Sat.Jun 19, 2021 - Fri.Jun 25, 2021

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BioNTech takes its first cancer vaccine into phase 2

pharmaphorum

It would be easy to forget that back in 2019, BioNTech was an early-stage biotech firmly focused on cancer vaccines, before being catapulted onto the world-stage with its COVID-19 shot. Now, the German company has issued a reminder of its original R&D mission with the start of the first phase 2 trial of BNT111 – the first of several cancer vaccine candidates – in patients with skin cancer.

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Takeda reports promising results for potential lung cancer treatment

Outsourcing Pharma

The pharmaceutical company reports favorable results in a recent study exploring mobocertinib in treating certain non-small cell lung cancer patients.

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Dynamic Global Events 2021

Pharma Marketing Network

Dynamic Global Events (“DGE”) is the Life Science Leader in providing B2B Events. Our name is derived from our Goal – to serve the dynamic informational and networking needs of the Pharmaceutical, Biotechnology, Healthcare, Medical Device and allied industries. DGE Virtual, Hybrid and Live Events: Engage Audiences. Facilitate Information Exchange. Accelerate Partnerships.

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A Primer on Reproductive Justice for Pharmacy Professionals

Birth Control Pharmacist

What is reproductive justice? Reproductive justice is “the human right to maintain personal bodily autonomy, have children, not have children, and parent the children we have in safe and sustainable communities” as defined by SisterSong Women of Color Reproductive Justice Collective [1]. Reproductive justice exists in a trinity of frameworks also consisting of reproductive health and rights. .

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Position Your Pharmacy for Expansion

Speaker: Chris Antypas and Josh Halladay

Access to limited distribution drugs and payer contracts are key to pharmacy expansion. But how do you prepare your operations to take the next step? Meaningful data: Collect and share clinical data regarding outcomes, utilization, and more Reporting: Limited distribution models require efficient tracking and reporting systems Workflows: Align workflows with specific pharma and payer contractual requirements For in-depth, expert insights on pharmacy expansion, watch this webinar from Inovalon.

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Sanofi and Translate take first mRNA flu vaccine into clinic

pharmaphorum

Sanofi and Translate Bio have started a first clinical trial of an mRNA-based seasonal flu vaccine, adding to the COVID-19 shot already in testing as part of their three-year old collaboration. Enthusiasm for mRNA vaccines is riding high amid the successful rollout of COVID-19 shots from Pfizer/BioNTech and Moderna, and attention is now turning toe the possibility of using the approach to tackle other infectious diseases.

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Sanofi, CytoReason join forces on AI-based asthma research

Outsourcing Pharma

The project will use the artificial intelligence specialistâs cell-centered models and deconvolutions to gain insights for each individual asthma endotype.

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Planning With Intention: Lessons in Authentic Communication From SXSW 2021

Pharma Marketing Network

After a year of tech-mediated communication, it’s hard to get excited about another screen interaction. Most of us want to connect in person … to have authentic interactions. Of course, tech can’t take the place of in-person – but a mindful approach to tech can make communication more meaningful. Whether it’s planning season or not, it’s worth considering how this insight can inform how brands communicate with patients and healthcare providers (HCPs).

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Farxiga faces first heart failure rival as EU OKs Boehringer/Lilly’s Jardiance

pharmaphorum

AstraZeneca’s SGLT2 inhibitor Farxiga has been growing fast thanks to a first-in-class approval in heart failure, but will now have to share the market with Boehringer Ingelheim and Eli Lilly’s rival therapy Jardiance. . The European Commission has become the first regulator to approved Jardiance (empagliflozin) as a treatment for adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), also known as systolic heart failure.

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DCAT Week 2021 to take on industry education, innovation

Outsourcing Pharma

The annual event (scheduled July 12-16 online) will feature educational sessions, presentations, and networking opportunities for drug manufacturing pros.

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What is Registration Drift in pharmaceutical manufacturing, and how can I avoid it?

Pharma Mirror

By Dr Ash Ramzan, founder and principal consultant, Woodley BioReg During a pharmaceutical product’s lifetime, it’s widely known and accepted that manufacturing processes will drift within their specified ranges — typically due to equipment wear-and-tear and operator variance. To maintain the ‘validated state’, diligent producers spend a lot of time and effort in ensuring validation and periodic re-validation of processes to ensure that any process drift is accounted for and controlled.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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Richard Schwartz

Pharma Marketing Network

Richard has been focused on optimizing healthcare experiences for patients, clinicians, and the people surrounding and supporting them. He has worked within life sciences organizations, leading publishers, consultancies, agencies, digital health, and technology solutions support our journeys through illness and to wellness. He has served as an advisor to TEDMED, DreamIT Ventures, Thomas Jefferson University’s Health Design Lab, the NYC Media Lab, and NYC’s Combine Accelerator.

