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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NZ To Replace Outdated And Piecemeal Device Rules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

View article
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

View article
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

View article
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

View article
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.

View article
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

View article
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

View article
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

View article
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

View article
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

View article
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

View article
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

View article
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

View infographic

Latest headlines

Pink Sheet

18 Jan 2019

UK NICE OKs Melanoma Combo Treatment From Array/Pierre Fabre

Link
Scrip

18 Jan 2019

Dark Days For Sun As Governance Saga Escalates

Link
Scrip

18 Jan 2019

Catalan Biotechs Boosted By International Backers

Link
Scrip

18 Jan 2019

Novartis’ Data-Centric R&D Strategy Adds Pact With UK-based Big Data Institute

Link
Pink Sheet

18 Jan 2019

Recent And Upcoming FDA Advisory Committee Meetings

Link
Medtech Insight

18 Jan 2019

AUDIO: Device Week, Jan. 18, 2019 - Key Topics At This Year's JP Morgan Healthcare Conference

Link
Scrip

18 Jan 2019

Q4 Pharma Earnings Preview: J&J, Bristol And AbbVie

Link
Medtech Insight

18 Jan 2019

AdvaMed Code Update Focuses On Compliance Standards

Link
Medtech Insight

18 Jan 2019

IVDR Notified Body Numbers – Has Enough Progress Been Made?

Link
Pink Sheet

18 Jan 2019

PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny

Link
Pink Sheet

18 Jan 2019

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Link
Pink Sheet

18 Jan 2019

Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth

Link
Medtech Insight

18 Jan 2019

Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

Link
Medtech Insight

18 Jan 2019

DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

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Medtech Insight

17 Jan 2019

QUOTED. Jan. 17, 2019. Nicholas Berg.

Link

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Pharma Intelligence latest insights

NZ To Replace Outdated And Piecemeal Device Rules

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

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

Monumental Year Ahead For Korean Pharmas As New US Approvals Eyed

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

You May Be Making These Drug Forecasting Mistakes

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

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

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

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

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

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

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

Global Approvals Infographic

Cancer Treatment is HARD!

Latest headlines

UK NICE OKs Melanoma Combo Treatment From Array/Pierre Fabre

Dark Days For Sun As Governance Saga Escalates

Catalan Biotechs Boosted By International Backers

Novartis’ Data-Centric R&D Strategy Adds Pact With UK-based Big Data Institute

Recent And Upcoming FDA Advisory Committee Meetings

AUDIO: Device Week, Jan. 18, 2019 - Key Topics At This Year's JP Morgan Healthcare Conference

Q4 Pharma Earnings Preview: J&J, Bristol And AbbVie

AdvaMed Code Update Focuses On Compliance Standards

IVDR Notified Body Numbers – Has Enough Progress Been Made?

PhRMA Adds Genentech, Gilead To Its Ranks Ahead Of House Democrats’ Drug Pricing Scrutiny

Irish $1.9bn Tax Bill 'Out Of Nowhere' Perplexes Perrigo, Troubles Analysts

Perrigo Expanding Consumer Portfolio After Finding Problems Slowing Growth

Compliance Corner: J&J Quality Expert Urges Makers Of Combo Products To Be 'Bilingual' In Device- And Drug-Speak

DTC Ads For Genetic Tests Increased 18-Fold Over 20 Years, Study Says

QUOTED. Jan. 17, 2019. Nicholas Berg.

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