Congress Votes to Legalize Hemp, Cuts Schedule I Classification

The US House of Representatives has passed the 2018 Farm Bill by an overwhelming vote of 369-47, joining the US Senate in approving the bill that allows farmers to expand cultivation of industrial hemp.

The Farm Bill includes the Hemp Farming Act of 2018, which would make hemp legal in the United States. The Farm Bill passed the Senate in June. The bill now goes to President Donald Trump, who is expected to sign it into legislation.

For decades, hemp was classified as a schedule I controlled substance. Although it’s a type of cannabis, hemp does not have psychoactive properties or produce the “high” of tetrahydrocannabinol.

Hemp, which is used in industrial products, also contains cannabidiol. Its seeds and flowers are used in health foods, organic body care, and nutraceuticals. The fibers and stalks are used in hemp clothing, construction materials, paper, biofuel, and plastics, among other things.

In April, Senate Majority Leader Mitch McConnell (R-KY) introduced the Hemp Farming Act of 2018 as part of the larger Farm Bill, with the goal of removing federal barriers to hemp production.

The measure legalizes hemp as an agricultural commodity by removing it from the federal list of controlled substances. It also allows states to become the primary regulators of hemp production, enables hemp researchers to apply for competitive federal grants from the US Department of Agriculture, and makes hemp eligible for crop insurance.

State Oversight

“Last year alone, Kentucky hemp recorded more than $16 million in product sales through the state pilot program I previously secured, demonstrating that hemp holds great potential for the future of Kentucky agriculture,” Senator McConnell said in a statement.

“My Hemp Farming Act as included in the Farm Bill will not only legalize domestic hemp, but it will also allow state departments of agriculture to be responsible for its oversight. In Kentucky, that means that Commissioner Ryan Quarles, another champion of hemp, will be able to help farmers thrive,” said McConnell.

“When the Senate votes on this legislation in the coming days, we will also be voting to give farmers throughout the country the chance to tap into hemp’s potential and take part in its future,” he added.

Hemp, noted Quarles, “is no longer a novelty but a serious crop that will unleash economic opportunity for our farmers.”

Some forecasts suggest that the hemp industry could generate revenues of $20 billion by 2022 once the Farm Bill is signed into law.

https://www.medscape.com/viewarticle/906586

Supernus announces FDA approval of sNDA for Oxtellar XR

https://thefly.com/landingPageNews.php?id=2837565

Amgen says FDA approves Nplate for use in pediatric patients with ITP

https://thefly.com/landingPageNews.php?id=2837564

Early physical therapy can reduce risk, amount of long-term opioid use

Patients who underwent physical therapy soon after being diagnosed with pain in the shoulder, neck, low back or knee were approximately 7 to 16 percent less likely to use opioids in the subsequent months, according to a new study by researchers at the Stanford University School of Medicine and the Duke University School of Medicine.

For patients with shoulder, back or knee pain who did use opioids, early physical therapy was associated with a 5 to 10 percent reduction in how much of the drug they used, the study found.

Amid national concern about the overuse of opioids and encouragement from the Centers for Disease Control and Prevention and other groups to deploy alternatives when possible, the findings provide evidence that physical therapy can be a useful, nonpharmacologic approach for managing severe musculoskeletal pain.

“We asked ourselves, ‘How can we address the pain that people are having, while not increasing their risk of needing opioids?'” said Eric Sun, MD, PhD, assistant professor of anesthesiology, perioperative and pain medicine at Stanford. “And what our study found was that if you can get these patients on physical therapy reasonably quickly, that reduces the probability that they’ll be using opioids in the longer term.”

The study, from an analysis of private health insurance claims for care and prescriptions between 2007 and 2015, will be published Dec. 14 in JAMA Network Open. Sun is the lead author. Steven George, PhD, professor of orthopaedic surgery at Duke, is the senior author.

Fewer opioid prescriptions

The researchers reviewed claims for outpatient and emergency room visits for the earliest instance of a diagnosis of shoulder, neck, knee or low back pain among privately insured, nonelderly adult patients.

The study screened out patients who had recently taken opioids by including only those who hadn’t filled an opioid prescription within the prior year. The study also screened out patients with less serious pain by including only those who had visited a doctor for their condition within 30 days of their initial diagnosis and were given at least one opioid prescription within 90 days. The final sample consisted of 88,985 patients.

After adjusting for co-morbidities, such as diabetes and hypertension, Sun and his colleagues found that the odds of patients filling an opioid prescription three months to a year after their initial pain diagnosis were lower if they had participated in at least one physical therapy session within 90 days of their diagnosis. The odds were reduced by 16 percent for patients with knee pain, 15 percent for shoulder pain, 8 percent for neck pain and 7 percent for lower back pain.

The findings, Sun said, could be helpful to clinicians in search of pain-management options that carry fewer health risks than opioids. Studies have shown exercise therapy, a component of physical therapy, reduces pain and improves function for some musculoskeletal conditions. Other studies have shown that patients with past prescriptions for opioid pain medication are at increased risk for overdose and misuse.

“This isn’t a world where there are magic bullets,” Sun said. “But many guidelines suggest that physical therapy is an important component of pain management, and there is little downside to trying it.”

Less need for pain relief

The study also measured whether early physical therapy was associated with a decreased need for opioids in the long term among patient who filled prescriptions. The researchers measured the quantity of opioids by converting prescribed amounts to oral morphine milligram equivalents.

They found, after adjusting for confounding factors, that patients who had undergone early physical therapy used 10.3 percent less opioid medication for knee pain; 9.7 percent less for shoulder pain; and 5.1 percent less for back pain in the period three months to a year after their diagnosis. There was no significant reduction for neck pain.

