Recon: Merck Acquires Immune Design for $300M; CMS Projects US Health Spending to Rise 5.5% Annually Over the Next Decade

• US health spending to rise 5.5 percent per year over next decade: CMS (Reuters) (STAT)
• Merck’s Roger Perlmutter pays $300M to scoop up a battered Immune Design for its I/O work (Endpoints)
• Bill would let patients buy cheaper insulin from other countries (The Hill)
• Florida governor wants to import drugs from Canada (AP)
• Canadian shelves ‘would run dry’ if US imports drugs (Politico)
• How Drug Company Ads Downplay Risks (Scientific American)
• Keep Calm and Carry On: How to Survive an FDA Inspection (LifeSciVC)
• The Financial Toxicity of Illness (NYTimes)
• Johnson & Johnson receives federal subpoenas related to baby powder litigation (Reuters) (NBC)
• More States Say Doctors Must Offer Overdose Reversal Drug Along With Opioids (KHN)
• Ending rebates will increase Medicare Part D premiums. Most seniors will be insulated from it (STAT)
• Details on Amazon, Berkshire Hathaway, JPMorgan Venture Emerge in Court Testimony (WSJ) (STAT)
• Stat: The Seven Executives Who Will Defend Pharma Before Congress (STAT)
• Did ‘opportunism’ prompt drug makers to take bigger price hikes after competition arrived? (STAT)
• Activist Starboard targets Bristol-Myers Squibb ahead of Celgene deal (Financial Times) (Endpoints) (Fierce) (CNBC)
• Starboard reportedly target Magellan Health to explore potential sale (CNBC)
• Nonprofits Grow Uneasy With Philanthropy Tainted by Opioid Proceeds (WSJ)

• WHO Reacts to Chinese Gene-Edited Twins With Plan for Global Guidelines (WSJ)
• Ebola vaccine will be provided to women who are pregnant, marking reversal in policy (STAT)
• Tough Going Forces Chinese Biotechs To Form Domestic Alliances (Scrip-$)
• Avara Avlon falls into administration putting 270 Bristol jobs at risk (Pharmafile)
• It's not a Brexit problem, Sanofi says of epilepsy drug shortages (Fierce)
• Microsoft, Takeda, Eurordis take on rare diseases in children with report, pilots (mobihealthnews) (Report)
• SC exempts painkiller Saridon from the banned list in India (Economic Times)

• Insulin Maker Lilly Seeks US FDA Assurances On ‘Authorized Biologics’ (Pink Sheet-$)
• FDA cites an ‘ongoing review’ for Pfizer’s blockbuster Xeljanz, with implications for the class (Endpoints)
• Pfizer overhauls Xeljanz study over concerns of increased risk of pulmonary embolism and death (Pharmafile)
• Expired drugs may remain effective, safe to use in a pinch (Reuters)
• 40 Sites Across The Country To Test New Alzheimer's Drug (Forbes)
• Sorting it Out – FDA AdComm Review for 2018 (Eye on FDA)
• FDA Responds to Applicants on Bendamustine Orphan Exclusivity (FDA)
• 130 medicines in development for asthma, allergies and other respiratory diseases (PhRMA)
• J&J steps up alongside AbbVie to partner with fast-growing Morphic on its small molecule approach to integrins (Endpoints) (Fierce)
• Allogene Therapeutics to build out facility for allogeneic CAR T treatments (Fierce)
• Ramaswamy’s rare-disease offshoot Enzyvant poaches Alexion exec Rachelle Jacques to replace Alvin Shih at the helm (Endpoints)
• Doctors’ advice for pharma in 2019? Lay off DTC and ramp up generics: study (Fierce)
• Cell therapy trial shows 'significant' vision restoration (PharmaTimes)
• Pfizer CNS spinout Cerevel brings on new CMO to launch phase 3 work in Parkinson’s disease (Fierce)
• Using Bristol-Myers’ popular leukemia drug to improve anti-PD-1 cancer immunotherapy (Fierce)
• Off-the-shelf CAR-T from stem cells? An early look at UCLA tech — licensed by Gilead (Endpoints)
• MPM adds $408M for its next big wave of biotech startups — and oncology still dominates the menu (Endpoints) (Fierce)
• Serono spinoff Calypso Biotech becomes resident at J&J’s European incubator, raises $22M+ in Series A (Endpoitns)

