Merck TIGIT drug misses goal in lung cancer trial, adding to doubts over approach
Bio Pharma Dive
MARCH 17, 2023
The combination drug didn’t help patients any more than chemotherapy, but Merck will continue the trial to test it together with chemo
Fri.Mar 17, 2023
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Tapping into digital therapeutics to improve neurological outcomes
Pharmaceutical Technology
MARCH 17, 2023
As the field of digital therapeutics continues to broaden, specific uses in mental health and neurology are increasingly making headway for patients and on the market.
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Sanofi joins other diabetes drugmakers in cutting insulin prices
Bio Pharma Dive
MARCH 17, 2023
The pharma is the last of the three major insulin suppliers to reduce U.S. list prices, responding to persistent criticism and policy changes that will affect Medicaid rebate payments
Pharmanovia signs licence deal for Aeterna Zentaris’ Ghryvelin
Pharmaceutical Technology
MARCH 17, 2023
Pharmanovia and Aeterna Zentaris have entered an exclusive licensing agreement for the latter’s medicine Ghryvelin (macimorelin). Under the deal, Pharmanovia will acquire the exclusive rights and license to commercialise Ghryvelin in the EEA and the UK from Consilient Health.
What the FDA's New Dosage Guidance Means for the Future of Clinical Research
Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist
This webinar will go over the FDA's guidance on pharmacological and toxicological considerations for optimizing doses for prescription drugs.
FDA reversal sets up high-stakes hearing on Sarepta gene therapy
Bio Pharma Dive
MARCH 17, 2023
The regulator will convene a panel of advisers to consult on an approval decision for the biotech’s Duchenne treatment, a change from just a few weeks ago when Sarepta had said a meeting wouldn’t be held
Risk sharing agreements soar as market access risk increases
Pharmaceutical Technology
MARCH 17, 2023
Over the last twenty years, there has been a major rise in risk sharing agreements in the pharmaceutical space, said Alex Watt, GlobalData’s principal research analyst, at a recent webinar on the same topic.
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LCRF, Daiichi Sankyo and AstraZeneca enter research collaboration
Pharmaceutical Technology
MARCH 17, 2023
The Lung Cancer Research Foundation (LCRF) has announced a new research partnership with Daiichi Sankyo and AstraZeneca. This collaboration is intended to fund up to three research grants that are focused on antibody-drug conjugates (ADCs) for improving the outcomes for lung cancer patients.
iOnctura reveals roginolisib research results
Pharma Times
MARCH 17, 2023
Therapy prevents tumour proliferation while breaking immune tolerance among cancer patients
US FDA approves Novartis’ Tafinlar and Mekinist combination therapy
Pharmaceutical Technology
MARCH 17, 2023
The US Food and Drug Administration (FDA) has granted approval for Novartis ’ combination therapy, Tafinlar (dabrafenib) and Mekinist (trametinib), to treat BRAF V600E low-grade glioma (LGG) in paediatric patients as young as one year.
Astellas, Pfizer look to broaden Xtandi’s patient base with new prostate cancer win after 8 years
Fierce Pharma
MARCH 17, 2023
Astellas, Pfizer look to broaden Xtandi’s patient base with new prostate cancer win after 8 years aliu Fri, 03/17/2023 - 10:22
2022 Research: The Rapid Rise of Ocean Freight Visibility
Advertiser: FourKites
Download this a benchmark study from FourKites and The Journal of Commerce exploring how international shippers’ usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19.
Great Ormond Street Hospital and Leucid Bio collaborate
Pharma Times
MARCH 17, 2023
GOSH will collaborate with Leucid at the Zayed Centre for Research into Rare Disease in Children
Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices
Fierce Pharma
MARCH 17, 2023
Sanofi answers the call, joining Eli Lilly, Novo Nordisk in cutting insulin prices kdunleavy Fri, 03/17/2023 - 09:07
FDA Finalizes the Definitions of “Suspect and Illegitimate” Pharma Products
Pharmaceutical Commerce
MARCH 17, 2023
Industry is still scrambling to handle clerical errors of DSCSA transactions.
