Recon: FDA Approves Lilly's Acute Migraine Drug Reyvow; J&J, Bayer's Xarelto Picks up its 8th Indication

• Pfizer posts detailed phase 3 data on its Dupixent rival (Fierce) (Endpoints) (Press)
• FDA approves Eli Lilly drug to ‘resolve’ migraine pain in 2 hours (CNBC) (Reuters) (FDA) (Press)
• OxyContin maker Purdue gets brief shield from litigation (Reuters) (NYTimes)
• J&J, Bayer's Xarelto scores FDA nod to treat acutely ill patients during and after hospitalization (Fierce) (Press)
• In-house FDA review flags a suspicious imbalance in deaths as Shionogi hunts an OK for antibiotic (Endpoints)
• In a U-turn, ICER takes more positive view of AbbVie’s Rinvoq (PMLive)
• California’s New Transparency Law Reveals Steep Rise In Wholesale Drug Prices (KHN) (ArsTechnica)

• Time is of the essence for patients who have serious and life-threatening conditions. Fast Track designation is one of four programs that can help expedite the development and review of drugs intended to address unmet medical need in the treatment of serious conditions. If you’re interested in pursuing a Fast Track designation for your therapy, here are some of the basics you’ll need to know.

• Congo to start using Johnson & Johnson Ebola vaccine in November (Reuters)
• Strides Regains Controlling Share in Stelis BioPharma, Will Focus on Sterile Injectables (Big Molecule Watch)
• UK Signs First No-Deal Brexit Ferry Contracts (Pink Sheet-$)
• European Network of Paediatric Research at EMA elects new chair (EMA)
• US mulls tariffs on Swiss drug exports, weighing on Novartis and Roche –  report (Endpoints) (NZZ)
• Canada's Decision To Make Public More Clinical Trial Data Puts Pressure On FDA (NPR)
• Classifying Software Under MDR, IVDR: New Guidance From MDCG (Focus)

• FDA is smashing the status quo for regulatory science (STAT)
• CBER Advice on CGT Process and Facility Management Includes Early Consideration of Engineering and Capacity Needs (IPQ)
• Will Some Biologics Get 30 Years of Exclusivity? (Focus)
• Have FDA’s Generic Approvals Helped With Competition? Researchers Say Too Early to Tell (Focus)
• Accounting for hope: using ‘mean survival gain’ to price new cancer drugs (STAT)
• AZ got past FluMist's efficacy woes, but now it's plagued by production problems (Fierce)
• Why High Drug Prices Persist Despite The Fact Good Medicines Are Lowering Healthcare Spending (Forbes)
• Sun Pharma is accused of distributing medicines in Washington state without a license (STAT)
• Real-World Data Playing a Bigger Role in Drug Development (Medpage)
• HR violation pushes Revance co-founder out, vaulting former Zeltiq chief to the helm (Endpoints)
• GSK and AZ on continuous manufacturing platform ‘grand challenge’ (InPharmaTechnologist)
• BridgeBio scraps plan to buy Eidos after bids rebuffed (Fierce) (Endpoints)
• Torrent Pharma recalls 74k bottles of hypertension drug from US (Economic Times)
• Sun Pharma launches Cequa to treat dry eye disease in US (Economic Times)
• Researchers Try A Genetic Diabetes Test To Prevent Emergency Hospitalizations (NPR)
• Eyeing $86M, Galera leads a pack of three modest biotech IPOs pushing past high profile stumbles (Endpoints)
• Cell therapy startup raises $16 million to fund its quest for the Holy Grail in regenerative medicine (Endpoints)
• A predator's world? Top analyst sees the 'haves' and the 'haven'ts' diverge as biotech bubbles form — and collapse (Endpoints)
• Covance clinical development lead takes the reins at Pharm-Olam (Fierce)
• ReNeuron shares clinical data on stem cell vision loss therapy (Fierce)
• Quality Advice On How To Surf The Approaching Wave of Cell And Gene Therapies (Pink Sheet-$)
• FDA advises consumers not to use Rompe Pecho cough syrup (FDA)

