Sat.Jun 19, 2021 - Fri.Jun 25, 2021

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New patent expiration for Teva Pharm drug AIRDUO RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+RESPICLICK Airduo Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from three suppliers. There are twenty-one…. The post New patent expiration for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 97
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Ethicon Expands Advanced Biopolar Energy Portfolio With Launch Of Enseal X1 Curved Jaw Tissue Sealer

The Pharma Data

Ethicon*, part of the Johnson & Johnson Medical Devices Companies,**today announced the launch of the ENSEAL X1 Curved Jaw Tissue Sealer, a new advanced bipolar energy device that increases procedural efficiency [1] and provided stronger sealing [2] and better access to more tissue than LigaSure Maryland. [3] The device is indicated for colorectal, gynecological, bariatric surgery and thoracic procedures.

Science 52
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Gross-to-Net Bubble Update: Net Prices Drop (Again) at Six Top Drugmakers (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for today’s live video webinar: Drug Channels Update: 340B Controversies and Outlook. More than 2,000 people have already registered. Click here to see the original post and comments from April 2021. Time for Drug Channels ' annual update on pricing at six of the largest pharmaceutical manufacturers—Eli Lilly, GlaxoSmithKline, Janssen, Merck, Novartis, and Sanofi.

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New patent expiration for Teva Pharm drug ARMONAIR RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for ARMONAIR+RESPICLICK Armonair Respiclick is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are nineteen…. The post New patent expiration for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 95
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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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New patent expiration for Duchesnay drug DICLEGIS

Drug Patent Watch

Annual Drug Patent Expirations for DICLEGIS Diclegis is a drug marketed by Duchesnay and is included in one NDA. It is available from three suppliers. There is one patent protecting…. The post New patent expiration for Duchesnay drug DICLEGIS appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 92
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New patent expiration for Teva Branded drug PROAIR RESPICLICK

Drug Patent Watch

Annual Drug Patent Expirations for PROAIR+RESPICLICK Proair Respiclick is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are…. The post New patent expiration for Teva Branded drug PROAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Galderma Labs drug SOOLANTRA

Drug Patent Watch

Annual Drug Patent Expirations for SOOLANTRA Soolantra is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from three suppliers. There are eleven…. The post New patent for Galderma Labs drug SOOLANTRA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 59
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New patent for Global Blood drug OXBRYTA

Drug Patent Watch

Annual Drug Patent Expirations for OXBRYTA Oxbryta is a drug marketed by Global Blood Theraps and is included in one NDA. There are eight patents protecting this drug. This drug…. The post New patent for Global Blood drug OXBRYTA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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Merck’s KEYTRUDA® (pembrolizumab) Given After Surgery Reduced the Risk of Disease Recurrence or Death by 32% Versus Placebo as Adjuvant Therapy in Patients With Renal Cell Carcinoma (RCC)

The Pharma Data

KEYNOTE-564 is the First Phase 3 Study to Show Positive Results for Adjuvant Immunotherapy in RCC. First-Time Disease-Free Survival Data to be Presented During Plenary Session at the 2021 ASCO Annual Meeting. KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced first-time results from the pivotal Phase 3 KEYNOTE-564 trial evaluating KEYTRUDA, Merck’s anti-PD-1 therapy, for the potential adjuvant treatment of patients

Disease 52
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First Patient Dosed in Phase 3 Systemic Lupus Erythematosus Study

The Pharma Data

Global Phase 3 TOPAZ-1 study will evaluate the efficacy and safety of BIIB059, as compared to placebo, in active systemic lupus erythematosus (SLE) , a debilitating autoimmune disease which has limited treatment options Positive Phase 2 LILAC study efficacy results support the further evaluation of BIIB059 in SLE. Biogen today announced that the first patient has been dosed in the global clinical study, TOPAZ-1.

Disease 52
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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Biogen to Participate in SVB Leerink’s 3rd Annual CNS Forum

The Pharma Data

Biogen Inc. (Nasdaq: BIIB) announced today that it will participate in SVB Leerink’s 3 rd Annual CNS Forum. The webcast will be live on Tuesday, June 29, at 1:50 p.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available following the presentation.

