrials) (SCRIP) (WSJ-$) (Reuters) (NBC) (MedPage Today) (Science-Based Medicine) (Bloomberg)
• French plan to push copycat biotech drugs worries Big Pharma (Reuters)
• Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products (EMA)
• Indian authority withdraws Ranbaxy plant export permit (Fierce)
• China FDA Review Of Multi-Regional Clinical Trials May Throw Up Domestic Roadblock (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• FDA is Asked to Reconsider Denial of NCE Exclusivity for STRIBILD; Gilead Says FDA Erred in Not Applying the New (and Old) Interpretation (FDA Law Blog)
• CHC Weighs in on FDA's Social Medical Draft Guidance (CHC)
• Can States Overturn the FDA's Limits on Compassionate Use? (NCPA)
• FDA Refers Some Patient-Specific Compounders To States For Oversight (IHP-$)
• Upcoming FDA Meeting: Immune Responses to Enzymes Replacement Therapies: Role of Immune Tolerance Induction (FDA)
• Foreign customers look to US FDA as stamp of quality (In-Pharma)
• Massachusetts Bans Painkiller Zohydro: Can States Overrule the FDA? (WSJ) (BioFlash) (AP)
• Sen. Tim Kaine Presses Hamburg on Zohydro (Augusta Free Press)
• Groups Wants DMD Drug Eteplirsen Approved in Next Month (Press)

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

• Bristol-Myers hepatitis C treatment cures up to 90 percent: study (Reuters) (Press)
• Merck's HepC Drug Combo Aces Phase II Trials, 98% Cure Rate (Press) (Fierce) (Reuters)
• Biogen's blood disorder drug succeeds in late-stage trial (Reuters)
• Gilead Announces Phase 2 Results for Two Investigational All-Oral Sofosbuvir-Based Regimens for the Treatment of Chronic Hepatitis C (Press)
• Celladon Gets FDA's "Breakthrough Therapy" Status for Gene Therapy (Xconomy)

US: Pharmaceuticals and Biotechnology: General

• Should Academic Physicians Serve on Drug-Company Boards? (The Atlantic)
• Drugmaker's dual role as friend, foe (Boston Globe)

US: Medical Devices

• Heart docs seek curbs on kidney-zapping hypertension devices (Reuters)
• ReGen Biologics appeals loss to FDA (Mass Device)
• Analogic wins FDA clearance for handheld Sonic Window vascular ultrasound (Mass Device)
• NEC Display Solutions Receives FDA 510(k) Clearance on MD302C4 Diagnostic Review Monitor (Press)

US: Assorted And Government

• Q&A with FDA Commissioner Margaret Hamburg (APHA)
• Better Late Than Never: OIRA's Meeting Logs Just Got a Lot More Transparent (CPR)

Europe

• Researchers, regulators and Roche row over stockpiled drug Tamiflu (Reuters) (PMLive) (WSJ-$) (In-Pharma) (Pharma Times) (Guardian) (MNT) (AllTrials) (SCRIP) (WSJ-$) (Reuters) (NBC) (MedPage Today) (Science-Based Medicine) (Bloomberg)
• French plan to push copycat biotech drugs worries Big Pharma (Reuters)
• How does the EDQM process CEP Applications? A new Policy provides Information (ECA)
• Eucomed sets out stall on medtech reforms as EP finalises its stance (Clinica-$)
• Draft concept paper on the establishment of a guideline on the selection of sterilisation processes for drug products (EMA)
• Guideline on stability testing for applications for variations to a marketing authorization (EMA)
• Medtronic snags EU approval for an MRI-safe ICD (Fierce)
• NHS needs to understand drug costs better, says ABPI (Pharmafile)
• Boehringer: 'devil in detail' on new drug pricing policy (Pharmafile)
• Hospira Wins U.K.Challenge of Roche Cancer-Drug Patents (Bloomberg)

India

• Indian authority withdraws Ranbaxy plant export permit (Fierce)
• Natco moves to oppose Gilead hepatitis C drug patent in India: source (Reuters)
• CDSCO plans more steps to further streamline clinical trial sector (PharmaBiz)

Japan & China

• China FDA Review Of Multi-Regional Clinical Trials May Throw Up Domestic Roadblock (PharmAsia-$)
• Chugai seeks Japanese approval of Zelboraf (BioCentury)

Other International

• EU funds African falsified medicines project (Securing Industry)
• General Regulatory And Interesting Articles
• Strengthening Compliance Through Effective Process Management (PCM)
• Pain Relievers Tied to Heart Rhythm Disorder (NYTimes)

Regulatory Reconnaissance #295 - 10 April 2014

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

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