Recon: Acne Drug Fails Late-Stage Trials; New Tracking Tool for EMA’s Move

• Vividion Therapeutics to get $101 million upfront from alliance with Celgene (The San Diego Union-Tribune) (Fierce) (Endpoints News)
• Dermira discontinues development of acne drug after two late-stage trials fail (Stat News) (Fierce) (Endpoints News)
• Reshaping 180-Day Exclusivity: The FAIR Generics Act Returns as the Expanding Access to Low Cost Generic Drugs Act (FDA Law Blog)
• In tussle over ‘right to try,’ court presses FDA to shed light on Ebola drug decisions (Stat News-$)
• In Two Months, Biotech Startups Raised More Money Than In All Of 2013 (Forbes)
• Unum plays its first glimpse of human data in an $86M IPO, revealing two deaths and an FDA hold (Endpoints News) (Fierce) (Stat News-$)
• Despite push for a universal flu vaccine, the ‘holy grail’ stays out of reach (Stat News)
• FDA request for comment: Post-Marketing Pediatric-Focused Product Safety Reviews; Establishment of a Public Docket (FDA)
• A summary of FDA’s FY2017 enforcement activities (FDA)
• Google rolls out a new tool to help health providers solve the medical record mess (CNBC)

• Britain's health service 'not for sale' in U.S. trade talks: PM May (Reuters)
• Brexit: Theresa May reveals UK willing to pay to remain part of European agencies for medicine, chemicals and aviation (Focus) (The Independent) (pharmaphorum) (PharmaTimes) (ABPI)
• Britain braces for an exodus of E.U. doctors and nurses feeling hurt by Brexit (The Washington Post)
• Lassa fever: The killer disease with no vaccine (BBC News)
• Investors urge Novartis to exert 'moral influence' amid Greek probe (Reuters) (Fierce)
• New tracking tool for EMA’s relocation to Amsterdam (EMA)
• China's Tasly to list biotech arm in $1 billion Hong Kong IPO: sources (Reuters) (Endpoints News)
• Chinese investors pump new dollars into Maryland’s pharmaceutical industry (The Washington Post)

• Homology seeks $100M from IPO, reveals Novartis deal numbers (Fierce)
• Owlstone raises $15M to bring cancer breath test to market (Fierce)
• Celgene Announces Expiration of Cash Tender Offer for Shares of Juno Therapeutics, Inc. (Press)
• Is tech money bad for business? Silicon Valley cash makes some biopharma VCs bristle, others cheer (Endpoints News)
• Cheaper DNA sequencing unlocks secrets of rare diseases (Financial Times)
• Generic Pharmaceutical Pricing Under Review in Illinois (Peoria Public Radio)
• CSL revamps branding to recruit employees, partners (Fierce)
• Migraine maven Lilly finds 'understanding gap' between patients, nonpatients in new survey (Fierce)
• Lonza reorganization means changes for company's Walkersville facility (Frederick News Post) (Fierce)
• Senator questions big pharma buyback strategy (BioPharma Dive)
• Medeon acquires Terumo’s large bore vascular closure system for $20M (Fierce) (BioSpectrum)
• Medicine’s long, thin supply chain (Wired)
• MedGenome brings series C haul up to $40M to expand access to genetic tests (Fierce) (Economic Times)
• Novavax’s flu vaccine for older adults shows early promise against Sanofi’s Fluzone (Fierce)
• Records: Drug distributors push back on proposed Ohio rules (AP News)

• Stock flies high on Clearside’s PhIII macular edema trial results as drug improves vision (Endpoints News) (Reuters)
• Broadly neutralizing antibody treatment may target viral reservoir in monkeys (NIH)
• Short-term increases in inhaled steroid doses do not prevent asthma flare-ups in children (NIH) (Drug Delivery Business News)
• CRISPR ‘gone wild’ has made stocks swoon, but studies show how to limit off-target editing (Stat News)
• FDA’s updated standards remove an unnecessary barrier to testing Alzheimer’s drugs (Stat News)
• Santhera’s Raxone fails NIH’s MS study in latest setback, shares plunge (Endpoints News) (Reuters)
• Stimguard set to study its tibial nerve OAB system against Medtronic's Interstim device (BioWorld MedTech)
• Gilead Announces Data from New Preclinical Study Evaluating a Combination of an Investigational TLR7 Agonist and an Investigational HIV Envelope Targeting Antibody in SHIV-Infected, Virally Suppressed Monkeys (Press)
• Richard Lehman’s journal review (BMJ Opinion)
• Positive data pushes G1 to speed up development of its CDK inhibitor (BioPharma Dive)
• FDA Accepts Shire's SHP555 NDA for Chronic Idiopathic Constipation (MD Magazine) (Press)

