Sat.Apr 17, 2021 - Fri.Apr 23, 2021

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UK Vaccine Taskforce head lifts lid on Novavax deal

pharmaphorum

The UK’s unique offering as a life sciences research hub helped convince US biotech Novavax to develop its COVID-19 jab there, according to the head of the country’s Vaccines Taskforce. . Last August the UK government finalised a deal with Novavax to purchase 60 million doses of the NVX-CoV2373 vaccine, which will also be manufactured in the country at a plant owned by FUJIFILM Diosynth Biotechnologies in Stockton-on-Tees.

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Canine cancer research startup impacts treatment in humans

Outsourcing Pharma

One Healthâs FidoCure is using genomics and AI technology to develop precision oncological treatments, and the work is benefiting human cancer research.

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DarshanTalks: Sales & Marketing Oversight – April 21, 2021

Pharma Marketing Network

[link]. The Pharma Marketing Podcast is pleased to present this special guest episode from our friend and Editorial Advisory Board member Darshan Kulkarni, Sales and Marketing Oversight – April 21, 2021. Darshan Kulkarni and Marc Banjak, General Counsel at Dova Pharmaceuticals, discuss sales compliance in the life sciences. Sales and marketing representatives in the life science industry must comply with state and federal regulations.

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Can you use montelukast for allergies? [ANSWERED]

Druggist

Montelukast, a prescription-only medication, is mainly used as add on therapy in the treatment of asthma , usually in patients who cannot control their condition with an inhaled steroid and who cannot control their asthma with ‘short acting’ inhaler such as Ventolin (Salbutamol). Today I will explore a different use of montelukast and answer the main question: can you use montelukast for allergies?

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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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AI is having a productive time in pharma and healthcare

pharmaphorum

Two years ago the use of AI in pharma and healthcare looked to be quickly heading for what Gartner’s Hype Cycle model would term the Plateau of Productivity. After the COVID-powered digital transformations of both pharma and healthcare , there can be little doubt that artificial intelligence is already having a productive time across our sector. It could even be, as consultants GlobalData predicted back in January, this year’s most disruptive technology across the pharmaceutical industry, though

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Study explores synthetic cannabinoid for cancer-related anorexia

Outsourcing Pharma

Artelo Biosciences is investigating the viability of its novel cannabinoid product as a solution to treat cancer-related anorexia in oncology patients.

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Comparison of Oral Iron Preparations

Med Ed 101

Oral iron supplements (podcast) are the cheapest and most effective treatment for iron deficiency anemia. Iron deficiency anemia can occur commonly in infants and women with menorrhagia. For most cases of iron deficiency, oral iron supplementation is sufficient. Occasionally intravenous iron may be necessary if oral iron is insufficient or not tolerated.

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NICE says yes to Novartis’ multiple sclerosis therapy Kesimpta

pharmaphorum

Novartis has secured backing from NICE for its relapsing multiple sclerosis (RMS) therapy Kesimpta in the UK, just two weeks after the drug was approved by the national drugs regulator. . The cost-effectiveness agency has said that anti-CD20 antibody Kesimpta (ofatumumab) can be prescribed via the NHS in England and Wales as a treatment for adults with RMS with active disease, as either a first-line therapy or after alternative drugs have been tried.

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Immunomics firm reels in $14m to advance drug discovery

Outsourcing Pharma

ImmunoScape plans to use the investor funds to grow its Asia presence, expand into the US, and to further develop its Deep Immunomics platform technology.

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An Interview with Dr. Sandra Horning, 2020-21 HBA Woman of the Year

Pharma Marketing Network

Tune into an exclusive Pharma Marketing Network (PMN) interview with Amy Turnquist, a member of the PMN Editorial Advisory Board and Dr. Sandra Horning, the Healthcare Businesswomen’s Association Woman of the Year (WOTY) 2020-21. Dr. Horning holds a very special place in HBA history as the only woman to hold the WOTY title for two years. Being named HBA’s Woman of the Year is just the latest recognition in her career, having previously received the prestigious Stanford School of Medicine Excelle

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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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Switching From Brand to Generic Phenytoin

Med Ed 101

Brand to generic drug changes can occur due to demands by insurance companies. These changes are often forced due to the low costs of generic medications compared to brand name products but are there certain classes of medications where brand to generic changes may be less beneficial or potentially even harmful. It is unfortunate, but […]. The post Switching From Brand to Generic Phenytoin appeared first on Med Ed 101.

