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Wednesday, July 3, 2019

Social Media Sites Cracking Down on Misleading Medical Claims

For centuries people have sold various types of snake oil as a panacea for all kinds of medical conditions. Those so-called cures in a bottle made dubious claims about the efficacy of the treatment. Today, snake oil treatments are still sold but the marketing of these products have gone viral.
In films and literature, snake oil salesmen worked from a cart as they traveled from town to town, selling their products and then fleeing with the cash before people realized the so-called medicine didn’t work. Today, those salesmen use social media to promote treatments that are often billed as holistic and promise extraordinary results in a wide range of disease states, including cancer.
This morning, the Wall Street Journal pointed to the numerous posts circulating on social media sites like Twitter, YouTube and Facebook that contain “scientifically dubious and potentially harmful information” about alternative treatments for diseases and conditions. The owners of the platforms have become concerned about the claims made in these posts, particularly because they are not backed up by hard scientific data. Many of the claims made in the online posts are false or are based on inflated results from early laboratory studies. The Journal found that these posts are being viewed millions of times by users of the various platforms and that has led to a crackdown on such posts.

On Tuesday, Facebook issued a statement regarding the importance of minimizing health content that is “sensational or misleading.” The company made changes to its content management to reduce posts that have exaggerated or sensational health claims. Part of the problem is that people see these ads with misleading remedies and either forego the advice of their doctors or confront their doctors with inaccurate data.
“People come together on Facebook to talk about, advocate for, and connect around things like nutrition, fitness and health issues. But in order to help people get accurate health information and the support they need, it’s imperative that we minimize health content that is sensational or misleading,” Facebook said in its blog post.
Earlier this year, Facebook also tackled misinformation regarding vaccines and their efficacy. The social media giant said when it find ads that include misinformation about vaccinations, it will reject them. Such posts have, in part, helped to a growing mistrust of vaccines across the globe as some claims regarding safety spread like wildfire online.
The Journal noted that YouTube, which is owned by Alphabet (Google) had guidelines that do not allow videos that can cause harm, which includes videos with misleading medical information. Over the course of the first quarter of 2019, YouTube said it removed 8.3 million videos making such claims.

British Researchers Blocked as the Result of Brexit

According to a University College London (UCL) report, British researchers are being shut out of major European research partnerships because of concerns over a no-deal Brexit.
Brexit, which stands for Britain Exit, was a referendum voted on June 23, 2016, for the UK to stay or remain in the European Union. The decision to leave won by 51.9% to 48.1%. There was originally a decision to leave the EU on March 29, 2019, but a withdrawal agreement between the EU and UK was rejected three times by the UK’s parliament. It was then extended several times and is currently set at October 31, 2019. The UK may leave earlier if a withdrawal agreement is ratified by the UK and the EU before then.
The referendum and the two parties’ inability to finalize negotiations has had an impact on numerous industries, including biopharma. For example, major European drug companies, including GlaxoSmithKline, AstraZeneca and Gilead were stockpiling drugs to ensure there were no shortages.

In addition, many in the life sciences industry and others believe there is going to be long-term damage to the industry. The Association of the British Pharmaceutical Industry (ABPI)warned earlier this year that the UK was in “danger of losing its world-leading research and development status, backed by the country’s two biggest pharma investors, AstraZeneca and GlaxoSmithKline.”
This is consistent with the last UCL report, which analyzed EU research funding. The data showed that UCL and eight other Russell Group universities had about 50 large European research collaborations in 2016, but only 20 in 2018.
Michael Arthur, president of UCL told The Guardian, “What we are seeing is we are still participating in European networks, but we are leading less.”
Apparently, if not being outright excluded from partnerships, UK researchers are being asked to keep a low profile because of fears a no-deal Brexit might make success less likely or that if a UK academic is heading an important partnership proposal, the research might not be funded.
For example, Birmingham University was asked to “step down from leading five bids for training networks, funded by the EU’s Marie Sklodowska-Curie Actions, in case a UK partner compromises their chances,” The Guardian reports.
Pamela Kearns, who leads Cancer Research UK’s national clinical trial center at Birmingham University, is sponsoring 16 clinical trials, most for childhood cancers, in 21 European countries. She told The Guardian that the Brexit uncertainty has research partners on edge.
“In one recent discussion about a funding bid with very longstanding European partners, it was decided they wouldn’t have a UK partner on the project as it would be too great a risk,” Kearns said.

As a result, Kearns has spent a lot of time in the last year working to make sure that the clinical trials can continue running if Britain leaves the EU. But the universities and hospitals involved have expressed their concern.
The European Commission is focusing on cancer with a new 100-billion-euro research funding program, Horizon Europe, which will follow the current Horizon 2020 program. If Britain exits the EU on October 31, it’s not clear if Britain will be allowed to participate.
“For the UK not to be able to be a partner in a united European approach to making a difference in cancer would be unacceptable,” Kearns said.
An unidentified head of one UK research university, who asked not to be named, told The Guardian, “Leaving with no deal will be a f*%ing disaster for research. We are already hearing that researchers in the EU are being told ‘Why take the risk of partnering with the UK?’”

Marker started at Outperform by Oppenheimer

Target $15

Inogen cut to underweight from Neutral by JPMorgan

Target $72

Glaxo launches late-stage development of RA med otilimab

GlaxoSmithKline (NYSE:GSKannounces the start of its Phase 3 program evaluating otilimab, an anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis (RA) who have failed to respond adequately to disease-modifying antirheumatic drugs (DMARDs) or targeted therapies.
The program, called ContRAst, will include head-to-head comparisons with current treatments across all studies, including Pfizer’s (NYSE:PFE) XELJANZ (tofacitinib) Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi’s (NASDAQ:SNY) KEVZARA (sarilumab).
The primary endpoint for the pivotal trials will be the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20).
GSK owns exclusive global rights to otilimab under a 2013 agreement with MorphoSys AG (NASDAQ:MOR).
Shares are up 1% premarket on the European nod for ViiV Healthcare’s Dovato for HIV-1 infection.

Ligand Pharma out-licenses OmniAb platform to Millennium Pharma

Ligand Pharmaceuticals (NASDAQ:LGND) has entered into an OmniAb commercial platform license and services agreement with Millennium Pharmaceuticals, a wholly owned subsidiary of Takeda Pharmaceutical (NYSE:TAK).
Under the license, Takeda and its affiliates will be able to use OmniAb platform rodents and birds in campaigns to discover antibodies as well as therapies using engineered cells and OmniAb-derived binders.
LGND is receiving annual access fees and will receive milestone payments and tiered single-digit royalty payments for each product incorporating or delivering an OmniAb antibody and any scientific services provided. Takeda will be responsible for all costs related to the programs.

RedHill Bio’s Talicia nabs accelerated review status

The FDA has accepted for review RedHill Biopharma’s (NASDAQ:RDHL) NDA for Talicia (RHB-105) for H. pylori infection. The NDA has also been granted Priority Review designation.
PDUFA action date is November 2, 2019.
If approved, Talicia would be eligible for eight years of U.S. market exclusivity.
Talicia (RHB-105) is an oral capsule combination of two antibiotics, rifabutin, and amoxicillin, and a proton pump inhibitor, omeprazole.
Shares are up 3% premarket.