Recon: Pfizer Buys Swiss Rare Disease Biotech Therachon for up to $810M

• Pfizer to Acquire Therachon for Up to $810M (GEN) (Endpoints) (PMLive) (BioPharmaDive) (Press)
• Gilead goes for Goldfinch in $109M kidney deal (BioCentury) (STAT) (Endpoints)
• J&J Pays About $1 Billion to Resolve Pinnacle-Hip Suits (Bloomberg) (Reuters)
• Pharma pushes back against setting international standards for drug-pricing transparency (STAT)
• List prices in drug ads on TV coming as CMS finalizes rule (Focus) (STAT) (NYTimes) (Reuters)
• Facing pressure across Washington, drug industry courts pro-business Democrats (STAT)
• New documents reveal Third Rock Ventures is set to launch a cancer diagnostics company (STAT)
• Graham: Doing nothing on drug prices 'unacceptable' (The Hill)
• Looking to topple Pfizer’s Prevnar 13 dynasty, Merck claims another win for its ‘breakthrough’ pneumococcal conjugate vaccine (Endpoints) (Press)
• Purdue executive Richard Sackler cast blame on opioid victims, old emails show (CBS) (AP)
• Sacklers Discussed Selling Purdue in 2000 (WSJ)
• Bausch Health shares jump after the company, formerly Valeant, raises outlook (CNBC)
• The Money And Politics Of Prescription Drugs: What You Need To Know (KHN)
• Drug Industry Patents Go Under Senate Judiciary Committee’s Microscope (KHN) (STAT)
• Silicon Valley’s health-tech start-ups need to stop getting in so much trouble (CNBC)

• In Canada, a little-known drug regulator shows its teeth (Reuters)
• WHO experts recommend ramping up Ebola vaccine after Congo cases surge (Reuters)
• Clashes in Ebola-affected Congo city kill at least nine (Reuters)
• Drug buying plan leaves hundreds without HIV treatment in Mexico (Thomson Reuters)
• AstraZeneca-Daiichi breast cancer treatment shows promise in latest study (Reuters) (Endpoints)
• Pfizer scores conditional European approval in ALK-positive lung cancer with Lorviqua (Pharmafile)
• Akcea gets first OK for Waylivra in rare triglyceride disorder (PMLive)
• EMA Chief Says Brexit Has Impaired Ability To Support R&D (Pink Sheet-$)
• Bubonic Plague Strikes In Mongolia: Why Is It Still A Threat? (NPR)
• Cholera, more civilian casualties feared in Libya: WHO (Reuters)

• Pfizer Calls for Compromise on Retroactively Using Suffixes in Biologic Names (Focus)
• BioNTech snaps up struggling MabVax's lead asset, labs, eyeing San Diego R&D site (Fierce)
• Mallinckrodt stock swings up 16%, then down, after drugmaker beats earnings estimates and raises 2019 profit outlook (CNBC)
• Health tech start-up uBiome suspends clinical operations following FBI raid (CNBC)
• Regeneron’s star bispecific is linked to 2 deaths in a small study — which was no help for its Q1 call (Endpoints)
• Bicycle Therapeutics enters dementia discovery with venture capital fund (PMLive)
• Whole-Genome Sequencing Plus AI Yields Same-Day Genetic Diagnoses (NIH)
• Laura Jacobus hopes to provide her newly approved drug at ‘little or no’ cost to patients (STAT)
• Oh My Gut! Allergan and Ironwood's IBS-C push links patients to telemedicine (Fierce)
• Epigenetic route to recovery for spinal cord injury (Nature)
• Prioritizing synthetic lethal targets with functional genomics (Nature)
• Bristol-Myers Squibb Company Prices $19 Billion of Senior Unsecured Notes (Press)
• All To Play For: CAR-T Specialist Celyad’s Big Year (Scrip-$)
• Complex Generic Mid-Cycle Meetings: US FDA Suggests Taking The Date Offered (Pink Sheet-$)
• Resubmission After Withdrawal: US FDA’s Mavenclad Approval Acknowledges Long Regulatory History (Pink Sheet-$)
• ‘It is a bit uncomfortable’: Before the criminal allegations, an awards program honored Insys and Theranos (STAT)
• Sarepta goes back to the gene therapy well at Nationwide Children’s for its latest muscle-wasting program (Endpoints)
• Tillman Gerngross isn’t out to impress you with biobucks, but here are 3 partner deals that should (Endpoints)
• FDA Warns French Drugmaker Over GMP Concerns (Focus)

