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In Vivo

Six of the Greatest Therapeutic R&D Challenges

23 Aug 2019

Explore the six biggest therapeutic R&D challenges facing the industry today with a free infographic from In Vivo. This snapshot view of the major issues facing R&D is packed with data and insights about everything from drug resistance to diagnostics challenges.

Topic Drug development landscape

View infographic
Medtech Insight

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

By Shawn M. Schmitt 23 Aug 2019

US FDA Compliance Branch directors Gina Brackett and Melissa Michurski shed light on the agency's use of regulatory meetings. The FDA has been pulling enforcement punches in recent years, relying more on holding the face-to-face meetings than sending warning letters.

Topic Policy and regulation

View article
Medtech Insight

Updates On The European Commission’s Medtech Agenda And Deadlines For The Rest Of 2019

By Amanda Maxwell 23 Aug 2019

The European Commission updates its rolling plan on progress with key document and structures toward implementation of the new medtech regulations every few months. What is new and what is still to come this year?

View article
Datamonitor Healthcare

Reimbursement and Payer Management of Immune Checkpoint Inhibitors

21 Aug 2019

As immune checkpoint inhibitors continue to gain approvals in expanded patient populations, payers express concern surrounding the potential budget impact of the drug class. Considering the high costs of these treatments in comparison to standard chemotherapy, HTA and reimbursement agencies stress the requirement for solid survival data and highlight that price will be a major factor during negotiations

Topic Drug review

Single report
In Vivo

In Vivo Content - Relied Upon by Senior Decision Makers

21 Aug 2019

There are many ways to market your brand and establish your business as a thought leader - but none of these methods compare to the distinct advantage gained through marketing with In Vivo and Informa Pharma Intelligence. The articles, news and interviews we feature are used daily by senior decision-makers to support their decisions, and to keep abreast of what their competitors are doing.

Topic Business strategies Medtech

Single report
Datamonitor Healthcare

NASH Disease Coverage Extract

16 Aug 2019

Datamonitor Healthcare recently surveyed 60 gastroenterologists in the US and five major EU markets after the approval of the first disease-specific therapies for the treatment of non-alcoholic steatohepatitis (NASH). The market for these treatments will exceed $21bn in 2027.

Topic Drug development landscape Diseases

Single report
In Vivo

MedTech Forum 2019: The Future Is Here But Industry Still Needs A Long-Term Vision

By Ashley Yeo 16 Aug 2019

In a world where national economies are beset by conflicting spending priorities, health care is oftentimes too low on the agenda, health care observers say. One of these is Boston Scientific senior vice-president Eric Thépaut, who understands the dilemmas, but says that health care will soon force its way up the priority list. He has advice for future-ready medtech innovators.

Topic Medtech Business strategies

View article
Generics Bulletin

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

By Aidan Fry 15 Aug 2019

By acquiring global rights to epinephrine and naloxone nasal spray candidates from Insys, Hikma is following its strategy of moving its non-injectable Generics business segment in the US towards differentiated products.

Topic Business strategies

View article
Scrip

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

By Mandy Jackson 15 Aug 2019

The US FDA informed the company it will convene an advisory committee meeting to review the REDUCE-IT sNDA for the proprietary fish oil pill, delaying the approval by at least three months and surprising investors.

Topic FDA Drug approval

View article
Scrip

Taltz Tops Tremfya In Head-To-Head Psoriasis Study On Complete Skin Clearance

By Jessica Merrill 15 Aug 2019

Lilly's IL-17A inhibitor ixekizumab outperformed J&J's IL-23 inhibitor guselkumab on achieving complete skin clearance in moderate-to-severe psoriasis patients at 12 weeks in a head-to-head trial.

Topic Clinical trials

View article
Pink Sheet

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

By Derrick Gingery 14 Aug 2019

Gene therapy should remain on the market, FDA says, but Novartis could face civil or criminal penalties. Firm knew of problems before approval.

Topic FDA Company analysis

View article
Generics Bulletin

Chirag Patel And Chintu Patel Return As Co-CEOs Of Amneal

By David Wallace 14 Aug 2019

Chirag Patel and Chintu Patel have returned to being co-CEOs of Amneal, just over a year after the firm completed its merger with Impax. Rob Stewart – who was president and CEO of Amneal – and executive chairman Paul Bisaro have resigned from the roles.

Topic Company analysis

View article
Medtech Insight

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

By Shawn M. Schmitt 14 Aug 2019

Phil Pontikos, who is also the US agency's national device expert, explains how device-makers can avoid running afoul of the FDA's rules and expectations for sterilization activities.

Topic FDA

View article
Medtech Insight

CMS Weighs Merits Of New Pass-Through Payments For Aquabeam System, Eluvia Stents In OPPS Proposal

By Sue Darcey 14 Aug 2019

The US Medicare agency has been scrutinizing two new devices that have generated some buzz within the industry for pass-through payment status under its proposed 2020 Outpatient Prospective Payment System (OPPS) rules. The devices are Procept BioRobotic’s AquaBeam System for removal of prostate tissue in men with urinary tract symptoms, and Boston Scientific’s Eluvia drug-eluting stent for treatment of peripheral artery disease.

