Recon: GSK to Pay Merck KGaA up to $4.2B to Develop Immunotherapy Drug

• Roche adapts newer breast cancer drug in face of Herceptin imitations (Reuters) (Endpoints) (Press)
• The bispecific boom: Genentech pays $120M to tie the knot with Xencor on an IL-15 alliance (Endpoints)
• Uncertainties remain in Trump rebate plan (Politico)
• The health care themes to watch in Trump's address (Politico)
• Flip the Script: Drugmakers Blame Middlemen for Price Hikes (WSJ)
• Congress wants these 7 drug company CEOs to testify about prices (STAT) (Reuters) (The Hill) (Senate Finance)
• J&J Agrees to Resolve Most Pinnacle Hip-Device Lawsuits (Bloomberg) (Reuters)
• Trump Expected to Announce Plan to Stop Spread of HIV in the US by 2030 (NYTimes)
• Novum Pharma Files for Chapter 11 Bankruptcy (WSJ)
• Storm clouds gather over pharma companies as price hikes ease (STAT)
• Allergan asks the ITC to investigate its new Botox rivals for stealing secrets (STAT)
• Allergan rises after David Tepper's Appaloosa ups pressure on the struggling drugmaker (CNBC)
• Gilead takes an $820M hit after axing a Kite CAR-T (Endpoints) (Fierce)
• Gilead’s new CEO hasn’t shown up for work yet, leaving the biotech rudderless, investors anxious (STAT) (Fierce)

• Glaxo to Pay Merck Up to $4.2 Billion in Cancer Deal (Bloomberg) (Reuters) (Endpoints) (Fierce) (PMLive)
• May taps business leaders to help push EU compromise on Brexit (Financial Times)
• Novartis and Vertex battle the Netherlands government over pricing (STAT) (DutchNews.NL)
• Chinese biotech feels chill in harsh winter for venture capital (Financial Times)
• Giant Strides in World Health, but It Could Be So Much Better (NYTimes)
• Ebola outbreak reminds us that we need pandemic preparedness (The Hill)
• Ebola poses vexing challenge six months after latest outbreak (The Hill)
• US, EU regulators back rapid reviews of AZ’s RSV med (PMLive) (Endpoints)
• Undisclosed financial relationships revealed between doctors and drug companies (The Guardian)
• Falsified copies of leukaemia drug Iclusig detected (Securing Industry)
• Property tycoon Vincent Tchenguiz turns to biotech investing (Financial Times)

• 2018 Drug Approvals: A Closer Look (In the Pipeline)
• Where are pharma's biggest layoffs happening? (BioPharmaDive)
• USP’s Generics Access Plan to Aid FDA Efforts (Focus)
• Sanofi Raises Public Health Questions on Use of Nonsense Suffixes With New Vaccines (Focus)
• Study shows Purdue’s switch to ‘abuse-deterrent’ OxyContin helped drive a spike in hepatitis C infections (STAT)
• A Hard Choice For Abbreviated Biologics License Applicants (Law360-$)
• While There's No Easy Rx for Drug Shortages, Pharma Groups Have Some Ideas (Pink Sheet-$)
• US FDA Weighs Patent Listing Requirements For Digital Apps Used With Drugs (Pink Sheet-$)
• Here come the 2019 unicorns: Alector, Gossamer set to launch IPOs donning $1B-plus market caps (Endpoints)
• What Is A Data Science Mindset -- And Does Pharma R&D Really Need One? (Forbes)
• Baeuerle-backed Cullinan grows its pipeline of portfolio plays, adopts a new cancer drug with eye to clinical development (Endpoints)
• A ‘disoriented’ Pain Therapeutics flips out after FDA rejects appeal on Remoxy (Endpoints) (Market Watch)
• Custom pain creams do little for chronic pain relief (Reuters)
• Decibel hires new CMO ahead of proof-of-concept hearing loss studies (Fierce)
• Amazon hints at national online pharmacy plans with new licenses (MedCity)
• Like Nixon’s ‘war on cancer,’ President Trump should open a war on Alzheimer’s (STAT)
• Synthetic control arms can save time and money in clinical trials (STAT)

