Regulatory Recon: FDA Approves New Medtronic Pacemaker Pfizer, Allergan Seek New Deals (7 April 2016)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @RAPSorg on Twitter.

In Focus: US

• FDA Approves Medtronic Pacemaker That Attaches Directly to Heart (WSJ-$) (Mass Device) (Medscape) (EP Vantage) (FDA) (PR)
• We Can’t All Have It All: The Economic Limits of Pharmaceutical Innovation (JAMA)
• Bezos, Gates Chase Dream of a Blood Test That Detects Cancer (Bloomberg News)
• Google’s Biotech Venture Hit by Ethical Concerns (Stat)
• FDA’s Permanent Injunction Authority: Is There a Crack in FDA’s Resolve to Shut Down a Facility’s Operations? (FDA Law Blog)
• Pfizer, Allergan to Hunt for Deals of Their Own (WSJ-$) (Washington Post) (Pink Sheet-$)
• Solo again, Allergan strikes a $3.3B deal on Heptares' Alzheimer's portfolio (FierceBiotech) (In the Pipeline) (WSJ-$) (EP Vantage)
• Pfizer’s Read: Treasury Is Wrong About Our Merger and Growth (WSJ-$)
• Senate 'Cures' Companion Advances; Funding Unclear (Focus) (Detroit News) (SCRIP-$) (InsideHealthPolicy-$)
• Hatch Says He Can Find Offsets For Senate 'Cures' Package But Doesn't Offer Details (InsideHealthPolicy-$)
• Obama Administration to Transfer Ebola Funds to Zika Fight (NY Times)
• Second U.S. Biosimilar Approval Shows FDA's Confidence (Bloomberg)
• Patent Settlements Blocking Authorized Generics May Get US Supreme Court Review (SCRIP-$)
• FDA Calls Retroactive Exclusivity Unfair To Generics Makers (Law360-$)

In Focus: International

• Zika Situation Report (WHO)
• US FDA actions hurting exports, need govt intervention: Dr Reddy's Laboratories (Economic Times)
• Sun to Close Ranbaxy’s Ireland Plant This Year (In-Pharma Technologist)
• Pharmstandard to produce drugs for Eisai in Russia (PharmaLetter-$)
• Clinical Trial Involving Regenerative Cell Treatment for Patients with Traumatic Brain Injury Permitted in Japan (PR)
• IPRF Suggests Global Template for Sharing Biosimilar Assessment Data (SCRIP-$) (IPRF)
• Collecting high-quality data on antibiotic use in animals in support of the fight against antimicrobial resistance (EMA)

US: Pharmaceuticals and Biotechnology

• Pfizer beats hundreds of lawsuits alleging Zoloft birth defects (Reuters)
• Amgen Balks Over Meeting to Review Cost of Bone Cancer Drugs (Stat) (Drug Wonks)
• Insulin’s surging price turns diabetes staple into luxury good (Bloomberg)
• Drug dosing goes digital with software to personalize medication (Stat)
• As Rivals Make News, Intercept Heads To Daylong Hearing For Liver Drug (Xconomy)
• Heat Biologics to slash staff by a fifth, cut more than half of patients in cancer trial (FierceBiotech)
• Bind Therapeutics looks for big immuno-oncology partner as CEO mulls selling the company (FierceBiotech)
• Three Pfizer Presidents Still Get $1 Million After Failed Deal (Bloomberg)
• Commentary: Drug-import proposal would compromise safety (Philly Inquirer)
• Despite Second Biosimilar Approval, ‘Hamlet Moments’ Still Loom at FDA (Pharmacy Practice News)
• New tax inversion curb won't affect Baxalta deal, says Shire (PharmaTimes)
• U.S. drug developer Raptor Pharmaceuticals explores sale –sources (Reuters)
• Ackman says Valeant may find new CEO in weeks, not months (Reuters)
• Continuous Pharmaceutical Processes and Their Demands (Contract Pharma)
• How National Policies Impact Global Biopharma Innovation: A Worldwide Ranking (ITIF)
• Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA (Drug Testing and Analysis)
• Gilead antiviral API supplier expanding after Descovy OK (In-Pharma Technologist)
• Drug-Price Policy Discussions Are Focus Of MedPAC, Pew, Oncologists (InsideHealthPolicy-$)
• 6 Takeaways From Novartis FCPA Case (Law360-$)
• Gilead keeps Martin's pay going strong at $18.8M in his last year as CEO (FiercePharma)

