Regulatory Focus™ > News Articles > 9 > Recon: FDA Approves AstraZeneca’s Lumoxiti for Hairy Cell Leukemia

Recon: FDA Approves AstraZeneca’s Lumoxiti for Hairy Cell Leukemia

Posted 14 September 2018 | By Michael Mezher 

Recon: FDA Approves AstraZeneca’s Lumoxiti for Hairy Cell Leukemia

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Roche steps up efficiency drive to take sting out of biosimilars (Reuters) (Endpoints)
  • Top Sloan Kettering Cancer Doctor Resigns After Failing to Disclose Industry Ties (NYTimes) (Endpoints)
  • Regeneron maps a dramatic expansion with 1,500 new jobs (Endpoints)
  • FDA approves AstraZeneca's drug for rare form of blood cancer (Reuters) (Endpoints) (FDA) (Press)
  • Allergan chief snaps up a rival biotech for $195M in cash, plus. Deal beefs up the aesthetics pipeline (Endpoints)
  • Woodcock: Single FDA Center For Rare Diseases Could Be 'Negative' To Rare Disease Cause (BioCentury) (Pink Sheet-$)
  • The latest tempest over a dramatic drug price hike riles two powerful senators — who can’t actually do anything about it (Endpoints)
  • Update: A Young Man's Experiment With A 'Living Drug' For Leukemia (NPR)
  • Here’s the data behind the new Apple Watch EKG app (STAT)
  • NIH launches initiative to accelerate genetic therapies to cure sickle cell disease (NIH)
  • Congress proposes $90.5 billion in HHS appropriations, including opioid funding (Modern Healthcare)
  • The Worst Is Over for Generic-Drug Stocks (WSJ)
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In Focus: International
  • Sanofi pledges to keep up its restructuring efforts (Reuters)
  • Preparing for the incoming wave of biosimilars in oncology (EMSO Open)
  • Roche boss says Brexit and curbs on drug use pose threat to UK science (Reuters)
  • Regulators flag second impurity in China-made heart drug (Reuters) (Focus)
  • ViiV submits two-drug regimen for HIV in Europe (PharmaTimes)
  • Hua Raises $110m In Hong Kong IPO (BioCentury)
  • ‘Streamlined’ medicines regulation promised in ‘No Deal’ Brexit scenario (PMLive)
  • Sanofi Creating China/Emerging Markets And Primary Care Units (BioCentury)
  • Babylon Healthcare targets chronic disease in $100 million expansion (Reuters)
  • Wockhardt moves HC against ban on its fixed dose combination drug (Economic Times)
  • Landmark MS trial launches in UK (PharmaTimes)
  • Swedish Regulator Ends Investigation of Birth Control App (NYTimes)
  • Committee for Orphan Medicinal Products (COMP) elects new chair (EMA)
  • Teva Is Said to Draw Interest From Recipharm, EMS for Medis Unit (Bloomberg)
  • Scottish government invests £11m into Glasgow biotechnology centre (Pharmafile)
Pharmaceuticals & Biotechnology
  • J&J execs say new launches and label expansions will fuel 'above-market' growth through 2021 (Fierce)
  • Supernus bags early-stage CNS drug for $15M upfront in renewed epilepsy R&D efforts (Endpoints) (Fierce)
  • Upsized and top-of-the-range: Fall round of biotech IPOs starts with a solid hit for Principia (Endpoints)
  • Look out, AbbVie. Thanks to Boehringer, your Humira biosimilar defense isn't over yet (Fierce)
  • Galapagos Follows Positive RA Data With $300m Round (BioCentury)
  • Patient Groups Urge CVS To Reconsider ICER-Restricted Formulary (BioCentury)
  • AbbVie builds case for potential psoriasis blockbuster risankizumab ahead of regulatory decisions (Fierce)
  • Top scientist Thor Voigt vaults to CMO role at Boehringer Ingelheim; Celgene’s Scott Smith tapped as president at BioAtla (Endpoints)
  • Vericel brings cell therapy to knee patients (MedCity)
