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

Posted 21 February 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US

  • 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)

In Focus: International

  • 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-$)
  • Avara Avlon falls into administration putting 270 Bristol jobs at risk (Pharmafile)
  • It’s not a Brexit problem, Sanofi says of epilepsy drug shortages (Fierce)
  • Microsoft, Takeda, Eurordis take on rare diseases in children with report, pilots (mobihealthnews) (Report)
  • SC exempts painkiller Saridon from the banned list in India (Economic Times)
  • Canada’s Competition Bureau says not enough evidence to show abuse of dominance by Janssen (PharmaLetter-$)

Pharmaceuticals & Biotechnology

  • 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)

Pharmaceuticals & Biotechnology: Study Results, Filings & Designations

  • 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)

Medical Devices

  • 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)

US: Assorted & Government

  • 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)

Upcoming Meetings & Events


  • 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)

General Health & Other Interesting Articles

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

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.
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