Crispr Therapeutics named a top pick for 2019 at Piper Jaffray. Piper Jaffray analyst Edward names Crispr Therapeutics a top pick for 2019 and reiterates an Overweight rating on the shares with a $75 price target. The stock closed the trading day up $1.30 to $29.87. Crispr is developing “revolutionary” CRISPR/Cas-9 technology as a new therapeutic modality with broad ranging applicability, Tenthoff tells investors in a research note. The Phase I/II studies of CTX-001 in transfusion-dependent beta thalassemia and sickle cell disease will report first-in-man data this year potentially curing patients of disease, adds the analyst.
Thursday, January 3, 2019
FDA expands indication for Bristol-Myers’ Sprycel tablets
Bristol-Myers Squibb announced the U.S. Food and Drug Administration has expanded the indication for Sprycel tablets to include the treatment of pediatric patients one year of age and older with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia in combination with chemotherapy. Sprycel is the only second-generation tyrosine kinase inhibitor approved for this patient population. The approval, which was granted following priority review by the FDA, is based on data from the Phase 2 study, CA180-372. “We recognize the urgency around developing and delivering therapies for children and young adults living with cancer, and today’s approval is an important example of our commitment to pediatric oncology,” said Jeffrey Jackson, Ph.D., development lead, hematology, Bristol-Myers Squibb. “Building on our previous indication for children with Ph+ chronic myeloid leukemia in chronic phase, we’re pleased to bring Sprycel tablets to a second type of pediatric leukemia. This approval will give physicians another treatment option to offer appropriate pediatric patients with Ph+ ALL.”
Wednesday, January 2, 2019
Waters initiated at Needham
Waters initiated with a Hold at Needham. Needham analyst Stephen Unger started Waters Corp. with a Hold rating and $177 fair value estimate.
Humana revises FY19 Medicare Advantage members to 375,000-400,000
Based on final annual enrollment period results, the company is revising its net membership growth estimate for its individual Medicare Advantage products for the year ended December 31, 2019 to 375,000 to 400,000 members, compared to its previous estimate of 350,000 to 400,000 members. The revised membership estimate represents expected net membership gains of 12%-13% above the year ended December 31, 2018 membership level of approximately 3.07M members. The company also reiterates its expectations for group Medicare Advantage net membership gains for the same period, projecting an increase of approximately 30,000 members year over year. The membership estimate represents an expected net membership gain of 6% above the year ended December 31, 2018 membership level of approximately 500,000 members. For PDP, the company now estimates a net membership decline of 700,000 to 750,000 members for the year ended December 31, 2019, compared to its previous estimate of a decline of 750,000 to 800,000 members. The membership estimate represents a decline of 14%-15% below the year ended December 31, 2018 membership level of approximately 5M members. The revised estimate is primarily attributable to improved retention estimates.
Stryker initiated at Deutsche Bank
Stryker initiated with a Buy at Deutsche Bank. Deutsche Bank analyst Pito Chickering started Stryker with a Buy rating and $179 price target. Deutsche had a Buy rating on the shares under analyst Kristen Stewart before going restricted on the name in June of 2018.
Amgen, Teva resolve patent dispute over generic Cinacalet HCl product
Teva Pharmaceutical Industries (TEVA) announced that it has resolved its ongoing dispute with Amgen (AMGN) over Teva’s generic cinacalcet HCl product. Teva and Amgen have been involved in patent infringement litigation, and Teva recently received approval for, and launched its generic product in the US. By virtue of the settlement, the litigation between the parties will be ended and Teva has agreed to stop selling its generic product until its license date in mid-year 2021, or earlier under certain circumstances. Teva will pay Amgen an undisclosed amount as part of the settlement. That amount and other terms of the settlement remain confidential. Cinacalcet is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism in adult patients with chronic kidney disease on dialysis. It is also used for the treatment of hypercalcemia in adult patients with parathyroid carcinoma and severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy.
Pain Management Task Force Calls for ‘Integrative’ Treatment Plan
A Congressional task force stressed that non-opioid medications and non-pharmacologic therapies should be used as first-line treatment for pain management.
