Recon: Alexion Faces PTAB Review of Soliris Patents; Congo Ebola Outbreak Death Toll Tops 2,000

• Patent court to review Alexion's Soliris patents on Amgen challenge (Reuters) (Endpoints) (BioPharmaDive)
• Clock Ticking On Sharpless' Term As Acting FDA Commissioner (BioCentury) (Endpoints)
• The Little Known Legal Doctrine Making Big Pharma Pay for the Opioid Crisis (Politico)
• Proposed Opioid Deal With Purdue Drawing Pushback From States (WSJ)
• Where did the Sacklers move cash from their opioid maker? (AP)
• Opioid settlement would divide money based on local impact (AP)
• US FDA approves Mylan generic of Lilly lung cancer drug Alimta (Reuters) (Endpoints)
• Hospitals Should Replace Infection-Prone Scopes With Safer Models, FDA Says (NYTimes)
• Worst. biotech. deal. ever? Turns out AbbVie has plenty of competition for that title (Endpoints)

• Global public meeting on draft ICH guideline on clinical trials (EMA)
• Vaccines group seeks $7.4 billion to save up to 8 million lives (Reuters) (STAT)
• NHS leaders warn of no-deal Brexit flu vaccine delays (PMLive)
• Novartis takes aim at Roche's star MS drug (Reuters) (Endpoints)
• Hormone therapy during menopause raises breast cancer risk for years, study finds (STAT) (The Lancet) (MHRA 1, 2)
• New Zealand measles outbreak prompts travel warning (Reuters)
• Ebola death toll in east Congo outbreak climbs above 2,000 (Reuters) (NYTimes) (CDC)
• Congolese girl, 9, dies of Ebola in Uganda: hospital official (Reuters)

• Doctors are more likely to prescribe opioids later in the day — or if appointments run late (STAT)
• Animal activists are on the wrong side of the fight against AIDS (STAT)
• EMA Offers Edits on FDA Draft Guidance on Biosimilars (Focus)
• Getting ready for Dorian: Now would be a good time to refill prescription medications (Tampa Bay Times)
• Connecticut’s Measles Vaccination Rates Keep Falling (WSJ)
• FDA Patient-Focused Drug Development Guidance Series for Enhancing the Incorporation of the Patient’s Voice in Medical Product Development and Regulatory Decision Making (FDA)
• Shopping At The Apotheke: Compare German Pharmacies With Your Corner Drugstore (KHN)
• On track for first autoimmune drug approval, Bing Yao steers AstraZeneca spinoff to $150M IPO (Endpoints) (Fierce)
• Remember that post-marketing trial? New study confirms many drugmakers don’t do them — half drag their feet (Endpoints)
• Ex-Altimmune chief Bill Enright lands CEO role at Vaccitech; Reata poaches Alnylam CFO Manmeet Soni (Endpoints)
• Practicing What We Preach — Ending Physician Health Program Bans on Opioid-Agonist Therapy (NEJM)
• Baylor, Arizona State University Nab $1.6M NIH Grant to Develop Genome Editing Governance (GenomeWeb)
• MGB tops up cash pool to wrap up antibiotic phase 2a (Fierce)
• Engineering As Translation: What Biomedical Entrepreneurs Can Learn From A Petrol CEO (Forbes)
• Could gene therapy be the solution to obesity and diabetes? (Fierce) (Genome Research)

• The Lancet Infectious Diseases Publishes Results from Paratek’s Phase 3 Oral only Dosing Study of NUZYRA® (omadacycline) for Skin Infections (Press)
• New Updated Data Will be Presented From Oncopeptides' Pivotal Phase 2 HORIZON Study in Patients With Extra Medullary Disease (EMD) on September 15^th (Press)
• Seqirus Presents New Clinical Data that Reinforce the Ability of MF59® Adjuvanted Seasonal and Pandemic Influenza Vaccines to Increase Immune Response (Press)

• When FDA Can Accept Greater Premarket Uncertainty for Medical Devices (Focus)
• Concept Medical Inc. Granted 'Breakthrough Device Designation' From the FDA for Its MagicTouch AVF Sirolimus Coated Balloon (Press)

• Allergan To Pay $5M To Exit Ohio Opioid Bellwethers (Law360-$)
• PTAB Grants Inter Partes Review for Narcan Spray Patent (FDA News-$)
• Fed. Circ. OKs Order Blocking Generic Of Allergan Eye Drug (Law360-$)
• CDC, FDA report 215 cases of respiratory illness possibly tied to vaping (Reuters) (Press)
• FTC probes marketing practices of e-cigarette maker Juul: source (Reuters)
• Just the Stats, Ma’am: FDA Increases Inspections in Foreign Countries, Resulting in a Higher Rate of Enforcement Actions than Imposed on U.S. Facilities (FDA Law Blog)
• PTAB Redeclares CRISPR Interference and Grants Leave for Some (But Not All) of Parties' Proposed Motions (Patent Docs)
• Georgia Court Makes Short Work of PMA Medical Device Case (Drug & Device Law)
• Louisiana Physician’s Assistant Sentenced to Prison for Scheme to Unlawfully Distribute Controlled Substances (DoJ)

• FDA Advisory Committee Calendar
• Public Workshop on Patient-Focused Drug Development: Guidance 4 – Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making – 6 December 2019
• Fourth International Workshop on Global Bioequivalence Harmonization Initiative (GBHI) FDA/AAPS/EUFEPS CO-SPONSORSHIP AGREEMENT – 12-13 December 2019

• Young startups on new-look Hong Kong exchange see major CEO pay packets (Fierce)
• Lack of deal-making is restricting pharma innovation in Asia-Pacific; report (PharmaLetter-$)
• Japanese Drugmaker Rapped for Cleaning Violations (FDA News-$)

• India must review progress of Bangladesh & China in pharma to bring in best tech practices: Sunil Attavar (PharmaBiz)
• DCGI directs cos to submit data on 66 irrational FDCs by Sept 30, based on SC verdict (PharmaBiz)

• Consultation: Changes to permissible ingredients - Low-negligible risk (TGA)

• WHO Launches Registry for Gene Editing Studies (Focus)