Recon: Gilead Hires Roche’s Pharma Head as New CEO

• Investigation of generic ‘cartel’ expands to 300 drugs (Washington Post)
• Gilead Sciences snares Roche veteran O'Day as CEO (Reuters) (STAT) (Endpoints) (Financial Times) (WSJ) (Gilead) (Roche)
• Moderna’s record-setting IPO dives in its debut (STAT)
• Nasdaq celebrates epic biotech IPO success in 2018. But can the party on Wall Street rumba on? (Endpoints)
• The bruising battle looming over single-payer (Politico)
• ‘All I want for Christmas’ is the shingles vaccine, but it’s nearly impossible to find (Washington Post)
• What These Medical Journals Don’t Reveal: Top Doctors’ Ties to Industry (NYTimes)
• Generic EpiPen alternative to hit the market in early 2019 (CBS)
• The drug industry is headed back to Congress to make its case. Will Democrats keep the door open? (STAT)
• Akorn CEO resigns after $4.3bn Fresenius deal falls through (Pharmafile)
• How to Cut Drug Prices: Experts Weigh In (NYTimes)
• FDA slaps partial hold on MacroGenics for bispecific cancer trials as liver tox spurs safety fears (Endpoints)
• HIV research halted after NIH freezes acquisition of fetal tissue (STAT)

• Ethical issues plagued newly surfaced paper by ‘CRISPR babies’ scientist (STAT)
• Scientists to test tailor-made vaccine tech to fight epidemics (Reuters) (PharmaTimes)
• Roche Taps Genentech Chief to Lead Pharmaceuticals Division (WSJ)
• UN AIDS Agency Is in ‘State of Crisis’ and Needs New Leader, Report Says (NYTimes) (NBC)
• WuXi AppTec starts a global wave of expansion, jumping off in San Diego following $1B Hong Kong IPO raise (Endpoints)
• Bristol-Myers and Vedanta to develop new Opdivo combo (PharmaLetter-$) (Press)
• AstraZeneca, Cancer Research UK set up genomics hub to fight uphill battle against cancer (Endpoints)
• Pharma calls for more detail on plan for post Brexit meds access (PharmaTimes)
• NICE turns down Opdivo/Yervoy combo for kidney cancer (PharmaTimes)
• South Sudan health workers to get Ebola shots as Congo outbreak grows (Reuters)
• Ebola spreads to major Congo city amid worries over vaccine supply (NBC)
• Brexit Update: New Notified Body Designated in The Netherlands (Emergo)

• Four Rules For Being A Consistent US FDA Reviewer From Peter Stein (Pink Sheet-$)
• Stein, Temple Promoted At CDER (BioCentury)
• What’s holding pharma back from the next antibiotic breakthrough? (STAT)
• 'We're Fighting For Our Lives' — Patients Protest Sky-High Insulin Prices (NPR)
• Is It Rational For Employers And Payers To Be Hooked On Prescription Drug Rebates? (Forbes)
• 0-for-2: Another faded drug star in Axovant’s much-hyped pipeline falls, tarnishing Ramaswamy’s deal-making rep (Endpoints) (Fierce)
• DiaMedica pulls off IPO to fund midphase stroke trial (Fierce)
• With fresh company building lessons from Ablynx, Edwin Moses is ready to try it again as chair of neoantigen biotech Achilles (Endpoints)
• Biosimilar Litigation Settlement Score Card: Genentech-Pfizer Herceptin Agreement Is 10th Deal (Pink Sheet-$)
• LunaDNA Offers Stock for Data in Bid to Build Research Database (Xconomy)
• Su-Chiao Kuo: Debarment Order (FDA)

