Recon: Sarepta Wins Early Approval for DMD Drug After Earlier Rejection; PhRMA Sues Over Oregon Price Transparency Laws

• FDA gives early approval to Sarepta's DMD therapy  (Reuters) (STAT) (Endpoints) (Endpoints) (FDA)
• What's next for Sarepta? A third DMD approval, analysts predict (Endpoints)
• Biotech veteran Chris Garabedian on Sarepta’s legacy and Biogen’s future at the FDA (STAT)
• Biogen scraps development of therapy for rare brain disease (Reuters)
• Hahn Wins Senate Confirmation to be 24th FDA Commissioner (Focus) (NYTimes)
• House Passes Pelosi Drug Pricing Bill on Party-Line Vote (Focus) (NYTimes)
• Drug prices and health care are wild cards in the 2020 election (CNBC)
• PhRMA sues Oregon over drug pricing transparency laws, calling them ‘unconstitutional’ (STAT)
• Looming Medical Device Tax Has Makers Rushing to Capitol Hill (Bloomberg)

• GSK's ViiV seeks marketing license for baby-friendly HIV pill (Reuters)
• Ebola spreads in Congo after militants attack treatment camp: WHO (Reuters)
• Brexit nears as Conservatives sweep to victory in election (PMLive) (BBC)
• Pfizer's rare disease drug gets EMA's positive recommendation (Reuters) (Press)
• Novartis' Beovu scores CHMP recommendation after proving non-inferior to Eylea in wet age-related macular degeneration (Pharmafile)
• Roche's Tecentriq cocktail scores trial success in melanoma (Reuters) (Press)
• Scientists home in on potential treatments for deadly Nipah virus (Reuters)

• When FDA Requires Pediatric Studies for New Cancer Drug Submissions: New Draft Guidance (Focus)
• A new HIV vaccine effort with a different kind of strategy (MPR)
• Our 2019 Year In Review: Macro, Biotech, and Atlas (LifeSciVC)
• Bristol-Myers' strategy, BD chief Paul Biondi exited the company — just ahead of the $74B Celgene deal close (Endpoints) (Fierce) (Press)
• Paul Biondi's track record at Bristol-Myers covered billions in deals of every shape and size. Here's the complete breakdown (Endpoints)
• Biopharma has abandoned antibiotic development. Here’s why we did, too. (Endpoints)
• UK researchers make new Alzheimer’s disease discovery (PharmaTimes)
• Therapies for rare diseases: therapeutic modalities, progress and challenges ahead (Nature)
• Oncology drug shortages in the USA — business as usual (Nature)
• FDA and Industry Quality Metrics Initiatives Are Paving the Way to Manufacturing and Regulatory Advancements (IPQ)
• Gritstone posts 'one of the most potent immunogenic-responses for a neoantigen vaccine' (Fierce)
• Anixa delays CAR-T trial in bid to boost efficacy (Fierce)
• Intercept Provides Regulatory Update (Press)

• FDA Approves XELJANZ® XR (tofacitinib) Extended-Release Tablets for the Treatment of Ulcerative Colitis (Press)
• OncoSec Presents Interim Data of 28.5% Objective Response Rate (ORR) from Ongoing KEYNOTE-890 Study Evaluating TAVO™ in Combination with KEYTRUDA® for Heavily Pretreated, Late-Stage,
• Metastatic Triple Negative Breast Cancer (mTNBC) at the 2019 San Antonio Breast Cancer Symposium (Press)
• Boehringer Ingelheim and Lilly provide update on Jardiance® phase III exercise ability studies in chronic heart failure (Press)
• Hansa Biopharma has Agreed With the FDA on a Regulatory Path Forward for Imlifidase in Kidney Transplantation of Highly Sensitized Patients in the US (Press)
• Exelixis Announces Positive Results From IMspire150, the Phase 3 Trial of Atezolizumab Plus Cotellic and Vemurafenib in People With Previously Untreated BRAF V600 Mutation-Positive Advanced Melanoma (Press)
• Significant Effect of Diamyd® in Type 1 Diabetes Shown in a New Comprehensive Analysis of Previous Phase III and Phase II Trials (Press)
• BioLineRx Announces Updated Phase 2a Data From Triple Combination Arm of COMBAT/KEYNOTE-202 Study in Patients With Second-line Metastatic Pancreatic Cancer (Press)
• Senhwa Biosciences Reports Positive Phase 1 Data of CX-5461 in Patients With Advanced Solid Tumors at 2019 SABCS (Press)
• Transgene Reports on the Combination Trial of TG4010, Chemotherapy and Nivolumab in Non-Small Cell Lung Cancer (Press)

• FDA qualifies tool for assessing safety of implanted devices (MedtechDive)
• FDA authorizes first interoperable, automated insulin dosing controller designed to allow more choices for patients looking to customize their individual diabetes management device system (FDA)
• Iradimed renews CE mark for MRI-safe patient monitor (MassDevice)
• Livongo, Propeller, Omada tapped for Express Scripts digital health formulary (MedtechDive)
• Class 1 Device Recall Medfusion Model 4000 Pump (FDA)

• The ceasefire at the Humphrey Building (Politico)
• Investor Wants To Block $9.7B Novartis-Medicines Co. Deal (Law360-$)
• US Patent Office removes lawyer from high-profile case involving a Gilead HIV medicine (STAT) (Endpoints)
• Federal Watchdog Questions Billions of Dollars Paid to Private Medicare Plans (NYTimes)
• South Carolina Is the 10th State to Impose Medicaid Work Requirements (NYTimes)
• U.S. vaping-related deaths rise to 52, hospitalizations to 2,409 (Reuters)
• District of Nevada Dismisses Gadolinium Claim, Albeit Without Prejudice, on Personal Jurisdiction and Preemption Grounds (Drug & Device Law)
• Berkeley Files Responsive Motion to Broad's Substantive Motion No. 2 in Interference (Patent Docs)

• FDA Advisory Committee Calendar

• EU Preserves Status Quo On Drugs Under Additional Monitoring (Pink Sheet-$)
• EU Regulatory Roundup: Finland Prepares for 2020 Introduction of New Clinical Trial Regulations (Focus)
• CR UK research backs liquid biopsy for breast cancer (PharmaTimes)

• Food or drug? Government to take a call soon (Economic Times)

• Advertising: Advertising Code and guidance (TGA)
• IVD companion diagnostics: Guidance on proposed regulatory requirements (TGA)
• TGA webinar presentation: Good Manufacturing Practice (GMP) clearance applications - common pitfalls, 6 December 2019 (TGA)

• Costa Rica's president says therapeutic abortions will be allowed (Reuters)
• New Zealand Seeks Human Skin to Treat Volcano Burn Victims (NYTimes)

• How Prepared Are We For The Next Pandemic? Not Very, Experts Show (Forbes)
• Flu Season Is Here, and It’s Targeting Your Kids (Bloomebrg)
• How McKinsey infiltrated the world of global public health (Vox)
• BMJ should retract flawed research paper on chronic fatigue syndrome (STAT)