• Eli Lilly's Emgality shows positive Phase 3 results in treatment of migraine (Pharmafile)
• Isofol Reports 58 % Overall Response Rate in Patients with Metastatic Colorectal Cancer in Phase 1/2a Open Label Extension Study with Arfolitixorin (Press)
• Neuropore Initiates Phase 1 Clinical Trial in Healthy Volunteers with NPT520-34, a Therapeutic Candidate Aimed at Treating Parkinson’s Disease and Amyotrophic Lateral Sclerosis (Press)
• Roche to present new OCREVUS (ocrelizumab) data analyses showing significant reduction of disability progression in relapsing and primary progressive multiple sclerosis at the AAN Annual Meeting (Press)

• New Regs, New Tech Bring New Medical Device Cyber Liability (Law360-$)
• Connected medical device design for the Internet of Things (Emergo)
• Penumbra tops estimates with Q1 results, guides to high end of sales forecast (MassDevice)
• Judge orders Otto Bock to sell top U.S. microprocessor knee competitor (MassDevice)
• Experimental Surgery Gains Support as Opioid Deaths Rise (AP)
• FDA Finalizes Two Guidances to Align X-Ray Imaging Devices With International Standards (Focus)
• FDA Accepts Recros Medica De Novo Submission for Nuvellus™ Focal Contouring System (Press)
• FDA clears mobile AI platform for heart murmur screening (mobihealthnews)

• Bipartisan pair of senators urges Barr to defend ObamaCare in court (The Hill)
• Buffett: ‘No guarantee of success’ with Haven health venture (CNBC)
• Feds Want To Show Health Care Costs On Your Phone, But That Could Take Years (KHN)
• Trump ‘conscience’ rule for medical providers facing legal challenge in California (CNBC)
• Presidential hopeful Sen. Elizabeth Warren unveils $100 billion plan to combat the opioid epidemic (CNBC)
• FTC Would Get Green Light To Go After Patent Thickets Under Bipartisan Senate Bill (Pink Sheet-$) (Politico)
• Denver on track to reject 'magic mushroom' legalization (Reuters)
• California cites Cardinal Health for shipping controlled substances to a dead pharmacist (STAT)
• Insys Jurors Say They Thought Execs Were Guilty Early On (Law360-$)
• And if They Don’t Dance, Well They’re No Friends of Mine – And They’ll Probably Get Sued (FDA Law Blog)
• Fraudulently Joined at the Hip (Drug & Device Law)
• Thermolife Int'l LLC v. GNC Corp. (Fed. Cir. 2019) (Patent Docs)

• FDA Advisory Committee Calendar

• Brexit: The bigger picture—Rethinking supply chains in a time of uncertainty (McKinsey)
• Lupin gets more time from govt to complete project in Indore SEZ (Economic Times)
• Company led drug alert - Macopharma intravenous infusion bags (MHRA)
• Parents in Germany could face $2,800 fine for failing to vaccinate children (CNBC)

• Health ministry to amend Rule 96 of D&C Rules to streamline labeling requirements of iron tablets and polio drops (PharmaBiz)
• China to offer great opportunity for Indian drug makers as Chinese govt intends to reduce healthcare costs: Experts (PharmaBiz)

• Regulatory Decision Summary - Modification of MSM Blood Donor Deferral (Health Canada)