Recon: Pfizer Bets $425M on BioNTech to Develop Flu Vaccine; FDA Expands Kalydeco for Infant Use

• Pfizer bets on biotech flu vaccine in $425 million BioNTech alliance (Reuters) (BioCentury) (Endpoints)
• Vertex cystic fibrosis drug gets expanded approval for use in infants (Reuters) (Press)
• Apple is beefing up a team to explore making its own health chips (CNBC) (MassDevice) (MobiHealthNews)
• US FDA's Streamlined Hiring Pilot Restarts After Delay (Pink Sheet-$)
• Lawmakers Get Few Answers on Roots of Opioid Crisis (Medpage)
• National Coverage Analysis of CAR-T Therapies — Policy, Evidence, and Payment (NEJM)
• To lower state drug costs, governors association is promoting several ideas (STAT)
• Cleveland Biolabs forms anti-aging drugs joint venture with Everon (BioWorld)
• Most valuable unpartnered assets reveal a changing of the guard (EP Vantage)
• Armored CAR-Ts? Memorial Sloan Kettering engineers CAR-T loaded with checkpoint inhibitors (Endpoints)
• Oral arguments set for Texas Obamacare lawsuit (Politico)
• State Boards Turn Blind Eye to FDA-Sanctioned Docs (Medpage)

• Blackstone invests $400 million in HEC Pharm via convertible bonds (Reuters) (BioCentury)
• Chinese deputy governors, mayor fired over vaccine scandal (AP)
• Indian biotech owner detained in Dubai over £550m fraud allegations (Pharmafile)
• India's domestic pharma retail market grows 13% in July (Times of India)
• EU Report Probes Impact Of IP Incentives On R&D, Market Access (Pink Sheet-$)
• Artios raises $84M for developing cancer drugs targeting DNA repair pathway (MedCityNews)
• NPPA fixes ceiling price of 92 drug formulations (Economic Times)
• The ICH Q3D(R1) draft Guideline presentation available now on the ICH website (ICH)
• UK participation in Horizon 2020: UK government overview (MRC)

• Ortho resubmits Duobrii in the US (PharmaTimes)
• Scientists Race To Improve 'Living Drugs' To Fight Cancer (NPR)
• Pursuing an Effective Ovarian Cancer Vaccine (JAMA)
• 2019 Express Scripts Formulary Exclusions: Hepatitis C Changes Show Why the Drug Channel Must Change, Too (Drug Channels)
• Biohaven steps up big clinical plans for its reformulated ALS generic — now also aimed at anxiety (Endpoints)
• Cancer patients using alternative medicine may skip some standard care (Reuters)
• Karuna names Lilly veteran, ex-Voyager CEO Steven Paul as leader (Fierce)
• Stocking EpiPens at restaurants might reduce fatal allergic reactions (Reuters)
• Off-Label Use Of Transmucosal Fentanyl Creates Ethical, Practical Dilemma For US FDA (Pink Sheet-$)
• Third Rock names ex-Foundation executive Steven Kafka as venture partner (Fierce)
• US FDA approves first non-gene edited allogeneic CAR T-cell candidate for trials (BioPharmaReporter)
• Enthusiasm For US Biosimilars Wanes For Some, But Not Others (SCRIP-$)
• US FDA Advisory Panel Split On Value Of Education In Fentanyl REMS (Pink Sheet-$)
• Sun Pharma receives USFDA nod ophthalmic solution used to treat dry eye disease (Economic Times) (Press)
• In Conversation With Novo Nordisk CMO: The Ongoing Fight Against Diabetes (SCRIP-$)
• 2017 Perceptions and Insights of Clinical Research: An Excerpt (Part 1) (Lilly)
• Novocure speeds up trial of drug-device combo in pancreatic cancer (Drug Delivery)
• Opportunity to Co-Sponsor Office of Research Integrity Workshops (Federal Register)
• Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Staff; Information Available to Industry; Extension of the Proposal Period (Federal Register)

• A ‘high-risk, high-reward’ effort on NGF pain med fasinumab by Regeneron, Teva clears a revised PhIII — serious questions linger (Endpoints)
• CEL-SCI Reports Recent Data Review by the Independent Data Monitoring Committee for Its Pivotal Phase 3 Head and Neck Cancer Study (Press)
• US FDA grants Breakthrough Therapy Designation for food allergy drug Xolair (BioPharmaReporter)

• GE Healthcare Becomes Member of AdvaMed to Advance Medical Technology Globally (AdvaMed)
• NanoMedical Tackles Opioid Abuse with Combination Device (MDDI)
• Is FDA doing enough to support medical device security? (HealthcareITNews)
• AngioDynamics acquires Surgical Specialties’ BioSentry sealant, updates on Bard antitrust suit (MassDevice)
• MolecuLight wins FDA de novo nod for handheld fluorescence wound imager (MassDevice)
• What you need to know about medical device packaging (Medical Design and Outsourcing)
• Hologic will distribute analgesic system to aesthetic providers (Medical Design and Outsourcing)

• Judge tosses Zimmer Biomet hip suit over statute of limitations issues (MassDevice)
• Out-Of-State Drugs Can Be Taxed, Minn. High Court Rules (Law360-$)
• Ex-Katten Atty Loses Bid To Dodge Shkreli Fraud Charges (Law360-$)

• FDA Advisory Committee Calendar

• How are new medicines approved by EMA? (EMA)
• LenioBio and Fraunhofer Institute to develop protein expression platform (BioPharmaReporter)

• Medtronic Announces Commercial Launch of the IN.PACT(TM) Admiral(TM) Drug-Coated Balloon in Japan (Press)

• Can Indu Bhushan deliver PM Modi’s promise of healthcare? (Economic Times)
• Health ministry move to reclassify oxytocin as Schedule H1 drug leaves chemists perplexed (PharmaBiz)
• Lack of data transparency in healthcare sector hampering patients' abilities to make informed decisions (PharmaBiz)

• Notice: Medical Device Cybersecurity (Health Canada)

• Report Finds Traces of a Controversial Herbicide in Cheerios and Quaker Oats (NYTimes) (CBS)
• First Clinical Trial in Medicine Changed World History (Medpage)
• Cancer risk with diabetes is higher for women than men (Reuters)