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.
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?
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.
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?
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.
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?
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.
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?
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.
In response to the recent controversial European Commission decision to classify products containing cannabidiol (CBD) as “novel foods”, the Cannabis Trades Association UK has begun legal action to challenge the classification. Read more about the controversy and legal proceedings here.
The battle over traces of asbestos found in cosmetics products at Claire’s, a jewelry and accessories retail chain that caters to girls and young women, serves to illustrate the limitations of the US FDA’s oversight of cosmetics matters. Find out more here.
Find out who the big winners were at the 24th annual OTC Marketing Awards. This article contains highlights from the gala awards evening, as well as a full list of all winners announced at the event, which celebrates the best in the British OTC industry.
Reckitt Benckiser Group PLC is looking to become the leader in the booming brain health segment with its release of Neuriva, a dietary supplement whose main ingredient is coffee berry, and whose efficacy, the company says, is backed by a double-blind clinical study.
Will Novartis’ Zolgensma or Biogen’s Spinraza be the standard of care for spinal muscular atrophy? Novartis shared its perspective with Scrip. Find out what Biogen had to say about the competition during an earnings call–and read how Novartis’ Paul Hudson responded. Learn how Novartis plans to handle payments for the expensive therapy. Is it considering outcomes-based payments? Gain insights into the clinical benefits of both medications and learn what’s next.
Expect more industry consolidation, counsels Morningstar’s Healthcare Observer report. Among the potential deals: BioMarin is a logical acquisition target. But for whom? Find out what Morningstar’s Damien Conover predicts. Discover which companies could be targets for Pfizer, and learn what Conover thinks of Pfizer CEO Albert Bourla’s insistence that it plans to grow organically.
The cardiovascular risks associated with a higher-than-approved dose of Pfizer’s JAK inhibitor Xeljanz in a long-term rheumatoid arthritis study have raised questions about its other indications. Will the risk of pulmonary embolism for a higher unapproved dose of Xeljanz in arthritis trigger a label change in the drug’s other indications? Is the JAK-inhibitor class of therapies in jeopardy? Learn what the analysts are saying.
Shortly after US FDA approval of its blood-disorder drug Cablivi, Sanofi announced “a rigorous pipeline prioritization review.” It’s fast-tracking 17 programs and discontinuing 13 development and 25 research projects. What’s left? Will Sanofi divest its animal health and/or consumer healthcare units? Find out what experts are saying.
Paul Peter Tak, formerly of GlaxoSmithKline, is “following the science.” He’s joined Flagship Pioneering as a venture partner and is already CEO of an “undisclosed biotech start-up operating in stealth mode.” Learn more about Flagship’s approach–creating think tanks to build companies from scratch around important unmet challenges–and why Tak finds that so appealing.
In Vivo takes a look at the hot-button topic of drug value in this thought-provoking article, which examines the role of ICER (Institute for Clinical and Economic Review) and wonders if a more sophisticated method of assigning value in the US market is necessary.
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.
An informal round table discussion among more than 20 key market access leaders in biopharma convened by the Boston Consulting Group (BCG) yielded some interesting insights into the innovations that are forcing changes to the way the industry runs.
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.
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.
The European Medicines Agency is in the midst of huge changes as it relocates its headquarters from London to Amsterdam, effective March 1. Find out more about the move, spurred by the UK’s impending exodus from the EU, in this informative Pink Sheet article.
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.
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.
AbbeVie is banking on the success of a possible simultaneous European/US launch of Skyrizi, its psoriasis drug, to bolster the company’s declining revenues in Europe. Read about how the company plans to use Skyrizi to bounce back from the genericization of its blockbuster Humira in this informative article.
Scrip sat down with the heads of McKinsey & Company for an informative Q&A about pharma’s efforts to expand and update in the areas of advanced analytics and digitization. Tap into their insights about where the industry is now, and where it may soon be heading.
Gene therapy continues to be a hot area of investment, even as the inevitable challenges concerning manufacturing and reimbursement remain a concern. Take a look at the major deals in this area with expert reporting from Scrip.
2019 should be a big year for the generics and biosimilars industries, as a sizable number of blockbuster drugs are losing their market exclusivity. Find out which drugs will see their first generic and biosimilar versions this year and what the repercussions will likely be.
Knee and hip replacement company Corin Group PLC has acquired Omni Orthopedics Inc. The acquisition of Omni, which specializes in robotic-assisted total knee replacement, marks another major step in the company’s expansion in the orthopedic market.
With its first issue of guidance for the EU Medical Devices Regulation (MDR), the European Medicines Agency has focused on products that contain an “integral medical device” component, such as pre-filled syringes. Find out more about the guidance here.
In an announcement that came as a surprise to industry experts, Scott Gottlieb announced his resignation as head of the US FDA after only a 22-month tenure. See what his legacy will be, and what his departure means for pilot projects currently in the works.
In a recent update of the European Commission’s Rolling Plan, the Commission noted that while Eudamed, the EU’s databank on medical devices, is due to go live in March of 2020, some essential portions of the database may experience a delay in availability.
Verseon’s computational drug-discovery platform designs candidates that probably wouldn’t be found with conventional methods, according to CEO Adityo Prakash. Discover why he believes Verseon’s approach is paving the way for next-level drug discovery. Gain insights into his refusal to license Verseon’s technology and learn about the company’s blockchain-based subsidiary, BlockRules.
Bristol-Myers Squibb’s acquisition of Celgene wasn’t the only big news in January. Read this brief for a comprehensive review of announcements from diagnostic, device and biopharma companies. Gain insights into both business and clinical developments, and get a peek into the in vitro diagnostics, medical devices and pharmaceuticals pipelines.
ZS’ Brian Chapman’s five predictions for medtech in 2019 sound generally positive. Find out about what makes him optimistic–such as the use of real-world evidence to drive reimbursement discussions. Gain insights into why he’s concerned about the impact of geopolitical uncertainty.
Find out how Ascensia’s jump from blood glucose monitoring technology to continuous glucose monitoring has moved the company into the disease management space. Learn how the company is expanding into largely untapped global markets, including India and China. Discover how Ascensia plans to become a one-stop-shop for diabetes management solutions and why it’s placing greater emphasis on the patient voice.
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.
Herbalife CEO Richard Goudis stepped down from the top spot at the company following the discovery of inappropriate comments he had made prior to becoming CEO. Find out more about the Herbalife shakeup and what it means for the company.
Burt’s Bees is making another foray into the toothpaste category with a line for adults and children and a strategic licensing partnership with Procter & Gamble, makers of Crest. Discover the details of this third attempt to successfully enter the oral care space by the Clorox-owned Burt’s Bees.
For a view into where Johnson & Johnson stands now in the wake of both controversy over the safety of its talc products and the Johnson brand’s relaunch as a natural product line, tap into this article covering highlights of J&J’s remarks at the 2019 JP Morgan Healthcare Conference.
Sanofi and the Plug and Play venture fund are teaming up to explore digital technologies in the areas of nutrition and allergies. HBW Insight takes a deeper look at this partnership, as the pharma giant looks to take a lead role in European digital health innovation.
During their bi-annual meeting, Germany’s Expert Committee for Prescription was set to discuss a move from prescription to OTC status for hydrocortisone 1% for external use, and combination ibuprofen and phenylephrine hydrochloride. Get the details of the proposal with reporting from HBW Insight.
Find out which stories captured the attention of In Vivo readers last year, with In Vivo’s annual list of most-read articles. This top-ten list offers a glimpse into the issues, events, and trends that mattered most to In Vivo readers in 2018.
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