• Satsuma Pharmaceuticals Provides Corporate Update and Prepares to Advance Lead Product Candidate, STS101, Into Phase 3 Efficacy Trial for Acute Migraine (Press)
• Nexus Pharmaceuticals Receives FDA Approval for Prochlorperazine Edisylate Injection, USP (Press)
• Koutif Therapeutics Announces FDA Acceptance of IND Application for Novel New Treatment of IBD (Press)
• First Patient Dosed in Complexa Phase 2 Trial of Lead Candidate CXA-10 to Treat Pulmonary Arterial Hypertension (Press)
• Gamida Cell Presents New Data from Ongoing Phase 1 Study of NAM-NK and Initial Data from Phase 1/2 Study of NiCord® in Severe Aplastic Anemia at 2019 TCT Annual Meeting (Press)
• Five Prime Therapeutics Doses First Patient in Phase 1b Trial of FPA150 (Press)

• The Final Safety and Performance Based Pathway Guidance Is Out (FDA Law Blog)
• Abbott, Novo Nordisk ink deal for digital diabetes tools (MassDevice)
• NuVasive shares rise on Q4, 2018 EPS beat (MassDevice)
• Edwards Lifesciences wins CE Mark for Pascal mitral repair device (MassDevice)
• Hygieia wins FDA clearance for insulin management app (MassDevice)
• Henry Schein shares drop on mixed bag Q4 earnings (MassDevice)

• What’s Covered Under Medicare? A New App May Leave You Still Wondering (NYTimes)
• Bristol-Myers Gives FTC More Time To Review $74B Merger (Law360-$)
• Pinterest blocks all vaccine-related searches in effort to combat anti-vax content (The Hill)
• Law Review Article Advocates Supreme Court's Patent Eligibility Law is Unconstitutional (Patent Docs)
• Ohio AG Says OptumRx Owes State $16 Million in Prescription Overcharges (FDANews-$)
• Man Bites Dog – Plaintiff Argues that Device Manufacturer Liable for NOT Having a Representative in the Operating Room – Loses Anyway (Drug & Device Law)
• Judge Skeptical Of Ex-Novartis Exec's Whistleblower Claims (Law360-$)
• Boston Scientific Says 50K Mesh Settlements Almost Final (Law360-$)
• Fresenius Asks Chancery For Fast Akorn Damages Ruling (Law360-$)
• Calif. AG Pushes Bill Banning Generic Drug Pay-For-Delay (Law360-$)
• Amphastar Says Rivals' Patent Loss Is Antitrust Ammo (Law360-$)
• ResMed, Fisher & Paykel agree to settle all outstanding patent suits (MassDevice)

• FDA Advisory Committee Calendar

• Dipharma gains European approval of generic Zavesca (PharmaLetter-$)
• Advertising investigations: February 2019 (MHRA)

• Humira becomes first treatment of hidradenitis suppurativa in Japan (PharmaLetter-$)
• WuXi inks deal with Swiss firm for novel sublingual delivery tech (PharmaLetter-$)
• Sanofi appeals Philippines revocation of Dengvaxia’s certificate (PharmaLetter-$)

• Health ministry clears Sanofi proposal to import new TB drug with local clinical trial waiver to tackle latent TB infection cases (PharmaBiz)
• DCGI directs state drug controllers & industry associations to urgently address non-compliance to Schedule H, H1 and X (PharmaBiz)

• Australian Authorities Consider Adopting European MDR Classification Rules for Spinal Implants (Emergo)

• The Medical Tech that Helps You When Your Doctor Can’t (NYTimes)
• Dr. Theodore Rubin, High-Profile Psychoanalyst, Is Dead at 95 (NYTimes)