Drug Discovery Today
APRIL 14, 2022
Discovery Park, based at Sandwich in Kent, has become the first Life Science and Innovation Campus to join the Industrial Biotechnology Innovation Centre (IBioIC), further cementing its ambition to become a centre of excellence.
Drug Channels
APRIL 12, 2022
The econowonks at the Centers for Medicare & Medicaid Services (CMS) recently released the latest projections for U.S. spending on healthcare. (See links below.) These data provide our first official look at post-pandemic U.S. healthcare spending. As you will see below, outpatient prescription drugs dispensed by retail and mail pharmacies are projected to remain a small share (8.4%) of total U.S. healthcare spending.
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Drug Patent Watch
APRIL 14, 2022
Annual Drug Patent Expirations for ARISTADA Aristada is a drug marketed by Alkermes Inc and is included in two NDAs. It is available from one supplier. There are fifteen patents…. The post New patent for Alkermes Inc drug ARISTADA appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
APRIL 15, 2022
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test that detects chemical compounds in breath samples associated with a SARS-CoV-2 infection. The test can be performed in environments where the patient specimen is both collected and analyzed, such as doctor’s offices, hospitals and mobile testing sites, using an instrument about the size of a piece of carry-on luggage.
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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.
Drug Discovery Today
APRIL 14, 2022
April 7, 2022, VectorBuilder Inc. – a global leader in gene delivery solutions – has announced the construction of a new R&D and manufacturing center in Guangzhou, China. The ‘Gene Delivery Research and Manufacturing Campus’ will significantly expand VectorBuilder’s R&D capabilities and its production capacity for both research-use and cGMP-grade gene delivery vectors, allowing the company to continue supporting groundbreaking research worldwide.
Drug Channels
APRIL 15, 2022
Today’s guest post comes from Megan Marchal, Director of Specialty Pharmacy Strategy at CoverMyMeds. Megan discusses the access and affordability challenges faced by specialty therapy patients. She describes how CoverMyMeds’ centralized technology solutions—paired with experts familiar with each therapy—help patients navigate these challenges. And, she shares one patient’s personal journey.
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
The Pharma Data
APRIL 15, 2022
A new protein-based antiviral nasal spray developed by researchers at Northwestern University, University of Washington and Washington University at St. Louis is being advanced toward Phase I human clinical trials to treat COVID-19. Designed computationally and refined in the laboratory, the new protein therapies thwarted infection by interfering with the virus’ ability to enter cells.
Antidote
APRIL 15, 2022
Is it possible to be creative in clinical trial advertising while following FDA guidelines , social media ad rules, and additional IRB constraints? You can create compelling ads without breaking the rules if you take the time to strategize.
Drug Channels
APRIL 11, 2022
Informa Connect's Life Sciences Commercial Contracts & Chargebacks 2022 Hybrid. May 24-25, 2022 | Philadelphia, PA www.informaconnect.com/contracts-chargebacks. Save 10% by using code 22DC10. The Life Sciences Commercial Contracts and Chargebacks conference returns as a hybrid event May 24-25 with the options of attending in-person in Philadelphia or virtually.
Drug Patent Watch
APRIL 15, 2022
Annual Drug Patent Expirations for RINVOQ Rinvoq is a drug marketed by Abbvie Inc and is included in one NDA. It is available from one supplier. There are fourteen patents…. The post New patent for Abbvie Inc drug RINVOQ appeared first on DrugPatentWatch - Make Better Decisions.
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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.
The Pharma Data
APRIL 15, 2022
GlaxoSmithKline plc (LSE/NYSE: GSK) and Sierra Oncology, Inc (Nasdaq: SRRA) announced that the companies have entered into an agreement under which GSK will acquire Sierra Oncology, a California-based, late-stage biopharmaceutical company focused on targeted therapies for the treatment of rare forms of cancer, for $55 per share of common stock in cash representing an approximate total equity value of $1.9 billion (£1.5 billion).
Antidote
APRIL 13, 2022
We’re excited to share new ways that partners in our network are moving the research and advocacy fronts forward. BrightFocus Foundation funds exceptional scientific research worldwide to defeat Alzheimer’s disease, macular degeneration, and glaucoma. They recently started a live-streaming talk show, Brain Info Live , as part of their mission to provide expert information on Alzheimer’s disease and related dementias and overall brain health.
Eye on FDA
APRIL 13, 2022
We are four months into the year, and this week OPDP has issued its fourth regulatory action letter of 2022. Two of the previous were Warning Letters, considered the more serious of the two categories, and two, including the latest, were Untitled Letters. As noted in past updates, FDA’s OPDP enforcement letters have dropped off considerably over the years.
Drug Patent Watch
APRIL 14, 2022
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 four suppliers. There are twenty-two…. The post New patent for Teva Pharm drug AIRDUO DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
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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
The Pharma Data
APRIL 15, 2022
Data from a subanalysis of 30 sera from a Phase 2/3 clinical trial of children 5 through 11 years of age show a 36-fold increase in SARS-CoV-2 Omicron neutralizing titers following a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine In the Phase 2/3 clinical trial with 140 children a booster (third) dose of the Pfizer-BioNTech COVID-19 Vaccine increased neutralizing antibodies by 6-fold against the SARS-CoV-2 wild-type strain in this age group Companies plan to submit these data to U.