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SparingVision to buy GAMUT and potential Luxturna eye gene therapy competitor

pharmaphorum

French genomic medicines firm SparingVision has agreed to buy GAMUT Therapeutics, a biotech specialising in gene therapies for inherited eye diseases such as retinitis pigmentosa (RP) that could compete against Roche/Spark’s Luxturna in a wider patient group. . GAMUT’s lead product, now SPVN20, is a novel, mutation-agnostic gene therapy, which aims at restoring the function of dormant cone cells in the retina.

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FHIR can help tackle daunting digital challenges in research

Outsourcing Pharma

A leader from digital health solutions firm CitiusTech suggests use of fast healthcare interoperability resources is useful in the face of evolving tech.

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New advice on COVID-19 vaccination for pregnant women in UK

Pharma Times

JCVI advises pregnant women in the UK be offered COVID-19 vaccination at the same time as the rest of the population

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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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UK regulator backs Amarin’s cardiology drug Vazkepa

pharmaphorum

Amarin’s Vazkepa cardiology drug has been backed by the UK’s drugs regulator, following approval in Europe at the end of March. . The Medicines and Healthcare products Regulatory Agency (MHRA) granted a marketing authorisation for Vazkepa (icosapent ethyl) as a treatment to reduce risk of cardiovascular events in high-risk patients. These are defined as patients who have elevated triglycerides and either established cardiovascular disease or diabetes and at least one additional cardiovascular ri

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Healthware Group Acquires UK-Based SWM

pharmaphorum

SWM and Healthware Join Forces to Help Physicians Connect to Science & Learning. Salerno, Italy / London, UK | 20 April 2021 – Healthware Group , an integrated global digital health organization with a focus on strategic consulting, marketing communications, and healthcare innovation has announced its acquisition of London-based SWM (Streaming Well Motion) , a creative motion lab and consultancy focused on virtual hybrid experiences, content development, and medical education.

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EMA starts review of GSK/Vir COVID-19 antibody

pharmaphorum

The EMA has started reviewing the emergency use application for GlaxoSmithKline and Vir Biotech’s COVID-19 antibody VIR-7831, which could become the fourth drug of its type cleared for early use in the EU. . The monoclonal antibody – also known as GSK4182136 – is being evaluated for the treatment of people with mild or moderate COVID-19 who are aged over 12 and don’t need oxygen supplementation, but are considered to be at risk of developing more severe symptoms.

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NICE unveils five year plan promising faster access to medicines

pharmaphorum

NICE has included proposals to speed up evaluations and focus on new technology such as digital health in a new strategy to provide faster access to new medical treatments and innovations. . The cost-effectiveness body has produced a new vision for the next five years, after reflecting on lessons learned during the COVID-19 pandemic. NICE said the pandemic showed the importance of swiftness and flexibility and embracing new forms of innovation in healthcare technology.

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What comes next: digital transformation in B2B life sciences sales

pharmaphorum

As the contours of a post-pandemic world begin to take shape, those working B2B sales in the life sciences acknowledge that the industry must adapt to some permanent shifts. Mert Yentur looks at what is next for the industry. Even prior to COVID-19, sales teams reckoned with traditional online-only CRM systems that didn’t align well with the needs of health care providers’ customers.

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physIQ licenses virtual trial tech to Janssen in multi-year deal

pharmaphorum

Biosensor firm physIQ has licensed its technology to Johnson & Johnson’s Janssen pharma unit in a multi-year deal, to investigate use of wearable sensors in virtual clinical trials. Janssen will be able to scale up use of Chicago-based physIQ’s biosensors to support both R&D and commercial activities. The pharma company will use the technology known as accelerateIQ to collect data across its clinical studies through a variety of wearable biosensors. physIQ has a portfolio of FDA-cleared

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Healthware acquires UK creative motion lab and consultancy SWM

pharmaphorum

Healthware Group has expanded its long-standing collaboration with UK-based SWM by acquiring the creative motion lab and consultancy. Founded in London last year by Francis Mahmud Namouk and Genevieve Robson, SWM (Streaming Well Motion) is an evolution of Streaming Well , the health-focused video agency the duo set up in 2009. SWM managing director Namouk said: “Joining the Healthware Group allows us to solidify our years-long working relationship and leverage the Group’s outstanding network and

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Better Therapeutics begins ‘real world’ study of digital diabetes therapy

pharmaphorum

After announcing plans to go public, prescription digital therapeutics (DTx) firm Better Therapeutics has begun a “real world” study to test whether its BT-001 prescription cognitive behavioural therapy tool could change behaviours that are the root cause of type 2 diabetes. . The company has begun the open-label, non-randomised, controlled study to test whether the durability of treatment effect and total cost of care impact of the treatment.

