Drug Patent Watch
JULY 22, 2021
Annual Drug Patent Expirations for LENVIMA Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph…. The post New patent for Eisai Inc drug LENVIMA appeared first on DrugPatentWatch - Make Better Decisions.
Eye on FDA
JULY 19, 2021
It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’
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Drug Discovery Today
JULY 18, 2021
~ UK’s biggest trade show for the laboratory industry returns for 2021 ~
The Pharma Data
JULY 23, 2021
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Ronapreve (casirivimab and imdevimab), for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. The antibody combination was granted a Special Approval Pathway under article 14-3 of the Pharmaceuticals and Medical Devices Act. “Ronapreve has been shown to improve survival in high-risk, non-hospitalised COVID-19 patients by reducing the risk of h
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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 Patent Watch
JULY 21, 2021
Annual Drug Patent Expirations for GOCOVRI Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Adamas Pharma drug GOCOVRI appeared first on DrugPatentWatch - Make Better Decisions.
Pharmaceutical Development Group
JULY 22, 2021
Introduction Food and Drug Administration is a government entity in the United States whose objective is to protect the public by verifying that nutritional supplements are safe to use and accurately labelled. Businesses can even use the FDA Pre-submission to get feedback on possible and planned medical advice, biologics and medication submission. It’s a fantastic service to use, but we have noticed that it’s often overlooked.
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
JULY 23, 2021
Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced that the U.S. government has purchased an additional 200 million doses of the Pfizer-BioNTech COVID-19 Vaccine. These doses are expected to be delivered from October 2021 through April 2022. This brings the total number of doses to be supplied by the companies to the U.S. government under its existing supply agreement to 500 million.
Drug Patent Watch
JULY 23, 2021
Annual Drug Patent Expirations for AVYCAZ Avycaz is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are eight patents protecting…. The post New patent expiration for Allergan drug AVYCAZ appeared first on DrugPatentWatch - Make Better Decisions.
ProRelix Research
JULY 21, 2021
Emergency Use Authorisation Approval Process of US FDA and Treatments Approved for COVID – 19 in the USA The COVID-19 pandemic has transformed the worldwide regulator performing on approval of […]. The post COVID-19 Emergency Use Authorisation Approval Process of US FDA appeared first on ProRelix Research.
Dark Matter Blog
JULY 19, 2021
Back in 2015, I felt compelled to set out in a new direction in drug discovery. I was in my third year as VP of Chemistry for Celgene. This was a great gig – good people, good science. However, it required a level of travel that began to seem excessive. My kids were old enough to know I was missing and young enough to care. And I live in the “Hollywood” of biotech, the Boston/Cambridge area – there seems to be an exciting new biotech start-up in this neighborhood every six weeks!
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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
JULY 23, 2021
Real-world data from Canada showed 82% and 87% effectiveness after one dose against hospitalisation or death caused by Beta/Gamma and Delta variants respectively. Results from the Canadian Immunization Research Network (CIRN) with support from Public Health Agency of Canada and the Canadian Institutes of Health Research, published as a pre-print , demonstrated one dose of Vaxzevria was 82% effective against hospitalisation or death caused by the Beta/Gamma variants of the SARS-CoV-2 virus.
Drug Patent Watch
JULY 23, 2021
Annual Drug Patent Expirations for ABILIFY Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from two suppliers.…. The post New patent expiration for Otsuka drug ABILIFY appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
JULY 20, 2021
The 340B Drug Pricing Program continues to expand far more quickly than the overall pharmaceutical market—and some channels are benefiting more than others. As you will see below, mail and specialty pharmacies’ purchases of products that are eligible for 340B discounts have grown by an incredible 56% per year since 2017. That’s about six times faster than the overall mail and specialty market.
Dark Matter Blog
JULY 19, 2021
Arrakis has gone through many significant transitions since its founding in 2015. We’ve evolved and matured scientifically. We’ve added investors and partners. And, of course, people come and go. Today, we reach a bittersweet transition at Arrakis. We bid our head of research and employee #005, Jim Barsoum, au revoir , as he marches bravely into a well-earned retirement.
