Recon: UK Supreme Court Rules Against Pfizer in Lyrica Patent Case
In Focus: US- Pfizer Launches Epoetin Alfa Biosimilar, Retacrit, at 33.5% Discount to Reference Epogen (Center for Biosimilars)
- Celgene Doubles Down on Dragonfly, Pays $50M to Expand Cancer Pact (Xconomy) (Endpoints)
- Allergan Loses Appeal Over Validity of Restasis Patents (Bloomberg)
- The new Google Health unit is absorbing health business from DeepMind, Alphabet's AI research group (CNBC) (Fierce)
- HHS will bring in fetal tissue experts for ‘listening session’ (STAT)
- Covering the cost of high-priced therapies like CAR-T is ‘not sustainable,’ hospital chief says (STAT)
- We created a transparent pharmacy benefit management company. Here’s why (STAT)
- New Jersey Sues Pharmaceutical Company Amid Spiraling Opioid Crisis (NYTimes)
- As The Opioid Backlash Grows, Sickle Cell Patients Fear They'll Lose Critical Pain Treatment (KCUR)
- As social media ‘influencers,’ patients are getting a voice. And pharma is ready to pay up (STAT)
- Extraordinary tactics, perverse incentives: Makers of top-selling drugs hike prices in lockstep, and patients bear the cost (STAT)
- A Search For New Ways To Pay For Drugs That Cost A Mint (NPR)
- Merck Ups Sales View Despite Lower Profits (WSJ)
- Merck drug Keytruda succeeds in late-stage esophageal cancer trial (Reuters) (Endpoints)
- Polio-like disease may be caused by several viruses, CDC says (NBC)
Sponsored Content: RCRI – Regulatory & Clinical
FDA is maintaining scrutiny of in vitro diagnostic and genetic tests. Earlier this month, the FDA issued safety communications related to genetic tests and direct to consumer diagnostics. While the in vitro diagnostics field is a rapidly evolving science, the FDA is working hard to stay on top of the primary safety concerns. The safety alerts were provided to help educate the public on FDA’s role in regulating these products and describing the potential limitations.
In Focus: International
- Pfizer loses blockbuster drug patent fight in UK Supreme Court (Reuters)
- Congo's Ebola outbreak to last at least six more months: WHO (Reuters)
- AbbVie inks licensing deal to boost Mavyret access in nearly 100 countries (Fierce)
- Patients and industry fret over drug supplies, if no Brexit deal (Reuters) (BioCentury) (PMLive)
- AstraZeneca duplicating U.K. testing in EU as Brexit looms (BioPharmaDive)
- Samsung BioLogics violated accounting rules, says watchdog (Financial Times) (Pharmafile) (Endpoints)
- United Nations considers a test ban on evolution-warping gene drives (MIT Technology Review)
- In rural France, Macron seeks remedy for 'healthcare deserts' (Reuters)
- German health minister calls for faster adoption of biosimilar drugs (Reuters) (Pharmafile)
- Bayer VP Alan Westwood to lead antimicrobial firm Matoke Pharma (Fierce)
- NHS to fund continuous blood glucose monitoring system (PharmaTimes)
- UK launch for Mylan, Biocon insulin glargine biosimilar Semglee (PharmaTimes)
- New Abuse-Deterrent IR Oxycodone Drug to Be Reviewed (Medpage)
- Can a ‘rediscovered’ drug from India make it big in US immunology space? Dan Bradbury and his team at Equillium want to prove yes (Endpoints)
- Did Novartis get $150M worth of positive PhII cardio data from Akcea? (Endpoints)
- A Spark Of Good News For Precision Oncology In Breast Cancer (Forbes)
- SVB buys Leerink for $280M, boosting its life sciences business (Fierce) (Endpoints)
- Seniors want drug prices in ads. Young people? Eh, whatever: survey (Fierce)
- Mesoblast defends stem cell therapy for heart failure after trial miss (Fierce)
- At 24, Two Entrepreneurs Took On Cancer. At 32, They’re Worth Hundreds Of Millions (Forbes)
- Bayer's Stivarga First to Enter Adaptive Brain Cancer Trial (BioCentury)
- How can predictive analytics help pharmaceutical manufacturing? (EPR)
- Johnson & Johnson backs new Invokana CV nod with series of awareness tweets (Fierce)
- Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine, Receives Breakthrough Therapy Designation for Emgality™ (galcanezumab-gnlm) for Prevention of Episodic Cluster Headache (Press)
- Seattle Genetics Initiates Phase 1 Clinical Trial of SEA-BCMA for Patients with Relapsed or Refractory Multiple Myeloma (Press)
- Stallergenes Greer Announces U.S. FDA Approval of Pediatric Indication Extension for Oralair® Sublingual Immunotherapy Tablet for the Treatment of Grass Pollen Allergy (Press)
- ImmunoMolecular Therapeutics Awarded SBIR Grant and Receives Rare Pediatric Disease Designation from FDA for IMT-002 (Press)
- Baxter touts Hemopatch, Floseal study results (MassDevice)
- 5 award-winning medical device innovations for unmet needs (Medical Design & Outsourcing)
- Ziehm Imaging wins $135m DoD contract for radiology systems (MassDevice)
- Medtronic backs infant-sized miniature pacer (MassDevice)
- FDA clears Spinal Elements’ surface coating technology (MassDevice)
- Xeris Pharmaceuticals touts data for glucagon auto-injector (Drug Delivery)
- Valeritas inks Middle East distro deal for V-Go insulin delivery device (Drug Delivery)
- Abiomed shares slide despite Impella CP trial success (MassDevice)
- Canon Medical Receives FDA Clearance for Premium MR System: Vantage Orian 1.5T (Press)
- Tickborne diseases such as Lyme hit record highs in the U.S., CDC says (NBC)
- Mayo Clinic gets $200 million donation from turnaround expert Jay Alix (Reuters)
- Crazy Kind of Claims (FDA Law Blog)
- Hoosier Daddy, Pt. 2: S.D. Indiana Smacks Down Plaintiff Daubert Challenge (Drug & Device Law)
- U.S. physicians urge FDA to bolster labeling on high-sugar foods (Reuters)
- Blu e-cigarette maker plans to restrict online sales amid FDA crackdown on teen use (CNBC)
- Juul to halt sale of flavored e-cigarette products in stores after FDA crackdown (USA Today)
- FDA Advisory Committee Calendar
- Meetings: Evaluating the Pressor Effects of Drugs – 4 February 2019
- EMA Risk assessment guideline focus group meeting
- MHRA: requests under the Freedom of Information Act (FOIA) (MHRA)
- EMA gives guidance on safety monitoring of medicines used in children Share (EMA) (Focus)
- Australian pharma Phebra sets up UK operations (PharmaTimes)
- EMA PRIME designation for Modis’ MT1621 for TK2 deficiency (PharmaLetter-$)
- J&J Vision inks $26m Singapore collaborative myopia research deal (MassDevice)
- CDSCO starts inspecting drug companies to assess pharmacovigilance practices, regulatory compliance (PharmaBiz)
- Maha FDA detects racket of polio vaccine being traded in open market meant for govt supply (PharmaBiz)
- Glycerine, potassium permanganate disappear from retail drug shelves after price control by NPPA (Press)
- Health Canada Approves Two BCR-ABL Tests (GenomeWeb)
- Australian TGA Regulatory Changes for Implantable Medical Devices Starting in December 2018 (Emergo)
- Beekeeper therapist uses venom to heal his patients (Reuters)
- Papua New Guinea Is Rich in Resources but Poor in Health (NYTimes)
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.