Recon: Alexion Drug Succeeds in Late-Stage Study; FDA Hold on Gene Therapy Trial

• Elizabeth Holmes And Theranos Charged With 'Massive Fraud' By SEC (Forbes) (Focus) (Fierce)
• GV, Roche help Ideaya to $94M crossover round, setting stage for synthetic lethality, I-O trials (Fierce) (Endpoints News)
• Solid sinks after FDA places hold on Duchenne gene therapy trial (pharmaphorum) (Endpoints News) (Fierce) (Boston Business Journal)
• Time for Pharma to Play Defense With Deals (WSJ)
• FDA posts two new quarterly reports on generic drugs program (Focus)
• Hemophilia A: Evidence Report (ICER)
• FDA begins anti-smoking push to cut nicotine in cigarettes (AP News) (NBC News) (The Washington Post) (STAT) (FDA) (NEJM)
• White House Hails Success of Disease-Fighting Program, and Plans Deep Cuts (NYT)
• Alexion's rare blood disorder drug succeeds in late-stage study (Reuters) (Endpoints News) (Fierce)
• Ex-Google Ventures CEO Maris Set to Raise $100 Million Fund (Bloomberg-$) (Endpoints News)
• Flagship commits $50 million in Foghorn Therapeutics (The Boston Globe) (Fierce) 

• Takeda looks east for another Entyvio growth spurt (Fierce)
• UK And EMA Could Work Together Informally After Brexit (The Pink Sheet-$)
• Only a fifth of pharma companies connecting to EU FMD hub (The Pharmaceutical Journal)
• U.S., German antitrust authorities clear Varian’s $1.3B Sirtex buyout (Drug Delivery Business News)
• Drugmaker Hikma sees more layoffs in generics business (Reuters) (Financial Times) (The Pharma Letter)
• China biotech the new trend: Loncar launches index (Endpoints News)
• Ardian launches sale of German pharma firm Riemser: sources (Reuters)
• Charities link with BenevolentAI to discover new AMD therapies (PharmaTimes) (pharmaphorum) (The Pharma Letter-$)
• How a London physician came up with the idea for a 3D printed stethoscope (CBC News) (CTVNews)
• Australia and US join forces to advance cancer and paediatric healthcare (OpenGov)
• Regulators In Mexico, Chile And Colombia Take Steps Towards Regulatory Harmonization (The Pink Sheet-$)
• Pathways to Global Unity; Public Workshop (FDA) 

• Hospitals are confronting a new opioid crisis: an alarming shortage of pain meds (STAT)
• Cambridge biotech startup to pay $150m to license rare disease drug (The Boston Globe) (Endpoints News)
• Jennifer Doudna: ‘I still remember my first encounter with DNA’ (Financial Times)
• FDA's promo police put pharma marketing to the test with 6 new research studies (Fierce)
• Celltrion's manufacturing headache likely to delay Teva migraine drug until 2019: analysts (Fierce)
• Milwaukee County sues prescription drug-makers and distributors behind the opioid crisis (Milwaukee Journal Sentinel)
• NY Opioid Litigation Won't Be Stayed; Lawyers Seeking 1,000 More County-Plaintiffs (Forbes)
• Physicians and Patients Finally Avoiding Horizon's Expensive Low Value Pain Drugs, Duexis And Vimovo (Forbes)
• The biotech IPO party rocks on with $120M raise for I/O player Arcus Biosciences (Endpoints News)
• Drug makers are paying fewer and fewer fines for their bad behavior (STAT-$)
• Stealth biotech Arbor steps out of the shadows, announcing it’s found a new CRISPR enzyme (STAT-$)
• HHS is urged to investigate a Gilead hepatitis C patent for failing to disclose federal funding (STAT-$)
• GSK Says It Can’t Find Marketing Contracts In Zofran MDL (Law360-$)
• A Biotech Meltdown for the Ages (WSJ)
• Inside a drug pricing contract (Axios)
• Pediatric Exclusivity (2 of 3): Amgen v. Hargan (Objective Intent)
• US FDA approves Strides Shasun's HIV drug (BioSpectrum) (The Economic Times) 

• Eli Lilly gets a date with FDA experts for once-rejected rheumatoid arthritis drug baricitinib (Endpoints News) (FDA)
• J&J’s blockbuster hopeful erdafitinib gets ‘breakthrough’ moniker (Endpoints News)
• Incyte study could bring lessons for cancer immunotherapy (BioPharma Dive)
• Quest, Genomic Vision extend SMA screening R&D program (Fierce)
• Positive Phase III readout for Baremsis (The Pharma Letter-$)
• Nordic Tech House to invest in stem cell company NextCell Pharma (The Daily Telescope)
• VC Firm Flagship Commits $50M To Gene Control Researcher (Law360-$)
• Researchers call for investigation into rising mortality rates (PharmaTimes) (The Guardian) (HuffPost) (The Independent)
• Mayo Clinic boosts clinical trials with IBM Watson artificial intelligence (Healthcare IT News)
• Ingestible Electronic Capsule Measures Gases in the Gut (JAMA)
• Creative Minds: Programming Cells to Write Their Own Memoirs (NIH)
• Worldwide Clinical Trials Acquires Continuum Clinical’s Late Stage Research Practice (Press)
• Pediatric Advisory Committee and the Endocrinologic and Metabolic Drugs Advisory Committee; Amendment of Notice (FDA)
• Zymeworks Advances Clinical Candidate Incorporating Technology from Kairos Acquisition (Press)
• Healthy Nevada Project Announces Pilot Study Insights and Phase Two Enrollment (Press) 