• Flying solo for a change, Sanofi says isatuximab scored an important success in first PhIII myeloma study (Endpoints)
• Lilly's Olumiant impresses in twin Phase 3 atopic dermatitis trials (Pharmafile)
• FDA Accepts for Review New Drug Application (NDA) for Merck’s Investigational Combination of Imipenem/Cilastatin and Relebactam, and Supplemental NDA (sNDA) for ZERBAXA® (Ceftolozane and Tazobactam) (Press)
• Therapeutics Granted Orphan Drug Designation by the FDA for Autoimmune Hepatitis (Press)
• MaaT Pharma Announces Positive DSMB Safety Review and Continuation of its Phase II HERACLES Study in Acute GvHD (Press)
• Exicure Announces US Clinical Sites for Phase 1b/2 Oncology Trial (Press)

• CDRH Fleshes Out Guidance on Application of Least Burdensome Provisions (Focus)
• 4 Tips For Medical Device Cybersecurity (Law360-$)
• Becton Dickinson posts Street-topping FY2019 Q1 earnings (MassDevice)
• Class 1 Device Recall Sterile Water for Inhalation (FDA)
• FDA labels Edwards Lifesciences’ recall of Swan Ganz thermodilution caths as Class I (MassDevice)
• FDA: West Pharma recall of Vial2Bag fluid transfer systems is Class I (MassDevice)
• Stryker recalls select Lifepak 15 defibs on lock-up issues (MassDevice)
• Relievant back-pain device study stopped for positive results (MassDevice)
• Ascyrus Medical wins CE Mark for aortic dissection stent (MassDevice)
• Cook Medical wins FDA nod for Zenith aortic dissection repair stent (MassDevice) (Press)
• Oxipit wins CE Mark for AI-powered chest imaging suite (MassDevice)
• Teleflex Announces U.S. FDA Premarket Approval of MANTA™ Vascular Closure Device (Press)

• The opioid epidemic is a crisis, but Trump isn’t treating it like one (Vox)
• Opioid Executive Who Gave Up $5 Million Points Finger at Insys Founder (Bloomberg)
• 11th-Hour Deal Lets Pfizer Exit As Cancer Patent Trial Begins (Law360-$)
• Medicaid: CMS Action Needed to Ensure Compliance with Abortion Coverage Requirements (GAO)
• Congress Floats Discussion Draft of IVD Legislation (FDA Law Blog)
• Hospital price growth driving healthcare spending (Modern Healthcare)
• Methodology Fixes Coming for Calif. Death Certificate Project (Medpage)
• Amazon-led health venture hires technology chief to work under Gawande (CNBC)
• Lone Pine By Any Other Name... (Drug & Device Law)
• Ex-Pharma CEO Convicted Of $100M Puerto Rico Bank Fraud (Law360-$)
• Boehringer Wins Again as California Judge Tosses Pradaxa Lawsuit (FDANews-$)
• Par Pharma Seeks To Void Merck Diabetes Drug Patent (Law360-$)
• McKesson Must Face Omni's FCA Suit Over Drug Skimming (Law360-$)

• FDA Advisory Committee Calendar
• Vaccines and Related Biological Products Advisory Committee; Notice of Meeting – 6-7 March 2019
• Senate HELP: How Primary Care Affects Health Care Costs and Outcomes – 5 February 2019

• Kiadis poaches Ablynx CSO as it awaits HSCT booster approval in the EU (Fierce)
• New Russian tenders for orphan disease drugs include ones originated by Roche and Shire (Pharmaletter-$)

• Asia Regulatory Roundup: China’s Communist Party Expels Former Senior Vaccine Regulator for Corruption (Focus)
• Curetis Partner Submits MDx System, Pneumonia Test for Chinese Regulatory Approval (GenomeWeb)

• DoP's notification mandating bar-coding on primary pack of drugs being supplied to govt bodies irks SMEs (PharmaBiz)
• Union health secretary directs state drug controllers to form committees to address J&J faulty hip implant compensation cases (PharmaBiz)

• Health Canada Establishing Regulatory Framework for Software as a Medical Device (SaMD) (Emergo)

• Most U.S. kids not meeting sleep, exercise and screen time targets (Reuters)