Regulatory Focus™ > News Articles > 3 > Recon: Acne Drug Fails Late-Stage Trials; New Tracking Tool for EMA’s Move

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

Posted 05 March 2018 | By Ana Mulero 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US
  • 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)
In Focus: International
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical and Biotechnology: Study Results, Filings and Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Asia India
  • 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)
General Health & Other Interesting Articles
  • 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)
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.
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