Recon: BMS, Compugen to Test Investigational Antibody and Opdivo in Advanced Solid Tumors

• US crackdown on foreign investments could cool Asia’s desire for US biotech (STAT)
• As China Hunts For New Cures, Investors Flood US Biotech Firms With Cash (Forbes)
• A growing number of states consider legislation to treat pharma as a utility (STAT)
• A new era for drug pricing: the ‘accountable choice’ (STAT)
• Trump signs his first drug pricing bill — but whiffs on the details (STAT)
• FDA panel backs Celltrion copycat of Roche blood cancer drug (Reuters) (Endpoints) (Press)
• CRISPR Therapeutics, Vertex set for first sickle cell disease trial after FDA lifts clinical hold — just don’t look for any explanation (Endpoints) (Xconomy)
• Allogene raises $324m from record-breaking IPO for off-the shelf CAR-Ts (PMLive) (Xconomy)
• Ionis may have found a home for dry AMD drug with Roche in $760M deal (Fierce) (Endpoints)
• Price increases on top drugs drove majority of recent growth, analysis finds (BioPharmaDive)
• Allergan works toward blockbuster goal with new jawline approval for CoolSculpting (Fierce)
• Chipping Away at Disease—and Drug Testing (WSJ)
• CVS Health and Aetna $69 Billion Merger Is Approved With Conditions (NYTimes) (Forbes) (CNBC) (DoJ)
• Sen. Chuck Grassley Asks FTC to Probe Hospital Contracts (WSJ)

• Bristol-Myers to invest in Compugen, collaborate in clinical trials (Reuters) (Endpoints) (Press)
• WHO sees Congo's Ebola outbreak lasting 3-4 months at least (Reuters)
• Otsuka and Proteus extend digital drugs tie-up (Financial Times) (Fierce)
• Rewriting reproduction: With stem cells and CRISPR, scientists breed mice with same-sex parents (STAT)
• UK pharma leader warns on ‘untenable’ Brexit deal (PMLive)
• Surging R&D spending in China narrows gap with United States (Science)
• Top court rules against German certifier in French breast implant case (Reuters)
• UK and Indian authorities clamp down on international medicines crime (MHRA)
• Ex-Celgene dealmaker George Golumbeski joins up to guide Carrick on its cancer drug quest — and maybe an IPO as well (Endpoints) (Fierce) (Press)
• Teva has buyer for plant in Israel that could save 200 jobs: report (Fierce)
• Brazil's Backlog Is Nearly Clear, But Convergence Still A Work In Progress (Pink Sheet-$)
• Novartis' Gilenya tops Teva giant Copaxone in head-to-head MS study (Fierce)
• Can Sanofi's new long-term Lemtrada data amp up sales in a crowded MS field? (Fierce)
• Health Canada Developing MDL Policies for 3D-Printed Medical Devices (Emergo)

• Biosimilar Suffixes Appear Superfluous In Adverse Event Reporting (Pink Sheet-$)
• Can Big Pharma's moneymakers stay hot as price hikes slow down? (Fierce)
• Gene Therapy Company Audentes Raises $151M (BioCentury)
• Targeting Aging Comes Of Age (LifeSciVC)
• What’s behind the pharmaceutical sector’s M&A push (McKinsey)
• FDA’s Insanitary Conditions Revised Draft Guidance: Required Reading for Compounding Facilities (FDA Law Blog)
• Arie Belldegrun and David Chang score record IPO, now they plan to win the race to a historic FDA OK (Endpoints)
• Texas-based Children's Health pilots Proteus' ingestible sensor pills for heart transplant patients (mobihealthnews)
• AcelRx rally quickly fizzles after FDA offers a guarded warning about its latest pain drug pitch (Endpoints)
• Influenza Virus Vaccine for the 2018-2019 Season (FDA)
• FDA halts imports from China's Huahai Chuannan plant (Reuters)
• San Antonio’s BioAffinity Signs Licensing Deal for Cancer Diagnostic (Xconomy)
• Sprayology Issues Voluntary Nationwide Recall of Homeopathic Aqueous-Based Medicines Due to Microbial Contamination (FDA)
• Ireland’s largest generics maker invests €86m, targets US market (InPharmaTechnologist)
• Flu vaccine reduces risk of flu hospitalization among pregnant women (NIH)
• Ziopharm cuts Precigen ties, narrowing its R&D focus (Fierce)
• CDMO Almac adding 100 employees to its North Carolina site (Fierce)
• Balancing innovation and competition in the biologics marketplace (PhRMA)

• Transgene to Present Positive Results from Phase 1b Trial of TG1050 in Patients with Chronic Hepatitis B at Upcoming AASLD Liver Meeting 2018 (Press)
• Synspira Receives FDA Orphan Designation for PAAG15A for the Treatment of Cystic Fibrosis (Press)

• TransEnterix Receives FDA 510(k) Clearance for 3mm Diameter Instruments (Press)
• Medtech reporting would change under new opioid law (MassDevice)
• FibriCheck's a-fib detection app scores 510(k) clearance, targets 2019 US launch (mobihealthnews)

• FACT CHECK: Trump's False Claims On 'Medicare For All' (NPR)
• Meet the ex-HHS staffer running for Congress (Politico)
• Investor Says Teva Pharma Lied About Price-Hike Scheme (Law360-$)
• PTO Final Rule Dropping BRI Patent Claim Standard Offers No Deference To District Courts (Pink Sheet-$)
• Even in California, Failure To Report Requires Something Reportable (Drug & Device Law)
• Roche Molecular Systems, Inc. v. Cepheid (Fed. Cir. 2018) (Patent Docs)

• FDA Advisory Committee Calendar

• CAR-T Funding: It's (Nearly) All About The Price In The UK (Pink Sheet-$)
• Sequiris invest £40m into expansion of Liverpool plant creating 100 new jobs (Pharmafile)
• Rivaroxaban (Xarelto▼) after transcatheter aortic valve replacement: increase in all-cause mortality, thromboembolic and bleeding events in a clinical trial (MHRA)
• Ritonavir-containing products: reports of interaction with levothyroxine leading to reduced thyroxine levels (MHRA)
• Ponatinib (Iclusig▼): reports of posterior reversible encephalopathy syndrome (MHRA)
• Transdermal fentanyl patches: life-threatening and fatal opioid toxicity from accidental exposure, particularly in children (MHRA)
• Letters and drug alerts sent to healthcare professionals in September 2018 (MHRA)
• Medical Device Alerts issued in September 2018 (MHRA)

• Sanofi marches further into China’s rural market (PharmaLetter-$)

• UP to open 6 pharma parks; gets Rs 5,000-6,000 cr commitment (Economic Times)
• Indian pharma's efforts to market medicines in Japan still an uphill task: Makoto Shigemitsu (PharmaBiz)
• Aurobindo Pharma gets USFDA nod for infections treatment drug (Economic Times)

• Updates on GMP clearance application eforms (TGA)