Eye on FDA

AUGUST 13, 2021

What does “fully vaccinated” mean today? In the face of the widening spread of the SARS-Cov-2 variant, the rise in breakthrough cases, and data that suggests a slight waning effect over time of vaccines, FDA acted yesterday to protect some of the most vulnerable by amending the Emergency Use Authorization of the mRNA vaccines. People who have had organ transplants and people who are immunocompromised may now get a third dose.

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Drug Channels

AUGUST 11, 2021

The Medicare Payment Advisory Commission (MedPAC), the independent agency that advises Congress on the Medicare program, recently released its latest Health Care Spending and the Medicare Program databook. This annual report is a treasure trove of useful and fascinating data. The July 2021 edition provides us with the latest pre-pandemic details on the buy-and-bill market in Medicare Part B.

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Drug Patent Watch

AUGUST 13, 2021

Annual Drug Patent Expirations for PRADAXA Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are five patents…. The post New patent for Boehringer Ingelheim drug PRADAXA appeared first on DrugPatentWatch - Make Better Decisions.

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Molecule Blog

AUGUST 13, 2021

Announcing the first biopharma IP-NFT Transaction Funding the first longevity research project by utilizing intellectual property NFTs in the pharmaceutical space Summary The vote has passed, the decision is made: The Scheibye-Knudsen Lab will be the first research organisation to fund their longevity research via an IPNFT. This historic moment needs to be celebrated properly!

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Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

Treatment

ProRelix Research

AUGUST 12, 2021

Acceptance of foreign clinical trials data by US FDA Foreign Clinical Trials (FCTs) Prior to the 1962 Kefauver-Harrison Amendments, it was uncommon for a Sponsor to submit FCTs data. In […]. The post Acceptance of foreign clinical trials data by US FDA appeared first on ProRelix Research.

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Drug Channels

AUGUST 13, 2021

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey discusses how a patient support vendor can help specialty pharmacy patients attain prior authorizations and access critical therapies. She offers three criteria that manufacturers can use to evaluate e-support services providers.

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The Pharma Data

AUGUST 10, 2021

Florida A&M University, Howard University, Morgan State University, North Carolina A&T University and University of Arkansas at Pine Bluff will pioneer the program in collaboration with Bristol Myers Squibb Tomorrow’s Innovators hopes to create actionable change within the biopharma industry by improving the recruitment and retention of diverse talent and enhancing the student educational experience at participating Historically Black Colleges and Universities (HBCUs).

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Pharmaceutical Development Group

AUGUST 9, 2021

Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceutical companies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety.

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Drug Channels

AUGUST 9, 2021

Informa Connect’s Medicaid Drug Rebate Program — MDRP 2021 Hybrid. In-Person: October 11-13, 2021 | New Brunswick, NJ Virtual: October 18-20, 2021 www.informaconnect.com/MDRP. Informa Connect’s 26th Annual Medicaid Drug Rebate Program — MDRP 2021 Hybrid — is an important event for government pricing, rebates and regulation, providing direct access to government regulators creating the rules, the industry leaders interpreting them and the manufacturer experts implementing them.

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Drug Patent Watch

AUGUST 13, 2021

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

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Clinical Trials

The Pharma Data

AUGUST 9, 2021

– SKYRIZI is now the only four-dose-a-year biologic for psoriasis with options to administer via a single-dose pen or prefilled syringe. today announced that SKYRIZI ® (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, is now available in the U.S. as a single-dose 150 mg injection for the treatment of adults with moderate to severe plaque psoriasis.

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Drug Patent Watch

AUGUST 12, 2021

This chart shows the pharmaceutical companies with the most patents in Mexico. Patents must be filed in each country (or, in some cases regional patent office) where patent protection is…. The post Which pharmaceutical companies have the most drug patents in Mexico? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

AUGUST 12, 2021

Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are six patents…. The post New patent for Genentech Inc drug XOFLUZA appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

AUGUST 12, 2021

Annual Drug Patent Expirations for LEVULAN Levulan is a drug marketed by Dusa and is included in one NDA. It is available from one supplier. There is one patent protecting…. The post New patent for DUSA drug LEVULAN appeared first on DrugPatentWatch - Make Better Decisions.

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Clinical Trials

Drug Patent Watch

AUGUST 12, 2021

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

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Drug Patent Watch

AUGUST 10, 2021

This chart shows the pharmaceutical companies with the most supplementary protection certificates (SPCs) in Austria. SPCs are used in European Union and select others to encourage pharmaceutical innovation by compensating…. The post Which pharmaceutical companies have the most SPCs in Austria? appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

AUGUST 10, 2021

Annual Drug Patent Expirations for EXPAREL Exparel is a drug marketed by Pacira Pharms Inc and is included in one NDA. It is available from one supplier. There is one…. The post New patent for Pacira Pharms drug EXPAREL appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

AUGUST 9, 2021

Research by Lancaster University scientists to create a COVID-19 vaccine which can be administered through the nose has taken a significant step forward. The pre-clinical animal trials of the intranasal vaccine showed a reduction in both the impact of the disease itself and transmission of the virus. The findings – published in the journal iScience – open the door to addressing global health and vaccine inequalities.

