Recon: Novartis and Gilead CAR-T Therapies Win EU Marketing Authorization

• Pfizer rare heart disease drug reduces risk of death by 30 percent in study (Reuters) (Forbes) (Endpoints) (Press)
• Bayer, J&J's bid to further widen use of Xarelto hits snag (Reuters) (Endpoints)
• Lorcaserin — Elixir or Liability? (NEJM) (Study)
• US clears new treatment option for Dravet syndrome (PharmaTimes)
• A CRISPR cure for Duchenne muscular dystrophy is closer after a trial in dogs (MIT Technology Review)
• Antitrust Battle Next For Cigna After Shareholders Approve Express Scripts Deal (Forbes)
• Senate GOP want new bill to blunt ACA lawsuit (Politico)
• Draft Guidance Falls Short on Providing Clarity for Companies Denied Certificates to Foreign Government (FDA Law Blog)
• Gottlieb Interview - When Medical Innovation Meets Politics (WSJ)
• Negative fish oil study results raise the stakes for Amarin’s capsule (STAT)
• FDA approves Imbruvica plus Rituxan for Waldenström’s macroglobulinemia (Healio) (OncLive) (Press)

• Novartis's Kymriah wins EU approval for blood cancer treatment (Reuters) (Press)
• Gilead's Yescarta Receives EU Marketing Authorization for the Treatment of Relapsed or Refractory DLBCL and PMBCL (Press)
• China Biologic Rejects $3.9B Takeover Bid Led By Ex-CEO (Law360-$)
• Making markets deliver essential medicines (EC)
• Experts call for reversing the decision to deny the Ebola vaccine to pregnant women (STAT 1, 2)
• China health reforms help global pharma groups despite price cuts (Financial Times)
• Novartis brings in new CEO to clean up Korean branch (Fierce)
• England to Allow Women to Take Early Abortion Pill at Home (NYTimes)
• NICE clears Ipsen’s Cabometyx in first-line kidney cancer (PMLive)
• Australia Looks To Widen Access To Multiple Myeloma Drugs (Pink Sheet-$)
• China’s cancer drug market to reach $30 billion by 2024 (PharmaLetter-$)
• Russian incentives to attract Japanese drugmakers to establish production (PharmaLetter-$)
• J&J may have to compensate for faulty hip implants (Economic Times)
• New Dutch Foundation to Address High Medicines Pricing Announces Plan to File Complaint with Competition Authority (Medicines Law & Policy)

• Insurers, PBMs nudge FDA to finalize interchangeability guidance (BioPharmaDive)
• FDA Seeks Further Dialogue On Effort To Standardize CMC Application Data Elements (Pink Sheet-$)
• Cold Sore Ad Claims Review Poses Test For OTC Monograph Indications (Pink Sheet-$)
• Unraveling the mysteries of drug resistance in melanoma with CRISPR-Cas9 (Fdierce)
• TraceLink raises $93 million in Series D financing round (MedCity)
• Saving the brain with a new nerve agent antidote (CNBC)
• Y-mAbs’ story comes into the light: a shipping tycoon, the MSK researcher, a partial hold and a $92M IPO gamble (Endpoints)
• UPDATED:ADDITIONAL LOTS ADDED: Torrent Pharmaceuticals Limited Issues Voluntary Nationwide Recall of Valsartan/Amlodipine/HCTZ, Valsartan/Amlodipine and Valsartan Tablets (FDA)

• uniQure starts dosing in pre-pivotal hemophilia B gene therapy trial (Fierce)
• Esperion’s cholesterol drug cuts LDL-C in phase 3 (Fierce)
• Peptilogics Completes Successful Pre-IND Meeting With the Food and Drug Administration (FDA) for PLG0206 in Prosthetic Joint Infections (PJI) (Press)
• Zai Lab cans ex-GlaxoSmithKline eczema drug after phase 2 flop (Fierce)
• Johnson & Johnson to Host Investor Conference Call on the Phase 3 MARINER and COMMANDER HF Studies for XARELTO (Press)
• Vyxeos® Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia (Press)
• Bristol-Myers, AbbVie net FDA 'breakthrough' for myeloma drug Empliciti (Fierce) (Press)

• Whatever Happened To ... The Car Mechanic Who Invented A Device To Pop Out A Baby? (NPR)
• A Deluge Of Suits Over Connected Devices Could Be Coming (Law360-$)
• Gore Wins 3 Nods for Molding and Occlusion Balloon (MDDI)
• Immersive Technologies in Medical Device Development: Today and Tomorrow (MDDI)

• Ancestry Gets 23andMe Patent Killed, But TM Claims Survive (Law360-$)
• AdvaMed Commends HHS RFI To Modernize AKS To Advance Value-Based Health Care (AdvaMed)
• 7th Circ. Focuses On Impossibility Preemption In Dolin V. GSK (Law360-$)
• Opioid Lawsuits Look More Like A Tobacco Settlement Every Day (Forbes)
• Cigna, Express Scripts shareholders approve $54 billion acquisition deal (MedCity)
• NIH Investigating Foreign Influence In U.S.-Funded Research (BioCentury)
• Ex-Insys Execs Press Gov't for RICO Indictment Details (Law360-$)
• Novartis Prevails in Antitrust Suits Over Leukemia Drug (FDANews-$)
• Guest Post – The Drug Revolution, 3D Printing Drugs at Home (Drug & Device Law)

• FDA Advisory Committee Calendar
• Meeting of the Presidential Advisory Council on Combating Antibiotic-Resistant Bacteria – 26 September 2018

• Investigation of medicinal products containing valsartan: First analytical results now available (Swissmedic)
• Biocad to start producing cancer and autoimmune diseases drug in St Petersburg next year (PharmaLetter-$)
• ‘Invisible scalpel’ wins CE Mark for Guided Therapy Systems (Medical Design & Outsourcing)
• Medical Device Alerts issued in July 2018 (MHRA)
• Letters and drug alerts sent to healthcare professionals in July 2018 (MHRA)
• Esmya (ulipristal acetate) and risk of serious liver injury: new restrictions to use and requirements for liver function monitoring before, during, and after treatment (MHRA)
• Drug Safety Update: monthly PDF newsletter (MHRA)

• China FDA Simplifies Documentation Requirements for Renewals, Clinical Trial Applications (Emergo)

• USFDA conducts inspection of Sun Pharma’s Halol site: Sources (Economic Times)
• Lupin gets EIR from USFDA for Nagpur facility (Economic Times)
• Lupin launches contraceptive drug in the US market (Economic Times)
• CDSCO issues FAQs on new phytopharmaceuticals to help industry in manufacture, clinical trials & marketing (PharmaBiz)
• Bid to make ‘Made-in-India’ drugs in foreign lands a nonstarter as Indian API cos see window of opportunity in China price rise (PharmaBiz)
• Govt may change labelling regulations for fluoroquinolones to strengthen warnings about mental health side effect risk (PharmaBiz)

• Discontinuing pre-market evaluation of Herbal Component Names: Frequently asked questions (TGA)

• General surgeon shortage growing in U.S. (Reuters)
• Consumer Genetic Testing Will Change Your Life. In Fact, It Probably Already Has. (Forbes)