Regulatory Focus™ > News Articles > 2020 > 1 > Recon: Lilly to Acquire Dermira for $1.1B; Idorsia, Neurocrine Pair for $400M Epilepsy Drug Deal

Recon: Lilly to Acquire Dermira for $1.1B; Idorsia, Neurocrine Pair for $400M Epilepsy Drug Deal

Posted 10 January 2020 | By Michael Mezher 

Recon: Lilly to Acquire Dermira for $1.1B; Idorsia, Neurocrine Pair for $400M Epilepsy Drug Deal

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Lilly to acquire Dermira for $1.1 billion, adding eczema drug to its pipeline (STAT) (Endpoints)
  • Blackstone raises three-quarters of targeted $4.6 billion life sciences fund (Reuters) (Endpoints)
  • BMS confident of approvals linked to higher Celgene investor payout: Bristol executive (Reuters)
  • FDA approves Blueprint's stomach cancer therapy priced at $32,000 per month (Reuters) (STAT) (Endpoints) (FDA)
  • That company suing Patrick Soon-Shiong for $1B? Someone's trying to buy it for $1B (Endpoints) (Press)
  • Drug Price Requirement for TV Ads Gets Day Before Appeals Court (Bloomberg)
  • Startup Aligos Grabs $125 Million for Drugs to Combat Hepatitis B (WSJ PRO-$)
  • Pfizer signs $507m cancer deal with Effector Therapeutics (PMLive) (Press)
  • Top 5 Drug And Medical Device Developments Of 2019 (Law360-$)
  • 5 trends to watch at the FDA in 2020 (BioPharmaDive)
  • 5 biotech trends to follow in 2020 (BioPharmaDive)
In Focus: International
  • Idorsia pairs with Neurocrine in potential $400 million epilepsy drug deal (Reuters)
  • EU Clears $63B AbbVie-Allergan Deal With Drug Sale (Law360-$)
  • EMA Recommends Fewer New and Orphan Drugs in 2019 (Focus)
  • 23andMe Licenses Its Own Drug Compound to Spanish Firm Almirall (Bloomberg)
  • MedTech Europe pushes urgent action to keep devices on sale after MDR (MedtechDive)
  • Bayer and Exscientia to work together on AI in cardiovascular and oncology drug discovery (Pharmafile)
  • Sanofi secures expanded European approval for Toujeo in type 1 diabetes (Pharmafile)
  • UK Industry Gears Up For Tough Post-Brexit Talks With EU (Pink Sheet-$)
  • Engage Early With Regulators On Complex Trial Designs, Sponsors Told (Pink Sheet-$)
Pharmaceuticals & Biotechnology
  • Revamping OND: Drugmakers Offer Suggestions (Focus)
  • A Decade Of Novel CDER Approvals, By The Numbers (Pink Sheet-$)
  • US FDA’s Breakneck Approval Pace Clashes With Advisory Committee Mandate (Pink Sheet-$)
  • What are biopharma companies hiring CROs for these days? PPD spells it out in bid for $100M IPO (Endpoints)
  • Combining Multiple Antibiotics May Make Bacteria More Likely to Develop Resistance (Scientific American)
  • Should access to life-saving medicines be determined by economic evaluations? (The Hill)
  • Generation Bio grabs a $110M round to ramp up work on next-gen gene therapies (Fierce) (Endpoints)
  • Merck-partnered biotech hands Roche its half-life extension tech as it pivots to immuno-oncology (Endpoints)
  • Welcome to the bioengineering culture clash (STAT)
  • Moderna, though early in development, prepares its vaccine for market (BioPharmaDive) (Endpoints)
  • Biogen Teams Up With Startup CAMP4 to Scout for New Neuro Drugs (Xconomy) (Endpoints)
  • DTx Pharma Raises $10.6M to Advance New Way to Deliver RNA Drugs (Xconomy)
  • HP&M Releases 2019 Enforcement Briefing (FDA Law Blog)
  • PhRMA Starts New Year With Familiar Drug Pricing Proposals Targeting The Supply Chain (Pink Sheet-$)
  • Lilly, Strateos open remote-controlled robotic research lab in San Diego (BioPharmaDive)
  • New Report Demonstrates Potential for Cell and Gene Therapies to Provide Cost Savings (Alliance for Regenerative Medicine)
  • Eli Lilly vet jumps aboard Polaris Partners; Mirati shakes up its leadership team with new hires and promotions (Endpoints)
  • Ultragenyx shares jump on 'better than expected' gene therapy data (Fierce) (Press)
  • Nektar Therapeutics and Bristol-Myers Squibb Amend Strategic Collaboration Agreement for bempegaldesleukin Plus Opdivo (nivolumab) (Press)
  • STUNG: Aduro CEO Stephen Isaacs reaches for the budget ax — again — on the heels of their latest setback with Novartis (Endpoints) (Fierce)
