Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Swiss Exchange  >  Novartis    NOVN   CH0012005267

NOVARTIS (NOVN)

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 
The feature you requested does not exist. However, we suggest the following feature:

Novartis : Sandoz Head of US Regulatory Affairs Explores New FDA Biosimilar Interchangeability Guidelines

share with twitter share with LinkedIn share with facebook
share via e-mail
0
06/29/2017 | 09:01am CEST

Iselin, NJ, June 29, 2017 --(PR.com)-- SMi Group has announced that Dr Cindy Cao, Executive Director and Head of US Regulatory Affairs for Biopharmaceuticals at Sandoz has joined the speaker panel for the 4th Biosimilars North America, which takes place on November 15 & 16, 2017.

Earlier this year, the FDA released a highly-anticipated draft of guidelines for biosimilar interchangeability. Months later, more than 50 stakeholder groups have submitted comments on the draft guidance. Comments suggested that the agency still needs to clarify the standards for naming and labelling, as well as showing that a biosimilar is, indeed, interchangeable with the original biologic. Dr Cao’s presentation will aim to address questions relating to the FDA guidelines.

Speaking on Day 1 of the conference, Dr Cao will discuss the FDA's biosimilar interchangeability guidance. In her presentation, she will discuss the impact of the new guidelines and explore considerations for interchangeability, as well as how to engage with stakeholders.

Dr Cao joins a speaker lineup comprised of experts shaping up the biosimilars landscape in North America including representatives from Sandoz, Mylan, Harvest Moon Pharmaceuticals, Momenta, FUJIFILM Diosynth, Oncobiologics, Adelio, Covance, Zuckerman & Spaeder and more.

The full roster of speakers and their topics can be found on www.biosimilars-northamerica.com/prcom.

This year, the conference will also explore significant developmental topics within the sector including the impact of FDA’s newly implemented biosimilar interchangeability guidelines, the US market access landscape, and biosimilars of orphan drugs.

Registration is now live on the event website and there are currently Early Bird rates available.

4th Biosimilars North America
November 15 & 16, 2017
Renaissance Woodbridge Hotel, Iselin, NJ, USA
www.biosimilars-northamerica.com/prcom

For delegate registration enquiries, contact Fateja Begum on [email protected] For media enquiries, contact Honey de Gracia at [email protected]

About SMi Group:
Established since 1993, the SMi Group is a global event-production company that specializes in Business-to-Business Conferences, Workshops, Masterclasses and online Communities. We create and deliver events in the Defence, Security, Energy, Utilities, Finance and Pharmaceutical industries. We pride ourselves on having access to the world’s most forward thinking opinion leaders and visionaries, allowing us to bring our communities together to Learn, Engage, Share and Network. More information can be found at http://www.smi-online.co.uk

Contact Information:
SMi Group
Honey de Gracia
+44 (0) 207 827 6102
Contact via Email
http://www.biosimilars-northamerica.com/prcom

Read the full story here: http://www.pr.com/press-release/721481

Press Release Distributed by PR.com

Latest news on NOVARTIS
09:01a NOVARTIS : Sandoz Head of US Regulatory Affairs Explores New FDA Biosimilar Inte..
07:16a NOVARTIS : receives EU approval for first-line use of Zykadia® in ALK-positive a..
06/28DJVECTURA : In Asthma Collaboration With Novartis's Sandoz
06/28 NOVARTIS : Sandoz launches MabThera, Enbrel biosimilars in the UK
06/28 NOVARTIS : Sandoz receives approval in Europe for Erelzi (biosimilar etanercept)..
06/28 NOVARTIS : EC Clears Sandoz`s Erelzi Biosimilar Etanercept Copy of Amgen`s Enbre..
06/27 NOVARTIS : Sandoz receives approval in Europe for Erelzi® (biosimilar etanercept..
06/26 NOVARTIS : Health and Human Services Department (HHS); Food and Drug Administrat..
06/23 PFIZER : Global Latanoprost Sales Market 2017 - Pfizer, Jamp Pharma, Laboratoire..
06/23 NOVARTIS : NEJM publishes full analysis of Rydapt® (midostaurin) Phase III RATIF..
More news
Sector news : Pharmaceuticals - NEC
09:22a COVESTRO : vows to cash out to shareholders if no takeover on cards
04:55a MYLAN : Investors call on Mylan chairman, director to step down
06/28 UK blue chips led lower by Hargreaves as strong pound takes toll
06/28DJGLAXOSMITHKLINE : Announces US Filing For Mepolizumab
06/28DJMERCK AND : Today's Top Supply Chain and Logistics News From WSJ
More sector news : Pharmaceuticals - NEC
News from SeekingAlpha
06/28 GILEAD AND CAR-T OF SOLID TUMORS : The Next Revolution In Cancer Therapeutics
06/28 Unshakeable Alexion Sees Off Ra And Akari
06/27 Kala Pharmaceuticals Files For $86 Million IPO
06/27 CAR-T Value Calculation In The Firing Line
06/27 3 THINGS IN BIOTECH YOU SHOULD LEARN : June 27, 2017
Advertisement
Financials ($)
Sales 2017 48 383 M
EBIT 2017 11 853 M
Net income 2017 7 439 M
Debt 2017 15 454 M
Yield 2017 3,31%
P/E ratio 2017 25,68
P/E ratio 2018 22,62
EV / Sales 2017 4,94x
EV / Sales 2018 4,72x
Capitalization 223 476 M
More Financials
Chart NOVARTIS
Duration : Period :
Novartis Technical Analysis Chart | NOVN | CH0012005267 | 4-Traders
Full-screen chart
Technical analysis trends NOVARTIS
Short TermMid-TermLong Term
TrendsBullishBullishBullish
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 32
Average target price 82,4 $
Spread / Average Target -3,5%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
Joseph Jimenez Chief Executive Officer
Hans Jörg Reinhardt Independent Non-Executive Chairman
Harry Kirsch Chief Financial Officer
Vasant Narasimhan Chief Medical Officer & Head-Drug Development
Srikant Madhav Datar Independent Non-Executive Director
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
NOVARTIS11.74%223 476
JOHNSON & JOHNSON17.19%360 489
ROCHE HOLDING LTD.8.34%226 454
PFIZER3.91%200 985
MERCK AND COMPANY10.68%178 223
SANOFI12.74%124 566
More Results