Opinion &amp; analysis

Thinking about using CMMI? Here are tips from the experts

Learn about the voluntary U.S. FDA pilot program that uses Capability Maturity Model Integration (CMMI) from quality,compliance and regulatory officials at three major device firms. Walk through the CMMI process,and discover why it’s nothing like a typical regulatory audit.

June 25, 2018

Gottlieb’s Short Tenure Will Be Felt Long After He Leaves US FDA

Tap into Pink Sheet’s look back on Scott Gottlieb’s nearly two year tenure as Commissioner of the US FDA. Examine the legacy of his short-lived, yet productive stint, and look back on his list of accomplishments as leader of the agency.

March 6, 2019

Can Novartis Reclaim Pioneering Role In Transplantation?

Novartis is developing a new type of immunosuppressive agent, an anti-CD40 monoclonal antibody, which might allow organ transplants to last longer in recipients, reduce pressure on transplant waiting lists, and improve long-term outcomes. In Vivo interviewed Novartis’ Head of Immunology, Hepatology and Dermatology.

Culture Change At GSK: ‘We’re Doing What We Said We’d Do’

Hal Barron, Chief scientific officer at GSK recently spoke about winning the hearts and minds of 10,000 R&D employees and adopting practices from acquired company, Tesaro. Scrip covers the talk topics including how doubters are coming around amid recent successful approvals

ISO Wants To Tinker With Quality Systems Standard 13485:2016. Let ISO Know What You Think By Nov. 9

The most recent version of International Standardization Organization’s ISO 13485 hasn’t even gone into effect yet and already the Technical Management Board is looking for a rewrite, calling for the standard to be rewritten in a “high-level” format. Find out more here.

November 2, 2018

Eight Talking Points from ESMO

At the 2019 congress in Barcelona from 27 September to 1 October, the European Society for Medical Oncology (ESMO) proved once again it is a match for ASCO. Scrip shares the main points of the event including Seattle Genetics victory for mid-caps.

CAR-T Label Update Could Address Medicare Coverage Challenges, FDA’s Gottlieb Suggests

Lifesaving chimeric antigen receptor T-cell (CAR-T) therapies could soon move to outpatient settings, easing the financial burden currently felt by providers, according to US FDA Commissioner Scott Gottlieb, who said a label change to allow for outpatient treatment under Medicare Part B is in the works.

November 13, 2018

BSI Is Designated In Netherlands, Giving Clients Go-Ahead To Start Transfer Of Certificates

With the details of Brexit as yet unresolved, UK standards and certification body BSI has successfully achieved a notified body designation in the Netherlands, securing a more stable future by allowing certificate holders to migrate UK conformity assessment certificates from the UK to the Netherlands if they wish.

November 13, 2018

State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

What’s the ultimate task of an R&D organization? Industry veteran Tadataka Yamada shares his insights, offering a big-picture take on the state of the pharma R&D enterprise. Discover which areas most excite–and concern–him, and learn why “de-risking” the pipeline is harder than ever.

April 9, 2018

Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

Abbott’s Merlin patient care network works with the CardioMEMS HF sensor system. The Merlin 10.0 update to the network allows physicians to share custom messages directly with their patients. Medtech Insight looks closer at the software and its intended benefits.

Missed Opportunities: 10 Questions We Wish Senators Had Asked At The Drug Pricing Hearing

When the US Senate Finance Committee met recently with seven top pharma industry leaders to discuss drug pricing topics, they hit on some key issues, but left other items out of the discussion. Pink Sheet’s industry experts discuss what they wish would have been addressed during this unusual opportunity.

March 7, 2019

US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

Sanofi plans to continue distributing Zantac OTC heartburn remedy in the US while conducting its own tests to determine whether levels of N-nitrosodimethylamine (NDMA) in the active ingredient are above safe levels, Novartis AG, which licenses OTC Zantac, has said it stopped distribution worldwide.

Mail Order and Internet Pharmacy in Europe

$740.00

This 17-country study finds that continued growth of mobile technologies and e-commerce,combined with a more stable regulatory environment, are driving changes in the European mail order and Internet pharmacy market.

January 18, 2017

Biotech CEOs: Can Scientist-Founders Remain In Charge?

Founder-CEOs do not typically remain at the helm as biotechs mature, as the majority of scientist-founders lack the skills to lead a company beyond discovery and early development. Exceptions to that rule are multiplying, though, especially in Europe as companies aim directly for Nasdaq. In this fascinating read, In Vivo reviews the many, varied paths toward biotech CEO, and what it takes to lead a company to IPO and beyond.

May 20, 2019

UK Notified Body BSI Sets Out Clear Post-Brexit Paths As It Goes Dutch

Leading UK and EU notified body BSI expects the UK to remain a full member of the EU regulatory regime post-Brexit, but it has a contingency plan. Learn what this contingency plan means for device manufacturers. Gain insights into the implications of a non-negotiated Brexit, and find out if the other notified bodies have contingency plans.