Amgen cuts 450 workers, cites drug pricing pressure and inflation
Fierce Pharma
MARCH 17, 2023
Amgen cuts 450 workers, cites drug pricing pressure and inflation zbecker Fri, 03/17/2023 - 10:53
An Innovative & Creative Problem Solver Approach to Selling in the Medical Device Space
Speaker: Steve Goldstein, Sales Leader
Currently in sales or involved in a business that depends on strong sales results? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC. You will absorb critical strategies to become a trusted partner in greater sales success.
Using Pharmacovigilance Platforms to One’s Advantage
Pharmaceutical Commerce
MARCH 17, 2023
How these applications—combined with artificial intelligence, machine learning, and natural language processing—influence workflows.
AAD: AbbVie's Skyrizi clears psoriasis symptoms where Novartis' Cosentyx, Lilly's Taltz couldn't
Fierce Pharma
MARCH 17, 2023
AAD: AbbVie's Skyrizi clears psoriasis symptoms where Novartis' Cosentyx, Lilly's Taltz couldn't aliu Fri, 03/17/2023 - 16:54
It's Not All Bad News: Data Shows There's a Collaborative Future for 340B
Drug Channels
MARCH 17, 2023
Today’s guest post comes from Rhiannon Naslund, Chief Marketing Officer at Kalderos. Rhiannon discusses the growing collaboration between manufacturers and covered entities regarding 340B discount claims.
Alzheimer's Association campaigns for broader Leqembi coverage: report
Fierce Pharma
MARCH 17, 2023
Alzheimer's Association campaigns for broader Leqembi coverage: report fkansteiner Fri, 03/17/2023 - 10:20
Mandatory COVID Vaccination Policy Template
Advertiser: Aggregage
The federal government is developing a rule requiring employers with more than 100 employees ensure their workers are vaccinated or produce a negative COVID test weekly before entering the workplace. So, what can your organization do to prepare? Get Paycor’s COVID Vaccination Policy Template to help communicate important details to your employees.
Statement on the update of WHO’s working definitions and tracking system for SARS-CoV-2 variants of concern and variants of interest
The Pharma Data
MARCH 17, 2023
WHO has updated its tracking system and working definitions for variants of SARS-CoV-2, the virus that causes COVID-19, to better correspond to the current global variant landscape, to independently evaluate Omicron sublineages in circulation, and classify new variants more clearly when required. SARS-CoV-2 continues to evolve.
New patent expiration for Endo Ventures drug SUMAVEL DOSEPRO
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for SUMAVEL+DOSEPRO Sumavel Dosepro is a drug marketed by Endo Ventures Ltd and is included in one NDA. There are nine patents protecting this drug.
Merck Provides Update from Open-Label Arm of Phase 2 KeyVibe-002 Trial Evaluating MK-7684A, a Coformulation of Vibostolimab and Pembrolizumab, in Previously Treated Patients with Metastatic Non-Small Cell Lung Cancer (NSCLC)
The Pharma Data
MARCH 17, 2023
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today provided an update on the open-label arm of the non-registrational Phase 2 KeyVibe-002 trial.
New patent for Celator Pharms drug VYXEOS
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for VYXEOS Vyxeos is a drug marketed by Celator Pharms and is included in one NDA. It is available from one supplier. There are nine patents… The post New patent for Celator Pharms drug VYXEOS appeared first on DrugPatentWatch - Make Better Decisions. Patent Added
Sanofi cuts U.S. list price of Lantus®, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance
The Pharma Data
MARCH 17, 2023
Sanofi announces that it will cut the list price of Lantus (insulin glargine injection) 100 Units/mL, its most widely prescribed insulin in the U.S., by 78 percent. The company also will establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance, underscoring its longstanding commitment to offer affordable access to medicines.
