Recon: Roche Acquires Tusk Therapeutics for €655M; Novo to Cut 250 US Jobs
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.In Focus: US
- On the heels of a global R&D reorganization, Novo Nordisk outlines 250 US job cuts (Endpoints)
- Gritstone’s top-of-the-range IPO brings week’s biotech Nasdaq tally to $520M (Endpoints)
- Pfizer's lung cancer drug gets FDA approval (Reuters) (Endpoints) (Press)
- CRISPR-Based Drugmaker KSQ Raises $80 Million (Forbes) (Endpoints)
- U.S. FDA approves Lilly migraine drug; price same as rivals (Reuters) (Endpoints) (Press)
- Eli Lilly Strikes Deal for Diabetes Pill to Gain on Novo Nordisk (Xconomy) (Fierce)
- U.S. judge dismisses Teva lawsuits against Lilly on migraine drug (Endpoints)
- US FDA May Wait Until Late 2019 Before A Cures Hiring Enhancement Is Available (Pink Sheet-$)
- SEC Charges Salix Pharmaceuticals and Former CFO With Lying About Distribution Channel (SEC)
- With life-threatening food allergies on the rise, drug companies ramp up new approaches (CNBC)
- Key HHS leaders tee up priorities for Q4 (Politico)
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In Focus: International
- UK biotech raises bumper $2 billion, despite Brexit blues (Reuters) (Fierce)
- Novartis strikes deal with Chinese firm to make Kymriah (Reuters)
- Roche Acquires Cancer Immunotherapy Developer Tusk Therapeutics (GEN) (Endpoints) (Fierce)
- Bayer to challenge Avastin legal ruling (PMLive)
- FT Health: Time for action on NCDs (Financial Times)
- Harnessing the potential of real world data through a ‘learning healthcare system’ (EMA)
- EMA, MHRA and GlaxoSmithKline blast BMJ’s ‘flawed’ pandemic flu vaccine safety report (Fierce)
- Re-Examination Of Amgen, BMS Filings Highlights Difference Between EU And US Regulators (Pink Sheet-$)
- Reforming China's drug regulatory system (Nature)
- China’s Genscript jumps after denying faking allegations (Financial Times) (Endpoints) (Fierce)
- CDSCO issues draft norms on good distribution practices for pharma products (PharmaBiz)
- UK government accused of using Brexit to avoid antimicrobial resistance ruling (Pharmafile)
- Overhaul of New Drug Approval Process Moves Forward (PharmTech)
- Statement by FDA Commissioner Scott Gottlieb, M.D., on preparations for the upcoming flu season and vaccinations (FDA)
- Gritstone Raises $100M In Upsized IPO (BioCentury)
- Bayer taps veteran Sebastian Guth to lead American pharma as Carsten Brunn flees to biotech (Fierce) (Fierce)
- Mylan and Novartis Continue to Push Back Against FDA’s Biologics Suffixes (FDANews-$)
- Therapy applied directly inside the eye best for treating uveitic macular edema (NIH)
- You have questions about how to best analyze clinical trials. We have answers (STAT)
- Therapeutic strategies for Parkinson disease: beyond dopaminergic drugs (Nature)
- ‘Take on an Empty Stomach.’ How Do You Know When Your Stomach Is Empty? (NYTimes)
- Sun Wards Off Volini Infringers, Makes It Count Too (Pink Sheet-$)
- Fred Aslan returns to biotech as president of Vividion; Zai Lab scoops Portola’s Tao Fu to spearhead US operations (Endpoints)
- Loyola is working on a new and improved CAR-T product, looking to overcome high-frequency side effects (Endpoints)
- Sandoz Inc. announces US FDA approval of pediatric dose of SYMJEPI™ (epinephrine) (Press)
- TherapeuticsMD Enters Into Label Discussions for TX-001HR (Press)
- QIAGEN Receives FDA Approval to Expand Use of EGFR Test in Lung Cancer (Press)
- Novartis, Adamis keep swinging at EpiPen with Symjepi pediatric dose (Fierce)
- LeMaitre Vascular ponies up $14m for Applied Medical’s clot management tech (MassDevice)
- Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) (FDA)
- Inari begins ClotTriever outcome study (Medical Design & Outsourcing)
- Hologic Finds Focal Point in Breast Health with New Acquisition (MDDI)
- Gerresheimer’s Sensile Medical wins CE Mark for infusion pump (MassDevice)
- Saving the Privilege after an Inadvertent Disclosure (Drug & Device Law)
- FDA Seeks Information on Labeling and Consumer Use of Certain Plant-Based Products (FDA Law Blog)
- European Commission Continues With Mission To Assess Impact of Orphan Regulation (Pink Sheet-$)
- Takeda and Lundbeck seek Japanese approval with depression drug (PharmaLetter-$)
- In Hong Kong, Hepatitis E Strain Jumps From Rats to Humans (NYTimes)
- 'Reasonable Consumer' Concept Clarified In Revised Australian Advertising Guide (Pink Sheet-$)
- Complaints handling for the advertising of therapeutic goods to the Australian public (TGA)
- CVS Boosts Innovation Investment To Reinvent Pharmacies In Brazil (Forbes)
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