Recon: Mylan Launches Generic Advair at One-Third Price of Original

• Mylan launches Advair generic at one-third price (Reuters)
• FDA Panel to Assess Risks of Women’s Surgical Mesh (WSJ)
• Vaccine storage too often fails to meet standards (KHN)
• Gilead's Liver-Drug Setback Clouds $35 Billion Dream (Bloomberg) (STAT) (Endpoints) (Reuters) (Press)
• A big PBM wants drug makers to agree to rebate demands that would preserve its bottom line (STAT) (Fierce)
• AbbVie must fork over Humira documents after judge slams a ‘nonsense’ argument (STAT)
• Catalyst Pharma sees net price of drug, once free, topping $300,000 (Reuters)
• Almost half of US heart disease patients struggle with medical bills (Reuters)
• BMS can breathe easier now: Celgene’s Revlimid has escaped a big patent challenge (Fierce)
• Indivior loses US district court battle, copycat launches imminent (Reuters)
• Our Year In Review: Annual Talk On Macro, Biotech, and Atlas (LifeSciVC)

• Industry concerned about ‘rushed’ Brexit withdrawal legislation (PMLive)
• One of India’s biggest drug makers has a ‘deeply troubling’ pattern of manufacturing problems (STAT)
• Hillhouse Capital endorses China-based HaiHe Biopharma’s cancer pipeline in $146M round (Endpoints)
• Boehringer Ingelheim and IBM link up for blockchain-powered clinical trials in Canada (Fierce)
• What It Will Take For Trump To End AIDS 'Beyond' America (NPR)
• China's EpimAb Advances Bispecific Antibody To Rival Janssen Candidate (SCRIP-$)
• EU Looks to Craft Harmonized Definition of a Drug Shortage (Focus)
• Poland, Slovenia Added to GMP Agreement Between US and EU (Focus)
• UK's NICE Rejects US Industry Attack On Its HTA Methods (Pink Sheet-$)
• Lung cancer treatment combo given initial NHS ‘no’ in England (CRUK) (NICE)
• Blood cancer drug Kymriah approved by NHS is denied to Scots (The Times) (PharmaTimes)
• IPA appeals to USTR to remove India from Priority Watch List as country made rapid progress on number of fronts (PharmaBiz) (IPA)
• Global Regulators Promote Convergence With New Biowaiver Evaluation Template (Pink Sheet-$)
• Spain’s Competition Watchdog Targets Radiology Drug Makers (Law360-$)
• Tanzanian Tycoon Reginald Mengi To Establish Stem Cell Research Center (Forbes)

• The high rollers: The top 20 blockbuster biopharma deals of the past decade (Endpoints)
• Combination Products: US FDA Aims For Limited Two-Application Solutions (Pink Sheet-$)
• Bladder cancer readout sees Nektar shares hit (Fierce)
• Dr. Reddy’s Bachupally plant experiences a version of FDA déjà vu (Fierce)
• CERSI Collaborations With FDA: Priority Research (Focus)
• Dr Reddy's launches erectile dysfunction treatment drug in US (Economic Times)
• REMS Abuse Website: Has It Changed The Behavior Of Innovators? (Pink Sheet-$)
• The J.P. Morgan Healthcare Conference has grown. How can we make it work for everyone? (STAT)
• Generic Advair's Labeling Variation Stems From Permissible Design Differences, US FDA Says (Pink Sheet-$)
• Sanofi name current CMO Dr Ameet Nathwani as new Chief Digital Officer (Pharmafile)
• Pfizer Questions Drug ‘Total Content’ in Biosimilar Guidance (FDANews-$)
• Defending the middlemen: JC Scott on testifying before Congress, challenging Trump, and revamping PBMs’ image (STAT)
• NIH researchers home in on genes linked to age-related macular degeneration (NIH)
• As digital medicine explodes in the zeitgeist of healthcare, Sanofi follows peers in appointing chief digital officer (Endpoints)
• Real-World Evidence Takes Courage: A Conversation With IQVIA’s Nancy Dreyer (Pink Sheet-$)
• After a short stint at Intercept, Rachel McMinn makes the leap from biotech analyst to biotech CEO (Endpoints)
• Once interim, now full-time, Siffert becomes new Abeona chief (Fierce)
• Q&A: OIR Director Timothy Stenzel Discusses Precision Medicine Efforts During His First Year at FDA (GenomeWeb)
• GV names ex-Agios CEO David Schenkein as general partner (Fierce)
• Parexel Appoints Former FDA Senior Executives to Global Regulatory Consulting Services (Press)
• Determination of Regulatory Review Period for Purposes of Patent Extension; XADAGO (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; ZEJULA (FDA)
• Determination of Regulatory Review Period for Purposes of Patent Extension; EUCRISA (FDA)
• Hospira, Inc., et al.; Withdrawal of Approval of 12 Abbreviated New Drug Applications (FDA)