• FDA clears Corindus’ automated robotic surgery software (Fierce) (Press)
• Shire launches myPKFiT for ADVATE [Antihemophilic Factor (Recombinant)] in the U.S. (Press)
• Medtronic wins one lawsuit, settles state AG probes over Infuse (MassDevice)
• Boston Scientific picks up EMcision (MassDevice)
• Zimmer Biomet Holdings Considering Sale of Dental Unit (The Wall Street Journal)
• InspireMD Announces Expansion of its Distribution Network (Press)
• DePuy Synthes Announces Agreement with SERF to Add Dual Mobility System to Its Leading Hip Portfolio (Press)
• Preparing for commercial launch, Nemaura boosts manufacturing capabilities (Drug Delivery Business News)
• The guy who battled Republicans over Obamacare is investing in health tech for the 99 percent (CNBC)

• Upton & Dingell Working to Create Pathway for More Research on Non-Addictive Pain Medications (E&C) (Detroit Free Press)
• FDA warns of fraudulent and unapproved flu products (FDA)
• Right to Try and the FDA’s Proposed Ban on Kratom (Cato Institute)
• Senate bills include ‘common sense’ mandates around PDMPs and e-prescribing (Fierce)
• Making the Case: The Alliance’s “Ask” for FY 19 (Alliance for a Stronger FDA)
• Good Review Practice: Clinical Review of Investigational New Drug Applications (FDA)
• Management of opioid use disorders: a national clinical practice guideline (CMAJ)
• The Price They Pay (The New York Times)
• Arkansas becomes third U.S. state to add Medicaid work requirements (Reuters)
• Deputy Assistant Attorney General Ethan P. Davis Delivers Remarks to the FDAnews Off-Label Communication: Top Tips for Compliance Conference (DOJ)
• U.S. seeks time to consider joining opioid litigation (Reuters)
• Obamacare Hits Highs In Popularity And Profits (Forbes)
• Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance (FDA)
• FDA Investigates Multistate Outbreak of Salmonella Infections Linked to Products Reported to Contain Kratom (FDA)
• When it comes to interoperability, we need to think big (Allscripts)
• Kyruus Announces Collaboration with IBM to Leverage IBM Watson Virtual Agent with Kyruus ProviderMatch to Enable AI-Assisted Patient-Provider Matching and Scheduling (Press)

• FDA Advisory Committee Calendar
• Examining U.S. Public Health Preparedness for and Response Efforts to Seasonal Influenza

• Communication on the operation of REACH and review of certain elements. Conclusions and Actions. (EC) (Fact Sheet) (Press)
• Bulgaria reports outbreak of highly pathogenic H5N8 bird flu (Reuters)
• Siemens Plans Health IPO Valuing Unit at $38 Billion (Bloomberg)
• Europe’s new MDR: Is it as scary as you might think? (Medical Design & Outsourcing)
• Digital and service solutions to NHS challenges: apply for funds (MHRA)
• Edwards Lifesciences to create 600 mid-west jobs in €80m investment (Silicon Republic)

• Israel's Medivie signs $110 million medical cannabis export deal (Reuters)
• Amid health scare, Abbas vows not to end his life as a ‘traitor’ (Times of Israel)
• The typhoid superbug in Pakistan (The Express Tribune)
• Malawi cholera death toll rises to 19, health ministry says (Channel NewsAsia)
• China sees influx of blockbuster drugs as market grows (Nikkei Asian Review)

• India’s Aurobindo has another sterile manufacturing plant cited by FDA (Fierce)
• India’s huge ship-breaking industry is destroying its workers’ health (VICE News)
• Indian pharma companies correcting mistakes in manufacturing standards (Business Today)
• India’s Ambitious Health Care Plan Sparks Hope, Questions (Voice of America)
• Carlyle, Advent to submit bids for stake in Mankind Pharma (Mint)

• PCI completes acquisition of Australian based packaging solutions provider (EPM Magazine)
• Record 30 per cent increase in complaints about health insurance (The Sydney Morning Herald)
• Pre-submission meetings with TGA (TGA)
• Australian regulatory guidelines for biologicals (ARGB) (TGA)

• Health Canada Clarifies Risk Classification Process in Drug Manufacturing Site Inspections (Focus)
• This Company Is Testing A Flu Vaccine Made In Tobacco -- And Philip Morris Is On Board (Forbes)

• I Saw a Genocide in Slow Motion (The New York Times)
• NEJM survey spotlights payer-provider alignment barriers (Fierce)
• Trump's Short-Term Health Plans Will Legalize Affordable Care (Forbes)
• Lyft and Allscripts want to make it easier to get people to the doctor's office (CNBC) (USA Today)
• Improving the customer experience with telehealth (IHHR)