Recon: Appeals Court Invalidates Acorda’s MS Drug Patents; Nostrum CEO Defends 400% Price Hike

• US appeals court invalidates Acorda patents on MS drug (Reuters) (Biocentury)
• Orexo soars after winning opioid drug appeal against Teva (Reuters) (Law360-$)
• When Courts Allow Changes To Hatch-Waxman 30-Month Stay (Law360-$)
• Senate Poised to Pass Bill to Stop Flow of Opioids Through the Mail (NYTimes)
• Pharma chief defends 400% drug price rise as a ‘moral requirement’ (Financial Times) (Endpoints)
• The Secret Drug Pricing System Middlemen Use to Rake in Millions (Bloomberg)
• Fact-checking an ad war over drug prices, Celgene, and Bob Hugin (STAT)
• Merck KGaA, Pfizer's immuno-drug shown to alleviate kidney cancer (Reuters)
• More and More, New Drugs Clear the FDA With ‘Accelerated Approval’ (Undark)
• NZ's Fisher & Paykel Healthcare files complaint in the US against Resmed (Reuters)
• Opioids and the Sackler family (Financial Times)

• Novartis eyecare unit Alcon to set up new HQ in Geneva, Switzerland (Pharmafile) (Endpoints)
• EMA Postpones Decision On Next Phase Of EudraVigilance To End Of 2019 (Pink Sheet-$)
• Drug firms try to rip off taxpayers, says Matt Hancock (The Times) (Fierce) (PMLive)
• NHS moves to clamp down on incorrect/fraudulent prescriptions (PharmaTimes)
• Novo Nordisk stockpiles 16 weeks' worth of insulin in preparation for hard Brexit (Pharmafile)
• New UK microscopy centre launched to probe biological materials (Financial Times)
• Biological bounty is the ocean’s richest treasure (Financial Times)
• China sets 2022 target for new drug traceability system (SecuringIndustry)
• 'Major' NZ Funding Deal For Novartis Includes Five New Drugs (Pink Sheet-$)
• Johnson & Johnson case: Parliament panel members lash out at CDSCO (Economic Times)
• Controversial contraception app approved in U.S. drawing scrutiny overseas (STAT)
• Dismay as NICE rejects Roche’s MS drug Ocrevus (PMLive)

• Why Experts Can't Fix Pharma's Innovation Crisis (Part 1) And What to Do About It (Part 2) (Forbes)
• Lasker Awards honor four scientists for genetic research and developing anesthetic (STAT) (NYTimes)
• ICER Finds Opioid Use Disorder Treatments Are Not Cost-Effective (BioCentury)
• Amgen emerges as new multiple myeloma drug player, threatening Bluebird, Celgene (STAT) (Endpoints)
• How To Really Take Medical Conflicts Of Interest Seriously (Forbes)
• Joining the exodus at Gilead, CMO Andrew Cheng makes the switch to biotech CEO — triggering a cross-country move for Akero (Endpoints)
• Most Doctors Are Ill-Equipped to Deal With the Opioid Epidemic. Few Medical Schools Teach Addiction. (NYTimes)
• Young people with opioid addiction not getting proper treatment (Reuters)
• ANDA Sponsors Need To 'Slow Down' And Focus On Quality, US FDA Generics Director Says (Pink Sheet-$)
• Recent development of visceral leishmaniasis treatments: successes, pitfalls, and perspectives (DNDi)
• Biosimilar Bridging Study Waivers: Public Health Prerogative Or Trade Secret ‘Taking’? (Pink Sheet-$)
• WuXi and Inhibrx agree to work together on biologics manufacturing (PharmaLetter-$)
• Biodesy eyes expansion into therapeutics R&D with new CEO and $20M in VC funding (Fierce)
• Glythera rebrands as Iksuda, pledging to solve ADC problems (Fierce)
• This gene mutation is key to glioblastoma’s ‘immortality’ and could point to drug targets (Fierce)
• OncoResponse Nabs $40M for Cancer Drugs Based On Survivors’ Antibodies (Xconomy)
• Boehringer Ingelheim appoints new CMO (PharmaLetter-$)
• FDA Clears Lupin API Site Of NDMA Risk, Compliance Efforts Ongoing (Pink Sheet-$)
• Medivir names Linda Basse as CMO, adding Darzalex R&D experience to its clinical team (Fierce)
• Carsgen Solid Tumor CAR T Leads To Complete Response (Biocentury)
• Pharm D Solutions, LLC Issues Voluntary Nationwide Recall of all Sterile Compounded Drugs Due to A Potential Lack of Sterility Assurance (FDA)
• Determination That CEFZIL (Cefprozil) Tablets, 250 Milligrams and 500 Milligrams, and for Oral Suspension, 125 Milligrams/5 Milliliters and 250 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Federal Register)
• Receipt of Notice That A Patent Infringement Complaint Was Filed Against A Biosimilar Applicant  (Federal Register)

