Drug Channels

OCTOBER 1, 2021

Today’s guest post comes from David Fidler, Senior Director of Product Innovation at ConnectiveRx. David discusses how electronic prior authorization (ePA) and first-fill, buy-down programs can boost patient adherence to specialty therapies. On November 3rd at 1:00 pm ET, ConnectiveRx will host First Fill, No Wait: How to Make it Happen , a free webinar about copay ePA.

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The Pharma Data

OCTOBER 1, 2021

Pfizer today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved CIBINQO ® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and older with inadequate response to existing therapies. CIBINQO will be available in Japan in doses of 100mg and 200mg.

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Drug Patent Watch

SEPTEMBER 30, 2021

Annual Drug Patent Expirations for BOSULIF Bosulif is a drug marketed by Pf Prism Cv and is included in one NDA. It is available from two suppliers. There are four…. The post New patent for Pf Prism drug BOSULIF appeared first on DrugPatentWatch - Make Better Decisions.

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The Anticancer Fund

SEPTEMBER 29, 2021

30 September 2021 Language EN Drug repurposing is a strategy for identifying new uses for approved drugs, outside the scope of the original indication. It is one of the focus areas of the Anticancer Fund. Below, we have listed recent findings about the repurposing of generic drugs in oncology. Our intention is to help bring these findings to the attention of the broader cancer research community.

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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.

Clinical Trials

Drug Channels

SEPTEMBER 28, 2021

Autumn is here! Curl up with your favorite pumpkin-spiced blog and savor these stories harvested from the Drug Channels patch: Fresh insights about hospitals’ specialty drug profits SSR Update: Drug prices keep dropping My $0.02 on international benchmarking goes viral Amazon is finally disrupting CVS—but not how you expected Plus, the best article ever about Elizabeth Holmes’s Theranos trial.

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The Pharma Data

SEPTEMBER 30, 2021

Survey of Over 1,000 Asthma and COPD Patients Conducted in Partnership with AAFA Finds Symptoms are Disruptive to Daily Lives for Majority of Respondents Despite Treatment Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced the launch of Inhaler Tales – a national campaign aimed toward raising awareness about the role inhaler misuse may play in inadequate disease control.1.

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Drug Channels

SEPTEMBER 27, 2021

Informa Connect’s Trade & Channel Strategies. Delivered as a Hybrid Event. In-Person: December 13-14, Hilton Philadelphia at Penn’s Landing, Philadelphia, PA Virtual: December 16-17 www.informaconnect.com/trade-channel/. Year after year, the life science industry marks Informa Connect’s Trade and Channel Strategies as the “go-to” event for trade, channel, market access, account strategy and brand professionals.

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The Pharma Data

SEPTEMBER 30, 2021

Extension analyses observed patients taking AJOVY experienced a reduction in migraine and headache days and evaluated disability and health-related quality of life. Online symposium to highlight healthcare and neurology disparities as a major public health issue and discuss the state of diversity in migraine clinical studies, barriers to recruitment, and the need for more inclusive and diverse studies.

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The Pharma Data

SEPTEMBER 30, 2021

Boehringer Ingelheim again joins efforts to fight rabies under this year’s theme for World Rabies Day by GARC: “Rabies: Facts, not Fear” Boehringer Ingelheim strives to raise awareness of the disease and its preventio. Today on World Rabies Day, we commemorate the death of Pasteur who developed the primary rabies vaccine, laying the foundations for rabies prevention.

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The Pharma Data

SEPTEMBER 30, 2021

Lilly’s Insulin Lispro Injection, 100 units/mL — first introduced at half the list price of branded Humalog® (insulin lispro injection, 100 units/mL) in 2019 — will now have a 70 percent lower list price than Humalog U-100 starting January 1, 2022 Insulin Lispro Injection can be ordered through all U.S. retail pharmacies Monthly prescriptions for all Lilly insulins — including Insulin Lispro Injection — remain available for $35 through the Lilly Insulin Value Progra

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Clinical Trials

The Pharma Data

OCTOBER 1, 2021

Results from the Phase 3 POETYK PSO-1 and POETYK PSO-2 trials show that response rates for deucravacitinib continued to extend through Week 24 and were maintained through Week 52 in patients with moderate to severe plaque psoriasis. Deucravacitinib demonstrated efficacy no matter baseline characteristics, including weight , disease severity and former treatment with biologic or non-biologic therapies.

