Regulatory Focus™ > News Articles > 2019 > 1 > Recon: FDA Approves Imbruvica Combo for Treatment-Naive CLL Patients

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

Posted 28 January 2019 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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-$)
Pharmaceuticals & Biotechnology
  • 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-$)
  • A two-fisted punch against cancer metastasis (Fierce)
  • Lupin gets 6 observations from USFDA for its Pithampur Unit-2 (Economic Times)
  • Steep Climb In Benzodiazepine Prescribing By Primary Care Doctors (NPR)
  • Father who lost son to addiction wants justice from Sackler family, owners of OxyContin makers (CBS)
  • Flu vaccine safe for hospitalized patients (Reuters)
  • Gates Foundation’s Expanded Commitment to Global Medicines Encompasses CMC/Regulatory Problem Solving (IPQ)
  • Amgen adds bone drug Xgeva to pharma's cancer-related lineup on TV (Fierce)
  • Awareness is in: DTC disease campaigns surge in the US (Fierce)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • Dicerna Announces Dosing of First Volunteer in Phase 1 Clinical Trial of DCR-HBVS Designed for the Treatment of Chronic Hepatitis B Virus (Press)
  • First-In-Human Case Using Biostage's Bioengineered Esophageal Implant is Presented at Major Surgical Meeting (Press)
Medical Devices
  • Boston Scientific touts 4-year Rezūm BPH treatment trial data (MassDevice)
  • Medtronic Announces US Commercial Launch of Mazor X Stealth(TM) Edition for Robotic-Assisted Spine Surgery (Press)
  • Masimo Announces FDA Clearance of RRp®, Respiration Rate from the Pleth, on the MightySat™ Rx Spot-Check Fingertip Pulse Oximeter (Press)
  • Neurvana Medical alleges Balt sought to ‘sabotage and destroy’ after spinout (MassDevice)
US: Assorted & Government
  • Shutdown- and BA-Related Q&As Continued (Alliance for a Stronger FDA)
  • Judge will rule next week on media request to disclose allegations against Purdue Pharma (STAT)
  • Walgreens, CVS And Rite Aid Among Winners At Shopko Pharmacy Auction (Forbes)
  • Fed. Circ. Ruling Clears Path For Longer Drug Patent Terms (Law360-$)
  • 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)
Upcoming Meetings & Events Europe
  • 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)
Other International
  • Thailand to revoke foreign patent requests on marijuana (Reuters)
General Health & Other Interesting Articles
  • The Unsung Role of the Pharmacist in Patient Health (NYTimes)
  • Beware "Pseudomedicine" Claims Made To Sell Brain-Health Supplements, Warn Neurologists (Forbes)
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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