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You are here: Home > Opinion & analysis

Opinion & analysis


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  • The Case For Agile Innovation In Health Care

    $131.00

    According to a recent Bain & Company survey, while nearly 80% of health care executives said they needed to be more agile, more than half said they were not familiar with formal agile methodologies and tools and were not using them in their companies.

    September 2, 2019
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  • Roche: We’ve Abandoned Budgets And It’s Liberated Employees

    $131.00

    Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? In Vivo talks to one CEO who knows.

    September 2, 2019
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  • MorphoSys: A European Champion Crossing The Biopharma Rubicon

    $200.00

    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.

    September 2, 2019
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  • Can Novartis Reclaim Pioneering Role In Transplantation?

    $131.00

    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.

    September 2, 2019
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  • Defying FDA: Shanghai Lab Gets Warning Letter But Won’t Relent

    $131.00

    A Shanghai testing laboratory has been handed an FDA warning letter for refusing a GMP inspection but told the agency it rightfully did so. Pink Sheet shares the exact working of the FDA letter as well as the highly unusual response from the laboratory.

    September 2, 2019
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  • Nitrosamine Episode Could Lead To Paradigm Shift In Quality

    $131.00

    The detection of cancer-causing impurities in drugs with well-established safety profiles may call for regulators across the globe to revise their approach for evaluating quality. Pink Sheet looks at whether or not companies seem to know their own products.

    September 2, 2019
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  • Countdown To Transition: US FDA Says 91 Drugs Will Become Biologics In March 2020

    $131.00

    A Pink Sheet infographic shows how insulins account for the largest category of transition products, with 27 NDAs that will be deemed BLAs in six months as the FDA is addressing the transition of authorized generic insulins to regulation under the PHS act.

    September 2, 2019
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  • EMA under Pressure again as Staff Losses Worsen

    $131.00

    Higher than expected staff losses at the European Medicines Agency due to the relocations to Amsterdam are posing challenges to implement new EU legislation. While the planned move to a permanent HQ in the Dutch capital has led to a decrease in staff, the agency is having to further prioritize its business activities.

    September 2, 2019
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  • US FDA’s Temple on Real-world Evidence: “I Find the Whole Thing Very Frustrating”

    $131.00

    At the October FDA panel discussion at the Biopharma Congress, CDER deputy director for clinical science reiterated his long-held skepticism about whether real-world evidence can be used to demonstrate efficacy claims. Pink Sheet looks deeper at his words.

    September 2, 2019
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  • 86% Rise In GMDN Usage Heralds New Era Of Postmarket Data Analytics

    $200.00

    The Global Medical Device Nomenclature is emblematic of the global trend toward building high-quality data sets in the public arena to derive better information about how medical devices perform. Medtech Insight covers that the new chair of the agency saying how the GMDN usage is poised to explode.

    September 2, 2019
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  • US House Panel Approves Medicare Hearing, Dental And Vision Coverage; Senate Bill Introduced

    $131.00

    Three bills that would cover eye, dental and hearing examination for US Medicare beneficiaries were passed by the US House Ways and Means Committee on 22 October and there is a similar bill in the Senate. Medtech Insight looks at the next steps for these House bills and the related Senate bill.

    September 2, 2019
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  • Six Key New Commission Documents Relating To EU Directives And New Regulations

    $131.00

    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.

    September 2, 2019
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  • Drug/Device Combinations: Shock For Pharma As It Seeks Notified Body Resources Too

    $131.00

    The delivery of drugs via medical devices being commonplace and introduction of new EU rules for these products via the MDR has the pharma industry dismayed at the uncertainty ahead and searching for notified body capacity. Medtech Insight look at the ongoing uncertainty and the state of Europe’s healthcare regulations.

    September 2, 2019
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  • Abbott Launches New App To Keep Heart Failure Patients Out Of The Hospital

    $131.00

    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.

    September 2, 2019
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  • Eight Talking Points from ESMO

    $200.00

    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.

    September 2, 2019
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  • Ranbaxy Brothers Arrested, Downward Spiral Intensifies

    $131.00

    With the Singh brothers of Ranbaxy being arrested over allegations of financial fraud, Scrip looks at the history of issues at the company and how things appear headed even further downhill with Daiichi Sankyo also separately pursuing enforcement of damages against the brothers.