• Merck, Pfizer combo treatment boosts kidney cancer survival (Reuters) (Endpoints)
• Opdivo (nivolumab) Plus Low-Dose Yervoy (ipilimumab) Demonstrates Continued Survival Benefit at 30-Month Follow-up in Patients with Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (Press)
• Calliditas Therapeutics Granted Orphan Drug Designation by the FDA for Primary Biliary Cholangitis (Press)
• Pfizer, Astellas chase new Xtandi nod with big survival numbers in prostate cancer (Fierce) (Press)
• GenSight Biologics Announces Publication of Positive Safety Data from Phase I/II Trial of GS010 in the JAMA Ophthalmology (Press)
• FDA Accepts sBLA and Grants Priority Review for BAVENCIO® (avelumab) Plus INLYTA® (axitinib) for the Treatment of Advanced Renal Cell Carcinoma (Press)
• Neurotech Pharmaceuticals, Inc. Granted Fast Track Designation from the U.S. FDA for the Treatment of Macular Telangiectasia type 2 (Press)
• Clementia Granted Rare Pediatric Disease Designation by FDA for Palovarotene for Fibrodysplasia Ossificans Progressiva (Press)

• HHS Floats Digital Health PreCert Approach as CDRH Limits Pilot Participation (Focus)
• Carl Zeiss Meditec revenue up nearly 10% in Q1 (MassDevice)
• Qualcomm Sells Medical Device Connectivity Business to PE Firm (Xconomy)
• Brain tumor ‘monorail’ lands FDA breakthrough device nod (MassDevice)
• Edwards Lifesciences to acquire Casmed for $100m (MassDevice)
• ConMed closes $365m Buffalo Filter buy (MassDevice)
• Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System (Press)

• Genetic Testing Company Agrees to Pay $1.99 Million to Resolve Allegations of False Claims to Medicare for Medically Unnecessary Tests (DoJ)
• FTC Returns Almost $3.5 Million to Consumers Who Bought Deceptively Marketed “Weight-Loss” Supplements from Direct Alternatives and Original Organics, LLC (FTC)
• The ‘Big Pharma’ candidate? As he runs for president, Cory Booker looks to shake his reputation for drug industry coziness (STAT)
• Sen. Amy Klobuchar’s 2020 policy agenda: Lower drug costs, prepare for ‘digital disruption,’ expand savings accounts (Washington Post)
• Utah GOP partially rolls back voter-approved Medicaid expansion (Politico)
• GenomeDx Biosciences to Pay $2M to Settle Allegations of Improper Medicare Billing (GenomeWeb)
• Roche To Settle Enzo Biotech IP Fight For $21M (Law360-$)
• $785M In Debt, Diagnostics Provider Files For Bankruptcy (Law360-$)
• Fed. Circ. Backs J&J Trial Win In Contact Lens Patent Suit (Law360-$)
• What About Sikkelee and Conklin? (Drug & Device Law)
• FDA’s Tenth Annual Report to Congress on 505(q) Citizen Petitions: New Numbers and the Same Message (FDA Law Blog)

• FDA Advisory Committee Calendar

• NHS Announces Workforce Plan For Genomics, AI And Digital Medicine (Forbes)
• MHRA Clarifies Medical Devices Policies for Users (Focus)

• China to publish first rare disease treatment guidelines (Pacific Bridge Medical)
• China institutes new medical device label requirements (Pacific Bridge Medical)

• Traditional knowledge, cheaper drugs on India's agenda for WTO (Economic Times)

• Australia Proposes to Reclassify Spinal Implants in Line With EU MDR (Focus)

• A.I. Shows Promise as a Physician Assistant (NYTimes)
• The 'Strange Science' Behind The Big Business Of Exercise Recovery (NPR)
• One in six U.S. kids have mental health disorders (Reuters)
• 'Church Of Safe Injection' Offers Needles, Naloxone To Prevent Opioid Overdoses (NPR)