Recon: Edwards Pays Boston Scientific $180M to End Patent Dispute

• Lawmakers want feds to look at how a Bristol-Celgene deal affects prices and competition (STAT) (Letter)
• Edward Lifesciences pays Boston Scientific $180 million to end patent row (Reuters)
• Biopharma Dealmaking in 2018 (Nature)
• 2018 FDA approvals hit all-time high — but average value slips again (Nature)
• Vermont Report Finds that the Costs of Prescription Drug Importation May Outweigh Savings (FDA Law Blog) (Report)
• The Strange Marketplace for Diabetes Test Strips (NYTimes)
• If the shutdown drags on at FDA, it will put anticipated new treatments in jeopardy (STAT)
• Aimmune says shutdown blocks peanut allergy drug review (Fierce)
• Medicare Part D could have saved $14.4 billion in 2016 by negotiating as the VA did (STAT)
• Medicare changes could have some patients paying more for drugs (Reuters)
• Walmart pharmacies likely to leave CVS network because of pricing dispute (CNBC)
• In a first, China’s BeiGene scores FDA ‘breakthrough’ status for BTK inhibitor — potential rival for Imbruvica (Endpoints)
• FDA approves expanded use of Adacel vaccine (PharmaLetter-$) (Press)
• Americans more likely to die from opioid overdose than in a car accident (CBS)

• Crunch time as Brexit deal faces ‘meaningful vote’ (PMLive)
• Novartis battles with the Dutch health minister for raising the price of a cancer drug (STAT) (Pharmafile)
• SMC OK's four meds for NHS use, including Roche's Perjeta (PharmaTimes) (Pharmafile)
• EU approval for Opdivo combo in renal cell cancer (PMLive) (Press)
• European Commission Approves Seqirus Flu Vaccine (PharmaTimes)
• Public mistrust after Congo election raises Ebola epidemic anxiety (Reuters)
• North Korea’s Less-Known Military Threat: Biological Weapons (NYTimes)
• Lilly cuts 250 jobs and invests €100m at French site (InPharmaTechnologist)
• Ironwood Pharmaceuticals Announces Approval of LINZESS® (linaclotide) in China for the Treatment of Adults with IBS-C (Press)

• How a 'regulatory dead zone' may be holding up copycat insulin (BioPharmaDive)
• Investment ideas for 2019 (Open Reading Frame)
• Researchers Uncover Major Clue In Predicting Response To Immunotherapy (Forbes)
• The Demise Of A Once Promising Pancreatic Cancer Drug Is All Too Common (Forbes)
• Public/Private Cooperation, Tailored Assistance Deemed Key To Enhancing Quality Of US Drug Imports (Pink Sheet-$)
• A Silver Bullet Against the Brain-Eating Amoeba? (NYTimes)
• FDA Cites GlaxoSmithKline for Problems With SOPs (FDANews-$)
• Former CEO of Novartis' US operations joins board of cancer immunotherapy firm (Pharmafile)
• CDER’s Office of Pharmaceutical Quality is Opening New Regulatory Pathways to Span Its Broad Responsibilities and Global Reach (IPQ)
• May the candle burn forever: Polite reminders about the JPMorgan confab (Endpoints)
• Attendees fed up with venue, high prices call to move JPM out of San Francisco (Fierce)
• Two more big pharma vets at Roche, AstraZeneca make the leap to top biotech R&D jobs as the great migration continues (Endpoints) (Fierce) (Fierce)
• Harvard prof David Sinclair backs anti-aging upstart Life Bio, which just raised $50M for research (Endpoints)
• Insmed CMO out the door, headed for 'West Coast' (Fierce)
• Seres elevates CFO Eric Shaff to CEO post as it advances immunology therapies (Fierce)

• Merck highlights crucial hit for Keytruda in second-line esophageal carcinoma — but there are also 2 misses (Endpoints) (Press)
• Exelixis Announces U.S. FDA Approval of CABOMETYX® (cabozantinib) Tablets for Previously Treated Hepatocellular Carcinoma (Press)
• Pierre Fabre and its Partner Array BioPharma Announce 15.3 Months Median OS Observed from the Phase 3 BEACON CRC Safety Lead-in of BRAFTOVI®, MEKTOVI® and ERBITUX® in BRAF-Mutant Metastatic CRC (Press)
• Innovent Announces First Patient Dosed in a Phase I Clinical Trial of Anti-CD47 Monoclonal Antibody (Press)
• Post-Hoc Analyses from Pivotal Phase 3 REFLECT Trial of LENVIMA® (lenvatinib) in Unresectable Hepatocellular Carcinoma to be Presented at 2019 Gastrointestinal Cancers Symposium (Press)

• Medtronic Launches Mobile App That Communicates Directly with World's First Smartphone-Connected Pacemakers (Press)
• Shockwave Medical launches U.S. pivotal for coronary lithotripsy (MassDevice)
• What’s ahead for the drug delivery market in 2019? (Drug Delivery)
• Impact of the USMCA on the Medical Device Industry (MDDI)
• TransEnterix wins FDA clearance for Senhance Ultrasonic (MassDevice) (Press)
• Olympus inks precision cancer imaging and treatment dev deal with USC (MassDevice)
• FDA Additionally Clears RAPID™ Imaging Platform for Use in Selecting Acute Stroke Patients for Clot Removal (Press)

• Purdue appeals order to unseal OxyContin records to Kentucky Supreme Court (STAT)
• Democrats to quiz AG nominee on health care views (Politico)
• The Trump Administration's Latest Drug Pricing Initiatives (Law360-$)
• Here Is What Republicans And Democrats Don't Understand About Obamacare (Forbes)
• In Blockbuster Alliance, Walgreens And Microsoft To Develop 'New Healthcare Models' (Forbes)
• Ethicon Gets One Covidien Claim Tossed In Patent Dispute (Law360-$)
• Allergan, St. Regis Urge Justices To OK PTAB Tribal Immunity (Law360-$)
• Administrative burdens are blocking access to health insurance (STAT)
• Second U.S. judge blocks Trump administration birth control rules (Reuters)
• Eighth Circuit Doesn’t Let Swallowing Pills Swallow the Statute of Limitations (Drug & Device Law)
• FDA to resume food safety inspections Tuesday (NBC)
• J&J Faces Retrial After $151M Hip Implant Loss Reversed (Law360-$)
• Allergan's Attack On Drug Compounding Falls Flat (Law360-$)
• Pharma. Co. Egalet's Ch. 11 Confirmed In Delaware (Law360-$)
• Doc Who Shared Teen Patient Info With Drug Co. Avoids Jail (Law360-$)

• FDA Advisory Committee Calendar

• Marketing authorisations granted in December 2018 (MHRA)

• Dr Reddy’s Labs to expand business in China by setting up new units & forging partnerships with local cos (PharmaBiz)

• India’s Supreme Court approves settlement amounts for J&J hip patients (MassDevice)
• Indian pharma market growth at 9.8% in December 2018 to Rs.11,122 cr; full year 2018 IPM reaches at Rs.1,17,878 cr (PharmaBiz)
• Roche Calls For Harmonized Regulation As Subcutaneous Herceptin Is Denied Trial Waiver In India (Scrip-$)

• Valeo Pharma and Zambon announce the approval of Onstryv® (safinamide) for Canada (Press)
• QIAGEN’s QuantiFERON®-TB Gold Plus Gains Approval in Canada (Press)

• Medicinal gases guidance (TGA)