Recon: CA Judge Orders J&J to Pay $344M in Pelvic Mesh Case; HHS Clears Novartis to Cover Travel Expenses for Some Kymriah Patients

• Johnson & Johnson Is Told to Pay $344 Million in Pelvic Mesh Suit (NYTimes) (AP) (MedtechDive)
• US officials will let Novartis pay travel expenses for some Kymriah patients (STAT)
• Vertex impresses with strong Trikafta launch (BioPharmaDive) (Endpoints)
• Black Diamond doubles in value hours into Nasdaq debut (Endpoints)
• Preventive Alzheimer's trial data due within weeks, Lilly says (BioPharmaDive) (Endpoints)
• Biogen gears up for potential launch of Alzheimer's drug (Reuters)
• How Chaos at Chain Pharmacies Is Putting Patients at Risk (NYTimes 1, 2)
• Conservative groups call on Trump administration to scrap looming drug price move (The Hill)
• Unlawful stem cell products continue to harm people as FDA deadline looms (The Hill)
• Azar tries to fend off coronavirus, White House critics (Politico)

• WHO declares China virus outbreak an international emergency (Reuters) (NYTimes)
• WHO says countries should keep borders open, trade & people moving despite coronavirus (Reuters)
• Astellas Pharma keeps profit forecast as prostate cancer drug sales rise (Reuters)
• It’s Brexit day – now comes the really hard stuff (PMLive) (MedicalDevicesLegal)
• 60% of UK unis expect Brexit to affect pharma industry relationships (PharmaTimes)
• EU court backs UK on GlaxoSmithKline ‘pay-for-delay’ fine (Financial Times)
• Takeda selling off its Dunboyne facility (The Irish Times)
• Merck KGaA continues manufacturing buildout with $275M investment (BioPharmaDive) (Press)
• Celltrion to Launch REMSIMA SC (infliximab) in Europe in March, 2020 (Big Molecule Watch)

• ICER Finalizes 2020 Updates to Methods and Public Meeting Procedures for Value Assessment Framework (ICER)
• Another AI-Generated Drug? (In The Pipeline)
• Incentivizing Antibiotic Development: Why Isn’t the Generating Antibiotic Incentives Now (GAIN) Act Working? (Open Forum Infectious Diseases)
• Go or no go? Esperion's double whammy and a look to priority reviews (Evaluate)
• Hahn's Priorities For US FDA Eschew Hot-Button Issues, Focus on Traditional Themes (Pink Sheet-$)
• US FDA’s Inner Circle Takes Shape: Shah Seen As Potential Successor To Abernethy (Pink Sheet-$)
• Drug Pricing Activity At US FDA May Be Unique To Gottlieb Tenure (Pink Sheet-$)
• Biogen, PTC and more back BioMarin's genetic seizure testing effort for kids (Fierce)
• Resistant to CAR-T therapies? It's the cancer, not your immune system — study (Endpoints)
• With $45M, Mammoth Bio Expects Big Things From Tiny CRISPR Cas14 (Xconomy) (Endpoints)
• The Rise of Biosimilars: Success of the BPCIA? (Part I) (Harvard Bill of Health)
• Understanding the Rewards of Successful Drug Development — Thinking Inside the Box (NEJM)
• Prime Time for Genome Editing? (NEJM)
• Multi-drug therapy for epilepsy influenced bispectral index after a bolus propofol administration without affecting propofol’s pharmacokinetics: a prospective cohort study (Nature)
• Vertex drops VX-961 to continue search for perfect pain drug (Fierce)
• Immuno-oncology combination for melanoma using Nektar drug boosts cell therapy in mice (Fierce)
• GeNeuro raises €17.5M for multiple sclerosis clinical trial (Fierce)
• Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Application for Participation in Food and Drug Administration Fellowship and Traineeship Programs (FDA)