  • BioLyte Laboratories Issues Voluntary Nationwide Recall Due to the Voluntary Nationwide Recall initiated by King Bio Inc. (a Raw Material Supplier) for NeoRelief for Muscle Cramping and Restlessness Topical Gel Due to Possible Microbial Contamination (FDA)
  • Agency Information Collection Activities; Proposed Collection; Comment Request; Obtaining Information for Evaluating Nominated Bulk Drug Substances for Use in Compounding Drug Products Under Section 503B of the Federal Food, Drug, and Cosmetic Act (FDA)
Pharmaceuticals & Biotechnology: Study Results, Filings & Designations
  • FDA to review Regeneron’s Eylea for diabetic retinopathy (Drug Delivery)
  • Genentech wins FDA nod for subcutaneous formulation of arthritis drug (Drug Delivery) (Press)
  • Bone Therapeutics’ cell therapy hits goal in phase 1/2a, but manufacturing changes slow progress (Fierce)
  • Sun Pharma and SPARC Announce US FDA Approval of XELPROS™ to Treat Open-angle Glaucoma or Ocular Hypertension (Press)
  • AbbVie Presents Upadacitinib Longer-Term (32-Week) and Patient-Reported Outcomes Data from Phase 2b Atopic Dermatitis Study at 27th European Academy of Dermatology and Venereology (EADV) Congress (Press)
  • Alnylam Announces Publication in Circulation of Exploratory Cardiac Endpoint Data from APOLLO Phase 3 Study of Patisiran (Press)
Medical Devices
  • Will a “Quik” 510(k) be a Quick 510(k)? (FDA law Blog)
  • FDA nod to Apple Watch notable, but … (MedCity)
  • Motus GI wins FDA nod for Pure-Vu slim colonoscopy sleeve (MassDevice)
  • Smiths Medical spikes merger talks with ICU Medical (Drug Delivery)
  • Globus Medical picks up Surgimap for ExcelsiusGPS robot-assisted surgery device (MassDevice)
  • Hologic lowers Cynosure revenue outlook in response to FDA warning on ‘vaginal rejuvenation’ products (MassDevice)
  • STAAR Surgical Announces Approval by the FDA of the Visian Toric ICL for the Correction of Myopia with Astigmatism (Press)
US: Assorted & Government
  • New Medicare Advantage Tool To Control Drug Prices Could Narrow Choices (NPR)
  • Boston Joins In Suing Purdue, Others Over Opioid Epidemic (Law360-$)
  • How health providers are prepping for Hurricane Florence (Politico)
  • Want To Know What Opioid Lawyers Are Up To In Texas? It Costs Thousands To Find Out (Forbes)
  • Correct Application of the Discovery Rule Means Summary Judgment in Hip Implant Decision out of the Eastern District of Pennsylvania. (Drug & Device Law)
Upcoming Meetings & Events Europe
  • EuroBiotech Report—Gilead-Galapagos, Boehringer, Crescendo and Medivir hire CMOs and Pfizer-Cytoo (Fierce)
  • EU Guide On Handling IMPs Draws Industry Concern (Pink Sheet-$)
  • NHS summer performance hits new lows (PharmaTimes)
  • Marketing authorisations granted in August 2018 (MHRA)
  • Parallel import licenses granted in August 2018 (MHRA)
  • Outperformers: Maintaining ASEAN countries’ exceptional growth (McKinsey)
  • States yet to form panels to determine quantum of compensation in J&J hip implant imbroglio despite ministry directive (PharmaBiz)
  • TimesIndia’s Singh brothers end public feud after mother urges deal (Financial Times)
  • Submissions and TGA response: Miconazole and fluconazole: proposed additional advisory statements for medicines (TGA)
General Health & Other Interesting Articles
  • “Hundreds” of crimes will soon be solved using DNA databases, genealogist predicts (MIT Technology Review)
  • Which Screening Prevents The Most Cervical Cancer? Go With Co-Testing (Forbes)
  • Demand A Scan: Luck Is Not An Option (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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