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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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  • 2018 Completed Clinical Trials: Change Is The New Constant

    $200.00

    Trialtrove’s 2018 Completed Trials: State of Industry-Sponsored Clinical Development report takes a detailed look at the record of completed trials over the calendar year, highlighting key trends by therapeutic area; the company sponsorship landscape; and trial phase, including progress of designated pivotal trials and success in meeting endpoints. This insightful annual review of clinical trials initiated by industry sponsors is a useful gauge of the diversity and innovative potential of biopharma’s investments in R&D. This year’s report reveals that, for all the consistencies in many aspects of the clinical trial landscape, changes are in the wind – particularly as companies outside the “Pharma Top 20” now contribute more completed trials than any other type of sponsor.

    August 21, 2019
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  • Novartis Swaps Two AveXis Executives For One Following Zolgensma Data Manipulation

    $200.00

    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
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  • What Does It Take To Launch And Lead An Oncology Biotech Today?

    $200.00

    Oncolytic virus company Theolytics has emerged ready to raise a series A round and get its preclinical assets into human trials by 2021. CEO Charlotte Casebourne talks to In Vivo about the challenge of standing out from the crowd in oncology, how viruses have evolved as a treatment approach in cancer, and how oncolytic viruses might be the answer to the cancer drug pricing conundrum. Learn what this young CEO (at age 26) has to say about the skills required to be a biotech CEO today, the concerning issue of access to novel personalized cancer treatments, and the biggest challenges she sees in cancer drug development today.

    August 12, 2019
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  • Top 10 Drugs: Biologic Blockbusters And The Biosimilar Threat

    $131.00

    Pharma companies faced a “patent cliff” a decade ago with generic competition threatening to slash sales of certain blockbusters. The new threat is biosimilars. Scrip shows how some mature cancer and autoimmune biologics are still the major drivers of revenues, and how biosimilars are gaining on them.

    August 9, 2019
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  • Novartis Battens Down Hatches Over Falsified Zolgensma Data

    $131.00

    The FDA is investigating data manipulation issues associated with Novartis’s filing for their type 1 spinal muscular atrophy drug, Zolgensma. This Scrip story looks at the claims, background on the issue, and the Swiss manufacturer’s recent response.

    August 7, 2019
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  • Top 10 Drugs: Weighing Pharma’s Golden Eggs

    $131.00

    A relatively small number of costly drugs account for a sizable portion of pharma industry revenues. This informative and easily scannable Scrip infographic shows which drugs are the golden eggs, which companies are behind them, and how the landscape has changed in the past decade.

    August 6, 2019
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  • Made In China Gene Therapy A Father’s Quest To Save Son With UltraRare Condition

    $131.00

    China has the potential to be the world’s largest market for rare disease treatments but may need to develop their own gene therapies as imported products will be too costly.  Read about a father’s journey to find a gene therapy to treat his young son’s rare condition.

    August 5, 2019
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  • Made In China Gene Therapy A Father’s Quest To Save Son With UltraRare Condition

    $131.00

    With a population of 1.3 billion and a large patient pool with rare genetic conditions, China has the potential to be the world’s largest market for rare disease treatments. It is believed, however, that China will need to develop its own gene therapies, given that such imported products will be simply too costly for what is a largely self-pay market.  Read about one very determined Chinese father’s journey on two continents to find a research provider with the particular expertise to find a new gene therapy to treat his young son’s very rare condition.

    August 5, 2019
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  • Novartis’ Zolgensma Had Manipulated Data In Application, US FDA Says

    $200.00

    The gene therapy Zolgensma will remain on the market, but Novartis and subsidiary AveXis Inc. may face civil or criminal action after revelations by the FDA that data used for approval had been manipulated. In fact, the drug giant knew about the problem months before Zolgensma was approved and said nothing. Learn what happened, why the FDA still asserts confidence in its approval of Zolgensma, and what these events could mean to Novartis and the gene therapy industry moving forward.

