- FDA accepts the gene spark BLA therapy (endpoints) (press)
- Big pharma buys in crowdsourcing for drug discovery (by cable)
- Large pharmaceutical companies spent on share repurchase, but R & D? Not so much (New York Times)
- Pascal Soriot remains AstraZeneca (Financial Times) (final points)
- FDA rejects Amgen romo anti-osteoporosis drug as rival Radius surprises with new CEO (Fierce) (PharmaTimes) (Presse)
- The FDA is firmly committed to the partial coverage of Repros Therapeutics struggling with a large trial application (endpoints)
- CAR T cells "very exciting" as "living medicine" (Medscape)
- The new NIH report found a low morale, persistent concerns about patient safety (Washington Post)
- Gilead rich in species should consider taking Incyte, but it will not be cheap (fierce)
- In truth, Robot will raise 20 million sterile mosquitoes to free California (MIT Technology Review)
- McCain surgery delays vote on health care; The recovery may be more serious than previously thought, according to experts (New York Times)
- US health insurance companies want the proposal to be dropped Senate cross-law (Reuters)
In Focus: International
- This secret clan wants to beat the world's biggest drug makers (Bloomberg)
- The participation of the increases of the meeting of the regulatory committee of EMA non member of the EU ($ type of leaf pink)
- Shire boss said stock price is at odds with the range of drugs (Financial Times)
- TGA Approves Roche Ocrevus for Progressive Primary Recurrent MS (Press)
- The government has earmarked more than £ 120 million for Global Health Research (UK DOH)
- Indian pharmaceutical companies should increase investment in R & D (Economic Times)
- Despite pressure on prices, India's pharmaceutical exports to the US Could increase during the year 18 (Business Standard)
- The implementation program of the clinical inspection program of clinical trials of Chinese regulations (Emergo)
- Does WHO's revised standards mask safety signals in vaccines? ($ -pink sheet)
- Quebec expects $ 1.2 billion savings with new drug market (Bloomberg)
- Brexit talking about the second round: what are the key issues? (Bloomberg)
- The pharmacist must know the unitary European patent in the light of Brexit (Pharmafile)
- Street vendors Port-au-Prince pills (NPR)
Pharmaceuticals & Biotechnology
- FDA Classification on Opioid Prescription Education (MedPage)
- I had the wrong medication. And a $ 2 help band. (New York Times)
- With cancer screening, better safe than sorry? (New York Times)
- This is not the first American opiate additive crisis (Bloomberg)
- Can the FDA climate to be too good? ($ -pink sheet)
- The FDA determined that deuter compounds are different NCE orphan drugs compared to non-deuterated versions (FDA Blog Law)
- Back to the roots of Ipsen (BioCentury)
- For Alsonex target the complement system C5a for the treatment of ALS (BioCentury)
- CAR-T therapy: non-compliance with publication specifications can not prohibit patient use (pink leaves $)
- As part of the taxpayer-funded research, Sanofi's boss says he has never rejected a fair price request for Zika (fierce)
- Novartis says Cosentyx is safe and effective for five years (PharmaTimes)
- Five questions to ... Austin Biotech businessman Laura Bosworth (Xconomy)
- TherapeuticsMD presents the CRL data with FDA (Seeking Alpha) (Presse)
- More fake Avastin found, this time in Cyprus (Fixing Industry)
Pharmaceuticals and Biotechnology: Study Results, Filings and Designations
- CymaBay stocks get a rebound on positive data PBC PHII (end points)
- The Non-Alcoholic Fatty Liver Test / EHNA Phase II Can-Fite with Namodenoson to Begin Recruiting Patients Following the Conclusion of a Successful Clinical Researcher Meeting (Press)
- Onda Life Sciences is launching Phase 1b / 2a clinical trials: PRECISION-HD1 and HD2-precision in patients with Huntington's disease (Press)
- Alzheon presents new data for the leading candidate ALZ-801 in the new Ministry of Agriculture and long-term clinical efficacy at the International Conference of the Alzheimer's Association (Press)
- Merck announces presentations of clinical data and the real world at the International Conference of the Alzheimer's Association (Press)
- Symbiomix Therapeutics announces the publication of key data for the Solosec research for the treatment of bacterial vaginosis (Press)
- Perrigo announces final approval of the FDA for its generic version evaluated by the first envelope of AndroGel®, 1.62% packages (press)
- Impax Announces FDA Approval of Its Generic Tablet (Methylphenidate Tablet) Reviewed by AB Generic CII Rating (Press)
Medical Devices
- Sailing HIV Melanoma Assays to Ensure Regulator Supply (GenomeWeb)
- Mobius Bionics sells the first use of the prosthesis bionic arm LUKE DEKA (MassDevice)
- Study: cybersecurity attacks create a risk of manipulation of medical data, devices (MassDevice)
- Five-year data show that InterStim Therapy (TM) offers efficacy and quality of life improvements for long-term sustainable bladder hypertensive patients (Press)
US: Assorted & Government
- Biosimilars In Medicare payments: CMS Signals will change ($ type of pink sheet)
- The hymn meets Insys a "creative" scheme to gain the return of its analgesic properties (STAT)
- Governors of both parties denounced the Senate bill repeal proposed Obamacare (New York Times)
- The latest Senate health plan cuts costs for chronic diseases (KHN)
- The marginalized health care lobby hinders the Republican health effort (Reuters)
- Sometimes it is forgotten in the express warranty (Law of medicines and devices)
- Calif. Nerve strikes When choosing cardiac surgeons with the highest patient death rates (KHN)
Upcoming Meetings & Events
- FDA Advisory Committee Calendar
Europe
- Gerresheimer allows the safety solution of the West syringe (Reuters)
- The best 'Brexit-tested' tips to tackle the most difficult of EU production (Forbes)
- Pierre Fabre guarantees the Italian distribution rights for Aprotecol de Noventure (Pharmafile)
- India
- Site of the first test laboratory devices in India in Gujarat approved by the Ministry of Health (Pharmabiz)
- Alembic Pharma Opens Rs 300 Million Rupees Unit in Cancer of Gujarat (Economic Times)
- Alkem Laboratories Plant Eliminates FDA Inspection (Economic Times)
- The pharmaceutical industry South has great potential in the production of medicines against chronic disease: S V Veeramani (Pharmabiz)
- Pharmaceutical sector is a major beneficiary of GST because cold chain materials become problems Dr Piyush Gupta (Pharmabiz)
General Health & Other Interesting Articles
- 3-D-Printed Artificial Heart Beats as the real thing, but still not widely used (MIT Technology Review)
Regulatory recognition is our daily press conference on intelligence to regulatory space, bringing the best new regulations around the world. Every Monday through Friday, we want to get you the latest moments in the approval of new developments, meetings, legal and policy, regulations and guidelines, as well as the latest trends that can influence regulatory professionals and the industry in which they work.