New patent for Vertex Pharms drug SYMDEKO (COPACKAGED)
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for SYMDEKO+%28COPACKAGED%29 Symdeko (copackaged) is a drug marketed by Vertex Pharms Inc and is included in one NDA. It is available from one supplier.
FDA Advisory Committee Votes in Support of Favorable Benefit-Risk Profile for Pfizer’s PAXLOVID™
The Pharma Data
MARCH 17, 2023
The target Prescription Drug User Fee Act (PDUFA) action date for a decision by the FDA is May 2023 Pfizer Inc. NYSE: PFE) announced today that the U.S. Food and Drug Administration’s (FDA) Antimicrobial Drugs Advisory Committee (AMDAC) voted 16 to 1 that available data support the safety and effectiveness of PAXLOVID™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of mild-to-moderate COVID-19 in adult patients who are at high risk for progression to severe illness.
New patent for Axsome Malta drug SUNOSI
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for SUNOSI Sunosi is a drug marketed by Axsome Malta and is included in one NDA. It is available from two suppliers. There are ten patents… The post New patent for Axsome Malta drug SUNOSI appeared first on DrugPatentWatch - Make Better Decisions. Patent Added
FDA Authorizes Copenhagen Classic Snuff to be Marketed as a Modified Risk Tobacco Product
The Pharma Data
MARCH 17, 2023
Today, the U.S. Food and Drug Administration authorized U.S. Smokeless Tobacco Company’s Copenhagen Classic Snuff , a loose moist snuff smokeless tobacco product, to be marketed as a modified risk tobacco product (MRTP). Copenhagen’s moist snuff smokeless tobacco product is a pre-existing tobacco product that has been marketed in the U.S. for years without modified risk information.
New patent expiration for Takeda Pharms drug GATTEX KIT
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for GATTEX+KIT Gattex Kit is a drug marketed by Takeda Pharms Usa and is included in one NDA. It is available from one supplier. There are… The post New patent expiration for Takeda Pharms drug GATTEX KIT appeared first on DrugPatentWatch - Make Better Decisions.
Phase 3 Study Shows XTANDI® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer
The Pharma Data
MARCH 17, 2023
Pfizer Inc. NYSE: PFE) and Astellas Pharma Inc. TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., Astellas”) today announced positive topline results from the Phase 3 EMBARK trial evaluating XTANDI® (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC; also known as non-metastatic castration-sensitive prostate cancer or nmCSPC) with high-risk biochemical recurrence (BCR).
New patent for Dermavant Sci drug VTAMA
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for VTAMA Vtama is a drug marketed by Dermavant Sci and is included in one NDA. It is available from one supplier. There are four patents… The post New patent for Dermavant Sci drug VTAMA appeared first on DrugPatentWatch - Make Better Decisions. Patent Added
TREMFYA® (guselkumab) Real-World Data Analyses Show Greater Treatment Persistence Than IL-17s in Both Bio-naïve and Bio-experienced Patients Living With Moderate to Severe Plaque Psoriasis
The Pharma Data
MARCH 17, 2023
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data, showing that initiation of TREMFYA ® (guselkumab) was associated with greater treatment persistence a compared to secukinumab or ixekizumab in bio-naïve and bio-experienced patients b living with moderate to severe plaque psoriasis (PsO), based on pairwise analyses c of real-world data. [1]
New patent for Myovant Sciences drug ORGOVYX
Drug Patent Watch
MARCH 17, 2023
Annual Drug Patent Expirations for ORGOVYX Orgovyx is a drug marketed by Myovant Sciences and is included in one NDA. It is available from one supplier. There are six patents… The post New patent for Myovant Sciences drug ORGOVYX appeared first on DrugPatentWatch - Make Better Decisions.
Key alerts to setup on GCP violations during the clinical trial
Cloudbyz
MARCH 17, 2023
Good Clinical Practice (GCP) is an international standard that outlines ethical and scientific quality requirements for designing, conducting, recording, and reporting clinical trials involving human subjects.
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