Methylphenidate

Tris Pharma Announces US District Court Upholds Validity of QuilliChew ER® Patents; Rules Teva Infringes Tris Patents

Retrieved on: 
Thursday, August 18, 2022
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The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio providing exclusivity until August 2033.

Key Points: 
  • The ruling prevents Teva from launching generic versions of QuilliChew ER until the expiration of Tris's patent portfolio providing exclusivity until August 2033.
  • "The decision of the District Court not only confirms the validity and infringement of our QuilliChew ER patents, but also validates the innovative nature of our LiquiXRtechnology which we utilized to develop QuilliChew ER and our other branded ADHD medications."
  • QuilliChew ER is approved for treatment of ADHD in people 6 years and older.
  • Call the doctor right away if any signs of unexplained wounds appear on fingers or toes while taking QuilliChew ER.

Gravity Branding names Novartis’ Vijoice® (alpelisib)

Retrieved on: 
Monday, August 8, 2022
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SAN FRANCISCO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Gravity Branding, the agency behind naming blockbuster drugs including Novartis Kisqali (ribociclib), Genentechs Herceptin (trastuzumab) and Janssens Concerta (methylphenidate HCl), recently announced its success naming Vijoice (alpelisib), a Novartis drug to combat PIK3CA-Related Overgrowth Spectrum (PROS).

Key Points: 
  • SAN FRANCISCO, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Gravity Branding, the agency behind naming blockbuster drugs including Novartis Kisqali (ribociclib), Genentechs Herceptin (trastuzumab) and Janssens Concerta (methylphenidate HCl), recently announced its success naming Vijoice (alpelisib), a Novartis drug to combat PIK3CA-Related Overgrowth Spectrum (PROS).
  • Weve enjoyed a highly collaborative, productive working relationship with the Novartis team over many years on a wide range of projects, said Edward Saenz, Managing Director, Gravity Branding.
  • For naming Vijoice, as with other initiatives, we employed our proven Brand Bullseye process, which helps teams align around a singular expression of brand value.
  • In addition to Gravitys pharmaceutical naming experience, the agency works alongside Novartis and its technology partners on branding ground-breaking digital therapeutics.

Tris Pharma announces U.S. Court of Appeals for the Federal Circuit Affirms Validity of Quillivant XR® Patents; Rules Teva Infringes Tris Patents

Retrieved on: 
Wednesday, July 20, 2022
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"We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.

Key Points: 
  • "We are very pleased with the ruling of the CAFC, which affirms the strength of our patents protecting Quillivant XR.
  • You and your doctor should decide if you will take Quillivant XR or breastfeed
    What should I avoid while taking Quillivant XR?
  • Quillivant XR should not be taken with MAOI medicines or if you stopped taking an MAOI in the last 14 days.
  • Quillivant XR may cause serious side effects, including:
    Other serious side effects include:
    Painful and prolonged erections (priapism) have occurred with methylphenidate.

Brand Institute Partners on Brand Name Development for FDA Approved Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Retrieved on: 
Monday, July 11, 2022
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MIAMI, July 11, 2022 /PRNewswire/ -- Brand Institute is proud to announce its work with Osmotica Pharmaceuticals in developing the brand name RELEXXII.

Key Points: 
  • MIAMI, July 11, 2022 /PRNewswire/ -- Brand Institute is proud to announce its work with Osmotica Pharmaceuticals in developing the brand name RELEXXII.
  • RELEXXII (methylphenidate hydrochloride extended-release tablets) is an oral medication indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults up to the age of 65 and pediatric patients 6 years of age and older.
  • "The entire Brand Institute and Drug Safety Institute team congratulates Osmotica Pharmaceuticals on the FDA approval for RELEXXII," said Brand Institute's Chairman and C.E.O., James L. Dettore.
  • The company partners on over 75% of pharmaceutical brand and nonproprietary name approvals globally every year with healthcare manufacturers.

Methylphenidate Hydrochloride (CAS 298-59-9) Global Market Research Report 2022: Trends and Developments, Prices, Patents, Manufacturing Methods, Major Players, Applications, Key Downstream Industries - ResearchAndMarkets.com

Retrieved on: 
Tuesday, July 5, 2022
Health, Pharmaceutical, CAS, Methylphenidate, Industry, Generic drug

The "Methylphenidate hydrochloride (CAS 298-59-9) Global Market Research Report 2022" report has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Methylphenidate hydrochloride (CAS 298-59-9) Global Market Research Report 2022" report has been added to ResearchAndMarkets.com's offering.
  • This global report is a result of industry experts' diligent work on researching the world market of Methylphenidate hydrochloride.
  • The report helps to build up a clear view of the market trends and development, identify major players in the industry, and estimate main downstream sectors.
  • The Methylphenidate hydrochloride global market report key points:

TELUS Health releases annual Health Drug Data Trends Report 2022: Pandemic side effects include rise in medications for depression and ADHD

Retrieved on: 
Wednesday, June 22, 2022
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The report shows a noticeable increase in ADHD medication and antidepressants in 2021.