Topic Medtech

View article
Scrip

Oncology Market Leaders Maintain Their Upper Hand

By Jessica Merrill 14 Aug 2019

Drugs like Ibrance and Lynparza show that in the cancer market, it can be hard for new entrants to catch early standouts.

Topic Drug development landscape Drug review

View article

Latest headlines

Scrip

23 Aug 2019

DREAMM-2 Put GSK’s BCMA Drug In Pole Position In Multiple Myeloma

Link
Pink Sheet

23 Aug 2019

Pink Sheet Podcast: Golodirsen CRL, Trump's Appeal Of DTC Ad Ruling, Pharmas' Statement Of Purpose'

Link
Pink Sheet

23 Aug 2019

Germany Remains In The Dark On UPC Implementation

Link
Scrip

23 Aug 2019

Lupin Rationalizes Japan Operations, Sheds Injectables Business

Link
Scrip

23 Aug 2019

Deal Watch: Themis Leverages Measles Vector Platform In Collaboration With Merck & Co.

Link
Pink Sheet

23 Aug 2019

Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen

Link
Scrip

23 Aug 2019

Finance Watch: Five More Biopharmas Enter US Queue Even As IPO Returns Dip

Link
Medtech Insight

23 Aug 2019

German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported

Link
Pink Sheet

23 Aug 2019

NICE Says Initial No To Epidyolex In England, But GW Pharma Remains Upbeat

Link
Pink Sheet

23 Aug 2019

Behind-The-Scenes Battles As Opioid MDL Jury Trial Nears

Link
Pink Sheet

23 Aug 2019

Opioid Litigation Pushes American Pain Society Into Bankruptcy

Link
Pink Sheet

23 Aug 2019

Recent And Upcoming FDA Advisory Committee Meetings

Link
Pink Sheet

23 Aug 2019

UK’s No-Deal Brexit Plans For SPC Waiver Could Reduce IP Rights, Warns BIA

Link
Pink Sheet

23 Aug 2019

£197m Payments Made Under New UK Pricing Scheme But Access Promises Still To Materialize

Link
Medtech Insight

22 Aug 2019

Roche Diagnostics Sees Data Sourcing, AI and Partnerships As Paving The Way to Personalized Health Care, But Challenges Remain

Link

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Pharma Intelligence latest insights

Six of the Greatest Therapeutic R&D Challenges

Compliance Corner: 2 FDA Compliance Branch Heads Talk Regulatory Meetings – And What You Can Expect

Updates On The European Commission’s Medtech Agenda And Deadlines For The Rest Of 2019

Reimbursement and Payer Management of Immune Checkpoint Inhibitors

In Vivo Content - Relied Upon by Senior Decision Makers

NASH Disease Coverage Extract

MedTech Forum 2019: The Future Is Here But Industry Still Needs A Long-Term Vision

Hikma Snaps Up Insys Sprays As Part Of US Drive Towards Differentiation

An AdComm After All: Amarin's Vascepa Labeling Update Now Delayed By FDA

Taltz Tops Tremfya In Head-To-Head Psoriasis Study On Complete Skin Clearance

Novartis' Zolgensma Had Manipulated Data In Application, US FDA Says

Chirag Patel And Chintu Patel Return As Co-CEOs Of Amneal

Compliance Corner: FDA Investigator Sees These 4 Common Sterilization Problems When Inspecting Facilities

CMS Weighs Merits Of New Pass-Through Payments For Aquabeam System, Eluvia Stents In OPPS Proposal

Oncology Market Leaders Maintain Their Upper Hand

Latest headlines

DREAMM-2 Put GSK’s BCMA Drug In Pole Position In Multiple Myeloma

Pink Sheet Podcast: Golodirsen CRL, Trump's Appeal Of DTC Ad Ruling, Pharmas' Statement Of Purpose'

Germany Remains In The Dark On UPC Implementation

Lupin Rationalizes Japan Operations, Sheds Injectables Business

Deal Watch: Themis Leverages Measles Vector Platform In Collaboration With Merck & Co.

Keeping Track: US FDA Greenlights Two More Novel Drugs, But Smacks Down Golodirsen

Finance Watch: Five More Biopharmas Enter US Queue Even As IPO Returns Dip

German Industry Says MDR Implementation 'Too Slow' But Negative Economic Effects Still Largely Unreported

NICE Says Initial No To Epidyolex In England, But GW Pharma Remains Upbeat

Behind-The-Scenes Battles As Opioid MDL Jury Trial Nears

Opioid Litigation Pushes American Pain Society Into Bankruptcy

Recent And Upcoming FDA Advisory Committee Meetings

UK’s No-Deal Brexit Plans For SPC Waiver Could Reduce IP Rights, Warns BIA

£197m Payments Made Under New UK Pricing Scheme But Access Promises Still To Materialize

Roche Diagnostics Sees Data Sourcing, AI and Partnerships As Paving The Way to Personalized Health Care, But Challenges Remain

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