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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
JULY 22, 2021
Some antibiotics appear to be effective against a form of skin cancer known as melanoma. Researchers at KU Leuven, Belgium, examined the effect of these antibiotics on patient-derived tumours in mice. Their findings were published in the Journal of Experimental Medicine. Researchers from KU Leuven may have found a new weapon in the fight against melanoma: antibiotics that target the ‘power plants’ of cancer cells.
Drug Patent Watch
JULY 22, 2021
Annual Drug Patent Expirations for COSELA Cosela is a drug marketed by G1 Therap and is included in one NDA. There are nine patents protecting this drug. This drug has…. The post New patent for G1 Therap drug COSELA appeared first on DrugPatentWatch - Make Better Decisions.
Drug Channels
JULY 19, 2021
Finance and Accounting for Bioscience Companies – Hybrid Events. September 20-21, Boston MA | September 22, Virtual Experience | September 23-24, Burlingame, CA. www.informaconnect.com/financeaccountingeast. www.informaconnect.com/financeaccountingwest. Tailored to the unique nuisances of bioscience companies, these CPE-accredited annual events bring together the brightest financial and accounting minds from the nation’s leading trailblazers.
Nvidia Developer: Drug Discovery
JULY 21, 2021
Solving a mystery that stumped scientists for decades, last November a group of computational biologists from Alphabet’s DeepMind used AI to predict a. Solving a mystery that stumped scientists for decades, last November a group of computational biologists from Alphabet’s DeepMind used AI to predict a protein’s structure from its amino acid sequence.
The Pharma Data
JULY 22, 2021
Collaboration combines Arvinas’ investigational estrogen receptor-targeting breast cancer therapy with Pfizer’s deep experience in breast oncology therapeutics – – ARV-471 is currently in Phase 2 development for the treatment of patients with locally advanced or metastatic ER+/HER2- breast cancer – – Arvinas to receive $650 million in an upfront payment, in addition to a potential $1.4 billion in milestone payments; profits and costs to be shared 50/50 worldwide – – Pfizer to complete a $350 mil
Drug Patent Watch
JULY 21, 2021
Annual Drug Patent Expirations for XPOVIO Xpovio is a drug marketed by Karyopharm Theraps and is included in one NDA. There are five patents protecting this drug. This drug has…. The post New patent for Karyopharm Theraps drug XPOVIO appeared first on DrugPatentWatch - Make Better Decisions.
The Pharma Data
JULY 22, 2021
The Board of GSK (GSK) today announces that Brian McNamara, the CEO of GSK Consumer Healthcare (a Joint Venture between GSK and Pfizer) has been appointed as CEO Designate of the new, listed Consumer Healthcare company which will result from the proposed demerger of Consumer Healthcare from GSK in 2022. As set out at GSK’s Investor Update on 23 June 2021, subject to approval from shareholders, the separation of Consumer Healthcare will be by way of a demerger in mid-2022 of at least 80% of GSK’s
The Pharma Data
JULY 22, 2021
Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma That is Not Microsatellite Instability-High or Mismatch Repair Deficient, Who Have Disease Progression Following Prior Systemic Therapy in Any Setting and Are Not Candidates for Curative Surgery or Radiation. Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a
The Pharma Data
JULY 22, 2021
Data Include Phase 3 Results Showing that the Primary Endpoint of Spontaneous, Treated Annualized Bleeding Rates During Prophylaxis with Recombinant von Willebrand Factor in Adults with von Willebrand Disease, was Met 12 Abstracts Presented Across Takeda’s Hematology Portfolio and Pipeline Support Takeda’s Commitment to Improving Patient Care Today as well as Transforming Future Care.
The Pharma Data
JULY 22, 2021
Sanofi has concluded an agreement to divest an integrated portfolio of dental care brands and related medical devices to Septodont, a French privately-owned company headquartered near Paris. Divested portfolio includes four dental care brands Ultracain ® , Rodogyl ® , Birodogyl ® and Dontisolon ® , as well as related medical devices, mostly marketed in Europe.