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Biogen and Eisai Update for the Alzheimer’s Disease Community

The Pharma Data

Biogen (Nasdaq: BIIB) and Eisai Inc. , U.S. subsidiary of Eisai Co., Ltd. today issued the following statement: On June 7, 2021, ADUHELM (aducanumab-avwa) 100 mg/mL solution for injection was granted accelerated approval by the U.S. Food and Drug Administration (FDA). We are committed to responding to questions from the Alzheimer’s disease community and providing more details about our plans.

Disease 52
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PFIZER AND BIONTECH TO SUPPLY THE EUROPEAN UNION WITH UP TO 1.8 BILLION ADDITIONAL DOSES OF COMIRNATY

The Pharma Data

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced a new agreement with the European Commission (EC) to supply 900 million doses of COMIRNATY ® , the companies’ COVID-19 vaccine, to the European Union (EU), with an option for the EC to request up to an additional 900 million doses. This press release features multimedia. View the full release here: [link].

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COADMINISTRATION OF ITS 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE

The Pharma Data

today announced that the first enrolled subjects have received their immunizations as part of a new study in adults ages 65 or older exploring the coadministration of the company’s 20-valent pneumococcal conjugate vaccine (20vPnC) candidate following a booster dose of the Pfizer-BioNTech COVID-19 Vaccine, currently authorized by the Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA).

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Clinical Data Like You´ve Never Seen It Before: Why Spotfire Is the Leading Tool for Clinical Analytics

Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic

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FIRST AUTHORIZATION IN EUROPEAN UNION FOR COVID-19 VACCINE IN ADOLESCENTS

The Pharma Data

today announced that the Conditional Marketing Authorization (CMA) for COMIRNATY ® in the European Union (EU) has been expanded to include individuals 12 to 15 years of age. This follows the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion to authorize the vaccine in this age group. The extended indication for the CMA for COMIRNATY is valid in all 27 EU member states.

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First Participant Dosed in Pfizer’s Pivotal Phase 3 TALAPRO-3 Combination Study of Talazoparib and Enzalutamide in Metastatic Castration-Sensitive Prostate Cancer (mCSPC)

The Pharma Data

today announced that the first participant has been dosed in TALAPRO-3, a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial. The study will evaluate the efficacy and safety of talazoparib, an oral poly (ADP-ribose) polymerase (PARP) inhibitor, in combination with enzalutamide, an androgen receptor inhibitor, compared with placebo plus enzalutamide in men with DNA damage response (DDR)-deficient metastatic castration-sensitive prostate cancer (mCSPC).

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New patent expiration for Kowa Co drug LIVALO

Drug Patent Watch

Annual Drug Patent Expirations for LIVALO Livalo is a drug marketed by Kowa Co and is included in one NDA. It is available from one supplier. There are three patents…. The post New patent expiration for Kowa Co drug LIVALO appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Celgene Intl drug ZEPOSIA

Drug Patent Watch

Annual Drug Patent Expirations for ZEPOSIA Zeposia is a drug marketed by Celgene Intl and is included in one NDA. It is available from one supplier. There are three patents…. The post New patent for Celgene Intl drug ZEPOSIA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Teva Pharm drug AIRDUO DIGIHALER

Drug Patent Watch

Annual Drug Patent Expirations for AIRDUO+DIGIHALER Airduo Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from three suppliers. There are twenty-five…. The post New patent expiration for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Teva Branded drug PROAIR DIGIHALER

Drug Patent Watch

Annual Drug Patent Expirations for PROAIR+DIGIHALER Proair Digihaler is a drug marketed by Teva Branded Pharm and is included in one NDA. It is available from two suppliers. There are…. The post New patent expiration for Teva Branded drug PROAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Orexo Us drug ZUBSOLV

Drug Patent Watch

Annual Drug Patent Expirations for ZUBSOLV Zubsolv is a drug marketed by Orexo Us Inc and is included in one NDA. It is available from one supplier. There are seven…. The post New patent for Orexo Us drug ZUBSOLV appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Astrazeneca drug TUDORZA PRESSAIR

