Recon: FDA Approves Imbruvica Combo for Treatment-Naive CLL Patients

• Pfizer Pivots to Cancer Drugs for Growth (WSJ)
• CVS to cover migraine drugs from Teva, Lilly; excludes Amgen (Reuters)
• These Patients Had Sickle-Cell Disease. Experimental Therapies Might Have Cured Them. (NYTimes)
• Officials pick up pieces as shutdown ends (Politico) (Fierce)
• Short-term budget deal comes just in time for biotech firms (CNBC)
• Big Pharma Should Accept Cap On Drug Price Increases (Forbes)
• Insys founder, former executives face opioid kickback scheme trial (Reuters) (Boston Globe)
• Alexion’s newly approved rare-disease drug notches another clinical trial win (STAT) (Fierce) (Endpoints) (Press)
• AstraZeneca strikes a ‘novel’ deal with a Medicare plan to lower patient out-of-pocket costs (STAT) (Fierce)
• Imbruvica regimen wins FDA approval as first non-chemotherapy treatment for untreated patients with common form of leukemia (Endpoints) (PMLive) (Press)
• Indian Tribe Joins Big Pharma at the Supreme Court, Defending a Lucrative Deal (NYTimes)
• Moms of the dead from drugs: “Where is the outrage for us?” (Miami Herald)
• By the numbers for 2018: The top 100 venture players in biotech — and who’s been paying the piper in cancer R&D? (Endpoints)

• UK biotech funding increased by 85 percent in 2018 (EPR) (Endpoints)
• CEO Emma Walmsley takes GlaxoSmithKline on a quest for identity (STAT)
• GSK’s venture team at SR One in talks to spin off from its big pharma founder, now under new R&D management (Endpoints)
• Swiss Drugs Boss Optimistic on Finding an Alzheimer’s Treatment (Bloomberg)
• South Sudan vaccinates health workers against Ebola (WHO)
• Pfizer Launches China's First Pay-For-Performance Model For Cancer (BioCentury)
• Zai Lab nabs speedy China regulatory review for PARP drug Zejula (Endpoints)
• Philip Hampton to step down from chairman role at GSK (Pharmafile)
• UK committee warns universities over failures to report clinical trials (STAT)
• US citizen leaks data on thousands in Singapore with HIV, government says (Reuters) (AP)
• EMA staff lower flags at London office as move nears (Fierce) (PMLive) (Endpoints) (The Guardian)
• Biopharma Companies Explain Brexit Preparations (Focus)
• UK Drafts Contingency Legislation for Drug and Device Regulations Under No-deal Brexit (Focus)
• Novartis warns of huge impact of no-deal Brexit (Pharmafile) (PharmaTimes)
• EU Updates Brexit Advice On Changing UK Applicant For Ongoing Procedures (Pink Sheet-$)

• Pfizer, Novartis, Amgen add to 2019 drug price hikes (BioPharmaDive)
• The Hidden Reason Behind Low Vaccination Rates In The US (Forbes)
• Some doctors helping anti-vaccine parents get medical exemptions (NBC)
• Editorial: Legislature should limit vaccine exemptions (Seattle Times)
• Balancing the Risks and Benefits of Opioids for Children (NYTimes)
• Disgraced at Vertex, Ian Smith’s career implosion ends with swift exile from biotech boards (Endpoints)
• Insulin has become so expensive that this diabetic is trying to make his own (CNBC)
• Based On Sales Forecasts For 2018 FDA Approved Drugs, Big Pharma Not Just Focused On Blockbusters (Forbes)
• AbbVie Loses $8b In Market Cap On Steeper Humira Erosion (BioCentury)
• Preventing flu with an antibody-plus-Tamiflu universal vaccine (Fierce)
• PhRMA comments to administration on Medicare Part D proposed rule (PhRMA)
• Where Is OxyContin Abuse Deterrent Data? Purdue Has Sent Two Studies, But Wait Continues (Pink Sheet-$)
• Biosimilars Begin To 'Pay Off' For Biocon (Scrip-$)
• A two-fisted punch against cancer metastasis (Fierce)
• Lupin gets 6 observations from USFDA for its Pithampur Unit-2 (Economic Times)
• Steep Climb In Benzodiazepine Prescribing By Primary Care Doctors (NPR)
• Father who lost son to addiction wants justice from Sackler family, owners of OxyContin makers (CBS)
• Flu vaccine safe for hospitalized patients (Reuters)
• Gates Foundation’s Expanded Commitment to Global Medicines Encompasses CMC/Regulatory Problem Solving (IPQ)
• Amgen adds bone drug Xgeva to pharma's cancer-related lineup on TV (Fierce)
• Awareness is in: DTC disease campaigns surge in the US (Fierce)

