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Pharmaprojects

Microbiome Modulators for Gastrointestinal Disorders In 2018: Market Overview & The Current Phase I Candidates

13 Jul 2018

The discovery and deep investigation of the microbiome has been one of the most significant recent biomedical advances. Extensive research suggests that dysbiosis of the gut microbiome plays a significant role in multiple gastrointestinal (GI) disorders such as; Crohn’s disease, ulcerative colitis, and irritable bowel syndrome (IBS).

Single report
Pharmaprojects

2018 R&D Review: 5 Key Takeaways

13 Jul 2018

Welcome to Pharmaprojects’ roundup of key trends in pharmaceutical R&D in 2018, focusing on five key takeaways from our full annual report

Single report
Scrip

Authorities Find Accounting Violation By Samsung BioLogics, Prosecutors To Probe

By Jung Won Shin 13 Jul 2018

South Korean financial authorities conclude Samsung BioLogics violated accounting standards by omitting certain information on its joint venture agreement with Biogen from public disclosures, and have ordered further investigation of a corporate governance decision on the handling in accounts of the JV, Samsung Bioepis. The latest ruling in the prolonged affair could hurt the credibility and business of Samsung BioLogics going forward, although the firm maintains it has done nothing improper.

Topic Policy and regulation

View article
Scrip

Mylan's Fulphila Sets Up The US Market For The Next Biosimilar Showdown

By Jessica Merrill 13 Jul 2018

Mylan has priced its biosimilar version of pegfilgrastim at a 33% discount to Amgen's WAC for Neulasta, steeper than the 15% discount Pfizer initially offered for Inflectra. The commercial outcome for Fulphila could set the tone for future US biosimilars, which have yet to take off.

Topic Biosimilars Business strategies

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In Vivo

Cancer Vaccines: Is There A Future Beyond Trial And Error?

By William Looney 12 Jul 2018

Strong foundational research in immunology and some promising early phase trial results have so far failed to expedite the validation of vaccines to treat cancer. In Vivo examines biopharma’s enduring optimism about the future of cancer vaccinology, including a closer look at one company’s platform to tackle the incurable malignancies that beset the mother of all organs: the human brain.

Topic Cancer Vaccines

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Rose Sheet

Hawaii's Sunscreen Ingredient Ban Is On The Books; To Industry, An Affront To Science

By Lauren Nardella 12 Jul 2018

As in the case of plastic microbeads some four years ago, the personal-care industry finds itself in the position of having to reformulate potentially on a mass scale due to environmental rather than human safety concerns. And once again the legislation was driven in large part by shoddy science, industry says.

Topic Policy and regulation

View article
Rose Sheet

EU Watch: Next Steps Re Controversial CMR Ban Approach, Fragrance Allergens Labeling

By Ryan Nelson 12 Jul 2018

EU sources update Rose Sheet on contentious initiatives to cement the Commission’s pathway for banning carcinogenic, mutagenic or reprotoxic substances in cosmetics and to promote fragrance allergen awareness and risk management.

Topic Policy and regulation

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Scrip

Downward, Eastward or Inward? Blockbuster Film Puts Cancer Drug Prices In China Spotlight

By Brian Yang 11 Jul 2018

Bagging a $200m box office in its opening week in China, "Dying to Survive" is a sentimental movie about a Chinese businessman selling cancer drugs smuggled from India but unapproved in China that sees his life taking a drastic turn, from convicted felon to a Robin Hood-like hero as he helps those in need. The Chinese film authority’s clearance for the screening of the movie and the smash success signal three key messages about the future potential direction of oncology drugs in the country.

Topic Cancer

View article
Scrip

Pfizer Agrees To Roll Back Prices On 40 Drugs, Yielding To Pressure From Trump

By Jessica Merrill 11 Jul 2018

After a conversation with President Trump, CEO Ian Read agreed to cancel price increases on 40 drugs that took effect July 1, to give the administration time to work on its blueprint for improving the health care system.

Topic Policy and regulation

View article
Medtech Insight

Inside Toyota's 'Cult' Car-Makers Quality VP Tells Device-Makers How To Adopt 4-Pronged Quality Strategy

By Shawn M. Schmitt 10 Jul 2018

Toyota Motor North America's Kristen Tabar told a roomful of medical device quality and regulatory professionals at a Case for Quality forum that they can infuse quality concepts into every nook and cranny of their firms by adopting the car-maker's quality strategy of reflection, education, celebration and planning. "I don’t want to make it sound like it’s sort of cult-y, but it’s kind of cult-y," Tabar quipped.

Topic Company analysis Strategy

View article
Medtech Insight

US Starts Imposing China Medtech Tariffs, But Offers Path To Product Exclusions

By Sue Darcey 10 Jul 2018

Although the 25% tariffs initiated July 6 by the US Trade Representative will impact about $836m worth of medical technology entering the US from China, the administration late last week offered a process for gaining exclusions for specific products. AdvaMed members are “looking into” the process, the group said, and Medical Imaging and Technology Alliance members have already started to try to use it.

Topic Medtech Strategy

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In Vivo

Back To The Future: Novo’s Sørensen Reflects On CEO Years And Tasks Ahead For Industry

By Lucie Ellis 06 Jul 2018

Lars Rebien Sørensen scrutinizes the pharmaceutical industry and shares with In Vivo his vision for the future of the Novo Nordisk Foundation. With 16 years as CEO of Novo Nordisk under his belt, as well as many more years in leadership roles at the Danish company, Sørensen reflects on the past and gives his predictions for the future of the innovative drug development sector.