May 25, 2018

US FDA’s Office Of New Drugs Reorganization Approved, But Not Happening Overnight

After more than two years of work, the US Food and Drug Administration is ready to formally begin its reorganization of the Office of New Drugs. Pink Sheet covers how this could cause signatory authority and other changes for sponsors with pending applications.

Novartis R&D Chief Tsai On 2019 Goals, Priorities, BD And Digital Advances

Scrip interviewed Novartis AG’s Head of Global Drug Development at the 2019 J.P. Morgan Healthcare Conference to get his views on how his past experience has prepared him for the job, and where he plans on taking Novartis, especially in regards to business development and digital technology.

January 16, 2019

Bayer’s US Playbook: The Smart Way To Top-Line Growth

Tap into Bayer AG’s plans to establish itself as a global innovator, particularly with their oncology, cardiovascular, and women’s health franchises. In this exclusive interview, In Vivo talks strategy with Dr. Carsten Brunn, Bayer’s Head of Pharmaceuticals, Americas Region.

June 18, 2018

MorphoSys: A European Champion Crossing The Biopharma Rubicon

MorphoSys, out of Munich, is one of a handful of mature European biotech companies appearing ready for greatness. In Vivo spoke with the CEO about the firm’s next generation antibody platform and why US expansion is crucial to its future.

Schleifer, Yancopoulos And The $36 Billion Friendship

Examine the 30-year friendship that built Regeneron in In Vivo’s interview with company leaders Len Schleifer and George Yancopoulos. The two reflect back on the company’s beginnings and take a look at what’s in store for the future in this insightful – and often funny – interview.

November 23, 2018

Nail Polishes Contain Undeclared DEHP, Among Other ‘Regrettable Substitutions’ – Study

Plasticizer Dibutyl phthalate (DBP) is said to have been phased out of use in nail polishes, but a recent study by Harvard public health researchers wonders what is being used to replace the ingredient, and whether it is any safer than DBP.

October 12, 2018

Virtual AI Nurses And The Future Of Chronic Disease Management

What’s in store for chronic disease management in the future? Tap into this informal discussion with health entrepreneur Julia Hu, founder of Lark Health, for a look at her views of what’s to come, including the use of artificial intelligence nursing.

March 6, 2019

Game On For Akili’s Cognitive Control Tech

$100.00

A digital video game developed by Akili Interactive Labs for treating cognitive disorders has demonstrated in a pilot study its ability to improve cognitive control test scores of neurotypical children and children with sensory processing dysfunction (SPD).

February 5, 2018

Let’s Make A Deal: Sanofi Regeneron Extend A Hand On Praluent, Express Scripts Takes It

Sanofi and Regeneron made an offer: They would drop the cost of their PCSK9 inhibitor Praluent (alirocumab) for improved access. Express Scripts took them up on it. Learn whether this deal will affect the high rejection rate for PCSK9 drugs. Find out whether this deal is a one-off or the start of a trend.

May 1, 2018

Takeda To Press On With Core R&D Strategy Post-Shire

Tap into the state of Takeda’s R&D strategy and how it might change in the wake of their Shire acquisition, due to take place in 2019 to the tune of $62.4b. Find out more about Takeda’s new rare diseases therapeutic areas unit, their partnering efforts to build out the pipeline, near term highlights, progress in penetrating Chinese markets, and more.

October 2, 2018

Six Key New Commission Documents Relating To EU Directives And New Regulations

To help companies respond and adapt the processes they may have in place as rapid EU regulatory activity continues, Medtech Insight summarizes the six documents that have recently appeared on the European Commission’s medtech website.

Commission Looks Set To Expand MDR Extension So Notified Bodies Can Focus On High-Risk Devices

The European Commission seems like it will widen the grace period for MDD-approved products to comply with the new Medical Device Regulation (MDR), including Class I medical devices that have never before been reviewed by notified bodies. This extension will allow notified bodies to focus on higher-risk products.

Transforming Pharmaceutical R&D with Data

$2,995.00

Ongoing pressures on drug pricing and reimbursement mean that current research and development (R&D) economics are unsustainable. The process of discovering and developing a drug has not fundamentally changed for decades, and on average it still costs $2.6bn and takes over 10 years. Fortunately, tools are emerging to help improve R&D success rates. Most are built on better use of more kinds of data, including using artificial intelligence (AI) to process massive quantities of information that humans cannot manage. Some of these new tools promise cost and time savings of between 20–50%

May 2, 2017

Modernizing FDA’s Supplement Industry Regulation Mapped Out In Five-Point Plan

Before stepping down as FDA commissioner, Scott Gottlieb announced “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” Through warning letters and advisory letters, the agency is already signaling a move toward more aggressive enforcement. Find out about the agency’s five-point plan and how FDA plans to balance innovation with regulation.

February 11, 2019

Pharma Intelligence Report Store Article Collection Innovation, Data and Machine Learning Report 2

$500.00

OTC drug firms should offer more digital tools that guide consumers in product purchases, says a health care marketing executive. The American Pharmacists Association suggests firms also strengthen outreach with pharmacists.

