Recon: Editas Gets FDA Go-Ahead to Study CRISPR Therapy for Rare Genetic Disorder

• FDA signs off on Editas CRISPR study on patients with a rare genetic disorder (STAT) (Endpoints) (GEN)
• Despite CRISPR baby controversy, Harvard University will begin gene-editing sperm (MIT Technology Review)
• NIH director says there’s work to do on regulating genome editing globally (STAT)
• Nimble biotechs become vital partners for large pharma groups (Financial Times)
• Harvard Medical School Dean Weighs In On Ethics Of Gene Editing (NPR)
• US judge raises prospect of not approving CVS-Aetna deal (Reuters)
• ‘A loss for the rest of us’: An FDA approval is a boon for a drug maker, but could come at a major cost for patients (STAT)
• Republican senator: pharma’s arguments against putting drug prices in TV ads are ‘patronizing’ (STAT)
• Top Biopharmaceutical Research Companies Publish Update On The State Of Alzheimer's Research In US (Forbes)
• GOP lawmakers air concerns with Trump drug pricing move in meeting with health chief (The Hill)
• Express Scripts' Miller says Washington at incredible moment on drug pricing (CNBC)
• A drug pricing duel: Tying U.S. drug prices to what other countries pay (STAT)
• “Lame Duck” Congress Has High Stakes For Pharma Companies (Pink Sheet-$)
• FDA hits Sanofi's struggling Lemtrada with new safety warning over reports of stroke, artery tears (Fierce) (FDA)

• Pfizer Reaches a Global Agreement with AbbVie for Adalimumab Biosimilar (Press)
• Takeda could rack up $10B in selloffs after controversial Shire buyout: report (Fierce)
• European regulatory experience with advanced therapy medicinal products (Nature)
• WHO says spread of polio remains international health emergency (Reuters)
• Measles cases rise in Europe, Latin America: WHO report (Reuters)
• Ebola outbreak in east Congo now world's second biggest (Reuters)
• Daiichi Sankyo Launches Biosimilar Trastuzumab in Japan (Center for Biosimilars)
• Meeting highlights from EMA’s safety committee (PRAC) 26-29 November 2018 (EMA)
• Survey: Brexit blues hit biopharma as industry execs overwhelmingly turn thumbs down on the UK’s future (Endpoints) (PMLive)
• NICE U-turn sees Opdivo backed as adjuvant therapy for skin cancer (PMLive) (Fierce)
• Shire’s angioedema drug Takhzyro claims EU approval (PMLive)
• How Drug Preparations Undermine Europe’s Regulatory System (Pink Sheet-$)
• MHRA Tackles Post Brexit Distribution Worries (Pink Sheet-$)
• Pfizer, Gilead Emails Reveal Behind-The-Scenes Battle Over Malaysia's Drug Pricing, Compulsory Licensing Policies (Pink Sheet-$) (KEI)
• ICH Aims For Drug Quality Standards That Promote Continual Improvement, New Technology (Pink Sheet-$)
• EMA Proposal Would Give Popular Alternative For Pharmaceutical Water A Foothold in Europe (Pink Sheet-$)
• Mercosur Bets On Joint Pricing Negotiations And Procurement For Lower Prices, But Slams Hep C Companies (Pink Sheet-$)
• Eurasian Common Medicines Market Gets Off The Ground (Pink Sheet-$)

