Regulatory Recon: Celgene Abandons Late-Stage Trial in Crohn’s Disease (20 October 2017)
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- Celgene just lost a crucial drug for its revenue stream after a clinical trial blowup (Stat) (Endpoints) (PharmaTimes) (Reuters) (Press)
- Merck plans to lay off 1,800 sales staffers in U.S. commercial shakeup (Fierce)
- Hacking Is a Risk for Pacemakers. So Is the Fix (Wall Street Journal-$)
- Statement by FDA Commissioner Scott Gottlieb, M.D. on medical device manufacturing recovery in Puerto Rico (FDA)
- What’s Missing from FDA’s Recent Approval Letter for Generic COPAXONE 40 mg/mL? (FDA Law Blog)
- Gene therapy helped these children see. Can it transform medicine? (Financial Times-$)
- Rare Diseases: Growing Understanding Will Unlock Accelerated Approval, FDA Says (Pink Sheet-$)
- Prosecutors seek pharmacist's conviction over U.S. meningitis outbreak (Reuters)
- Trump blindsides advisers with promised opioid plan (Politico)
- A Woman Went Blind After Stem Cells Were Injected in Her Eyes (The Atlantic)
In Focus: International
- NICE no for Opdivo in urothelial carcinoma (PharmaTimes)
- Webcast: Can The World Finally Wipe Out Polio? (NPR)
- Small-cap focus: UK life sciences groups look across Atlantic (Financial Times-$)
- Dr Reddy's Lab recalls Famotidine tablets from US market (Economic Times)
- WHO supports containment of rare virus on Uganda-Kenya border (WHO)
- Plague kills 94 in Madagascar, WHO says working to prevent spread (Reuters)
Pharmaceuticals & Biotechnology
- Cancer drug prices have been rising much, much faster than inflation (Stat-$)
- Reframing the Conversation on Drug Pricing (NEJM Catalyst)
- CPhI Annual Report reveals slow and discouraging trends in current drug pipelines (European Pharmaceutical Review)
- AbbVie Must Face Suit Over Failed Shire Deal In Ill. Court (Law360-$)
- Allergan's stock-price struggles sure to trigger breakup questions: analyst (Fierce)
- Merck cyber attack may cost insurers $275 million: Verisk's PCS (Reuters)
- Reckitt Benckiser, eyeing Pfizer OTC, carves out consumer health unit in reorganization (Fierce)
- The challenges gene therapies pose for logistics (MedCity News)
- Blaming Pharma Won’t Lower Health Care Costs (BIO)
- Why doctor and hospital groups are fighting a measure to rein in drug costs (Stat)
- FDA Approval Letter for Gilead’s Yescarta (FDA)
- First ESMO Award in Immuno-Oncology Goes to Laurence Zitvogel (ESMO)
- FDA-ASCO: Geriatric Oncology Workshop (FDA)
Pharmaceuticals and Biotechnology: Clinical Study Results, Filings & Designations
- Johnson & Johnson, tiny RNA biotech Arcturus combine for hepatitis B work (Fierce)
- Seattle’s Universal Cells brings Astellas into its fold of off-the-shelf cell therapy partners (Endpoints)
Medical Devices
- GE Healthcare profits, sales rise despite overall EPS miss (Mass Device)
- The 11 most innovative medical devices of 2017 (Mass Device)
US: Assorted & Government
- No One Values Your Life More Than the Federal Government (Bloomberg)
- Product-Specific Guidance for Methylphenidate Hydrochloride; New Draft Guidance (Federal Register)
- FDA Releases Flurry of New, Revised Drug-Specific Guidance Documents (Focus)
Upcoming Meetings & Events
General Health & Other Interesting Articles
- Will the World's Most Worrying Flu Virus Go Pandemic? (The Atlantic)
- Report: Pollution Kills 3 Times More than AIDS, TB And Malaria Combined (NPR) (Guardian)
- Can Immigration Ease a Growing Psychiatrist Shortage? (Bloomberg)
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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A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.