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Andy Molnar named head of Digital Therapeutics Alliance

pharmaphorum

Former Cognoa executive Andy Molnar has been appointed chief executive of the Digital Therapeutics Alliance, a global trade association for companies developing evidence-based DTx products. Molnar, who served as vice president of market access and government affairs at Cognoa, joins the four-year-old trade association at a time when the potential of using DTx to deliver remote healthcare has been thrust into the spotlight by the coronavirus pandemic.

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Gilead shares positive findings for potential COVID-19 treatment

Outsourcing Pharma

The pharma firm reports its Veklury (remdesivir) led to a reduction in mortality rate among hospitalized patients in three analyses of real-world data.

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Vectura Signs Pre-Clinical Development Agreement with Incannex to Advance IHL-216A for the Treatment of Traumatic Brain Injury

Pharma Mirror

Vectura Group plc, an industry leading inhalation CDMO, today announced it has signed an agreement with Incannex Healthcare Limited, an Australian cannabinoid medicines development company, to provide pre-clinical development services for IHL-216A, Incannex’s proprietary inhaled drug product for the treatment of traumatic brain injury (TBI). Under the terms of the agreement, Vectura will undertake formulation screening studies, manufacturing process optimisation studies and stability assessments

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5 Reasons to Upgrade Your Pharmacy Management Software

Are you still using workarounds to manage your daily operations? To achieve peak performance, it's time to explore other options for specialty and infusion pharmacy software. Streamline pharmacy operations and improve clinical performance with automated processing, real-time data exchange, and electronic decision support. Download this helpful infographic to: Drive efficiency and patient adherence from referral receipt to delivery and ongoing care – all with our Pharmacy Cloud.

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4 Questions to Ask When Building a Better Workplace

Mission-Driven Marketing Blog

In May, I attended the virtual one-day Introduced Conference , hosted by Technical.ly as part of Philly Tech Week Presented by Comcast. The Introduced Conference was described as an opportunity to learn what some of the “most innovative orgs in the world are doing to recruit, retain and support savvy professionals.” Like many organizations, Tapp is thinking about how we grow our company and build our culture, particularly in a post-pandemic world.

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NHS app downloads spike after COVID jab status update

pharmaphorum

The NHS App has soared in popularity since it was updated in May to allow people to record their COVID-19 vaccination status, with more than 2 million new signups taking the total number of users to 6 million. . The app – which should not be confused with the NHS COVID-19 track and trace app – was used by five million people in the last month, according to the Department of Health and Social Care.

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COTA, University of Chicago to study racial disparities in cancer treatment

Outsourcing Pharma

The research collaboration is aimed at studying disparities in care with a focus on multiple myeloma, a cancer disproportionately affecting Black patients.

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Guest Blog Post #15: Patient and Public Involvement in Deprescribing Research

The deprescribing.org Blog

Hello, deprescribing world! Today we have four people involved in the CHARMER Research Programme – Katherine Murphy (Patient and Public Involvement and Media Lead), Doreen Pegg (Patient and Public Involvement Member), David Wright (Professor of Pharmacy Practice, University of East Anglia) and Caroline Smith (Research Associate, University of East Anglia) – talking about Patient & Public Involvement (PPI; no not the bad kind) in deprescribing research.

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Overview of Newly Approved Insulin Products

Med Ed 101

With insulin products continually coming to market, it can be challenging to stay current with the new information. Here is a brief overview of newly approved insulin products in the last few years, some highlights that might make them unique, and how to switch your patients’ insulin therapy to these products. As a clinical pharmacist, […]. The post Overview of Newly Approved Insulin Products appeared first on Med Ed 101.

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GSK sees £20bn peak sales potential in late-stage pipeline

pharmaphorum

GlaxoSmithKline’s pitch to shareholders kicked off this afternoon with an optimistic view of its late-stage pipeline – including some big sales predictions for products like its respiratory syncytial virus (RSV) vaccine and new blood cancer drug Blenrep. By 2031, the UK drugmaker expects sales to top £33 billion ($46 billion), despite facing a patent cliff for big-selling HIV drugs including dolutegravir towards the end of this decade, with double-digit profit growth expected over the next

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Cancer patient survey shows COVID's impact on care decisions

Outsourcing Pharma

The survey, conducted by Ai-powered study matching company TrialJectory, indicates more patients than ever are interested in clinical trial participation post-pandemic.

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NHS England announces extra funding for young people’s mental health services

Pharma Times

An extra £40m will go toward enhancing mental health services for children and young people

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Drugs That Induce Mania

Med Ed 101

When caring for patients with bipolar disorder, one of the greatest concerns that we have is manic episodes. Drug therapy in the form of mood stabilizers are utilized to help prevent manic episodes from happening. As a pharmacist, it is critical to review the medication history of any patient presenting with symptoms of mania. For […]. The post Drugs That Induce Mania appeared first on Med Ed 101.

