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Outlook 100 2019 - Rankings, commentary and infographic

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Clinical Breakthroughs in Urological Cancers Whitepaper

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Cercival Cancer Awareness Week: 21-27 January 2019

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Webinar: How Real-World Evidence Is Playing Out In The Real World

Medtech Insight 100 2019 - Rankings & Commentary

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Entries for the CARE Awards 2019 are now open

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Whitepaper: Horizons in HIV Drug Development - What's past is prologue

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Welcome to your Pharma Intelligence advantage

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Gain a competitive edge with comprehensive clinical trial intelligence. Find out what competitors are doing in key areas, understand regulations, view clinical trial and program timelines, identify sites and investigators.

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Medtech Insight

NZ To Replace Outdated And Piecemeal Device Rules

16 Jan 2019

There are significant changes in store for New Zealand’s medical device sector, including a new regulator and a set of pre- and post-market regulatory controls.

Topic Medtech

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Pink Sheet

Shutdown Bite Tightens At US FDA, But Gene Therapy To Get 50 More Reviewers

By Michael Cipriano 16 Jan 2019

FDA continues to emphasize the routine and the positive, even though strains on staff and sponsors increase as shutdown grinds on. CBER's new clinical reviewers would oversee the clinical investigation, development and review of cell and gene therapies, although a timeline on the hiring is unclear.

Topic FDA

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Medtech Insight

About Three Months Worth Of Carryover Device Fees Remaining FDAs Gottlieb Says

By David Filmore 16 Jan 2019

US FDA has about three months' worth of medical device carryover user-fee funds to burn if the partial federal government shutdown continues, although the agency is still finalizing its shutdown balance sheet, Commissioner Scott Gottlieb says.

Topic FDA

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Scrip

Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed

By Jung Won Shin 16 Jan 2019

2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.

Topic FDA Business strategies

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Scrip

The Gene Therapies Are Coming – And So Are New Ways To Pay For Them

By Jessica Merrill 16 Jan 2019

Annual payment plans for gene therapies appear closer to becoming reality now that bluebird bio detailed plans at J.P. Morgan. Novartis, Sarepta and others are also talking to payers about alternative payment models. Harvard Pilgrim's Michael Sherman applauded the effort in an interview.

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In Vivo

You May Be Making These Drug Forecasting Mistakes

By Alex Chiang + Adrian Watson 15 Jan 2019

What are the top 10 most common drug forecasting errors, and how can these be avoided? Life sciences consulting firm, Trinity Partners, explores the ins and outs of forecasting.

Topic Drug approval Drug review

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Datamonitor Healthcare

Clinical Breakthroughs in Urological Cancers can be a Double-Edged Sword as Payers are Forced to Act

By Louisa Joseph 10 Jan 2019

The three urological cancers are undergoing tremendous changes in treatment practices as a result of new product launches and indication expansions.

Topic Cancer

View white paper
In Vivo

Clinical Trials In 2019: Is Biopharma Ready To Tackle The Iron Triangle of Time, Cost and Quality?

By William Looney 10 Jan 2019

The clinical trial embodies the hope and the hassle of biopharma’s mission to develop new drugs for patients. It is an endlessly imperfect process: C-suite calls for more efficiency and speed at lower cost has been the story for decades. But an In Vivo conversation with a leading expert on trial management pinpoints three key trends that suggest better days are ahead for this central pillar of the innovation imperative.

Topic Clinical trials

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Medtech Insight

UK To Demand 'Responsible Person' Be Physically Located In Country Under No-Deal Brexit

By Amanda Maxwell 10 Jan 2019

The recent no-deal Brexit notice from the UK government says that companies selling devices in the UK would need a "Responsible Person" in the UK if the firm is not based there. The government clarifies to Medtech Insight that such person must be physically present in the UK, and not simply have an address there.

Topic Brexit

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Scrip

Scrip Asks... What Will 2019 Hold For Biopharma? Part 1: Therapeutic Advances

By Eleanor Malone 10 Jan 2019

Scrip journalists asked industry executives, consultants and analysts what they believe the big themes, trends and events will be in 2019. Here's what they told us about advances in therapeutic technologies and areas of clinical innovation.

