Recon: ICT to Investigate Claims That Allergan Rivals Stole Botox Trade Secrets

• House Dems to begin considering drug pricing legislation next week (The Hill)
• If Purdue Pharma declares bankruptcy, what would it mean for lawsuits against the opioid manufacturer? (STAT)
• Opioid maker Purdue Pharma seeks to have Massachusetts lawsuit thrown out (STAT) (Forbes) (AP)
• The drug pricing debate in America reaches a boiling point at #JPM19 (Endpoints)
• Citing lingering concerns, FDA stops Evoke at the 10-yard line a month before PDUFA date (Endpoints)
• With $1.4B bet riding on their decision, myelofibrosis drug left for dead by Sanofi hits FDA’s inside track to a blockbuster comeback (Endpoints)
• FDA Expected To Approve Esketamine Nasal Spray For Depression (NPR)
• Patients Question How FDA Approves Medical Devices (KHN)
• Mixing medicine and money: Why the rise of health system VCs is raising ethical concerns (HealthCareDive)

• ITC agrees to investigate Allergan claims that Botox rivals stole secrets (STAT)
• French court dismisses damages claims against Merck over thyroid drug (Reuters)
• MSF-run hospital develops 3D printed prosthetics for war victims (Reuters)
• PMDA Sacks Employee for Doing Side Business with Companies with COI (PharmaJapan)
• China creating national medical ethics committee to oversee high-risk clinical trials (STAT)
• London HIV patient becomes world's second AIDS cure hope (Reuters) (NYTimes) (Endpoints)
• Seventure holds first close of €200M microbiome fund (Fierce)
• WHO Consults On Applying Key Quality Standard To Regulatory Authorities (Pink Sheet-$)
• Merck KGaA, Pfizer added to BioXcel’s pancreatic cancer deal (PharmaTimes)
• EU ‘Repurposing’ Project Plans Pilot Phase (Pink Sheet-$)
• Roche’s EU Accelerated Assessment Bid For Tumor Agnostic Entrectinib Backfires (Scrip-$)
• UK Drug Pricing & IP Targeted As US Gears Up For Post-Brexit Trade Deal Talks (Pink Sheet-$)
• BBC warns of illegal STI drugs being sold online (PharmaTimes)
• Shanghai Exchange Eases Rules For Biopharmas Listing On New Innovation Board (BioCentury)
• Even a No-Deal Brexit Will Not Erase Prior, Adverse CJEU Precedent (Drug & Device Law)
• Bayer submits darolutamide for marketing authorization in Japan (Press)

• The Unintended Benefits Of Vaccines (NPR)
• A Large Study Provides More Evidence That MMR Vaccines Don't Cause Autism (NPR) (Reuters)
• Senators Seek Changes to FDA Guidance to Speed Entry of Insulin Biosimilars (Focus)
• New Impurity Found in Blood Pressure Drug Prompts Expanded FDA Recall (Focus)
• What financial ties? Most Americans were unaware of database showing pharma payments to docs (STAT)
• Prescription drug prices can vary by thousands of dollars depending on where you buy them (CBS)
• With eye on Heron’s rival product, Pacira to buy MyoScience to fortify its Exparel franchise (Endpoints)
• Sagent buys U.S. sterile injectables plant in boost for parent Nichi-Iko (Fierce)
• Ionis Pharmaceuticals Funds Its Pipeline of More Than 40 Drugs (Motley Fool)
• Ultrasound Societies Urge FDA to Remove “Black Box” on Ultrasound Contrast Agents (Press)
• Hoerter to replace Taylor as CEO of Deciphera (Fierce)
• Novartis, Lilly and more look for psoriasis edge with new data at AAD (Fierce)
• IQVIA debuts research platform to de-ID links between genomic and clinical data (Fierce)
• Backed with $180M-plus in cash, I/O trailblazer Lieping Chen spotlights NextCure’s preclinical work on next-gen antibody (Endpoints)
• Astellas taps ReForm to improve clinical-phase biologics (Fierce)
• Was AstraZeneca CEO Pascal Soriot happy with his $14.8M in ’18 compensation? Probably not so much (Endpoints)
• Bad year at Celgene? Forget about it. CEO Mark Alles nabbed a big raise as compensation gyrated to $16.2M (Endpoints)
• Apotex Corp. Issues Voluntary Nationwide Recall of Drospirenone and Ethinyl Estradiol Tablets, USP, 28x3 Blister Pack/Carton Due to Possibility of Missing/Incorrect Tablet Arrangement (FDA)