Physical therapy within three months of diagnosis also was associated with a decreased likelihood that patients with two of the conditions would chronically use opioids in the long term, according to the study. After early physical therapy, patients with knee pain were 66 percent less likely in the period three months to a year after their diagnosis to either fill 10 or more prescriptions or acquire a supply of opioid medication for 120 days or more. Patients with low back pain were 34 percent less likely to be chronic users if they had early physical therapy. There was no association between physical therapy and chronic opioid use among patients with shoulder or neck pain.

“The general consensus is that for musculoskeletal pain, opioids generally aren’t a long-term solution,” Sun said. “Aside from all the other side effects, even if the medication is doing well for you, it will have less and less effect over time as your body builds up a tolerance.”

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Story Source:

Materials provided by Stanford Medicine. Note: Content may be edited for style and length.

https://www.sciencedaily.com/releases/2018/12/181214121814.htm

Statement on Reuters Talc Article

Johnson & Johnson (NYSE: JNJ) today issued the following statement regarding speculation about the safety of our products.

The Reuters article is one-sided, false, and inflammatory. Johnson & Johnson’s baby powder is safe and asbestos-free. Studies of more than 100,000 men and women show that talc does not cause cancer or asbestos-related disease. Thousands of independent tests by regulators and the world’s leading labs prove our baby powder has never contained asbestos. Johnson & Johnson will continue to defend the safety of our product. For the truth and facts about talc, please go to www.factsabouttalc.com.

The Reuters article is wrong in three key areas:

1. The article ignores that thousands of tests by J&J, regulators, leading independent labs, and academic institutions have repeatedly shown that our talc does not contain asbestos.
2. The article ignores that J&J has cooperated fully and openly with the U.S. FDA and other global regulators, providing them with all the information they requested over decades. We have also made our cosmetic talc mines and processed talc available to regulators for testing. Regulators have tested both, and they have always found our talc to be asbestos-free.
3. The article ignores that J&J has always used the most advanced testing methods available to confirm that our cosmetic talc does not contain asbestos. Every method available to test J&J’s talc for asbestos has been used by J&J, regulators, or independent experts, and all of these methods have all found that our cosmetic talc is asbestos-free.

https://www.biospace.com/article/releases/statement-on-reuters-talc-article/

Lilly to acquire pre-clinical pain program from Hydra, terms not disclosed

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Wainwright upgrades Bausch, says now is time to become more bullish

Eyes are on Bausch as H.C. Wainwright more than doubles price target and Wells Fargo highlights J&J risk

Shares of Bausch Health (BHC) were in focus after an analyst from H.C. Wainwright upgraded the stock and raised his price target on the shares. Meanwhile, an analyst from Wells Fargo commented on the risk to the company from Johnson & Johnson’s (JNJ) high-profile talc lawsuit.

WAINWRIGHT UPGRADES TO BUY: In a research note to investors, H.C. Wainwright analyst Raghuram Selvaraju upgraded Bausch Health to Buy from Neutral and upped his price target on the stock to $58 from $25, saying that he believes now is an appropriate time to become more bullish on the story. The analyst said that the significant price target hike is in keeping with the firm’s view that continued evidence of organic growth should have a “substantial impact” on the company’s debt-to-EBITDA ratio and thus make it a less leveraged company. The analyst added that he believes that the market has underrated and underappreciated the “tuck-in” and “complementarity-driven developments” of the past several months, while these have gradually begun to position Bausch Health “more strongly” in several core markets. In particular, the analyst highlighted the launches of Altreno and Bryhali and the inclusion of Doptelet, a drug complementary to Xifaxan.

SYNERGY BID: Selvaraju also noted that Bausch’s “stalking horse bid” for Synergy Pharmaceuticals “intrigues” him. The firm has followed Synergy and its marketed drug Trulance for nearly a decade, and remains convinced that this agent has “best-in-class” properties in the constipation-predominant irritable bowel syndrome and chronic idiopathic constipation indications, Selvaraju said. The analyst added that while Synergy itself has “failed to capitalize on the unique qualities” of Trulance, he believes that Bausch Health’s Salix unit could constitute the perfect fit for the drug. In addition, he believes that Bausch Health is likely to view Synergy’s pipeline as “ripe for development and rife with possibilities.”

WELLS FARGO NOTES J&J RISK: Meanwhile, Wells Fargo analyst David Maris maintained an Underperform rating on Bausch Health, noting that the comapny acquired Johnson & Johnson’s Shower to Shower body powder in 2012 and has subsequently been named as a defendant in over 160 lawsuits. Maris pointed out that Bausch Health recently said in a regulatory filing that, “While Johnson & Johnson continues to indemnify the Company, the Company has initiated proceedings in arbitration against Johnson & Johnson relating to the scope and amount of such indemnification.” Maris argued that if Bausch is going to arbitration with J&J in an effort to clarify the extent of J&J’s indemnification, it should be viewed as a risk investors take into account that J&J and Bausch come to different conclusions as to this indemnification.

WHAT’S NOTABLE: After Bausch Health announced its agreement to acquire Synergy earlier this week, Stifel analyst Annabel Samimy said that Synergy’s GI assets “fit squarely” into Bausch’s GI wheelhouse, which would immediately leverage the company’s sales and payer infrastructure and physician relationships in the space. On the other hand, however, Wells Fargo’s Maris called the acquisition “an inconsequential financial deal that points to a bigger picture of [Bausch] returning to its cost-cutting deal roots and a potential lack of confidence in growth of the core business.”

https://thefly.com/landingPageNews.php?id=2837546&sd=2018-12-14%2014:58:22