Drug & Device Law
APRIL 13, 2022
Bostic v. Ethicon, Inc. , 2022 WL 952129 (E.D. Pa. March 29, 2022), is a Pennsylvania mesh case raising a host of familiar issues in a motion to dismiss context. The complaint is of the typically overpleaded (14-count) variety. Dickens was not really paid by the word, but plaintiff lawyers seem to think they might be. Or perhaps they hope that if enough counts make it to the jury, compromise or charity might result in throwing a bone the plaintiff’s way.
Drug Patent Watch
APRIL 14, 2022
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 four suppliers. There are sixteen…. The post New patent for Teva Pharm drug AIRDUO RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 14, 2022
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 thirteen…. The post New patent for Teva Pharm drug ARMONAIR RESPICLICK appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 14, 2022
Annual Drug Patent Expirations for ARISTADA+INITIO+KIT Aristada Initio Kit is a drug marketed by Alkermes Inc and is included in one NDA. It is available from one supplier. There are…. The post New patent for Alkermes Inc drug ARISTADA INITIO KIT appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 14, 2022
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 nineteen…. The post New patent for Teva Pharm drug ARMONAIR DIGIHALER appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 14, 2022
Annual Drug Patent Expirations for VIZIMPRO Vizimpro is a drug marketed by Pfizer and is included in one NDA. It is available from two suppliers. There are two patents protecting…. The post New patent for Pfizer drug VIZIMPRO appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 13, 2022
Annual Drug Patent Expirations for MEKTOVI Mektovi is a drug marketed by Array Biopharma Inc and is included in one NDA. It is available from one supplier. There are eleven…. The post New patent for Array Biopharma drug MEKTOVI appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 13, 2022
Annual Drug Patent Expirations for CABOMETYX Cabometyx is a drug marketed by Exelixis Inc and is included in one NDA. It is available from one supplier. There are ten patents…. The post New patent for Exelixis Inc drug CABOMETYX appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 13, 2022
Annual Drug Patent Expirations for COMETRIQ Cometriq is a drug marketed by Exelixis and is included in one NDA. It is available from one supplier. There are six patents protecting…. The post New patent for Exelixis drug COMETRIQ appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
APRIL 12, 2022
Navitoclax is being studied in myelofibrosis, a rare, difficult-to-treat blood cancer – Results are from an exploratory analysis of 34 myelofibrosis patients who received at least one dose of navitoclax in combination with ruxolitinib after suboptimal response or disease progression with ruxolitinib monotherapy – Median overall survival was not reached for patients who had a ?
The Pharma Data
APRIL 12, 2022
– U.S. Pivotal Studies to Restart Enrollment Immediately –. – Decision Based on Review of the Comprehensive Safety Data from Each Trial –. Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold placed on studies evaluating its investigational agent magrolimab in combination with azacitidine.
The Pharma Data
APRIL 12, 2022
WHO welcomes the establishment of a new Heads of State and Government Group to accelerate progress towards the SDG target for noncommunicable diseases ? a one-third reduction in “premature” deaths from diseases like diabetes, cancer, heart and lung disease and the promotion of mental health and well-being. The decision was taken at the inaugural International Strategic Dialogue on Noncommunicable Diseases (NCDs) and the Sustainable Development Goals, held today in Accra, Ghana, where a new Globa
The Pharma Data
APRIL 13, 2022
SHP643-301 is A Multicenter, Open-Label Phase 3 Study to Evaluate Safety, PK, Pharmacodynamics, And Clinical Activity/Outcomes of TAKHZYRO for Prevention Against Acute Attacks of HAE in Pediatric Patients 2 To <12 Years of Age Safety Profile Was Consistent With That Seen in the Clinical Program for Patients 12 Years and Older; There Were No Serious Adverse Events Global Regulatory Filing for Children Ages 2 to <12 Years of Age Planned to Begin this Fiscal Year.
The Pharma Data
APRIL 13, 2022
Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) announced today an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis. In accordance with the ongoing review of the application, on April 6, 2022, the U.S.
Drug Patent Watch
APRIL 12, 2022
Annual Drug Patent Expirations for ZERBAXA Zerbaxa is a drug marketed by Cubist Pharms Llc and is included in one NDA. It is available from one supplier. There are thirteen…. The post New patent for Cubist Pharms drug ZERBAXA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 12, 2022
Annual Drug Patent Expirations for SLYND Slynd is a drug marketed by Exeltis Usa Inc and is included in one NDA. It is available from one supplier. There are six…. The post New patent for Exeltis Usa drug SLYND appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 12, 2022
Annual Drug Patent Expirations for ZOLADEX Zoladex is a drug marketed by Tersera and is included in two NDAs. It is available from two suppliers. There are two patents protecting…. The post New patent expiration for Tersera drug ZOLADEX appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 11, 2022
Annual Drug Patent Expirations for GALAFOLD Galafold is a drug marketed by Amicus Therap Us and is included in one NDA. There are twenty-nine patents protecting this drug. This drug…. The post New patent for Amicus Therap drug GALAFOLD appeared first on DrugPatentWatch - Make Better Decisions.
Drug Patent Watch
APRIL 11, 2022
Annual Drug Patent Expirations for BRILINTA Brilinta is a drug marketed by Astrazeneca and is included in one NDA. It is available from two suppliers. There are three patents protecting…. The post New patent for Astrazeneca drug BRILINTA appeared first on DrugPatentWatch - Make Better Decisions.
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