  • What’s Missing From Biotech Graduate Education? With Free Course, RA Capital Attempts to Fill the Gaps (Harvard Bill of Health)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Meissa Vaccines Receives U.S. FDA Fast Track Designation for Respiratory Syncytial Virus Vaccine, MV-012-968 (Press)
  • Moderna Announces Additional Positive Phase 1 Data from Cytomegalovirus (CMV) Vaccine (mRNA-1647) and First Participant Dosed in Phase 2 Study (Press)
  • Terns Pharmaceuticals Presents Results From An Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH (Press)
  • Clover Biopharmaceuticals Doses First Patient in Phase I Study of SCB-313 in China for Malignant Pleural Effusions (MPE) (Press)
Medical Devices
  • CDRH Draft Guidance Offers Further Info on 510(k)s for PTA, Specialty Catheters (Focus)
  • At CES, digital health gadgets gave me a detailed accounting of my flaws and failures (STAT)
  • Medtronic wins CE Mark for Percept PC neurostimulator (MassDevice)
  • US FDA clears NuvoAir's connected spirometer device (mobihealthnews)
  • Study links paclitaxel devices to better survival in PAD, muddying debate (MedtechDive)
  • JenaValve TAVR tech amid wave to get breakthrough device status from FDA (MedtechDive)
  • Intuitive closes 2019 by topping Q4 expectations (MedtechDive)
  • A 'Discommon' Approach to Medical Device Accessorizing (MDDI)
US: Assorted & Government
  • Drug price outrage threatens to be liability for GOP (The Hill)
  • NEJM Perspective: Congress Needs to Help FDA Combat Procedural Abuses (Focus)
  • B-MS, Sanofi Claim Hawaii is Violating Their Free Speech in Plavix Suit (Focus)
  • USMCA Trade Deal Could Get Senate Vote Next Week (Law360-$)
  • US vaping-related deaths rise to 57, cases of illness to 2,602 (Reuters)
  • Florida joins U.S. government in probing foreign ties of researchers (Science)
  • Is nationwide Medicaid expansion inevitable? (Politico)
  • Kansas governor, top Republican reach deal to expand Medicaid (NBC)
  • Fed. Circ. Casts Doubt On Novartis MS Drug PTAB Win (Law360-$)
  • Ethicon Beats Most Claims In Defective Pelvic Mesh Suit (Law360-$)
  • Immunex and Samsung Bioepis Seek to Stay Etanercept Biosimilar Litigation (Big Molecule Watch)
  • FDA, USDA and EPA announce joint platform to streamline information about agricultural biotechnology products (FDA)
  • Facebook Is Running Anti-Vax Ads, Despite Its Ban On Vaccine Misinformation (BuzzFeed)
  • Masimo claims Apple infringed 10 of its health-monitoring patents (MassDevice)
  • The "Ending the Diagnostic Odyssey Act of 2019" (Patent Docs)
  • Tolling Agreement’s Clear Language Saves The Day (Drug & Device Law)
  • Monthly Round-Up of What to Read on Pharma Law and Policy (Harvard Bill of Health)
  • Biopharma Co. Gets Nod For $4.5M Ch. 11 Sale Of Drug Rights (Law360-$)
Upcoming Meetings & Events Europe
  • Denmark To Adopt QALY For Cost-Effectiveness Assessments (Pink Sheet-$)
  • Belgian CDMO Ardena gets new private equity owners (BioPharmaDive)
Asia
  • Pilot study of Asian genomes finds novel gene variants, highlights diversity (Reuters)
  • 10 Commercial Trends To Watch In China in 2020 (Scrip-$)
India
  • Events And Losses That Shook India Pharma In The Decade (Scrip-$)
Australia
  • Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 (TGA)
  • No shortage of salbutamol asthma inhalers (TGA)
General Health & Other Interesting Articles
  • Money-Losing Companies Mushroom Even as Stocks Hit New Highs (WSJ)
  • Second U.S. Baby to Be Born From a Dead Donor’s Uterus Is Delivered (NYTimes)
  • Body Temperature 2.0: Do We Need to Rethink What’s Normal? (NYTimes)
  • From surgery simulators to medical mishaps in space, video game tech is helping doctors at work (Washington Post)
  • When the Cobra Bites, You’ll Be Glad Someone Sequenced Its Genome (NYTimes)
  • Teen Girls Don't Need Routine Pelvic Exams. Why Are Doctors Doing So Many? (NPR)
  • A massive study of 200,000 veterans identifies genetic links to anxiety (CNN)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
 
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