• Flexion Therapeutics Announces Extended FDA Review of Supplemental New Drug Application for ZILRETTA® (Press)
• Roche’s MabThera beats incumbent drug in pemphigus vulgaris phase 3 (PMLive) (Press)
• Daiichi Sankyo show low CV events and bleeding in NVAF patients on Lixiana (Pharmafile) (Press)
• Incyte Announces Positive 52-Week Results From a Randomized Phase 2 Study of Ruxolitinib Cream in Patients With Vitiligo (Press)
• Concert Pharmaceuticals Presents Positive Phase 2 Data in Alopecia Areata During Late-Breaker Session at EADV Congress (Press)
• Allergan and Molecular Partners Present Late-Breaking Data from Phase 3 Studies of Investigational Abicipar pegol in Neovascular Wet Age-Related Macular Degeneration (Press)
• REGENXBIO Announces Additional Positive Interim Phase I/IIa Trial Update for RGX-314 for the Treatment of Wet AMD at the American Academy of Ophthalmology 2019 Annual Meeting (Press)
• Kodiak Sciences Announces Safety, Efficacy and Durability Data from Ongoing Phase 1b Study of KSI-301 in Patients with Wet Age-Related Macular Degeneration, Diabetic Macular Edema and Retinal Vein Occlusion (Press)
• Forbius Completes Enrollment into Phase 1a Solid Tumor Trial of AVID200, First-in-Class TGF-beta 1 & 3 Inhibitor; Closes Series C Financing (Press)

• 2020 Guidance: CDRH Offers a Look at What’s Coming (Focus)
• Hearing aids may help delay dementia, depression in elders (Reuters)
• New Coalition, Stakeholder Groups Push Back Against FDA 'Backdoor' Attempts to Regulate PGx Tests (GenomeWeb)
• DiaMedica Therapeutics Announces Clearance to Initiate Phase II Clinical Trial of DM199 for Chronic Kidney Disease (Press)
• OssDsign Receives US FDA Clearance for Cranial PSI Accessories - Strengthening Business Position in the US (Press)
• Sky Medical Technology Nabs FDA Clearance for VTE Device (MDDI)

• FDA in Brief: Readout of Acting FDA Commissioner Ned Sharpless, M.D., Visit to FDA’s Forensic Chemistry Center (FDA)
• E-Cigarettes Went Unchecked in 10 Years of FDA Inaction (NYTimes)
• US vaping-related deaths rise to 29 (Reuters)
• Reynolds American files for FDA review of e-cigarette (Reuters)
• Glaukos Beats Last Of Rival's PTAB Challenges To Stent IP (Law360-$)
• “ALI” Should Not Mean “Always Liability Increases” – Apportionment Misadventures (Drug & Device Law)
• New California Requirement for Some Cosmetics (FDA Law Blog)

• FDA Advisory Committee Calendar

• Plans to keep EU budget funding in 2020 in the event of a no-deal Brexit (European Parliament)
• Disappointing End For MolMed’s Zalmoxis Cell Therapy In EU (Pink Sheet-$)
• Report: British drugmakers worry about damage to competitiveness after possible Brexit deal (medcity)
• UK Tackles GCP Concerns Over Electronic Health Records (Pink Sheet-$)
• Assistive technology: definitions, examples and safe use (MHRA)

• Definition of medical devices to include nebulisers, syringes (Economic Times)
• CDSCO issues guidelines on performance evaluation of IVDs for grant of manufacturing and import licenses (Pharmabiz)
• Glenmark Pharma working towards building cost-efficiency: Glenn Saldanha (Pharmabiz)
• Indian Pharma Market registers 11.9% growth in September 2019 (Pharmabiz)
• Pharma professionals must upgrade skills regularly to ensure highest quality standards of products: Experts (Pharmabiz)

• AIVC recommendations for the composition of influenza vaccine for Australia in 2020 (TGA)

• You’re Swabbing a Dead Gorilla for Ebola. Then It Gets Worse. (NYTimes)