Drug Patent Watch

Annual Drug Patent Expirations for TUDORZA+PRESSAIR Tudorza Pressair is a drug marketed by Astrazeneca and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent for Astrazeneca drug TUDORZA PRESSAIR appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Teva Pharm drug ARMONAIR DIGIHALER

Drug Patent Watch

Annual Drug Patent Expirations for ARMONAIR+DIGIHALER Armonair Digihaler is a drug marketed by Teva Pharm and is included in one NDA. It is available from one supplier. There are twenty-one…. The post New patent expiration for Teva Pharm drug ARMONAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Gilead Sciences drug VOSEVI

Drug Patent Watch

Annual Drug Patent Expirations for VOSEVI Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. It is available from one supplier. There are seventeen…. The post New patent for Gilead Sciences drug VOSEVI appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Galderma Labs drug AKLIEF

Drug Patent Watch

Annual Drug Patent Expirations for AKLIEF Aklief is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from one supplier. There are four…. The post New patent for Galderma Labs drug AKLIEF appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent for Actelion drug OPSUMIT

Drug Patent Watch

Annual Drug Patent Expirations for OPSUMIT Opsumit is a drug marketed by Actelion and is included in one NDA. It is available from one supplier. There are four patents protecting…. The post New patent for Actelion drug OPSUMIT appeared first on DrugPatentWatch - Make Better Decisions.

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New patent for Collegium Pharm drug NUCYNTA ER

Drug Patent Watch

Annual Drug Patent Expirations for NUCYNTA+ER Nucynta Er is a drug marketed by Collegium Pharm Inc and is included in one NDA. It is available from two suppliers. There are…. The post New patent for Collegium Pharm drug NUCYNTA ER appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Mylan Speclt drug PERFOROMIST

Drug Patent Watch

Annual Drug Patent Expirations for PERFOROMIST Perforomist is a drug marketed by Mylan Speclt and is included in one NDA. It is available from one supplier. There are six patents…. The post New patent expiration for Mylan Speclt drug PERFOROMIST appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Sunovion drug BROVANA

Drug Patent Watch

Annual Drug Patent Expirations for BROVANA Brovana is a drug marketed by Sunovion and is included in one NDA. It is available from two suppliers. There are eleven patents protecting…. The post New patent expiration for Sunovion drug BROVANA appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Cppi Cv drug SUTENT

Drug Patent Watch

Annual Drug Patent Expirations for SUTENT Sutent is a drug marketed by Cppi Cv and is included in one NDA. It is available from two suppliers. There are three patents…. The post New patent expiration for Cppi Cv drug SUTENT appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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New patent expiration for Takeda Pharms drug INTUNIV

Drug Patent Watch

Annual Drug Patent Expirations for INTUNIV Intuniv is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are two…. The post New patent expiration for Takeda Pharms drug INTUNIV appeared first on DrugPatentWatch - Make Better Decisions.

Drugs 52
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EISAI and Biogen Inc. Announce U.S. FDA Grants Breakthrough Therapy Designation for LECANEMAB (BAN2401), an Anti-Amyloid Beta Protofibril Antibody for the Treatment of Alzheimer’s Disease

The Pharma Data

Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) and Biogen Inc. (Nasdaq: BIIB, Corporate headquarters: Cambridge, Massachusetts, CEO: Michel Vounatsos, “Biogen”) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (A?

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The Top 15 U.S. Pharmacies of 2020: Market Shares and Revenues at the Biggest Companies (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Update: 340B Controversies and Outlook. Click here to see the original post and comments from March 2021. Next week, Drug Channels Institute will release our 2021 Economic Report on U.S. Pharmacies and Pharmacy Benefit Managers. It’s the 12th edition of our popular and comprehensive examination of the entire drug pricing, reimbursement, and dispensing system.

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How GoodRx’s Rapid Growth Creates Conflict between PBMs and Payers (rerun)

Drug Channels

This week, I’m rerunning some popular posts while I prepare for this Friday’s live video webinar: Drug Channels Update: 340B Controversies and Outlook. Click here to see the original post and comments from March 2021. Pharmacy pricing and benefit design are fundamentally broken. For proof, look at GoodRx’s 2020 financial results for its discount card business.