Topic Research Business strategies BioPharmaceutical

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Scrip

J.P. Morgan Notebook Day 1: Pfizer, Gilead, Alnylam, Novartis, Sarepta, Deal Trends And Cell Therapy Challenges

By Jessica Merrill 10 Jan 2019

News and notes from the 2019 J.P. Morgan Healthcare Conference. Pfizer CEO Bourla underscores need for scientific and commercial innovation, Gilead makes M&A a priority, Novartis' new R&D chief reflects on first meeting with CEO Narasimhan, Sarepta CEO Ingram clarifies regulatory path for micro-dystrophin, J.P. Morgan outlines deal and macro biopharma trends in 2019, and cell therapy panel discusses manufacturing challenges.

Topic BioPharmaceutical Cell and gene therapy

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Pink Sheet

EU New Drug Approvals 2018: Anticancers, Orphans, The First CAR-Ts – And More

By Ian Schofield 10 Jan 2019

New drug approvals in the EU were again dominated by oncology in 2018, although medicines for infectious diseases came a close second. The number of orphan drugs more than doubled over the previous year, to 17. There were also some key new arrivals in the areas of multiple sclerosis, genetic disorders, metabolism and migraine.

Topic Drug approval Drug review

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Medtech Insight

2019 Will Be Testing Period For US FDAs Novel Pre-Cert Paradigm For Digital Health

By Ferdous Al-Faruque 10 Jan 2019

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Topic FDA

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Medtech Insight

Global Approvals Infographic

07 Jan 2019

Meddevicetracker recorded 62 medical device approvals from outside the United States in the first quarter for 2018, including 46 CE Marks from Europe.

Topic Medtech

View infographic
Pharmapremia

Cancer Treatment is HARD!

07 Jan 2019

Drug development – it’s an area rife with risk, but with great risk often comes great rewards. An area notoriously prone to failure is oncology, and nowhere is accurate risk assessment more critical. Developing Cancer Treatments is HARD! But is everyone bad at it? is a view into this failure-prone area from Pharmapremia.

Topic Cancer

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Latest headlines

Scrip

22 Jan 2019

Bone Therapeutics Cracks On With Allogeneic Cells For Spinal Fusion, Broken Bones

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Medtech Insight

22 Jan 2019

QUOTED. Jan. 22, 2019. Susan Neadle.

Link
Scrip

22 Jan 2019

TaiwanJ To Progress Liver Drug JKB-122 In AIH After Good Phase II Data

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Scrip

22 Jan 2019

Full Steam Ahead At Ferring To Unlock Microbiome Potential For Reproduction

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Pink Sheet

22 Jan 2019

'Rule Out No-Deal Brexit,' BIA Tells Government

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Medtech Insight

22 Jan 2019

DATA: Pacts In Medtech: Amarantus And Todos Form Breakthrough Diagnostics Inc.; Edwards Teams Up With Bay Labs To Find Heart Disease

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Scrip

22 Jan 2019

VIDEO: Biotech Showcase 2019: Mimicking plants creates GI infection antibiotic alternative

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Scrip

22 Jan 2019

Sun Firefights Governance Concerns

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Medtech Insight

22 Jan 2019

Warning Letter Roundup & Recap – Jan. 22, 2019

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Scrip

21 Jan 2019

Rare But Real: How One Startup Is Willing Itself To Lift China Orphan Drug Market

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Medtech Insight

21 Jan 2019

QUOTED. Jan. 21, 2019. Diana DeGette.

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Pink Sheet

21 Jan 2019

Pharmacists To Get New Substitution Powers To Tackle Brexit Shortage Risk

Link
Pink Sheet

21 Jan 2019

Financial Penalties Scope Widened Under New EU Regulation

Link
Pink Sheet

21 Jan 2019

Singapore Reveals Phase-In Plans For eCTD

Link
Scrip

21 Jan 2019

GSK Looks For New Chair To Lead It Through New Strategic Direction

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Trialtrove is the go-to resource for clinical trial research. Easily track your competitors' clinical R&D activity with expert insights and continually monitored trials.

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Datamonitor Healthcare: data analysis and insight

Datamonitor Healthcare's expert coverage of key diseases, companies, drugs and market trends makes it the go-to product for pharmaceutical and biotechnology companies to support the development and validation of their strategic plans and commercial decisions.

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Prioritize market opportunities
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Outlook 100 2019 - Rankings, commentary and infographic

Clinical Breakthroughs in Urological Cancers Whitepaper

Cercival Cancer Awareness Week: 21-27 January 2019

Webinar: How Real-World Evidence Is Playing Out In The Real World

Medtech Insight 100 2019 - Rankings & Commentary

Entries for the CARE Awards 2019 are now open

Whitepaper: Horizons in HIV Drug Development - What's past is prologue

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