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Acorda Therapeutics Announces Launch of New INBRIJA® Campaign: “For The Fighters™”

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星期三, 八月 2, 2023

Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has launched a new INBRIJA (levodopa inhalation powder) website and brand campaign.

Key Points: 
  • Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that it has launched a new INBRIJA (levodopa inhalation powder) website and brand campaign.
  • INBRIJA is not to be used by people who have taken a nonselective monoamine oxidase inhibitor, such as phenelzine or tranylcypromine, within the last 2 weeks.
  • I’m determined to make every day, every moment, count, and to live a full life with my family and friends.
  • The most common side effects of INBRIJA are cough, upper respiratory tract infection, nausea, and change in the color of saliva or spit.

Amneal Submits Abbreviated New Drug Applications to U.S. FDA for Three Key Complex Generics

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星期三, 七月 26, 2023

The filing of applications for three new complex generics are additional proof points in our successful innovation journey.

Key Points: 
  • The filing of applications for three new complex generics are additional proof points in our successful innovation journey.
  • Today, about 90% of our generics R&D pipeline is made up of complex products.
  • Injectable propofol emulsion, the generic version of Diprivan®, is an IV general anesthetic and sedation drug.
  • Amneal plans to manufacture propofol emulsion internally by leveraging the Company’s global injectables infrastructure.

Cipla Issues Voluntary Nationwide Recall of Six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to Container Defect

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星期五, 七月 7, 2023

There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.

Key Points: 
  • There were no adverse events reported for Albuterol Sulfate Inhalation Aerosol 90 mcg related to this recall.
  • Out of an abundance of precaution, the above mentioned 6 batches manufactured using the same lot of valves are being recalled.
  • Cipla is notifying its distributors and customers by letter and is arranging for return and replacement of all recalled products.
  • Cipla conducts regular investigation and assessment by committees consisting of subject-matter experts, quality management, and medical safety experts.

Phil and Teva Pharmaceuticals Launch New Program to Improve Access to the Digihaler® Family of Inhalers to Support Asthma Management

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星期二, 六月 6, 2023

The goal of Phil and Teva Pharmaceuticals’ partnership is to help enable patients to receive and refill their Digihaler medication quickly, easily and affordably.

Key Points: 
  • The goal of Phil and Teva Pharmaceuticals’ partnership is to help enable patients to receive and refill their Digihaler medication quickly, easily and affordably.
  • Using the PhilRx Patient Access Platform, patients can fill their prescription, review prescription records and obtain assistance navigating insurance benefits.
  • The PhilRx Patient Access Platform provides end-to-end visibility into the entire prescription life cycle, starting when the physician writes the prescription.
  • Physicians can select the PhilRx Patient Access Platform directly from an electronic medical record (EMR) to submit a prescription for a Digihaler product.

Y-mAbs Announces Presentation of Naxitamab Data at ASCO

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星期五, 五月 26, 2023

The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow.

Key Points: 
  • The ongoing Phase 2 Trial 201 (NCT03363373) evaluates naxitamab in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”) in patients with relapsed or refractory HR-NB with residual disease limited to bone and/or bone marrow.
  • Curie Score (“CS”) is a semi-quantitative scoring system used to assess the extent of bone metastases and treatment response.
  • An interim analysis of Trial 201 (data cutoff December 31, 2021) included 52 patients in the efficacy group and 74 patients in the safety group.
  • Patients with refractory disease had a lower frequency of serious naxitamab related adverse events compared to patients with relapsed disease.

Evoke Pharma Strengthens its Intellectual Property Portfolio with a Notice of Allowance from the USPTO for a Patent Application Related to GIMOTI®

Retrieved on: 
星期三, 十一月 30, 2022

This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.

Key Points: 
  • This patent application is a continuation of several other U.S. patent applications filed by the company over the last decade.
  • We are thrilled and highly encouraged by the strides we have made with the USPTO and its continued acknowledgement of the novel and inventive nature of GIMOTI, said Matt DOnofrio, Chief Business Officer of Evoke Pharma.
  • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.
  • Call your doctor for medical advice about whether you should take GIMOTI and the possible risk factors and side effects.

Evoke Pharma to Participate in the 2022 American College of Gastroenterology Annual Scientific Meeting

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星期四, 十月 20, 2022

SOLANA BEACH, Calif., Oct. 20, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases, today announced that the Company will participate in the 2022 American College of Gastroenterology Annual Scientific Meeting taking place from October 21 – 26, 2022 in Charlotte, North Carolina. Also, as a nominee for the Healio Industry Breakthrough Product Award, Evoke will attend the Healio Disruptive Innovators Awards Program on Sunday, October 23rd, in Charlotte during the ACG meeting.

Key Points: 
  • FollowEvoke Pharmaon Facebook: https://www.facebook.com/Evoke-Pharma-Inc-131313647029724
    FollowEvoke Pharmaon LinkedIn: https://www.linkedin.com/company/evoke-pharma/
    GIMOTI is indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis.
  • Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements.
  • The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved.
  • This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Aquestive Therapeutics Announces Positive EPIPHAST II Trial Data for AQST-109 When Compared to EpiPen®

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星期二, 九月 27, 2022

In comparison, the epi 0.3mg IM injection Cmax was 489 pg/mL after one dose and 911 pg/mL after two doses.

Key Points: 
  • In comparison, the epi 0.3mg IM injection Cmax was 489 pg/mL after one dose and 911 pg/mL after two doses.
  • After one dose of AQST-109, maximum mean effects on systolic blood pressure occurred within 5 minutes of dosing compared to 8 minutes for EpiPen.
  • Maximum mean effects in heart rate occurred within 8 minutes of administering AQST-109 compared to an average of 5 minutes within administering EpiPen.
  • PharmFilm, Sympazan and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other registered trademarks referenced herein are the property of their respective owners.

GIMOTI Receives Nomination for 2022 Healio Industry Breakthrough Award

Retrieved on: 
星期三, 九月 14, 2022

SOLANA BEACH, Calif., Sept. 14, 2022 (GLOBE NEWSWIRE) -- Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company focused primarily on treatments for gastrointestinal (GI) diseases with an emphasis on GIMOTI® (metoclopramide) nasal spray, today announced that its flagship product, GIMOTI has been nominated for Healio’s Annual Disruptive Innovators Awards under the Healio Industry Breakthrough Award category. GIMOTI was selected amongst other novel gastroenterology products from major pharmaceutical companies.

Key Points: 
  • The Disruptive Innovators Awards hosted by Healio is an annual event to celebrate the trailblazers, movers, and industry name-makers that are creating a revolution in gastroenterology.
  • "We are extremely honored to receive the nomination for GIMOTI as a Healio Disruptive Innovator.
  • We look forward to the Healio organization's unveiling of the award winners in each category and encourage all Evoke supporters to access the Healio survey and vote for GIMOTI."
  • Most common adverse reactions (5%) for GIMOTI are: dysgeusia, headache, and fatigue.These are not all of the possible side effects of GIMOTI.