Recon: Non-Profit Civica Rx Plans to Offer 20 Generic Drugs in 2019

• Not-for-profit to offer 20 generic drugs in 2019 to alleviate shortages (Reuters)
• Indivior temporarily stops rival Alvogen's generic launch (Reuters)
• Could the FDA keep working without more funding, if drug reviews are deemed essential to protecting lives? (STAT)
• Pharmacy benefit managers marked up generic drugs for NY Medicaid, but where’d the money go? (STAT)
• Sackler family, known for ties to prestigious institutions, stays quiet on opioid crisis accusations (CBS)
• Drug-Pricing Policies Find New Momentum As ‘A 2020 Thing’ (KHN)
• Vertex strikes deal with Merck KGaA to grow CRISPR/Cas9 toolkit (Fierce)
• Roche dispatches strategy executive Alexander Hardy to take Genentech helm (Fierce)

• After ‘CRISPR babies,’ international medical leaders aim to tighten genome editing guidelines (STAT)
• Ministerial revolt looming over ‘no-deal’ Brexit risk (PMLive)
• Ebola spreads to high-risk area of Congo: WHO (Reuters)
• UK Looks to Ensure Pharma Submissions Can Continue Under No Deal Brexit (Focus)
• Novartis urges Britain to secure drug supplies before Brexit (Reuters)
• China's NMPA approves Amgen's Repatha to reduce cardiovascular event risk (Pharmafile)
• China In 2019: Coming Regulatory Changes To Keep On Your Radar (Pink Sheet-$)
• Italy drugmaker Zambon ready to splash out in US, China push (Reuters)
• A stem cell therapy preps debut in Japanese market to the dismay of US researchers (Endpoints)
• GSK, Sanofi enlist in a big genomics project aiming to map genes of half a million Finns (Endpoints) (PMLive)
• Industry Prepares For Emerging ICH Q14 Quality-By-Design Approach To Analytical Methods (Pink Sheet-$)
• European biosimilars hit AbbVie’s Humira revenues in Q4 (PMLive)
• Bacteria and viruses are fighting back, but will big pharma save us? (The Guardian)
• Rubraca gets EU approval (PharmaTimes)

• How Great HIV Medicines Are Now (In Two Pictures) (Forbes)
• Assessing the Effectiveness of REMS: FDA Drafts Two New Guidances (Focus)
• FDA on Lilly's Lartruvo: No New Patients Outside an Investigational Study (Focus)
• Investigational monoclonal antibody to treat Ebola is safe in adults (NIH)
• FDA's Post-Shutdown ANDA Bolus Could Be Massive (Pink Sheet-$)
• Juggling Gene Therapies: Sarepta's Focus Grows, With Many Balls In The Air (Scrip-$)
• High-res genetic map by Amgen's deCODE offers new insight for disease research (Fierce)
• Midatech ‘urgently’ needs investor as cash reserves dwindle (Fierce)
• Shield Therapeutics Looking At US Options For Feraccru (Scrip-$)
• Lonza begins second-gen supply of Portola's Andexxa (BioPharmaDive)
• When Should I Take an Antibiotic? (NYTimes)

• Shutdown's Latest Victim: Hundreds Of Delayed Lifesaving Medical Devices (Forbes)
• Medtronic to acquire cardiac ablation tech dev Epix Therapeutics (MassDevice) (Press)
• Updates to FDA’s Software Pre-Certification Program (FDA Law Blog)
• Class 1 Device Recall Various Drger Breathing Circuits/Anesthesia Sets (FDA)
• Zimmer Biomet wins FDA nod for Rosa Knee robotic surgical system (MassDevice) (Press)
• FDA clears Rebound Therapeutics’ minimally invasive neurosurgical endoscope (MassDevice)
• FDA clears Imperative Care’s stroke treatment catheters (MassDevice)
• CorMatrix wins FDA IDE approval for Cor Tricuspid ECM cardiac valve trial (MassDevice)
• Intuitive Surgical shares dip on mixed-bag Q4, FY2018 earnings release (MassDevice)
• Hill-Rom’s fiscal Q2 results beat estimates (MassDevice)
• Gore touts 12-month Tigris stent study data (MassDevice)
• Histogenics to lay off 65% of workforce, including CMO & CBO, in restructuring (MassDevice)
• BD launches second-gen ergonomic injection pen (Drug Delivery)

• Utah voters want Medicaid expansion. Utah lawmakers are having second thoughts (Politico)
• Health care industry group launches digital ads against 'Medicare for all' (The Hill)
• Aetna, other health insurers team up with IBM on blockchain project (Reuters)
• Sanofi Suit Against Mylan To Stay In EpiPen MDL, For Now (Law360-$)
• Sen. Bill Would Let HHS Prevent Another 'EpiPen Fiasco' (Law360-$)
• Doctor who ordered outsize pain meds kept working for weeks (Miami Herald)
• 2019 is the year the US legalizes cannabis, CEO of pot firm Acreage says (CNBC)
• Appeals court backs spine doc inventor in $24m patent infringement spat with Medtronic (MassDevice)
• Shutdown Fever: How Washington’s Standstill Impacts Health (Harvard Bill of Health)
• Listen Up Youse Guys − The Fastest Way Out of Pennsylvania’s Deep End (Drug & Device Law)

• FDA Advisory Committee Calendar

• UK Details Plans to Tackle Antimicrobial Resistance Over the Next 20 Years (Focus)
• Melanoma Combos Get Mixed Reception From German HTA Body (Pink Sheet-$)
• EU Regulatory Roundup: Shire Raises ‘Substantial Concerns’ About ICH Guidelines (Focus)
• UK: NICE Hints At ’Significant Changes’ To Come (Pink Sheet-$)
• Nellix Endovascular Aneurysm Sealing (EVAS) System - Device recall and enhanced patient surveillance (MHRA)
• Britain’s House of Lords seeks clarity on medicines access (PharmaLetter-$)
• NHS Employers warning on level of NHS Vacancies (PharmaTimes)
• EU Guide On Drug Pack Safety Features Updated Ahead Of Feb. 9 Deadline (Pink Sheet-$)
• Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 22-24 January 2019 Share (EMA)
• Bournemouth Baddies Busted (MHRA)

• Indian pharma increases pace of technology adoption to transform manufacturing practices and enhance global competitiveness (PharmaBiz)

• The first six months: embedding the TGA advertising reforms (TGA)
• Public submissions on regulatory options for appropriate access and safety controls for alkyl nitrites (TGA)
• Recall of multiple products - potential for breaches of sterile packaging (TGA)

• Consultation on Draft Guidance Document: Regulatory Requirements for Drug Identification Numbers (DINS) (Health Canada)

• WHO warns of deadly outbreak of rat-borne hantavirus in Argentina (Reuters)

• In Davos, Prince William Calls for Action on Mental Health (NYTimes)