    August 3, 2019
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  • Ranitidine Recalls Begin In Europe As Regulators Take Action

    $200.00

    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
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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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  • 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
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  • Commission Would Back Limited Expansion Of Products Covered By MDR Grace Period

    $200.00

    After much speculation and urges of caution related to whether the European Commission would support a proposal to expand the range of products covered by the Medical Device Regulation’s four-year grace period, the European Commission has now said it will support it.

    August 3, 2019
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  • Novartis CEO Explains Delay In Telling US FDA About Zolgensma Data Fraud: We Wanted To Understand It First

    $200.00

    Novartis AG tried to squash any murmurings that it had a disreputable intent in not disclosing the data fraud it knew about before approval of its gene therapy Zolgensma, saying the company wanted a full understanding of the issue first before bringing it to the attention of regulators. In a recent conference call with analysts, Novartis execs were bombarded with questions about their “prescribed process” of internal investigation, and when exactly they knew about the fraud. Find out how the pharma giant is handling such close scrutiny, how they are dealing with the AveXis scientists involved in the “data inaccuracies,” and the recent EMA decision to downgrade Zolgensma’s accelerated assessment.

    August 2, 2019
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  • New Age Thinking: US FDA’s Temple Sees Third Era Of Drug Development

    $131.00

    Robert Temple, the FDA’s voice of institutional memory, believes drug regulation has quietly entered a third era: the “Age of Individualization.” Unlike the prior eras of safety and efficacy, there is no milestone legislation to set the ground rules. But, Temple stressed, there have been significant changes in areas like the assessment of drug-drug interactions, metabolic response to therapeutics, and in the FDA’s willingness for sub-population analyses. Is there a change in the air that will result in further change in drug development as it relates to the Age of the Individual?

    August 2, 2019
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  • US FDA’s Rush Following Novartis’ Delay Suggests Strong Displeasure With Handling Of Zolgensma Data Manipulation

    $131.00

    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.

    August 2, 2019
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  • FDA’s Withdrawn Reg On Data Fraud Hangs Over Zolgensma Incident

    $131.00

    Democratic senators push data-challenged gene therapy Zolgensma into the center of the drug pricing debate as they press acting commissioner Sharpless to bring the hammer down on Novartis, but also question the US FDA’s decision to withdraw its proposed rule about data falsification in clinical and nonclinical studies last year. Did the FDA do the right thing by abandoning a proposed rule that, as they state, is not needed to protect research subjects or ensure integrity of clinical trial data?

    August 2, 2019
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  • Contamination In Common OTC Antacid Adds To FDA’s API Impurity Concerns

    $131.00

    The US Food and Drug Administration is considering how to respond after a contaminant was found in drugs containing, ranitidine, the active ingredient in Sanofi’s Zantac OTC heartburn remedy and multiple generic equivalents. HBW also looks at similar investigations in Europe

    August 2, 2019
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  • US Zantac Sales And Distribution Continue As Sanofi Tests For NDMA

    $200.00

    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.

    August 2, 2019
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  • Amarin CEO: Consumers Have Heard About Omega-3 Heart Benefits ‘Too Long’

    $200.00

    Amarin’s John Thero says the firm expects a jump in sales for Vascepa from potential label expansion allowing a larger patient groups with lower triglycerides than current label indications. At the same time, he notes competitors fail to show broader cardiovascular risk reduction.

    August 2, 2019
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  • Sanofi Offloads Two German OTC Brands, New CEO Prepares To Make Mark

    $200.00

    Sanofi signaled earlier this year it would continue to rationalize its Consumer Healthcare portfolio and focus on several priority brands and categories. Now they have divested two brands in Germany and Austria. HBW covers the details including plans of the firm’s CEO.

    August 2, 2019
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  • Sunscreen Test Lab Used Fewer Subjects Than Reported, US Prosecutors Allege

    $131.00

    The owner of AMA Labs, which provides testing for cosmetic, drug, medical device and other products, was arrested on charges of wire fraud and conspiracy following an indictment in New York federal court. The firm that bills itself as “the premier sunscreen testing laboratory” falsified results for 30 years by testing products on fewer subjects than it reported, federal prosecutors allege. Letzia pleaded not guilty but four AMA Labs employees pleaded guilty to similar charges in May. Get the whole story, and what this could mean for the approval or compliance status of products tested by AMA that are currently available.