• Merck KGaA, Darmstadt, Germany Announces FDA Orphan Drug Designation for Bifunctional Immunotherapy M7824 in Biliary Tract Cancer (Press)
• Blue Earth Diagnostics Announces U.S. Food and Drug Administration (FDA) Filing Acceptance of Supplemental New Drug Application (sNDA) for 18F-fluciclovine PET Imaging in Glioma (Press)
• U.S. FDA Grants Fast Track Designation to Asana BioSciences’ Oral Dual JAK-SYK Inhibitor, ASN002, for the Treatment of Atopic Dermatitis (Press)
• Cancer Prevention Pharmaceuticals Announces Last Patient Completes Phase 3 Trial Protocol of CPP-1X/sul for Familial Adenomatous Polyposis (Press)
• New Data from the AEROSURF® Phase 2b Clinical Program shows AEROSURF® Appears to Reduce Incidence and Severity of Bronchopulmonary Dysplasia in Preterm Infants with RDS (Press)
• Generon Presented Positive Phase III Results From a Double-Blind, Placebo Controlled-Clinical Trial of F-627 in Women with Breast Cancer Receiving Myelotoxic Chemotherapy (Press)
• Ra Pharmaceuticals Announces Positive Top-line Data from Phase 2 Trial of Zilucoplan in Patients with Generalized Myasthenia Gravis (Press)
• Daiichi Sankyo Presents Updated Phase 1 Results of [Fam-] Trastuzumab Deruxtecan (DS-8201) in Patients with HER2 Low Expressing Metastatic Breast Cancer at 2018 San Antonio Breast Cancer Symposium (SABCS) (Press)
• Zymeworks Submits Investigational New Drug (IND) Application for ZW49 and Presents IND-Enabling Studies at the San Antonio Breast Cancer Symposium (Press)

• Brain implants might one day help paralyzed patients use tablets (Reuters)
• The Rise Of Use Of Medical Devices Force FDA To Change The Rules (Forbes)
• Hospital Beds Get Digital Upgrade (WSJ)
• San Antonio Seeks to Be Known as Silicon Valley of Military Medicine (Xconomy)
• FDA clears Contego Medical’s Vanguard IEP peripheral balloon (MassDevice)
• J&J’s Cerenovus launches global thrombectomy registry (MassDevice)
• Buzzy Startup 10x Genomics Buys Spatial Transcriptomics In Bet On Genetic Tools (Forbes)

• Michael Bloomberg: Here Is $50 Million To Address The Opioid Crisis (Forbes)
• Fentanyl Billionaire No More: John Kapoor's Net Worth Drops Below $1 Billion (Forbes)
• FDA De Novo Device Classification Process & Preemption (Drug & Device Law)
• FDA Takes First Step on Path to Monograph for Antiseptics for Food Handlers (FDA Law Blog)
• Novartis AG v. Ezra Ventures LLC (Fed. Cir. 2018) (Patent Docs)
• Merck, Glenmark Can't Shake Zetia Pay-For-Delay MDL (Law360-$)
• Fed. Circ. Upholds Patent On Novartis MS Drug (Law360-$)
• Genentech Asks Del. Chancery To Toss Takeda Patent Fight (Law360-$)
• Fed. Circ. Reverses Ax Of Novartis Patent Due To 1995 Law (Law360-$)
• Fed. Circ. Revives Medical Device Co. Laerdal's ITC Case (Law360-$)
• J&J Can't Escape Retailers' Antitrust Suit Over Remicade (Law360-$)
• Impax Says Investors' Drug Price-Fixing Suit Still Fails (Law360-$)

• FDA Advisory Committee Calendar

• First Step in EU MDR Compliance: The Gap Analysis (MedtechIntelligence)
• Exclusive: Dutch hospitals to drop U.S. body brokers, cite ethical concerns (Reuters)
• Greek pharma claims it’s overburdened, as pharma spend down 60% since 2009 (PharmaLetter-$)

• Government  to set up panel, boost production of medical devices in India (Times of India)
• Lupin gets EIR from USFDA for Pithampur facility unit (Economic Times)
• Alembic Pharmaceuticals gets USFDA nod for ophthalmic solution (Economic Times)
• How did Singh brothers turn so grim? Here's the story (Economic Times)
• Meril Life Sciences wins approval for TAVR in India (MassDevice)
• Bugworks Research set for pre-clinical drug trials (Economic Times)
• Maharashtra FDA orders stop sale notice on anti-anxiety drug Alprazolam in Malegaon to prevent abuse in open market (PharmaBiz)

• Australia To Test Direct-To-Manufacturer Payments For Costly Medicines (Pink Sheet-$)

• Hacking Health Care: How Tech Will Drive Down Costs (WSJ)
• Ending Weed Prohibition Hasn’t Stopped Drug Crimes (The Atlantic)