Key Points: 
  • The report shows a noticeable increase in ADHD medication and antidepressants in 2021.
  • With work-from-home and hybrid workstyles now the norm, it is clear that the pandemic created unique challenges for Canadians, impacting both their mental and physical health, said Shawn OBrien, Principal, Data Enablement and HBM Product, TELUS Health.
  • Five years ago, medications like Vyvanse and Concerta, used to treat neurodivergent-related disorders such as ADHD and narcolepsy, ranked 10th, while in 2021, these medications surpassed cancer medications.
  • TELUS Health is a leader in digital health technology, providing virtual care, home health monitoring, electronic medical and health records, benefits and pharmacy management, and personal emergency response services.

Vallon Pharmaceuticals Reports First Quarter 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Monday, May 9, 2022
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PHILADELPHIA, PA, May 09, 2022 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (Vallon or the Company), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today reported its financial results for the quarter ended March 31, 2022 and provided a corporate update.

Key Points: 
  • PHILADELPHIA, PA, May 09, 2022 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (Vallon or the Company), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today reported its financial results for the quarter ended March 31, 2022 and provided a corporate update.
  • The first quarter of this year proved to be challenging for Vallon with the unexpected, disappointing topline results from our pivotal SEAL study evaluating ADAIR.
  • This process is now underway, and we plan to identify the best pathway forward for Vallon in order to build shareholder value in the near and long term.
  • In March 2022, the Company reported topline results from its SEAL study (Study to Evaluate the Abuse Liability, Pharmacokinetics, Safety and Tolerability of an Abuse-Deterrent d-Amphetamine Sulfate Immediate Release Formulation).

Societal CDMO Signs Three-Year Manufacturing and Supply Agreement With InfectoPharm for Ritalin LA® in Europe

Retrieved on: 
Thursday, May 5, 2022
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SAN DIEGO, and GAINESVILLE, Ga., May 05, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (Societal CDMO or Societal; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has entered into a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) in Europe.

Key Points: 
  • SAN DIEGO, and GAINESVILLE, Ga., May 05, 2022 (GLOBE NEWSWIRE) -- Societal CDMO, Inc. (Societal CDMO or Societal; NASD: SCTL ), a contract development and manufacturing organization (CDMO) dedicated to solving complex formulation and manufacturing challenges primarily in small molecule therapeutic development, today announced that it has entered into a three-year manufacturing and supply agreement with InfectoPharm for Ritalin LA capsules (methylphenidate hydrochloride extended-release capsules) in Europe.
  • The new agreement, which is effective immediately and runs through April 2025, establishes Societal as the exclusive supplier of Ritalin LA capsules for the European market through 2023.
  • Novartis recently divested European rights to Ritalin LA capsules to InfectoPharm and this newly signed agreement serves to maintain Societal s role as the exclusive supplier of Ritalin LA capsules in Europe.
  • Societals exclusive Manufacturing and Supply Agreement with Novartis for Ritalin LA and Focalin XR capsules for the remainder of the world remains unchanged and continues through 2023.

Vallon Pharmaceuticals Announces Review of Strategic Alternatives

Retrieved on: 
Friday, April 22, 2022
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Ladenburg has been engaged to advise Vallon on the strategic review process, which could include, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets.

Key Points: 
  • Ladenburg has been engaged to advise Vallon on the strategic review process, which could include, without limitation, exploring the potential for a possible merger, business combination, investment into the Company, or a purchase, license or other acquisition of assets.
  • Thompson Hine LLP serves as Vallons legal counsel and will assist with the exploration of alternatives.
  • In the meantime, and in conjunction with the exploration of strategic alternatives, the Company is streamlining its operations in order to preserve its capital and cash resources.
  • Vallon Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company, headquartered in Philadelphia, PA.

Vallon Pharmaceuticals Reports Fiscal Year 2021 Financial Results and Provides Business Update

Retrieved on: 
Monday, February 14, 2022
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PHILADELPHIA, PA, Feb. 14, 2022 (GLOBE NEWSWIRE) -- Vallon Pharmaceuticals, Inc. (NASDAQ: VLON), (“Vallon” or the “Company”), a clinical-stage biopharmaceutical company primarily focused on the development of novel drugs that are designed to deter abuse in the treatment of central nervous system (CNS) disorders, today reported its financial results for the fiscal year ended December 31, 2021.

Key Points: 
  • Additionally, we continue to make progress with our second development program, ADMIR, and we expect to commence a first-in-human study this year.
  • Net loss was $9.3 million and $4.8 million for the fiscal years ended December 31, 2021 and 2020, respectively.
  • Research and development expenses were $5.2 million and $3.7 million for the fiscal years ended December 31, 2021, and 2020, respectively.
  • General and administrative expenses were $4.1 million and $1.2 million for the fiscal years ended December 31, 2021, and 2020, respectively.