• Non-invasive delivery strategies for biologics (Nature)
• Disclosing Prescription-Drug Prices in Advertisements — Legal and Public Health Issues (NEJM)
• US price truce cracks but biopharma may want to tread carefully (Evaluate)
• Vaccines: our greatest hope in defeating AIDS, Ebola, TB, and other infectious diseases (STAT)
• Why Should You Care About Amazon's New Medical Language Processing Service (Forbes)
• Spotlight on drug pricing could be catalyst for change in US biosimilar landscape (Endpoints)
• SOCMA's BPTF Executive Director Shares Perspective on API Supply Issues, Impact on PharmaChem Sector (Press)
• AstraZeneca’s respiratory team acknowledges its latest setback, trial flops (Endpoints)
• 'Echo chamber' surrounds parental decisions about childhood flu vaccine (Reuters)
• Prepping for key ASH presentation, little Aprea Therapeutics gets $57M to fuel PhIII p53 cancer study (Endpoints)
• Lundbeck’s Dunsire has something to cheer as Rexulti combo shows promise in PTSD (Endpoints)
• No, It's Not Just Out-Of-Pocket Costs That Are A Problem, John Arnold Tells Pharma (Scrip-$)
• US Biopharma IPOs Surge, Data For 2018 So Far (Scrip-$)
• CRI study highlights CTLA-4’s marquee role in PD-1/L1 combos — despite an increasingly troubled clinical profile (Endpoints)
• Principia chalks up a win for its BTK autoimmune program (Fierce)

• Cellerant Therapeutics, Inc. Presents Additional Phase 2 Results Showing Romyelocel-L Reduces Risk of Infections in AML Patients Undergoing High Dose Ara-C-Based (HiDAC) Induction Chemotherapy (Press)
• AstraZeneca’s TLR9 oligonucleotide misses goal in asthma phase 2 (Fierce)
• Bristol-Myers Squibb to Highlight New Data from Broad Oncology Portfolio at the 60th American Society of Hematology Annual Meeting (Press)

• Inspiring Medical Device Innovation to Combat the Opioid Crisis (FDA)
• J&J Subsidiary Launches IDE Study for AF (MDDI)
• Abbott faces suit from FlexStent over stent patent (MassDevice)

• Philadelphia looks to crack down on pharma reps with registration, gift banning (Fierce)
• CMS's Enhanced Controls Did Not Always Prevent Terminated Drug Utilization in Medicare Part D (HHS OIG)
• New Jersey lawmakers plan hearing on adenovirus outbreak that's killed 11 children (CBS)
• Pfizer Loses PTAB Challenge To Antibody Drug Patents (Law360-$)
• PTAB Upholds Patent For Akorn Glaucoma Drug Zioptan (Law360-$)
• In Hip Implant MDL, Preemption Cuts Across State Lines (Law360-$)
• Fund Manager Tries To Duck Valeant Insider Trading Claims (Law360-$)
• More from the Mirena IIH Daubert Decision (Drug & Device Law)
• HRSA: No Further Delay of 340B Ceiling Price and Civil Monetary Penalties Rule (FDA Law Blog)
• FDA Requests Input on Consumer Survey Regarding Allergens in Cosmetics (FDA Law Blog)
• FTC Returns more than $750,000 to Consumers Who Bought Two Deceptively Marketed Supplements from Health Research Laboratories, LLC (FTC)

• FDA Advisory Committee Calendar

• UK Government Focus On Strengthening Clinical Research Amidst Unique Challenges Of Brexit (ACRO)
• MHRA recalls Valsartan blood pressure and heart medication from pharmacies (MHRA)
• Clinical trials for medicines: manage your authorisation, report safety issues (MHRA)

• What's Keeping Korea From Becoming A Digital Healthcare Power? (Scrip-$)
• China's online healthcare platform jianke.com enters into strategic collaboration with Pfizer (mobihealthnews)

• Faulty medical devices: Patients can seek compensation (Economic Times)
• Patients with faulty Johnson & Johnson hip implants to be compensated up to Rs 1.23 crore (Economic Times)
• CDSCO proposes to add surgical gowns & drapes to notified devices list as high-risk pacemakers, defibrillators stay off radar (PharmaBiz)
• Health ministry's ICMED-plus certification designed to assure quality of medical devices based on international norms (PharmaBiz)

• PAHO urges testing as the first step towards preventing HIV and halting the AIDS epidemic (PAHO)