March 16, 2017

Novartis Swaps Two AveXis Executives For One Following Zolgensma Data Manipulation

AveXis co-founder and CSO Brian Kaspar and his brother are no longer with Novartis, the Swiss manufacturer who acquired AveXis and its Zolgensma drug in 2018. After disclosing data manipulation to the FDA earlier this year about Zolgensma filings, Novartis announced two employees would exit the company.

August 14, 2019

Ranitidine Recalls Begin In Europe As Regulators Take Action

Over the counter products are among the first to be recalled in Europe following the discovery of a human carcinogen in ranitidine-based drugs. HBW covers how investigations are underway worldwide while regulators across Europe are divided between “take immediate action” and “wait and see”.

August 3, 2019

Sunshine rules in the EU: Implications of a piecemeal approach

The EU’s piecemeal approach to transparency makes compliance harder, but this expert advice can smooth the path forward. Learn about implications of these”sunshine”rules in the EU and U.S., how they differ,and what the EU can learn from the U.S.

June 1, 2018

US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

The FDA’s early release of inspection findings of a testing lab’s possible involvement in data falsification in the testing (and subsequent FDA approval) of Zolgensma is unusual, signaling the likelihood that Novartis will face tough scrutiny of its actions – and perhaps stiff fines because of the fraud. Learn why one analyst is alluding to the possibility of a government investigation on the call Novartis held for the investment community, and why he’s calling for corporate officers to be held liable for statue violations, regardless of whether they knew of any wrongdoing.

Immuno-Oncology: What To Watch At ASCO 2018

Immunotherapy dominated the American Society of Clinical Oncology 2018 annual meeting. PD-1/L1 inhibitors were among those taking center stage–find out which ones hold the most promise for NSCLC. Gain insights into why Jounce’s ICOS antibody JTX-2011 proved to be such a disappointment–and why this affects Celgene investors.

May 17, 2018

Novartis Can’t Halt Janssen’s Promo Comparing Their Psoriasis Drugs

A US district court judge recently denied a request from Novartis for a temporary restraining order against Janssen. Novartis was railing against Janssen’s promotional claims that Novartis’ IL-17A inhibitor Cosentyx (secukinumab) compares unfavorably to Janssen’s IL-23 inhibitor Tremfya (guselkumab) in safety tests. Find out more here.

March 5, 2019

Patients’ Preferred Endpoints May Not Satisfy Regulatory Needs, US FDA Says

At a meeting of mitochondrial disease drug development, officials of US Food and Drug Administration said that just because a measure is relevant to the patient community does not mean it can capture meaningful change in a clinical trial. Pink Sheet looks at the implications to sponsors.

The Intersection Between Tech and Pharma Special Report (Part 2. Apple)

$3,000.00

In January 2015, Fortune reported that at $2.9tn, the state of the US healthcare industry is very strong and continues to grow. Additionally, a Top Issues report revealed that 40% of Fortune 50 companies pursued new healthcare partnerships in 2014. Given the rapid change in the healthcare industry over the last few years, it is no surprise that we are starting to see more non-traditional healthcare partnerships, specifically with big tech companies.

January 14, 2016

Oncology Leader Liz Barrett Joins UroGen As CEO As It Heads Towards Commercial Stage

There is new leadership at UroGen Pharma, Ltd., as Novartis AG Oncology’s former Oncology CEO takes the helm. Scrip sat down to talk to Liz Barrett about her plans as CEO of UroGen, including assuming the tasks of ushering the company’s lead asset through the FDA approval and launch processes.

January 9, 2019

Poseida, Legend/Janssen Look To Snag Celgene/ Bluebird’s BCMA Crown

The BCMA CAR-T therapies gap between industry leaders Celgene and bluebird bio and their competition in the space is closing, according to data released at the December 2018 American Society of Hematology (ASH) meeting in San Diego.

December 4, 2018

Cancer’s New Patient Demographic; Will Survivorship Change The Face Of Cancer Care?

As the number of cancer survivors increases, they are reshaping cancer research and clinical practice. Find out how–and discover the impact it will have on the allocation of research dollars. Learn how the looming physician shortage has implications for the emergence and increasing use of complex immunotherapy drugs.

August 6, 2018

Breakthrough Designation Rescissions: Who Might US FDA Drop Next?

Several drugs recently lost their Breakthrough Therapy Designations (BTDs), and Pink Sheet has identified others in the pipeline that might suffer the same fate soon. Take a look at the therapies possibly on the chopping block and the reasons behind it in this informative article.

March 10, 2019

State Of Pharma R&D: Ex-Takeda’s Yamada Takes The Long View

Biopharma industry veteran Tadataka “Tachi” Yamada sits down with In Vivo for an exclusive interview that draws on his years of experience in many roles across the R&D ecosystem to explore the state of today’s biopharma R&D enterprise.

April 9, 2018

Immuno-Oncology: Unicorns, China And The Perfect Storm

Immuo-oncology is proving to be that rare animal for investors in pharma, where return on invested capital doesn’t seem necessarily tied to risk, with mature assets returning liquidity similar to those of early assets. Examine transaction trends, investor activity, and the exit landscape for this important area.

October 24, 2018