Recon: Stryker to Buy Wright Medical for $4B; China Conditionally Approves First Domestically Developed Alzheimer’s Drug

• Stryker boosts bone implants with $4 billion Wright Medical buyout (Reuters) (Financial Times)
• Halozyme’s lead drug fails; company will cut 55% of workforce in bid for profitability (STAT) (Endpoints)
• Trump Nominates Hahn to be FDA Commissioner (Focus)
• FDA Keeps Brand-Name Drugs on a Fast Path to Market ― Despite Manufacturing Concerns (The Daily Beast)
• FDA Explains Levels of Impurity Found in Recalled Heartburn Drugs (Focus) (Reuters) (STAT) (FDA)
• FDA approves RedHill's bacterial infection treatment  (Reuters) (Endpoints)
• The American Way of Paying for Drugs Isn’t Working (NYTimes)
• Giroir Becomes Acting US FDA Commissioner, Giving Agency Experienced Political Hand (Pink Sheet-$)
• Scientists With Links to China May Be Stealing Biomedical Research, US Says (NYTimes)
• Blood Test to Detect Breast Cancer Could Be Five Years Away (Bloomberg)

• Canadian ambassador says drug imports would not lower US prices (Reuters)
• China gives conditional OK to its first self-developed Alzheimer's drug (Reuters) (Endpoints)
• Sino Biopharm, OrbiMed back Merck-partnered Akesobio's bet on made-in-China antibodies (Endpoints)
• Sanofi reveals positive phase 3 results for long-acting insulin Toujeo  (PMLive) (Endpoints) (Press)
• AstraZeneca wins kudos for pipeline turnaround in a new ranking of the top 10 R&D players in the biopharma world (Endpoints)
• NHS drugs bill could soar if Johnson signs Trump trade deal (The Guardian) (NHS Confederation)
• This Congolese Doctor Discovered Ebola But Never Got Credit For It — Until Now (NPR)

• FDA to Aveo: That's still a 'no' on tivo. Aveo: We'll be back. (Endpoints) (Press)
• Why Didn’t She Get Alzheimer’s? The Answer Could Hold a Key to Fighting the Disease (NYTimes)
• U.S. hospitals, FDA grapple with shortages of lifesaving drugs (NBC)
• Makena Withdrawal? A Look at the Timeline and Other Accelerated Approvals (Focus)
• The pursuit of excellence in new-drug development (McKinsey)
• Cleveland Clinic’s Nissen denies any communication with FDA about Amarin’s Vascepa (STAT)
• LEO Pharma inks novel compounds deal with Ubiquigent (PharmaTimes)
• Trends in clinical development for PD-1/PD-L1 inhibitors (Nature)
• Daiichi Sankyo pulls out of U.S. pain market amid oncology pivot, opioid scrutiny (Fierce)
• Worthless? Short attack on FibroGen claims their anemia drug roxa has a lethal Achilles’ heel — and it’s going down (Endpoints)
• Dentist group says antibiotics not needed for most toothaches (Reuters)
• Fagron Inc. Issues Voluntary Nationwide Recall of LETS GEL KIT Convenience Packs Due to Potential Microbial Contamination of Non-Sterile Products (FDA)

• GE Healthcare Announces U.S. FDA Approval of Macrocyclic MRI Contrast Agent Clariscan (gadoterate meglumine) Injection for Intravenous Use (Press)
• Ironshore to Present Data From a Pivotal Trial of JORNAY PM™ (methylphenidate HCl) CII at the 31st Annual International Conference on ADHD (Press)
• Bionomics Announces Fast Track Designation Granted by US FDA to BNC210 Development Program for the Treatment of PTSD (Press)
• Revolution Medicines and Amgen Partner on Phase 1b Study to Evaluate Combination of RMC-4630 and AMG 510 (Press)
• Small Alzheimer's hopeful biotech nabs $15M series B for metabolic drug approach (Fierce)
• Harbour BioMed Announces Initiation of First-in-human Study of Next-generation Anti-CTLA-4 Antibody for Treatment of Solid Tumors (Press)

• Device aimed at curbing 'dead-in-bed' opioid effects wins FDA breakthrough status (MedtechDive)
• Applying data science principles to FDA’s PreCert Program: Some scary stuff (mobihealthnews)
• DiFusion Inc. Announces FDA 510K Clearance for Xiphos ZFUZE (Press)
• Outcomes of Spineology US Clinical Trial for Interbody Fusion Shared at 2019 SMISS Meeting (Press)
• Abbot Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues (FDA)
• Class 1 Device Recall ROSA Brain 3.0 (FDA)

• FDA’s Proposed Rule on Drug Importation Lands at OMB (Focus)
• Sen. Cassidy on Trump drug plan: Price index still preferable to imports (STAT)
• Warren's health plan shakes up Democratic primary (Politico)
• Gottlieb On Being Senate-Confirmed US FDA Commissioner: It's Certainly An Advantage (Pink Sheet-$)
• State-based Analysis: ICER-based Formularies Could Upend Access to Current Treatments in Medicaid (Xcenda)
• Another Perspective on the FY 20 Tea Leaves (Alliance for a Stronger FDA)
• Viewing Buckman as a Logical Contradiction Decision (Drug & Device Law)
• Surveying The Fallout From The PTAB Constitutionality Ruling (Law360-$)
• FTC Sues Multi-Level Marketer Neora, formerly known as Nerium, Alleging it Operates as an Illegal Pyramid Scheme (FTC)

• FDA Advisory Committee Calendar
• Cardiovascular and Renal Drugs Advisory Committee; Notice of Meeting – 10 December 2019

• UK to be ‘transformed’ into radiotherapy research hub (PharmaTimes)
• Early access to medicines scheme (EAMS) scientific opinion: avelumab in combination with axitinib for first-line treatment of advanced renal cancer (MHRA)

• Medtronic thoracic stent graft system approved in Japan (MedtechDive)

• Cook Medical India opens new facility in Chennai (MassDevice)
• Draft law proposes compensation for faulty medical devices, implants (Economic Times)
• Regulator waives off clinical trials, clears Sanofi TB drug (Economic Times)
• Ranitidine recall impacts Dr Reddy's P&L by Rs 40-crore (Economic Times)

• Google Health is finally opening up about its plans, and they’re all about search (CNBC)