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

• Drug for Rare Disorder Linked to Reducing Cholesterol Plaque (WSJ-$)
• Broad Institute partners with Amazon, Google, IBM to bring genome analysis software to the cloud (MedCity News)
• Raising Capital As A Private Biotech: Insights From Unum Therapeutics’ Series B Round (Life SciVC)
• AZ and VentiRx team up for PDL1-oncology vax trial in ovarian cancer (FierceBiotech)
• Samsung Bioepis files lawsuit against AbbVie on Humira patents (Korea Herald)
• Valeant Gets Lender OK to Amend Debt Terms (WSJ-$)
• IBM and Pfizer are Partnering to Study Parkinson’s (Business Insider) (PR)
• Ionis Pharmaceuticals Provides Update on IONIS-TTRRX Program (PR)
• Roche steps in to help fund $34M Lumos round for rare disease R&D (FierceBiotech)
• Mysterious antidepressant target reveals its shape (Nature News)
• Means of Activating Latent Limb-Regenerating Genes Could Be Within Reach (GEN)
• Lilly returns Jakafi rights to Incyte, which now amends deal with Novartis (PharmaLetter-$)

US: Medical Devices

• Transcript From 2016 Meeting of the Circulatory System Devices Panel (FDA)
• Johnson & Johnson’s $5m mesh settlement could push costs higher (Mass Device) (Bloomberg)
• Report: Baxter to shutter Colorado plant (Mass Device)
• US regulators launch online tool for mobile medical app developers (Mass Device) (Focus)
• ReCor Medical launches trial for Paradise renal denervation device (Mass Device)
• McKesson Awarded $139M Department of Defense Contract for Patient Engagement and Interoperable Secure Messaging Solutions (PR)
• Meet PRIME, the New App That Wants to Help End Schizophrenia (Pacific Standard)

US: Assorted and Government

• Guidance for Industry on How To Submit Information in Electronic Format to the Center for Veterinary Medicine Using the FDA Electronic Submission Gateway (Federal Register)
• CMS Releases Final Summary Of Benefits And Coverage Template, Accompanying Materials (Health Affairs)
• White House, Allergan Spar Over 'Un-American' Claim (SCRIP-$)
• Alliance for Regenerative Medicine Letter to Sen. Kirk (Letter)

Upcoming Meetings and Events              

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• New EU lung cancer indication for Boehringer's Giotrif (PharmaTimes)
• World Health Day: Commissioner for Health and Food Safety Vytenis Andriukaitis highlights the Potential for the Prevention of Diabetes (EC)
• Eli Lilly to invest €35m in Kinsale plant (Irish Times)
• Medicines: new manufacturing and wholesale dealer licences (MHRA)
• Medicines: terminated and cancelled manufacturing and wholesale dealer licences (MHRA)

India

• Mylan launches generic Epivir (Drug Store News)
• FDA approves Aurobindo’s generic Valcyte (Drug Store News)

China

• China biotech Essex Bio signs $3.5M antibodies deal with U.S. antibody specialist Abpro (FiercePharmaAsia)

Other International

• Statement by the Union for Affordable Cancer Treatment on GlaxoSmithKline’s plans to license its patents on anti-cancer medicines to the Medicines Patent Pool (PR)
• AusBiotech offers clarification on tax incentives to keep research within Australia (PharmaLetter-$)
• Scientists seek crowdfunding to test 'chemical castration' of pedophiles (Reuters)

Zika

• Robbing Ebola To Pay For Zika: Playing With Fire? (SCRIP-$)
• Mouse model to aid Zika vaccine testing (Outsourcing-Pharma)
• Immunovaccine and Leidos Join Forces to Develop a Zika Virus Vaccine Candidate (PR)

General

• In high-tech hub, this scientist hunts for cures in a greenhouse (Stat)
• Conjoined Twins, a Trip to Saudi Arabia and a Risky Operation (NY Times)
• Flu Shot During Pregnancy May Reduce Risk of Stillbirths (NY Times)
• 'Anti-vax' mother's regret over whooping cough 'nightmare' (BBC)
• Advancing the understanding of autism disease mechanisms through genetics (Nature Medicine)

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.

Need to contact the editor of Regulatory Reconnaissance? Send him an email at [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.