• FDA Grants Breakthrough Therapy Designation for Concentric Analgesics’ CA-008 in Post-Surgical Pain (Press)
• Early stage clinical trial of antimalarial drug begins (NIH)
• Merck heralds a rare Big Pharma success for antibiotic PhIII, but it’s also a cautionary tale about the market (Endpoints) (Press)
• First Patient Dosed in a Phase III Trial of Anti-PD-1 Antibody as First-line Treatment for Patients with Non-Squamous Non-Small Cell Lung Cancer (Press)

• Start-up AliveCor can now detect a dangerous blood condition by monitoring heart signals, and the FDA has given it 'breakthrough status' (CNBC) (Press)
• Anatomy of a beep: A medical device giant and an avant-garde musician set out to redesign a heart monitor’s chirps (STAT)
• DARPA Wants Brain Interfaces for Able-Bodied Warfighters (IEEE Spectrum)
• Medtronic Announces One-Month DAPT Clinical Study in the U.S. and Japan with Resolute Onyx DES in High Bleeding Risk Patients (Press)
• Masimo's respiration sensor receives FDA nod for neonatal, infant use (mobihealthnews)
• Boston Scientific launches trial for drug-eluting peripheral stent (Drug Delivery)
• Pilot of Kiio’s digital back pain therapy reports improved outcomes among those who used it (mobihealthnews)
• Minnetronix rebrands, eyes neuro market (MassDevice)
• With Latest FDA 510(k), physIQ Achieves Another Clearance as a Pioneer in AI Analytics (Press)
• Cook Medical Announces Successful Resolution of 2014 FDA Warning Letter (Press)

• Unwitting Patients, Copycat Comments Play Hidden Role In Federal Rule-Making (KHN)
• Akorn Says FDA Report Rehashes Data From Fresenius Trial (Law360-$)
• Marijuana Bill Scheduled For Congressional Vote This Week (Forbes)
• Judge Dismisses Price-Fixing Suit Against Impax, Allows Amended Complaint (FDANews-$)
• Oh, How the Tables Have Turned: Court Requires FDA to Follow Law Requiring Graphic Warnings on Cigarettes (FDA Law Blog)
• Former FDA Chief Counsel Rebecca Wood Rejoins Sidley as Practice Leader in Washington, D.C. (Press)
• Regents of the University of California v. Broad Institute, Inc. (Fed. Cir. 2018) (Patent Docs)
• It’s Never Too Late to Take Out the Laundry (Drug & Device Law)
• NJ Doc Loses License Over Opioid Prescriptions, Insys Pay (Law360-$)
• Collins Defends NIH Alert Over Foreign Influence (Biocentury)

• FDA Advisory Committee Calendar
• Evidence-Based Treatment Decision in Transplantation: Patient Individualized Treatment; Choosing the Right Regimen for the Right Patient – Public Workshop – 27 September 2018
• Oncologic Drugs Advisory Committee; Notice of Meeting – 10 October 2018

• European CRO Nuvisan Group to take over part Galderma’s R&D (Outsourcing Pharma)
• Good clinical practice for clinical trials (MHRA)

• Jiangsu Hansoh to raise up to $3 billion in Hong Kong IPO (PharmaLetter-$)
• Tentative Schedule for 23rd AHWP Annual Meeting (AHWP)

• DoP asks pharma exporters to report country-specific export issues (PharmaBiz)
• Indian pharma market clocks growth of 8.7% in Aug 2018 to Rs.11,342 crore (PharmaBiz)
• Sun Pharma receives fresh warnings from US regulator over Indian facility (PharmaLetter-$)

• Zimbabwe declares cholera emergency in capital after death toll rises to 20 (Reuters)