• Almirall and Athenex Announce Positive Topline Results from Two Phase III Studies of KX2-391 Ointment 1% Featured in Late Breaker Program at the 2019 American Academy of Dermatology Annual Meeting (Press)
• Acceleron Receives FDA Orphan Drug Designation for ACE-083 in Charcot-Marie-Tooth Disease (Press)
• U.S. FDA Grants Priority Review for Fedratinib New Drug Application in Myelofibrosis (Press)
• Mitochon Pharmaceuticals Awarded Orphan Drug Designation (Press)
• Forbius Announces the First Patient Dosed in a Phase 1b Diffuse Cutaneous Systemic Sclerosis Trial of AVID200, a Novel TGF-beta 1 & 3 Inhibitor (Press)
• I-Mab Biopharma Announces the Achievement of First Patient Dosing in Phase 1b/2a China Trial of TJ107 for Cancer and Chemotherapy-induced Lymphopenia (Press)
• Imbrium Therapeutics Announces Enrollment of the First Patient in Expansion Phase of Tinostamustine Trial in Patients with Difficult-to-Treat Blood Cancers (Press)
• Bexion Pharmaceuticals Experiences Robust Enrollment of Phase I Part 3 First-In-Human Trial Using BXQ-350 for the Treatment of Cancer (Press)

• Study finds fault with ICD leads that Abbott inherited from St. Jude Medical (MassDevice)
• FDA Grants Saranas De Novo Designation for the Early BirdTM Bleed Monitoring System (Press)
• Zoll Medical acquires EMS tech dev Golden Hour Data Systems (MassDevice)
• Masimo wins CE Mark for next-gen SedLine pediatric brain monitor (MassDevice)

• 'Biosimilar V. Biosimilar' Patent Case May Be First Of Many (Law360-$)
• Ex-Insys Exec Moves For Mistrial After Salacious Testimony (Law360-$)
• FDA puts 15 national retailers on notice for allegedly selling tobacco products to minors (CNBC)
• Supreme Court Grants Certiorari in Iancu v. NantKwest, Inc. (Patent Docs)
• Laboratories Beware of EKRA (FDA Law Blog)
• How physicians are preparing to take on the Senate over gun control (Politico)
• Rush reports data breach involving 45,000 patients (Chicago Tribune)

• FDA Advisory Committee Calendar

• EU Taskforce of Pharma Regulators Issues its First Report on Big Data (Focus)
• MHRA Sets No-Deal Brexit Process for Pharma Submissions (Focus) (MHRA)
• EMA Explains Upcoming Pharmacovigilance Fee Increase (Focus)
• Novartis set to offer 14 weeks paternity leave (Pharmafile)
• Medtronic prices $8B EU-based debt offering (MassDevice)
• STAMP Commission Expert Group (EC)
• 11th Meeting of the Commission Expert Group on Safe and Timely Access to Medicines for Patients (STAMP) (EC)

• Asia Regulatory Roundup: China Floats Tighter Clinical Trial Oversight Following Gene Editing Scandal (Focus)
• Head of Japan’s Drug Regulatory Authority Will Keynote BIO Asia (BIO)
• The 3rd Subcommittee on Genome Editing (PMDA)

• Stents, knee implants undergird Trump’s new trade war with India (MassDevice)
• Health ministry to amend Section 71 of D&C Rules to make Pharm D professionals eligible to supervise drug manufacturing (PharmaBiz)

• Health Canada Outlines Plan to Adopt IMDRF Table of Contents (Focus)