The Pharma Data
JULY 22, 2021
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced changes to its leadership team. Brendan O’Grady, Executive Vice President, North America Commercial, will leave Teva to pursue a career opportunity outside of the pharmaceutical industry, and Sven Dethlefs, who currently serves as Teva’s Executive Vice President, Global Marketing and Portfolio and International Markets Commercial has been appointed the new head of North America Commercial.
The Pharma Data
JULY 22, 2021
Researchers in the field of parasitology celebrated for contributions early in their scientific careers Together with scientific publisher Parasites & Vector, Boehringer Ingelheim has sponsored the award since its founding in 2014 Award serves to foster career growth in parasitology as well as keep memory of parasitologist Odile Bain alive. To celebrate outstanding contributions in the field of parasitology early on in their scientific careers, Dr Goylette Chami, University of Oxford, UK, an
The Pharma Data
JULY 22, 2021
NOTE: ADUHELM TM (aducanumab-avwa)injection 100 mg/mL solutionis indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied.
The Pharma Data
JULY 22, 2021
Eli Lilly and Company (NYSE: LLY) will announce its second-quarter 2021 financial results on Tuesday, August 3, 2021. Lilly will also conduct a conference call on that day with the investment community and media to further detail the company’s financial performance. The conference call will begin at 9 a.m. Eastern time. Investors, media and the general public can access a live webcast of the conference call through a link that will be posted on Lilly’s website at [link].
The Pharma Data
JULY 21, 2021
Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company focused on the development and commercialization of prophylactic vaccines for infectious diseases with significant unmet medical need, and Pfizer Inc. (NYSE: PFE), today announced that they have completed recruitment for the Phase 2 trial, VLA15-221, of Lyme disease vaccine candidate, VLA15.
The Pharma Data
JULY 21, 2021
NEW YORK & MAINZ, Germany–(BUSINESS WIRE)– Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the signing of a letter of intent with The Biovac Institute (Pty) Ltd, known as “Biovac,” a Cape Town-based, South African biopharmaceutical company, to manufacture the Pfizer-BioNTech COVID-19 Vaccine for distribution within the African Union.
The Pharma Data
JULY 21, 2021
European Approval Granted to Bayer Marks Another Important Milestone for VERQUVO. KENILWORTH, N.J.–(BUSINESS WIRE)– Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the European Commission (EC) has granted marketing authorization in the European Union (EU) for soluble guanylate cyclase (sGC) stimulator VERQUVO® (vericiguat).
The Pharma Data
JULY 21, 2021
– Allergan, an AbbVie (NYSE: ABBV) company, today announced that it will present new data from its leading portfolio of eye care medicines at the 2021 ASCRS (American Society for Cataract and Refractive Surgery) Annual Meeting being held July 23-27 in Las Vegas, NV. Presentations will include new data on AGN-190584 (pilocarpine 1.25%), an investigational presbyopia treatment, and updated analyses on DURYSTA (bimatoprost intracameral implant), the first and only FDA-approved dissolvable
The Pharma Data
JULY 21, 2021
PRNewswire/ — AbbVie (NYSE: ABBV) announced today that the U.S. Food and Drug Administration (FDA) granted a Breakthrough Therapy Designation (BTD) to venetoclax (VENCLEXTA ® ) in combination with azacitidine for the potential treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes (MDS) based on revised International Prognostic Scoring System (IPSS-R).
The Pharma Data
JULY 21, 2021
PRNewswire/ — Today Allergan Aesthetics, now an AbbVie company, announces its third consecutive year of partnership with Girls Inc. and debut of its Empowering Confidence Workshops , a nationwide mentoring initiative. Based on a 2020 Girls Inc. report, many girls have a hard time picturing themselves in STEM. The virtual workshops will pair mentees with female physicians to offer career guidance and developmental skills to underserved, high school-aged girls as they look to higher educati
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