Recon: Canada Weighs Changes to Drug Pricing Rules; No AdComm for Biomarin’s Valrox

• BioMarin gene therapy won't need an AdComm as it nabs speedy FDA review (Fierce) (Endpoints) (Press)
• Stalled Initiatives to Cut Drug Prices Frustrate Trump (WSJ)
• Gilead loses another challenge to a pair of US patents for an HIV prevention pill (STAT) (Endpoints)
• Bankrupt antibiotics maker Aradigm turns to old partner/investor for final $3M fire sale (Endpoints)
• McKesson Dangles $1 Billion Legal Fund to Boost Opioid Deal (Bloomberg)
• DBV's peanut prevention patch approaches key stage of approval process (Endpoints)
• New group aims to stop use of Bayh-Dole Act for drug pricing moves (Politico)
• Tocagen restructuring leads to reverse merger with Forte (BioPharmaDive) (Endpoints) (Press)
• Few US residential drug rehabs give anti-addiction medicine (Reuters)

• Canadian regulator considers changes to new drug pricing plan (Reuters)
• Japan MHLW Approves Opdivo for Unresectable Advanced or Recurrent Esophageal Cancer (Press)
• WuXi Vaccines inks $3B manufacturing deal with 'global vaccine leader' (BioPharmaDive)
• Applications invited for the role of Chair of the MHRA (MHRA)
• Novartis Whistleblowers Covers Blown, Probe Whether They Took Bribes (The National Herald)
• EU GMP Annex I Proposal Would Maintain PUPSIT, Relax WFI Restrictions (Pink Sheet-$)
• Immutep spikes on trial of its LAG-3 drug with Keytruda (PMLive)

• Rare Disease Day 2020: FDA Continues Important Work on Treatments for Rare Diseases (FDA)
• NIH hosts nonhuman primate workshop amidst increased scrutiny of monkey research (Science Mag)
• This season's flu shot 45 percent effective, an improvement over last season's vaccine (NBC)
• In a cramped Kendall Square, biotech startups sublet desks and squeeze into shared labs (STAT)
• What's Holding Back Gene Therapy? (Medpage)
• Addressing barriers that inhibit value-based contracts (PhRMA)
• Do 2019 FDA-approved drugs reflect America’s diversity? (Healthcare Economist)
• Oncology Drug Safety Is Key Focus In US FDA’s Generic Label Updates (Pink Sheet-$)
• Providers Support FDA Quest For Public Drug Manufacturing Quality Ratings (Pink Sheet-$)
• Cleveland Clinic Drug Quality Dashboard Helps Guide Product Choices (Pink Sheet-$)
• Alexion Win Thwarts Roche’s EU Fast-Track Hopes (Pink Sheet-$)
• Effector co-founder leaves to take up CSO post at Turning Point (Fierce)
• Roche confirms departure of gene therapy pioneer Kathy High (STAT) (Fierce) (Endpoints)
• Antonio Gualberto starts post-Kura career at Eisai subsidiary H3; eFFECTOR co-founder Siegfried Reich jumps to Turning Point (Endpoints)
• Genfit's NASH key phase 3 data delayed (Fierce)

• Japan Ministry of Health, Labor and Welfare Approves Opdivo (nivolumab) for the Treatment of Patients with Unresectable Advanced or Recurrent Esophageal Cancer (Press)
• Baudax Bio Announces FDA Approval of ANJESO™ for the Management of Moderate to Severe Pain (Press)
• Harbour BioMed Announces Completion of Phase 1 Study in China of HBM9161, an Anti-FcRn Antibody (Press)

• Ortho, spine players Smith & Nephew, NuVasive and Globus post Q4 results (MedtechDive)
• Dexcom makes inroad in pregnant population with CE mark for CGM (MedtechDive)
• Cardiovalve gets FDA breakthrough status for tricuspid valve replacement system (MedtechDive)
• Integer shares up after Street-beating Q4 (MassDevice)
• J&J’s Ethicon mostly fends off Intuitive Surgical’s robotic surgery patent challenge (MassDevice)
• ReWalk Robotics down on Q4 losses, missed projections (MassDevice)

• The Alliance’s Assessment of the President’s FY 21 Budget Request (Alliance for a Stronger FDA)
• District Court Postpones Trial in Amgen v. Hospira Filgrastim Biosimilar Litigation (Big Molecule Watch)
• No Physician Testimony, No Causation in Georgia and Delaware (Drug & Device Law)
• Sens. Tell Azar That FDA's Deadline For Vapes Isn't Flexible (Law360-$)
• Vanda Isn’t Dropping This Bone Despite Negative Court Decision (FDA Law Blog)

• FDA Advisory Committee Calendar

• Ireland Embarks On New Stage Of Drug Verification System (Pink Sheet-$)

• Govt extends helping hand to pharma industry to boost API production (Pharmabiz)
• How Innovation-driven firms are introducing new medical devices that are disrupting traditional models (Economic Times)

• Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices (TGA)

• China reports 889 new confirmed cases of coronavirus on mainland on Feb. 20 (Reuters)
• Early trial results for potential coronavirus treatments expected in 3 weeks, WHO says (CNBC)
• Once widely criticized, the Wuhan quarantine bought the world time to prepare for Covid-19 (STAT)
• Experts say confusion over coronavirus case count in China is muddying picture of spread (STAT)
• Coronavirus patient re-hospitalized in China's Chengdu after testing positive again (Reuters)
• Co-Diagnostics Completes Submission of CE Marking Registration for COVID-19 Coronavirus Test (Press)
• Iran says coronavirus has spread to several cities, reports two new deaths (Reuters)
• Lebanon confirms first case of coronavirus, two more suspected (Reuters)
• Six coronavirus cases discovered in north Italy, hundreds to be tested (Reuters)
• Australia says two evacuees from Japan cruise vessel have coronavirus (Reuters)
• Buses carrying coronavirus evacuees attacked by protesters in Ukraine (CNBC)
• Why the Coronavirus Seems to Hit Men Harder Than Women (NYTimes)
• China says earliest coronavirus vaccine to be submitted for trials late April (Reuters)
• China says January-February trade to take sharp hit from virus outbreak (Reuters)
• China police handle 274 cases of price gouging, hoarding during virus outbreak (Reuters)

• Should ‘broken’ genes be fixed? My daughter changed the way I think about that question (STAT)