Topic Drug development landscape Business strategies

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Pink Sheet

Nevada Price Transparency Regs Have Trade Secret Safeguards; Industry Drops Lawsuit

By Cathy Kelly 06 Jul 2018

Regulations allow manufacturers to request that drug production and marketing costs and price contracting information provided to the state be kept confidential.

Topic Drug approval

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Pink Sheet

European Pharmacopoeia Moves Forward With MAb Quality Standards

By Ian Schofield 06 Jul 2018

A pilot project run by the European Pharmacopoeia is being expanded in an effort to produce general quality standards for monoclonal antibodies, following the adoption of a monograph for infliximab last November.

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Medtech Insight

Brexit: Will UK Now Stockpile Devices? And Is It Certain The Country Will Continue With MDR?

By Amanda Maxwell 06 Jul 2018

UK starts to discuss emergency measures around devices as no-deal Brexit concerns mount. But it is still looking like the UK will continue to implement the Medical Device Regulation, in the short-term at least. Will it be a different matter for the IVD Regulation?

Topic Brexit Medtech

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Latest headlines

Scrip

13 Jul 2018

Pharma Q2 Results Preview: Johnson & Johnson And Novartis

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Pink Sheet

13 Jul 2018

UK NICE Knock Back For Janssen’s ‘Game-Changing’ Darzalex Combo

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Pink Sheet

13 Jul 2018

Long-Awaited Brexit White Paper Lays Out UK’s Plans For Medicines Regulation

Link
Medtech Insight

13 Jul 2018

How Kavanaugh High Court Pick Could Increase IUD Sales

Link
Scrip

13 Jul 2018

Pipeline Watch: Phase III Starts With QPI-1002, Enfortumab Vedotin And ZYN-002

Link
Pink Sheet

13 Jul 2018

Recent And Upcoming FDA Advisory Committee Meetings

Link
Pink Sheet

13 Jul 2018

Vertex Refuses To Back Down On England Orkambi Deal

Link
Scrip

13 Jul 2018

Amgen Puts Evenity Filing Back On Track With TIMI Cardiovascular Risk Review

Link
Scrip

13 Jul 2018

Job Cuts Seen At Dr Reddy’s Amid Cost Recalibration

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Scrip

13 Jul 2018

Deal Watch: BioCryst Shareholder Dissent Scuttles Planned Merger With Idera

Link
Medtech Insight

13 Jul 2018

CMS Proposes To Cover More Telehealth, And Address Imaging, Lab Pay Matters

Link
Medtech Insight

13 Jul 2018

VC Deals Analysis: Mega-Rounds Abound, As H1 Deal Value Rockets Past $4bn

Link
Scrip

13 Jul 2018

Authorities Find Accounting Violation By Samsung BioLogics, Prosecutors To Probe

Link
Medtech Insight

13 Jul 2018

Localism & Local Languages Make For Better Medtech Business In Russia And EAEU

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Medtech Insight

13 Jul 2018

AUDIO: Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3

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Pharma Intelligence latest insights

Microbiome Modulators for Gastrointestinal Disorders In 2018: Market Overview & The Current Phase I Candidates

2018 R&D Review: 5 Key Takeaways

Authorities Find Accounting Violation By Samsung BioLogics, Prosecutors To Probe

Mylan's Fulphila Sets Up The US Market For The Next Biosimilar Showdown

Cancer Vaccines: Is There A Future Beyond Trial And Error?

Hawaii's Sunscreen Ingredient Ban Is On The Books; To Industry, An Affront To Science

EU Watch: Next Steps Re Controversial CMR Ban Approach, Fragrance Allergens Labeling

Downward, Eastward or Inward? Blockbuster Film Puts Cancer Drug Prices In China Spotlight

Pfizer Agrees To Roll Back Prices On 40 Drugs, Yielding To Pressure From Trump

Inside Toyota's 'Cult' Car-Makers Quality VP Tells Device-Makers How To Adopt 4-Pronged Quality Strategy

US Starts Imposing China Medtech Tariffs, But Offers Path To Product Exclusions

Back To The Future: Novo’s Sørensen Reflects On CEO Years And Tasks Ahead For Industry

Nevada Price Transparency Regs Have Trade Secret Safeguards; Industry Drops Lawsuit

European Pharmacopoeia Moves Forward With MAb Quality Standards

Brexit: Will UK Now Stockpile Devices? And Is It Certain The Country Will Continue With MDR?

Latest headlines

Pharma Q2 Results Preview: Johnson & Johnson And Novartis

UK NICE Knock Back For Janssen’s ‘Game-Changing’ Darzalex Combo

Long-Awaited Brexit White Paper Lays Out UK’s Plans For Medicines Regulation

How Kavanaugh High Court Pick Could Increase IUD Sales

Pipeline Watch: Phase III Starts With QPI-1002, Enfortumab Vedotin And ZYN-002

Recent And Upcoming FDA Advisory Committee Meetings

Vertex Refuses To Back Down On England Orkambi Deal

Amgen Puts Evenity Filing Back On Track With TIMI Cardiovascular Risk Review

Job Cuts Seen At Dr Reddy’s Amid Cost Recalibration

Deal Watch: BioCryst Shareholder Dissent Scuttles Planned Merger With Idera

CMS Proposes To Cover More Telehealth, And Address Imaging, Lab Pay Matters

VC Deals Analysis: Mega-Rounds Abound, As H1 Deal Value Rockets Past $4bn

Authorities Find Accounting Violation By Samsung BioLogics, Prosecutors To Probe

Localism & Local Languages Make For Better Medtech Business In Russia And EAEU

AUDIO: Device Week, July 13, 2018 – Medtech’s Next Top Maturity Model, Part 3

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