• EMA Validates Seattle Genetics’ Marketing Authorization Application for Tucatinib for Patients with Locally Advanced or Metastatic HER2-Positive Breast Cancer (Press)
• Bayer's Nubeqa scores key prostate cancer win in battle with Pfizer, J&J (Fierce)

• Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement (NEJM)
• Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication (FDA)
• Cardinal Health says Chinese supplier behind massive surgical gowns recall (MassDevice)
• Surgical gown recall sets Cardinal back $96M (MedtechDive)
• Olympus Announces FDA Clearance of the TJF-Q190V Duodenoscope (Press)
• Sony gets FDA clearance for OR integration system (MedCity)
• Edwards Lifescience boosts 2020 guidance amid strong TAVR sales (MassDevice)
• Medtronic obtains European approval for Cobalt and Crome devices (Verdict) (Press)
• Abbott wins 1st EU approval for transcatheter mitral valve replacement device (MedtechDive)

• Trump’s Medicaid changes offer states new powers to lower drug costs — with a catch (STAT) (Walden) (Wyden) (Grassley)
• Warren Is Right. Presidents Have The Power To Bypass Congress On Drug Pricing. (KHN)
• PBMs favor their own pharmacies in the Florida Medicaid program (STAT)
• All Not So Quiet on the Midwestern Front – Kaiser Continues String of Mesh Defeats (Drug & Device Law)
• Alto, a pharmacy start-up, just raised $250 million from SoftBank’s Vision Fund 2 and others (CNBC)
• Stimulant overdoses rising in the US (Reuters)
• Opioid MDL's Pharmacy Bellwether Trial Nudged To November (Law360-$)
• Funds Say Allergan Wants '2nd Bite At Apple' Dismissal (Law360-$)
• NJ Court Declines To Toss Sandoz Suit Over Blocked Generic (Law360-$) (Fierce)
• Feds, AbbVie Agree Drug Delay Case Belongs In 3rd Circ. (Law360-$)
• LabCorp Preserves Win In Blood-Testing Contract Row (Law360-$)

• FDA Advisory Committee Calendar

• Brexit strongly negative for medtech industry, say Verdict readers (Verdict)
• Fresh EU Cybersecurity Issues For Medical Device Cos. (Law360-$)
• Redistribution of seats in the European Parliament after Brexit (EP)

• Patent Strategies For Chinese Approval Of Medical Devices (Law360-$)

• NPPA seeks clarification on Gilead's drug pricing plea (Economic Times)
• Government regulation led to increase in price of essential drugs: Economic Survey (Economic Times)

• TGA Laboratories testing report: Gardasil 9 Human Papillomavirus (HPV) vaccine monitoring (TGA)
• Australia Prepares For Future Challenges In Regulatory Science (Pink Sheet-$)

• IMF says too soon to quantify China's coronavirus economic impact (Reuters)
• 'Do not travel to China', says US as virus deaths reach 213 (Reuters)
• Coronavirus: EU mobilises €10 million for research (EC)
• Healthcare company Novacyt launches new coronavirus test (Reuters)
• Chinese city of Wuhan says it should have acted sooner to contain virus (Reuters)
• Japan to enforce special virus measures from Sat, urges citizens against non-urgent China trips (Reuters)
• US authorizes departure of some employees from diplomatic facilities in China (Reuters)
• Siemens Healthineers supplies diagnostic equipment to Wuhan hospitals (Reuters)
• India bans export of protective masks, clothing amid coronavirus outbreak (Reuters)
• Britain reports first two cases of new coronavirus (Reuters)
• Italy government agrees state of emergency after confirmed coronavirus cases: government source (Reuters)
• Two first coronavirus cases confirmed in Italy: prime minister (Reuters)
• One case of coronavirus symptoms among French evacuated: minister (Reuters)
• German coronavirus cases climb to six after child infected: ministry (Reuters)
• France's Pasteur Institute Foundation hoping to develop coronavirus vaccine (Reuters)
• Germany expects coronavirus vaccine within months (Reuters)