    August 2, 2019
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  • L’Oréal E-Commerce Growth Approaches 50%: ‘We Are Now Clearly A Digital-First Company’

    $131.00

    Beauty products leader L’Oréal has enjoyed much success thanks to E-commerce, the Asian market and travel retail continue to fuel gains at L’Oréal, which just posted its strongest first half like for-like growth in more than a decade. Skin care remains a key driver as well, offsetting a global slowdown in makeup that has hit the firm’s US business hardest, with little improvement expected this year. Will all this be enough to make up for sluggish conditions in North America and the US in particular, where more than half of L’Oréal’s sales are in makeup? Read the article to find out what else the company is banking on.

    August 2, 2019
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  • Reckitt Invests In AI Symptom Checker To ‘Unlock Self-Care’

    $131.00

    Reckitt Benckiser has invested in ‘doctor in your pocket’ app Your.MD in response to consumers’ increasing demand for “personal, always-on mobile and data-driven” digital healthcare – that according to Aditya Sehgal, RB Health’s chief operating officer. The app’s AI-powered symptom checker claims to diagnose with high accuracy a range of medical conditions. For its part, Your.MD believes the tie-up with RB will be a game-changer for the firm. Will the new infusion of capital fulfill the goal of Your.MD to put a doctor in the pocket of every citizen in the world?

    August 2, 2019
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  • CBD Suits Challenge ‘THC-Free’ Claims After Users Fail Drug Tests; Plaintiffs Bar May Just Be Warming Up

    $131.00

    Attorneys are warning CBD product marketers to be on guard for litigation challenging the authenticity of their claims, the safety of their products and other aspects of their businesses – this after users in the US filed suit as a result of testing positive for THC, which they attribute to defendants’ purportedly THC-free cannabidiol products. So far, suits of this nature have been limited in the US, but the few known cases could be the first waves of an impending tsunami to come. Was it false advertising on the part of the defendants, or did they not know their claims of THC-free CBD products to be untrue? In either case, the cost of litigation could be steep.

    August 2, 2019
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  • GSK And Pfizer Assemble Consumer Healthcare Leadership Team As JV Closes

    $131.00

    GlaxoSmithKline PLC and Pfizer Inc. have closed their consumer health joint venture to create the “global leader in OTC products.” Operating under the GSK Consumer Healthcare name, the joint venture – announced in December last year – has around a 7.3% share of the global consumer health market, well ahead of the next competitor, Johnson & Johnson, at 4.1%. Under the leadership of Brian McNamara, the new company has begun to assemble a management team that combines talent from both GSK and Pfizer. Who’s on the dream team, and what’s on the horizon for this new superpower?

    August 2, 2019
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  • Orphan Drug Pricing And Reimbursement: Challenges To Patient Access

    $131.00

    While the drug industry and patient advocacy groups have worried about price controls or reimbursement restrictions for drugs that treat orphan diseases, a review of formulary data shows that patient access to high-priced drugs has not been severely hampered despite some payer pushback.

    August 2, 2019
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  • IXICO Targets Go-To Status In Neuro Data Analytics Space

    $131.00

    IXICO is a neuroscience data specialist that wants to partner with large and small pharmas to help them develop better-targeted clinical trials using imaging and digital biomarkers data. In Vivo looks at the CEO’s activity planning review and subsequent leadership restructuring.

    August 2, 2019
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  • FDA Announces More Actions On Drug-Coated Devices

    $131.00

    Based on a meta-analysis of randomized trials for paclitaxel-coated devices, the FDA is concerned that they may not be safe to use, as they may be linked to mortality. Until further information is available, the FDA is recommending doctors prescribe these devices on a case-by-case basis only.

    August 2, 2019
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