• Dicerna Announces Dosing of First Volunteer in Phase 1 Clinical Trial of DCR-HBVS Designed for the Treatment of Chronic Hepatitis B Virus (Press)
• First-In-Human Case Using Biostage's Bioengineered Esophageal Implant is Presented at Major Surgical Meeting (Press)

• Boston Scientific touts 4-year Rezūm BPH treatment trial data (MassDevice)
• Medtronic Announces US Commercial Launch of Mazor X Stealth(TM) Edition for Robotic-Assisted Spine Surgery (Press)
• Masimo Announces FDA Clearance of RRp®, Respiration Rate from the Pleth, on the MightySat™ Rx Spot-Check Fingertip Pulse Oximeter (Press)
• Neurvana Medical alleges Balt sought to ‘sabotage and destroy’ after spinout (MassDevice)

• Shutdown- and BA-Related Q&As Continued (Alliance for a Stronger FDA)
• Judge will rule next week on media request to disclose allegations against Purdue Pharma (STAT)
• Walgreens, CVS And Rite Aid Among Winners At Shopko Pharmacy Auction (Forbes)
• Fed. Circ. Ruling Clears Path For Longer Drug Patent Terms (Law360-$)
• Morphosys’ Darzalex patent challenge hits a hurdle (PMLive)
• Case Dismissed: Strike Two for PMRS (FDA Law Blog)
• Barry v. Medtronic – Be Careful What You Use and Sell! (National Law Review)
• Supernus Pharmaceuticals, Inc. v. Iancu (Fed. Cir. 2019) (Patent Docs)
• Supreme Court Leans Toward Reversal In Merck V. Albrecht (Law360-$)
• The Startup Drugmaker's Post-Helsinn Survival Guide (Law360-$)
• Abbott Labs, St. Jude Avoid Suit Over Battery Defects Again (Law360-$)
• Cannabis Cos. Adopting Biotech's Patent Playbook (Law360-$)
• Biosimilar Vs. Biosimilar: Coherus Sues Amgen For Infringing Adalimumab Formulation Patents (Pink Sheet-$)
• Massachusetts Gov. Proposes Direct Drug Negotiation Power for State Medicaid Program (FDANews-$)
• Clone Wars (Drug & Device Law)
• New Jersey To Allow Cannabis For Opioid Abuse Not A Moment Too Soon (Forbes)

• FDA Advisory Committee Calendar

• Committee for medicinal products for human use (CHMP) Draft Agenda (EMA)
• Germany seeks medical marijuana producers for home grown supply (Reuters)
• Poland Kick Starts 2019 With Three Rx-To-OTC Switches (Pink Sheet-$)
• Destiny Pharma to get £1.6M grant for AMR (PharmaTimes)
• People in England will be able to pay the NHS to sequence their genetic data, if they share it with scientists (Pharmafile)

• Takeda Said to Plan Biggest Japan Bond Sale After Shire Purchase (Bloomberg)

• Govt's new proposal: Manufacturer to pay penalty for entire batch if single drug found substandard (Economic Times)
• Use compulsory license and put ceiling to curb prices of patented medicines: Government panel (Economic Times)
• Dr Reddy's gets FDA nod for 'Tosymra' migraine nasal spray (Economic Times) (Press)
• Cipla gets USFDA nod for contraceptive injection (Economic Times)
• No separate pricing for insulin cartridges as NPPA panel finds ‘no significant therapeutic advantage’ in cartridges over vials (PharmaBiz)

• The first six months: embedding the TGA advertising reforms (TGA)

• Draft Guidance Document - Regulatory requirements for Drug Identification Numbers (DINs) (Health Canada)

• Thailand to revoke foreign patent requests on marijuana (Reuters)

• The Unsung Role of the Pharmacist in Patient Health (NYTimes)
• Beware "Pseudomedicine" Claims Made To Sell Brain-Health Supplements, Warn Neurologists (Forbes)