Piperidines

Cara Therapeutics to Announce Second Quarter 2021 Financial Results on August 9, 2021

Retrieved on: 
Monday, August 2, 2021

ET to report second quarter 2021 financial results and provide a corporate update.

Key Points: 
  • ET to report second quarter 2021 financial results and provide a corporate update.
  • To participate in the conference call, please dial (855) 445-2816 (domestic) or (484) 756-4300 (international) and refer to conference ID 1568596.
  • Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral KORs.
  • CR845/difelikefalin is an investigational drug product and its safety and efficacy have not been fully evaluated by any regulatory authority.

Pacira Announces FDA Approval of Enhanced EXPAREL Manufacturing Process

Retrieved on: 
Monday, August 2, 2021

PARSIPPANY, N.J., Aug. 02, 2021 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the company’s enhanced manufacturing process for EXPAREL® (bupivacaine liposome injectable suspension) which is housed at a custom facility in Swindon, England under a partnership with Thermo Fisher Scientific Pharma Services. The company expects to start selling commercial product manufactured in this 200-liter suite later this year.

Key Points: 
  • This FDA approval underscores the quality assurance of our enhanced manufacturing process, which is essential as we scale the production of EXPAREL, said Dave Stack, chairman and chief executive officer of Pacira BioSciences.
  • The patent, Manufacturing of Bupivacaine Multivesicular Liposomes, claims composition of EXPAREL prepared by the improved manufacturing process and has an expiration date of January 22, 2041.Pacira submitted this patent for listing in the FDAs Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) in July 2021.
  • The companys long-acting local analgesic, EXPAREL (bupivacaine liposome injectable suspension) was commercially launched in the United States in April 2012.
  • EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AcelRx, Rocket, 360 DigiTech, and Piedmont Lithium and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 29, 2021

The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

Key Points: 
  • The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.
  • OnFebruary 16, 2021, AcelRx disclosed that, onFebruary 11, 2021, the Company received a warning letter from the FDA concerning promotional claims for DSUVIA.
  • For more information on the Piedmont Lithium class action go to: https://bespc.com/cases/PLL
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AcelRx, Ocugen, Tarena, and DraftKings and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 22, 2021

The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

Key Points: 
  • The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.
  • misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative.
  • For more information on the DraftKings class action go to: https://bespc.com/cases/DKNG
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

The New England Journal of Medicine Publishes Results from the Phase 3 HARMONY Study Evaluating Pimavanserin in Patients with Dementia-Related Psychosis

Retrieved on: 
Wednesday, July 21, 2021

Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo.

Key Points: 
  • Second, in the 26-week double-blind period, patients on pimavanserin had a nearly three-fold reduction of risk of psychosis relapse compared to patients on placebo.
  • We are very pleased that the New England Journal of Medicine has chosen to publish the important results of this study.
  • HARMONY was a Phase 3 study designed to evaluate the efficacy and safety of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis.
  • The HARMONY study included a 12-week, open-label stabilization period during which patients with dementia-related psychosis began treatment with pimavanserin 34 mg once daily.

Bereaved Parents Create Non-Profit to Combat Fentanyl Epidemic

Retrieved on: 
Sunday, July 18, 2021

Fentanyl, a cheap and powerful opioid, is the primary driver of the dramatic increase in drug deaths over the past year, according to the CDC .

Key Points: 
  • Fentanyl, a cheap and powerful opioid, is the primary driver of the dramatic increase in drug deaths over the past year, according to the CDC .
  • "Educating kids and families about the real dangers of fentanyl is just as important as monitoring platforms for drug activity.
  • In addition, Snap will also run a special episode of its award-winning news show, Good Luck America (GLA), devoted to the fentanyl epidemic and featuring an interview with Ed Ternan.
  • "We are honored to partner with Song for Charlie to educate young people on the dangers of counterfeit drugs and fentanyl poisoning.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AcelRx, Ocugen, Tarena, and DraftKings and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 15, 2021

The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

Key Points: 
  • The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.
  • misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative.
  • For more information on the DraftKings class action go to: https://bespc.com/cases/DKNG
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the Alzheimer’s Association International Conference 2021 (AAIC)

Retrieved on: 
Wednesday, July 14, 2021

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.
  • The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication.
  • In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors.
  • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components.

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AcelRx, Ocugen, Tarena, and DraftKings and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 8, 2021

The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

Key Points: 
  • The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.
  • misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative.
  • For more information on the DraftKings class action go to: https://bespc.com/cases/DKNG
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Neurana Pharmaceuticals Announces Publication in Pain Management

Retrieved on: 
Wednesday, July 7, 2021

SAN DIEGO, July 7, 2021 /PRNewswire/ -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced the publication of a manuscript, "RESUME-1: A Phase III Study of Tolperisone in Treatment of Painful, Acute Muscle Spasms of the Back" in the journal of "Pain Management".

Key Points: 
  • SAN DIEGO, July 7, 2021 /PRNewswire/ -- Neurana Pharmaceuticals, a biotechnology company focused on the treatment of neuromuscular conditions, today announced the publication of a manuscript, "RESUME-1: A Phase III Study of Tolperisone in Treatment of Painful, Acute Muscle Spasms of the Back" in the journal of "Pain Management".
  • The study is designed to evaluate the efficacy and safety of tolperisone administered in subjects with pain due to acute back muscle spasms.
  • Key secondary objectives include assessing the tolerability, onset of action, and need for rescue medication when treated with tolperisone.
  • Neurana Pharmaceuticals, Inc. is a privately held, clinical-stage, biotechnology company focused on the treatment of neuromuscular conditions, including acute, painful muscle spasms of the back.