Recon: FDA Staff Unfazed by CV Signal in Amgen's Osteoporosis Trials; China Opens Probe Into Expired Polio Vaccines

• AstraZeneca Departures Continue as Medical Chief Bohen Exits (Bloomberg) (Endpoints)
• FDA staff largely unfazed by CV signal in Amgen osteoporosis drug trials (Endpoints)
• Trump falsely claims ‘drug prices declined in 2018’ (STAT)
• Booker tries to shake doubts about pharmaceutical ties ahead of 2020 (The Hill)
• Sanofi-Genzyme inappropriately sought confidential patient information, suit alleges (STAT)
• Kaleido, Cirius brace the IPO market seeking a combined $186M — despite barriers at shutdown-mode SEC (Endpoints)
• Biotech stocks are off to the best start of the year since 2012 on heels of J.P. Morgan conference (CNBC)
• US medic declared Ebola-free, leaves Nebraska quarantine (Reuters)
• Lilly eyes more cancer deals, but wary of CAR-T, gene therapy (Reuters)
• Early research on Apple's Health Records service suggests patients generally like it (CNBC)
• This is why the federal government has a hard time regulating prescription opioids (Washington Post)
• Teva shells out $135M to wrap Illinois AG's Medicaid pricing fraud suit (Fierce)
• A revolutionary drug that could treat a rare and devastating disease is prohibitively expensive. But one state has a plan to pay for its potential $5 million price tag. (Business Insider)

• Chinese police begin new probe into expired vaccines (Reuters)
• Brexit brinkmanship: playing chicken over Theresa May’s deal (Financial Times)
• Beyond ‘superbabies’: how Crispr is revolutionising medicine (Financial Times)
• Lupin developing new products to treat cancer, other diseases (Economic Times)
• Indonesia seeks to reassure HIV patients over drug supplies (Reuters)
• Fund battling AIDS, TB and malaria seeks $14 billion to invigorate fight (Reuters)
• Health Canada places restrictions on Allergan's fibroid treatment Esmya (Reuters)
• EMA approves Flutiform for children with asthma (PharmaTimes)
• PIC/S Considers New System For Monitoring Compliance By Members (Pink Sheet-$)
• Global ban on pharma freebies, including cultural gifts (PMLive)
• Celltrion Says Its Biosimilar Has Gained 56% of the European Infliximab Market (Center for Biosimilars)

• Make Uloric Second-Line for Gout, FDA Advisors Say (Medpage)
• Is JPM worth it? As the buzzy conference dies down, debate on its value rumbles on (Endpoints)
• The Game Isn’t Worth The Candle: Reflections On The JPM Healthcare Conference (LifeSciVC)
• Want to buy Clovis? Step up. ‘Everybody knows where to find me,’ CEO says (Fierce)
• First its CEO tells pharma to watch it on pricing—and then Johnson & Johnson raises them (Fierce)
• What If FDA Actually Shuts Down? (Pink Sheet-$)
• Memorial Sloan Kettering Curbs Executives’ Ties to Industry After Conflict-of-Interest Scandals (NYTimes)
• 2018 New Drugs Approvals: An All-Time Record, And A Watershed (Forbes)
• Hunting productivity, drugmakers pitch new 'pillars' of R&D (BioPharmaDive)
• A QALY Is A QALY Is A QALY, Or Is It? (Forbes)
• Buzz: This little biotech has so much going against it, somebody is going to want to buy it. Right? (Endpoints)
• Think Generics Will Lower the Cost of Chemo? Think Again (Forbes)
• New study points to best way to assess which cancer patients immunotherapy will help (STAT)
• Drug pricing conversations must take the cost of innovation into consideration (STAT)
• Parker-backed cancer scientists shine a light on an emerging pathway in pancreatic cancer (Endpoints)
• AI Picks Out 'Shapeshifting' Cancer Cells, Revealing Potential New Drug Targets (Forbes)
• Statins may help prevent diabetes-related eye problems (Reuters)
• Technology Roadmapping Leads NIIMBL Project Expansion Across Biopharmaceutical Manufacturing/Analytics/Workforce Landscape (IPQ)

• US FDA Accepts Regulatory Submissions for Review of Tafamidis to Treat Transthyretin Amyloid Cardiomyopathy (Press)
• PreP Impact trial to double in size (PharmaTimes)
• Amneal Announces Approval of Rivastigmine Transdermal System (Press)
• Nebulizer fails PhII COPD study, but Verona plans to march on (Endpoints)
• hVIVO preps phase 3 for ‘universal’ flu vaccine (Fierce)
• Aslan turns focus to biliary tract cancer as lead drug flops in PhII gastric cancer study (Endpoints)
• Compugen's Phase 1 Trial of COM701 Featured as a Trial-in-Progress at The ASCO-SITC Clinical Immuno-Oncology Symposium  (Press)

• AdvaMed Updates Ethics Code for Industry-Doctor Interactions (MDDI)
• Seizure-detecting wearable Embrace2 cleared by FDA for use by children (mobihealthnews)
• Gynesonics touts 1-year pivotal IDE Sonata trial data (MassDevice)
• Awak Technologies wins FDA breakthrough designation for portable PD device (MassDevice)
• Abbott wins FDA approval for Amplatzer Piccolo occluder for neonates (MassDevice)
• OSSIO Receives FDA 510(k) Clearance for OSSIOfiber™ Bone Pin Product Family (Press)
• Cook Medical to market Zelegent’s ‘facelift for the soft palate’ (Medical Design & Outsourcing)

• Inside the Medicare innovation lab's big plans (Politico)
• All of Congress’s ideas for bringing down prescription drug prices, explained (Vox)
• Supreme Court May Reset FDA-State Power Balance (BioCentury)
• US judge partially blocks Trump administration birth control rules (Reuters)
• Hospitals Must Now Post Prices. But It May Take a Brain Surgeon to Decipher Them. (NYTimes)
• FTC Must Appear In AndroGel Case Despite Shutdown (Law360-$)
• Updated CLIA Waiver Guidances Lack Details in Original Draft (FDA Law Blog)
• Personal Jurisdiction Wins Cases – Part Many (Drug & Device Law)
• PTAB Issues Final Written Decision in Cannabis Patent IPR (Patent Docs)

• FDA Advisory Committee Calendar

• Good pharmacovigilance practice (GPvP) Update (MHRA)
• Field Safety Notice: 7-11 January 2019 (MHRA)

• Zydus receives final approvals from USFDA for skin ointment, heart medicine (Economic Times)
• API import from China to be reduced by 50% as Indian manufacturers ramp up production (PharaBiz)
• India spends substantial foreign exchange to import 90% products in IVD, imaging, critical care segments (PharmaBiz)

• Puma Biotechnology out-licenses Nerlynx in Canada (PharmaLetter-$)

• CDC says it's another bad flu season with up to 7.3 million people sick so far (CNBC)
• Lab Severs Ties With James Watson, Citing ‘Unsubstantiated and Reckless’ Remarks (NYTimes)