    September 2, 2019
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  • Culture Change At GSK: ‘We’re Doing What We Said We’d Do’

    $131.00

    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

    September 2, 2019
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  • Sanofi’s New CEO Paul Hudson Poised To Write The Next Chapter

    $200.00

    Less than one month into his new job, Sanofi CEO Paul Hudson shared his perspective on how he plans to build on Sanofi’s strengths and deliver needed changes. Scrip shares details about Sanofi’s leadership history and Hudson’s early priorities at the helm.

    September 2, 2019
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  • Amarin CEO Thero On Gearing Up For Success Ahead Of The Big Vascepa Ad Comm

    $131.00

    Speaking with Scrip recently, Amarin CEO, John Thero talked about the upcoming US advisory committee meeting for Vascepa and commercial expansion plans and deflected questions about a big pharma buyout. What he did say was that, “We’re planning for success.

    September 2, 2019
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  • Schakowsky’s Loaded Cosmetics Bill Described as ‘Floor, Not a Ceiling’ for States to Build On

    $200.00

    The Safe Cosmetics and Personal Care Products Act reintroduced to the US House of Representatives calls for greater duties and resource demands on companies and the FDA than the proposed Personal Care Act in the Senate and allows room for states to impose more stringent regulations.

    September 2, 2019
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  • A Hangover Is A Disease, German Court Rules

    $131.00

    Alcohol-related hangovers are genuine illnesses according to a recent ruling by a high-level German court. HBW looks at the case against a German wellness manufacturer for health claims made for its “anti-hangover” supplements and how deeming hangover’s a disease affects the outcome of the case.

    September 2, 2019
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  • Serious Skin Reactions Reported with Ibuprofen Use in Europe

    $131.00

    The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee advises ibuprofen manufacturers to add warnings on patient information leaflets concerning acute generalized exanthematous pustulosis associated with use of the drug. HBW provides details about the skin reaction being noted and the informational changes required.

    September 2, 2019
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  • Anti-Aging Cosmetics Or Unlawfully Marketed Drugs? Two Federal Court Cases To Watch

    $131.00

    Skin-firming and anti-wrinkle claims on products marketed as cosmetics are being tested in California federal course. The results will have considerable implications on the health, beauty and wellness industry. HBW looks at similarities and differences of the two cases.

    September 2, 2019
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  • Testing Ranitidine with Too Much Heat Could Generate NDMA, FDA Say

    $131.00

    The US Food and Drug Administration says reports of high levels of N-nitrosodimethylamine in the histamine-2 blocker ranitidine resulted from a third-party laboratory’s use of the incorrect test for the drug treatment. HBW covers the recommended testing method.

    September 2, 2019
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  • How To Pay For The New Wave Of Gene Therapies

    $200.00

    Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, recently told Scrip, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”

    August 2, 2019
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  • Farxiga Data Change Heart Failure Treatment Outlook

    $200.00

    AstraZeneca’s Farxiga (dapagliflozin) appears set to become new standard or care in the treatment of hear failure based on results of the DAPA-HF Phase III trial present at the European Society of Cardiology Congress on 1 September. Scrip looks at Farxiga and its nearest competitors.

    August 2, 2019
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  • ESMO Preview: Five Key Oncology Battlegrounds To Watch

    $200.00

    With Europe’s biggest cancer congress ESMO attracting large and small companies to present the latest data readouts across a broad range of tumor types, Scrip looked at the key players and the five key battlegrounds at stake.

    August 3, 2019
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  • Novo Nordisk’s Oral Rybelsus Priced On Par With Injectable GLP-1s, But Big Discounts May Be Needed

    $200.00

    While a 30-day supply of the first oral GLP-1 agonist will cost $772.43, similar to the injectable version, this is still steeper than oral diabetes medicines and Scrip looks at how deep discounts may be needed to secure market access.

    August 2, 2019
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  • Roche: We’ve Abandoned Budgets And It’s Liberated Employees

    $200.00

    Imagine what would happen if a huge corporation abandoned the core competency of controlling its multi-million-dollar budgets and accelerating processes across R&D and commercial divisions. Would it survive? Would it actually thrive? Scrip talks to one CEO who knows.

    August 2, 2019
    Find out more

  • How To Pay For The New Wave Of Gene Therapies

    $131.00

    Pink Sheet spoke with Paul Goudreau, executive director & head of Phase IV Solutions at the CRO Covance, who says, “an ongoing and wide-ranging discussion is needed about assessment, payment and reimbursement of innovative products, as well as the evidence that supports them.”

    August 3, 2019
    Find out more
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