• MIT study reveals the problem with bioresorbable stents (Drug Delivery Business News)
• Scientists trick the brain into sensing the movement of a prosthetic (STAT)
• What Do Trump’s E-Health Changes Mean for Medical Research? (Bloomberg)
• TSO3 wins expanded FDA nod for Sterizone VP4 sterilizer (MassDevice) (Press)
• Cerapedics wins FDA IDE nod for P-15L bone graft trial (MassDevice) (Press)
• Philips receives U.S. FDA 510(k) clearance to market ProxiDiagnost N90, its premium digital radiography and nearby fluoroscopy system (Press)
• UroViu Corporation's Single-Use Cystoscope Receives FDA 510(k) Clearance and Allowance of U.S. Patent (Press)
• DxNow, Inc. Receives FDA 510(k) Clearance for ZyMōt ICSI and ZyMōt Multi Sperm Separation Devices (Press)
• If you think you are at high risk for colon cancer, a simple, painless test could let you know (CNBC)
• Fed. Circ. Backs PTAB In Upholding Uterine Endoscope IP (Law360-$)
• Tax Court Flubbed Analysis In Medtronic Case, 8th Circ. Told (Law360-$)
• Philips showcases digital pathology system for clinical use and advanced imaging analytics to transform pathology services at USCAP 2018 (Press)
• Hackers could kill patients by attacking their pacemakers, warns Royal Academy of Engineering (The Telegraph)
• Patients face high out-of-pocket fees for imaging (Reuters)
• Fitbit will start tracking your period in an attempt to add more value to Fitbit (The Verge)
• Mexico Turns To Digital Health To Improve Healthcare (Forbes)
• Genetic Testing Co. Probe `Ominous’ for Diagnostics Scrutiny (Bloomberg) 

• Ohio judge blocks legislation preventing abortions in Down syndrome cases (CNN) (The Hill)
• Looking At The Year Ahead In Cannabis, Technology, Microdosing, Home Brew and Blockchain (Forbes)
• The SEC Says Elizabeth Holmes' Fraud Was Worse Than Anyone Thought (Forbes)
• After a rough season, FDA chief Gottlieb says 'holy grail' flu shot is years off (Fierce)
• Hepatitis C Drugs Save Lives, but Sick Prisoners Aren’t Getting Them (NYT)
• Exclusive: Alexander's ACA market stabilization proposal (Axios)
• The One-Year Anniversary of the Oncology Center of Excellence (FDA Voice)
• Senators Introduce Bill to Abrogate Tribal Sovereign Immunity (Patent Law Weblog)
• Oregon Jumps on the Drug Pricing Transparency Bandwagon (FDA Law Blog)
• Eyes on Senate Bill to Nip Allergan’s Tribal Immunity Tactic (Bloomberg) 

• FDA Advisory Committee Calendar 

• EMA Explores How To Make Therapeutic Indication Wording More Consistent (The Pink Sheet-$)
• New guidelines recommend hysteroscopy test for heavy periods (PharmaTimes)
• Patients on diabetes scheme shed weight of 15 double cheeseburgers (PharmaTimes)
• PCI to tackle ‘wait and see’ approach with serialization suite in Ireland (In-PharmaTechnologist) 

• Johnson and Johnson creates new design lab in Singapore (CosmeticDesign-Asia)
• Smoking tied to higher risk of hearing loss (Reuters)
• Cellvizio Obtains Positive Assessment from the Korean National Evidence-based healthcare Collaborating Agency (NECA) (Press)
• MOH, GE delivering digital solutions (Saudi Gazette) (Tahawul Tech) 

• Johnson & Johnson , Mylan propose ways to cut TB drugs prices in India (The Economic Times)
• Bayer Pharmaceuticals committed to India growth; to push for more R&D (The Economic Times)
• Unichem Labs under regulator scanner for launching blood pressure medicines without price approval (The Economic Times)
• Prices of 851 essential drug formulations cut in past 2 year: Government (The Economic Times)
• India's leadership in cost-efficient generics is unchallenged: Sanjiv Kaul (Business Standard)
• India Begins Making a List of Essential Diagnostics Whose Prices Could Be Capped (The Wire)
• Indian medical device start-ups trying to tide over pricing & infrastructure issues to achieve domestic market acceptance: Vishnu Bhat (Pharmabiz) 

• Indigenous Australians far more likely to die from cancer, new data shows (The Australian)
• Multiple sclerosis drug recall: Zinbryta (daclizumab) (Herald Sun)
• Tougher Sanctions And Penalties Kick In For Advertising Breaches In Australia (The Pink Sheet-$) 

• Pharmacare and the chaotic world of Canadian drug prices (The Conversation)
• Information Update - Health Canada to conduct review of a new potential safety risk of Fibristal (ulipristal acetate), a medication used to treat fibroids (Press)
• Ipsen Announces Health Canada Approval of DYSPORT THERAPEUTIC (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults (Press) 

• Breast cancer patients in U.S. territories receive lower quality care (Reuters)
• Cigna tapping Amazon's Alexa to help define insurance terminology (Hartford Business)