In a draft report released on Dec. 28, 2018, members of the Pain Management Best Practices Inter-Agency Task Force also recommended developing condition-specific guidelines that incorporate a “biopsychosocial model” of care, and emphasized the importance of careful evaluation of patients and proper risk assessment, particularly in light of the nation’s growing opioid crisis, in patients with chronic and acute pain.
“It is imperative to strike a balance between ensuring that patients with painful conditions can work with their health care providers to develop an integrative pain treatment plan that optimizes function, quality of life… and productivity while also ending the devastating effects of opioid misuse,” they stated.
The task force was established to identify “gaps and inconsistencies” in pain management as part of the Comprehensive Addiction and Recovery Act of 2016. The task force includes representatives from the Department of Health and Human Services (HHS), the Department of Veterans Affairs, the Department of Defense, and the Office of National Drug Control Policy.
Members of the public will have 90 days to provide comments on the proposed recommendations.
Around 47,600 people died from opioid overdoses in 2017, according to the CDC. In addition, there are 50 million adults affected by chronic pain, of which 19.6 million have “high-impact chronic pain” that can make work and daily activities a challenge, the report noted.
Mounting public awareness and government pressure has seen clinicians reducing the number of opioids prescriptions they give patients, the task force said. This heightened concern over inappropriate prescribing of opioids that has, in some cases, led to unintended consequences, including “patient abandonment,” “forced tapering,” and patients moving from prescription drugs to illicit drugs such as fentanyl and heroin, according to the report.
The authors recommended increasing the use of specific clinical practice guidelines (CPG) for individual diagnoses or causes of pain. They also called for increased access to effective pain management treatment, and for pain management to become a part of “routine training” for clinicians, particularly during residency.
Other recommendations include:
- Use non-opioid medications (acetaminophen, nonsteroidal anti-inflammatory drugs or NSAIDS) with non-pharmacologic treatments as first-line therapy in both in-patient and out-patient settings “whenever possible”
- Begin opioid therapy only when “benefits outweigh the risk” and follow evidence-based guidelines
- Use “procedure-specific, multimodal regimens and therapies” before, during, and after an operation including nonopioid medications, nerve blocks, analgesia, and psychological therapies to lessen opioid exposure
- Primary care clinicians and other non-pain specialists should collaborate early with pain specialists for patients with complex pain to mitigate complications
- Establish appropriate reimbursement to enable a “multi-modal approach” to address acute pain in the perioperative setting
- Establish guidelines for managing acute pain for common surgical procedures and trauma
The task force suggested that guidelines emphasize an individualized approach to treatment of acute pain “accounting for patient variability” with respect to comorbidities, severity, and other factors, and focus on improved pain control, quicker recovery, and earlier mobilization, while reducing risk of blood clots, pulmonary embolism, and excess opioid exposure.
They also called for clinician training on prescription drug monitoring programs (PDMP), noting that clinicians should discuss PDMP data with patients to avoid errors that could lead to inappropriate care.
The task force discussed the risks and benefits of non-opioid pharmacotherapies used for chronic pain, such as anticonvulsants and antidepressants, and touched on restorative therapies (physical therapy, occupational therapy). They pointed out that use of the latter is “often challenged by incomplete or inconsistent reimbursement policies.”
As for opioids, the report noted that “although effective for moderate to severe acute pain, the effectiveness of opioids beyond 3 months requires more evidence.” The authors called attention to a 2018 study in JAMA that found that opioid treatment on its own was “not superior” to treatment with different combinations of non-opioid therapies over 12 months. The JAMA study authors concluded that “This study does not support initiation of opioid therapy for moderate to severe chronic back pain or hip or knee osteoarthritis pain.”
The report cited the debate over establishing a “ceiling dose” for opioids — the CDC’s dose limit of 90 morphine milligram equivalents per day — but determined that “establishing such a ceiling is difficult, and the precise level for such a ceiling has not been established. The risk of overdose increases with the dose, but the therapeutic window is highly variable.”
The task force also echoed a 2018 recommendation from HHS and encouraged “take-home naloxone” for patients and family members when a patient is on long-term opioids.
The task force held two public meetings in 2018 to gather feedback from patients and stakeholders. It also reviewed patient testimonials, best practices, and explored “relevant medical and scientific literature” in addition to consulting with government and nongovernment experts in pain management.
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