Regulatory Recon: Teva Warns on Profit Outlook Hospitals Vow to Keep Medicare Drug Subsidies (2 November 2017)
Posted 02 November 2017 | By
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In Focus: USCMS Finalizes Policies that Lower Out-of-Pocket Drug Costs and Increase Access to High-Quality Care (CMS)Hospitals Vow Fight to Keep Medicare Drug Subsidies (WSJ-$) (Modern Healthcare) (Politico)Want Drug Regulators To Consider Real-World Evidence? Then Disrupt Their Outdated Regulatory Infrastructure (Health Affairs)FDA Panels Like Long-Acting Buprenorphine (MedPage Today)EpiPen Failures Cited in Seven Deaths This Year, FDA Files Show (Bloomberg)FDA edges gingerly toward regulating tens of thousands of medical tests (Stat-$)Pharma execs would welcome Amazon into drug distribution, say the space is 'ripe for disruption' (CNBC) (Axios)FDA commissioner warns drug companies of 'disruptive' regulations to fight opioid epidemic (CNBC)Coordinated Efforts Needed to Further Strengthen Oversight of Select Agents (GAO)Pay-for-Delay Deals: FTC Notes Continued Decline Since SCOTUS Ruling (Focus)
In Focus: InternationalTeva lowers 2017 outlook again after third quarter earnings fall (Reuters) (FT-$)Measure by Measure: analysis of BMJ research into cancer drugs approved by the EMA (ABPI)EuroBiotech Report—AstraZeneca’s busy week, Big Pharma help Euro VC fund go big and Boehringer places NASH bet (Fierce)India and US soon to begin joint research in area of eye diseases (Pharmabiz)EU OKs low-dose Xarelto to prevent recurrent VTE (Pharma Times)Final NICE nod for Sanofi’s Kevzara (PharmaTimes)Review Panel Annual Report 2016 (MHRA)Consultation on the thirteenth General Programme of Work (WHO)
Pharmaceuticals & BiotechnologyGSK and Gilead go head to head as HIV drugs enter new phase (Reuters)Mallinckrodt to Acquire Ocera Therapeutics for Up to $117M (GEN)Most New Drug Patents Are for Old Remedies, Research Shows (Bloomberg)One Man's Quest to Cure Diabetes 2 (Forbes)“Mutual Recognition” Kicks Into High Gear (FDA Law Blog)In need of scrutiny: Misleading stem cell claims by academic medical centers (Health News Review)Creative Minds: A New Way to Look at Cancer (NIH Director’s Blog)Amazon should buy these companies if it wants to get into selling drugs (CNBC)Manufacturing cost transparency could combat pricing criticism, says expert (InPharma)Shortages mar Q3 as Pfizer says Hospira remediation taking longer (InPharma)Insys posts bigger loss amid bribery probe of founder (Reuters)Panel Recommends Opioid Solutions but Puts No Price Tag on Them (NY Times-$)Janssen Must Fork Over More Employee Info In Opioid Suit (Law360-$)Teva Beats Patent Claims Over Uceris Generic (Law360-$)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & DesignationsGSK gets boost for early cancer hopes with breakthrough status (Reuters)Prize fight in Paris: Alnylam and Ionis slug it out over PhIII data in preparation for a blockbuster showdown (Endpoints)Boehringer Ingelheim, Dicerna Launch Liver Disease Collaboration (GEN) (Fierce)Doubling Down on Gene Therapy for Heart Failure (MIT Tech Review)Gene therapy’s new hope: A neuron-targeting virus is saving infant lives (Science)Single-Dose Gene-Replacement Therapy for Spinal Muscular Atrophy (NEJM)Blood from young people does little to reverse Alzheimer’s in first test (Science)Researchers find fatal flaw in childhood tumors (Science)Fewer Flashy Drug Delivery Papers, Please (In the Pipeline)AZ’ experimental asthma drug fails in Phase III (PharmaTimes)GSK’s Anoro Ellipta beats BI’s Spiolto Respimat in COPD trial (PharmaTimes)Momenta’s Orencia biosimilar does not meet primary endpoints in Ph1 (Big Molecule Watch)
Medical DevicesFresenius shares fall on Q3 sales miss (Mass Device)Grifols posts Q3 sales, earnings gains (Mass Device)Philips sees 4-6 percent sales growth in health technology push (Reuters)Sen. Warren: Adding UDIs to Medicare Claims Forms Should be a 'No-Brainer' (Focus)Court Bars Philips From Manufacturing, Selling Some Adulterated Defibrillators (Focus)CDSCO issues notices to port offices for clarity in dealing with imported medical devices (PharmaBiz)The Mammography Quality Standards Act: A 25-year public health success story (Mass Device)
US: Assorted & GovernmentRepublican tax bill urges corporate tax cut, other changes (Reuters) (NPR)Waste not, want not: A new bill tries to reduce waste caused by drug makers (Stat-$)CMS Issues Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Payment System and Quality Reporting Programs Changes for 2018 (CMS)HHS activates aid for uninsured U.S. Virgin Islands residents needing medicine (HHS)FDA Warns Four Companies Selling Cannabidiol Over Unproven Claims (Focus)White House opioids panel offers 56 recommendations but not how to pay for them (SNL)
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General Health & Other Interesting ArticlesEugenics 2.0: We’re at the Dawn of Choosing Embryos by Health, Height, and More (MIT Tech Review)Mexican Doctors Safely Reuse Donated Pacemakers After Sterilization (Infection Control Today)
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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