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The Pharma Data

OCTOBER 1, 2021

Phase IV LEADER-75 study showed 25 percent reduction in standard dose of gadobutrol is non-inferior to gadoterate full dose in improvement of visualization imaging parameters / Diagnostic equivalence of the two contrast regimens was confirmed by a post hoc analysis. Bayer published today the results of its LEADER-75 (LowEr Administered Dose with highEr Relaxivity) study, demonstrating the clinical efficacy of a reduced dose of gadobutrol compared to a typical dose of gadoterate in patients under

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The Pharma Data

OCTOBER 1, 2021

Acquisition Complements and Strengthens Merck’s Cardiovascular Pipeline. Sotatercept is a Potentially First-In-Class Therapy in Phase 3 Development for the Treatment of Pulmonary Arterial Hypertension. REBLOZYL ® (luspatercept-aamt) is a First-In-Class Erythroid Maturation Recombinant Fusion Protein Approved for the Treatment of Anemia in Certain Rare Blood Disorders.

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The Pharma Data

SEPTEMBER 30, 2021

Today, the U.S. Food and Drug Administration authorized marketing of software to help medical professionals who examine body tissues (pathologists) within the detection of areas that are suspicious for cancer as an adjunct (supplement) to the review of digitally-scanned slide images from prostate biopsies (tissue faraway from the body). The software, called Paige Prostate, is that the first AI (AI)-based software designed to spot a neighborhood of interest on the prostate biopsy image with the v

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Clinical Trials

The Pharma Data

SEPTEMBER 30, 2021

Presentations focused on respiratory syncytial virus, meningococcal disease, and influenza New research from Sanofi Pasteur on respiratory syncytial virus (RSV), meningococcal disease, and influenza are going to be featured at IDWeek 2021, from Michaelmas to October 3, 2021, underscoring the company’s pledge to develop meaningful solutions for patients.

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The Pharma Data

SEPTEMBER 30, 2021

Blood vessels supply tumors with nutrients and, on the opposite hand, enable cancer cells to spread throughout the body. The settlement of circulating tumor cells during a distant organ is promoted by factors whose production is induced by the first tumor itself. Scientists from the German Cancer research facility (DKFZ) and therefore the Medical Faculty Mannheim, Heidelberg University, have now identified a replacement protein produced by blood vessels that permits tumor cells to metastatically

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The Pharma Data

SEPTEMBER 30, 2021

An expert review by a world group of scientists, including some at the WHO and FDA, concludes that, even for the delta variant, vaccine efficacy against severe COVID is so high that booster doses for the overall population aren’t appropriate at this stage within the pandemic. The review, published within the Lancet, summarises the currently available evidence from randomised controlled trials and observational studies published in peer-reviewed journals and pre-print servers.

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The Pharma Data

SEPTEMBER 30, 2021

Using a virus that grows in black-eyed pea plants, nanoengineers at the University of California San Diego developed a replacement treatment that would keep metastatic cancers cornered from the lungs. The treatment not only slowed tumor growth within the lungs of mice with either metastatic carcinoma or melanoma, it also prevented or drastically minimized the spread of those cancers to the lungs of healthy mice that were challenged with the disease.

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Drug Patent Watch

SEPTEMBER 29, 2021

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

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The Pharma Data

SEPTEMBER 29, 2021

The ‘Your Right to Plan’ campaign aims at improving family planning and reproductive health services to Egypt’s underserved communities / The five-year partnership involves a total donation of EUR 330,000 / The program provides access to medical services in relation to family planning, such as OB-GYN examinations, ultrasound diagnosis, and pediatric services.

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The Pharma Data

SEPTEMBER 28, 2021

Recommendation supported Data From Phase 3 KEYNOTE-355 Trial. Merck, referred to as MSD outside the us and Canada, today announced the Committee for Medicinal Products for Human Use (CHMP) of the ecu Medicines Agency (EMA) has recommended approval of KEYTRUDA, Merck’s anti-PD-1 therapy, together with chemotherapy for the treatment of locally recurrent unresectable or metastatic triple-negative carcinoma (TNBC) in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ?

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The Pharma Data

SEPTEMBER 29, 2021

Andes has developed novel seed treatment technology that allows crops to thrive without synthetic fertilizers / Funds will aid the development of revolutionary nature-based carbon capture technology. Leaps by Bayer, the impact investment arm of Bayer AG, today announced that it has co-led a USD 15 million Series A investment round in agriculture and biotechnology innovator, Andes , with Cavallo Ventures.