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Clinical Trials

The Pharma Data

AUGUST 9, 2021

Approval based on unprecedented DAPA-CKD Phase III data is the most significant advancement in chronic kidney disease in more than 20 years. AstraZeneca’s Forxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the European Union (EU) for the treatment of chronic kidney disease (CKD) in adults with and without type-2 diabetes (T2D).

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Drug Patent Watch

AUGUST 9, 2021

Annual Drug Patent Expirations for KYNMOBI Kynmobi is a drug marketed by Sunovion Pharms Inc and is included in one NDA. There are seventeen patents protecting this drug. Drug patent…. The post New patent for Sunovion Pharms drug KYNMOBI appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

AUGUST 9, 2021

The levels of IgG antibodies against SARS-CoV-2 Spike protein remain stable, or even increase, seven months after infection, according to a follow-up study in a cohort of healthcare workers coordinated by the Barcelona Institute for Global Health (ISGlobal), an institution supported by “la Caixa” Foundation, in collaboration with the Hospital Clinic of Barcelona.

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The Pharma Data

AUGUST 9, 2021

Today, the U.S. Food and Drug Administration approved Nexviazyme (avalglucosidase alfa-ngpt) for intravenous infusion to treat patients 1 year of age and older with late-onset Pompe disease. Patients with Pompe disease have an enzyme deficiency that leads to the accumulation of a complex sugar, called glycogen, in skeletal and heart muscles, which cause muscle weakness and premature death from respiratory or heart failure.

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The Pharma Data

AUGUST 9, 2021

Pivotal phase III POLARIX trial comparing Polivy in combination with chemotherapy regimen R-CHP versus the standard of care R-CHOP in treatment of first-line diffuse large B-cell lymphoma (DLBCL) met its primary endpoint of investigator-assessed progression-free survival Prolonging survival without disease advancement could be transformative for newly diagnosed DLBCL patients as currently 40% of patients relapse after disease progression Data will be submitted to health authorities globally as s

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Drug Patent Watch

AUGUST 8, 2021

This chart shows the patent expirations for suspension dosed drugs over the next decade. The term of drug patents varies. The basic term for a patent is 20 years from…. The post Suspension dosed drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

AUGUST 7, 2021

Pharmaceutical drug patents enable branded drug companies to prevent market entry by competitors until the patents expire. The term of drug patents varies. The basic term for a patent is…. The post Future drug patent expirations by year appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

AUGUST 7, 2021

Operating profit decreased by 1% in Danish kroner and increased by 9% at constant exchange rates (CER). Sales increased by 5% in Danish kroner and by 12% at CER to DKK 66.8 billion. Sales in International Operations increased by 7% in Danish kroner (13% at CER), and sales in North America Operations increased by 1% in Danish kroner (11% at CER). Sales within Diabetes and Obesity care increased by 5% in Danish kroner to DKK 56.9 billion (13% at CER), driven by GLP-1 growth of 21% in Danish kroner

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The Pharma Data

AUGUST 7, 2021

Acquisition strengthens Bayer’s drug discovery capabilities with cutting-edge chemoproteomics platform / Vividion’s unique approach identifies previously unknown binding pockets in undruggable targets to generate first-in-class novel compounds in indications of high unmet medical need / Vividion’s technology has already proven its applicability pre-clinically in oncology and immune-related diseases, with potential to expand into additional therapeutic areas / Vividion to operate autonomously and

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The Pharma Data

AUGUST 7, 2021

Approval is based on positive Phase 3 data demonstrating improvements in key disease burden measures and establishing its safety profile Nexviazyme specifically targets the M6P receptor, the key pathway for enzyme replacement therapy, to effectively clear glycogen build-up in muscle cells. The U.S. Food and Drug Administration (FDA) has approved Nexviazyme® (avalglucosidase alfa-ngpt) for the treatment of patients one year of age and older with late-onset Pompe disease, a progressive and debilit

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The Pharma Data

AUGUST 7, 2021

today announced that it re-filed its “Summary of Financial Statements for the Three-month Period Ended June 30, 2021 (IFRS, Consolidated)” to the Tokyo Stock Exchange, which was revised to reflect the impact of a subsequent event that occurred on July 30, 2021 on the consolidated financial statements for the fiscal quarter ended on June 30, 2021 (“Q1 FY2021”).

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Drug Patent Watch

AUGUST 9, 2021

This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA…. The post Pharmaceutical companies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.

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Drug Patent Watch

AUGUST 9, 2021

CAPRELSA (vandetanib) Genzyme corp Patent: 7,173,038 Expiration: Aug 14, 2021 See More … For more information on how DrugPatentWatch can help with your pharmaceutical business intelligence needs, contact admin@DrugPatentWatch.com or…. The post Drug Patent Expirations for the Week of August 8, 2021 appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

AUGUST 10, 2021

Data Supporting Application to Be Presented at ESMO Congress 2021. Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, Merck’s anti-PD-1 therapy, as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient

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The Pharma Data

AUGUST 9, 2021

IDMC recommended unblinding based on primary efficacy endpoint demonstrating superiority; results also indicate strong trend toward improved overall survival. Plans for global regulatory submissions underway. Positive high-level results from the head-to-head DESTINY-Breast03 Phase III trial showed that Enhertu (trastuzumab deruxtecan), the AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo) HER2-directed antibody drug conjugate (ADC), demonstrated superiority over trastuzumab emtans

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