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After FDA rejection, EU says yes to Sanofi’s Aubagio in kids with MS

pharmaphorum

Sanofi’s Aubagio has become the first oral therapy approved for first-line use in children and adolescents with multiple sclerosis in the EU, a few days after the same indication was turned down by the FDA in the US. The results of the phase 3 TERIKIDS trial were deemed adequate to get a green light from the European Commission, but were rejected as inadequate last week by the FDA, which has asked Sanofi to carry out another trial in paediatric MS.

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Cancer patient survey COVID's impact on care decisions

Outsourcing Pharma

The survey, conducted by Ai-powered study matching company TrialJectory, indicates more patients than ever are interested in clinical trial participation post-pandemic.

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Zolgensma shows promise in presymptomatic SMA patients

Pharma Times

Children treated with gene therapy prior to symptom presentation achieved motor milestones not seen in the natural history of SMA

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Libtayo gets a double with EU approvals in skin, lung cancer

pharmaphorum

Sanofi and Regeneron’s checkpoint inhibitor Libtayo has tripled its approved uses in Europe, after getting the nod for the treatment of advanced basal cell carcinoma (BCC) and advanced non-small cell lung cancer (NSCLC). The approval of Libtayo (cemiplimab) in advanced NSCLC is for first-line treatment of patients with 50% or more PD-L1 expression and no EGFR, ALK or ROS1 aberrations, taking the drug into a large market dominated by Merck & Co/MSD’s rival checkpoint inhibitor Key

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Medication adherence: how to ensure patients are not left behind

pharmaphorum

Poor medication adherence is both a costly issue for pharma manufacturers – with some estimating a loss of $600 billion each year – and a deadly issue for patients, with more than 100k preventable deaths estimated from patients not taking medications correctly, or at all. Tara Herington explores why medication non-adherence is a complex issue. Communication is ever evolving and comes with distinct challenges for the pharma industry.

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Is cardiovascular disease a ‘pandemic hiding in plain sight’?

pharmaphorum

Amarin’s Craig Granowitz discusses the impact of COVID on cardiovascular disease treatment and explains why there’s still a long way to go till we can truly tackle these diseases. COVID-19 has shone a light on the dangers of cardiovascular disease (CVD), with patients with these underlying conditions at much higher risk of dying from the virus. But Dr Craig Granowitz, chief scientific officer of cardiology drug developer Amarin, says that this is only the tip of the iceberg when it comes to the

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Roche eyes October decision by FDA for wet AMD implant

pharmaphorum

The FDA has started a review of a new implant version of Roche’s ranibizumab therapy for wet age-related macular degeneration, that could offer patients with the sight-robbing disorder an alternative to monthly eye injections. . The port delivery system (PDS) formulation of ranibizumab – a VEGF inhibitor already approved as Lucentis to treat wet AMD – was able to extend the time between treatments for six months or more in 98% of patients in a phase 3 trial, with no loss of efficacy.

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Health Innovators: Fredrik Debong, Hi.Health

pharmaphorum

In this episode of our Health Innovators series, Paul Tunnah is joined by tech entrepreneur Fredrik Debong. Fredrik is the founder of Hi.Health app which enables customers of private health insurance to submit their bills and prescriptions for medical services digitally. He discusses his career in tech and how he built the digital health company mySugr, which became one of the largest European digital health exits when it was sold to Roche in 2017.

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In a class first, Merck’s Keytruda extends survival in cervical cancer

pharmaphorum

Merck & Co’s Keytruda has become the first checkpoint inhibitor to help patients with advanced cervical cancer live longer when used as alongside standard first-line drugs. Keytruda (pembrolizumab) was given an accelerated approval in 2018 as a second-line therapy for PD-L1-positive cervical cancer, but the new survival data – from the phase 3 KEYNOTE-826 trial – could extend the use of the drug.

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Arcus preps more phase 3 trials for TIGIT antibody, as Gilead opt-in beckons

pharmaphorum

Armed with a positive mid-stage trial readout in lung cancer, Arcus Biosciences will expand a phase 3 programme for domvanalimab, its anti-TIGIT antibody. Details from the ARC-7 study of domvanalimab as a first-line treatment for PD-L1-positive, advanced non-small cell lung cancer (NSCLC) remain scanty, but Arcus said that the results were “encouraging” enough to warrant more pivotal trials.

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Novartis, HP team up on digital dengue fever surveillance

pharmaphorum

Novartis and Hewlett Packard Enterprise (HPE) have agreed to collaborate on the development of digital health technologies, starting with a project to develop a disease surveillance system for dengue fever. There are currently around 390 million cases of dengue each year, leading to 500,000 hospitalisations and 40,000 deaths, making it one of the World Health Organization’s top 10 global health threats.

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