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The Pharma Data

SEPTEMBER 29, 2021

In an updated analysis on the adult subset of non-central systema nervosum (CNS) / TRK fusion cancer patients from three larotrectinib clinical trials, a high overall response rate (ORR) of 67% with a median duration of response (mDoR) of 49.3 months was observed also as an extended progression-free survival (PFS; median of 25.8 months) as assessed by investigators / post hoc ergo propter hoc sub-analysis of investigator-assessed ORR, DoR and PFS of patients (n=218) show uniformly high ORRs in p

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The Pharma Data

SEPTEMBER 29, 2021

There are limited treatment options available for chronic renal disorder (CKD), and patients often still reach renal failure or premature death / The phase III clinical trial study FIND-CKD will investigate the effect of finerenone on kidney and cardiovascular outcomes in patients with non-diabetic chronic renal disorder Bayer announced today the initiation of the FIND-CKD study, a multicenter, randomized, double-blind, placebo-controlled phase III clinical trial study to research the efficacy a

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The Pharma Data

SEPTEMBER 28, 2021

Roche today presented new data from the phase III clinical trial IMpower010 study at the ecu Society for Medical Oncology (ESMO) Congress 2021 Presidential Symposium, reinforcing the many disease-free survival (DFS) benefit offered by Tecentriq® (atezolizumab) for people with Stage II-IIIA non-small cell carcinoma (NSCLC) whose tumours express PD-L1?

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The Pharma Data

SEPTEMBER 28, 2021

New data show pre-symptomatic babies with spinal muscular atrophy (SMA) treated with Evrysdi maintained the power to swallow Evrysdi has demonstrated consistent clinically meaningful efficacy in adults, children, and babies two months and older and is now approved in 58 countries worldwide Further presentations included data from studies supporting the efficacy, safety, and sturdiness of gene therapy, SRP-9001, within the treatment of Duchenne dystrophy (DMD).

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The Pharma Data

SEPTEMBER 27, 2021

The following quote is attributed to Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “The opioid crisis continues to evolve and there are still relevant concerns with overprescribing, especially among vulnerable populations. Although many public and personal entities have independently implemented their own education schemes and other interventions to encourage safe and effective prescribing practices for opioid analgesics, there’s no consistent edu

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The Pharma Data

SEPTEMBER 28, 2021

The following quote is attributed to Frank Yiannas, Deputy Commissioner for Food Policy and Response. “The COVID-19 pandemic has accelerated the necessity for the FDA to assist make sure that foods ordered online and delivered on to consumers are safe to eat and not in danger of contamination. We said within the New Era of Smarter Food Safety blueprint that we might hold a summit to deal with the potential safety vulnerabilities of those foods, especially during the critical “last mile” of deliv

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The Pharma Data

SEPTEMBER 28, 2021

As schools round the country are re-opening for in-person learning and families are returning to their busy academic year schedules, we all know many parents are anxious about the pandemic and protecting their children. Many parents have questions on COVID-19 and when vaccines are going to be available for youngsters younger than 12 years aged. Many of our team at the FDA are parents and grandparents themselves, and our team shares an equivalent concerns as many in our country about protecting o

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Drug Patent Watch

SEPTEMBER 27, 2021

Annual Drug Patent Expirations for TIBSOVO Tibsovo is a drug marketed by Servier and is included in one NDA. There are seven patents protecting this drug. This drug has ninety-four…. The post New patent for Servier drug TIBSOVO appeared first on DrugPatentWatch - Make Better Decisions.

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The Pharma Data

SEPTEMBER 27, 2021

Eli Lilly and Company (NYSE: LLY) announced today the pricing terms of its previously announced cash tender offer for specified series of its outstanding debt securities. Holders of notes subject to the tender offer who validly tendered, and did not validly withdraw, their notes on or before 5:00 p.m., New York City time, on September 20, 2021 (the early tender date), and whose notes are accepted for purchase by Lilly, are eligible to receive the applicable total consideration.

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The Pharma Data

SEPTEMBER 27, 2021

Approval Based on HAUSER-RCT Study Demonstrating a Significant Reduction in LDL-C. Amgen today announced that the U.S. Food and Drug Administration (FDA) has approved Repatha® (evolocumab) as an adjunct to diet and other LDL cholesterol (LDL-C)-lowering therapies for the treatment of pediatric patients aged 10 years and older with heterozygous hypercholesterolemia (HeFH) to scale back LDL-C.

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The Pharma Data

SEPTEMBER 27, 2021

AbbVie Submits Regulatory Applications to FDA and EMA for Upadacitinib (RINVOQ®) for the Treatment of Adults with Moderately to Severely Active colitis. today announced that it’s submitted applications seeking approval for upadacitinib (15 mg and 30 mg (maintenance dose) and 45 mg (induction dose)) for the treatment of adults with moderately to severely active colitis to the U.S.

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The Pharma Data

SEPTEMBER 27, 2021

AbbVie Submits Regulatory Application to FDA for Risankizumab-rzaa (SKYRIZI®) for the Treatment of Patients 16 Years and Older with Moderate to Severe regional enteritis. today announced that it’s submitted an application to the U.S. Food and Drug Administration (FDA) seeking approval for risankizumab-rzaa (600 mg intravenous (IV) induction and 360 mg subcutaneous (SC) maintenance therapy), an interleukin-23 (IL-23) inhibitor, for the treatment of patients 16 years and older with moderate

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