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Nobel winner Charpentier’s CRISPR Therapeutics gets $900m in reworked Vertex deal

pharmaphorum

CRISPR Therapeutics is to receive a hefty $900m payment from Vertex after the companies amended a collaboration to develop, manufacture and market a gene editing therapy for sickle cell disease and beta thalassemia. Founded by Nobel prize winner Emmanuelle Charpentier, CRISPR Therapeutics has been at the forefront of gene editing technology and has refined its technology to the point where it can be used to accurately edit someone’s DNA to correct genetic conditions.

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Ohio is third state to fund Pear’s digital therapeutics to tackle addiction

pharmaphorum

A third US state has agreed to fund Pear Therapeutics’ digital therapeutics (DTx) to treat people with substance and opioid use disorders. . The company has been pushing for more reimbursement of its three marketed DTx products in the US following a first FDA approval in 2017. Pear said that the Ohio Department of Mental Health and Addiction Services (OhioMHAS) and RecoveryOhio are providing access to Pear’s FDA-approved DTx reSET and reSET-O, for treatment of substance use disorder and opioid u

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Jazz lifted by third EU approval for GW Pharma’s Epidyolex

pharmaphorum

GW Pharmaceuticals’ Epidyolex has been approved in the EU for a third epilepsy indication, giving a boost for the company ahead of its $7.2 billion takeover by Jazz Pharma. . The cannabis-derived drug has been cleared by the EMA to treat seizures associated with tuberous sclerosis complex (TSC), a condition in which mostly benign tumours grow in vital organs of the body, including the brain.

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Centessa plans $100m IPO to fund R&D and potential acquisitions

pharmaphorum

Centessa has announced plans for a $100m US IPO just weeks after the company launched with $250m in private backing and an R&D powerhouse driven by the merger of 10 biotechs. In a filing with the Securities and Exchange Commission, Centessa said it plans to use proceeds to fund the development of the 16 drugs in its pipeline, as well as potential acquisitions.

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Seqster bags $12m funding for patient data platform

pharmaphorum

Digital health player Seqster has raised $12 million in first-round financing that will be used to develop its data platform, which aims to put all a patient’s medical history in one easily-accessible place. . The Series A was led by OmniHealth Holdings, with repeat investor Takeda and Anne Wojcicki – chief executive and founder of genetic testing firm 23andMe – also contributing to the round.

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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Shares in Hikma have rallied as it resumed the launch of its generic Advair Diskus in the US, after clearing up a final piece of bureaucracy with the FDA. The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market. Advair (fluticasone+salmeterol) is approved to prevent flare-ups or worsening of chronic obstructive pulmonary disease (COPD) and prevent asthma attacks.

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The next five years of NICE: Challenges, opportunities, and the future of technology assessment

pharmaphorum

If NICE is to remain a “beacon of evidence-based medicine”, it must become more agile, more flexible, and more ready to adapt – and COVID-19 has proved that it is more than capable of doing so. NICE is about to undergo a complete transformation in a bid to get ready – and stay ready – for the future of health and social care. As reported by pharmaphorum earlier this week , the organisation’s new five-year strategy proposes to speed up evaluations, focus on new technologies such as digital health

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Prime Global appoints Emma Sutcliffe as SVP Patient Insights and Solutions

pharmaphorum

Prime Global, the international medical communications and market access group, has appointed Emma Sutcliffe as senior vice president, patient insights and solutions. Sutcliffe will lead on patient engagement and support Prime Global’s seven agencies and four consultancies to deliver patient-centric communications. She has a strong heritage in patient engagement strategy, HCP and patient education, and developing patient-driven health solutions.

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EU orders another 100m doses of Pfizer/BioNTech COVID jab

pharmaphorum

The EU has continued a refocus of its COVID-19 vaccination drive on mRNA shots, ordering another 100 million doses of Pfizer and BioNTech’s Comirnaty shot. . The new deal takes the total number of Comirnaty shots ordered by the EU for delivery this year to 600 million, and comes amid an ongoing debate about the safety of adenovirus-based vaccines from AstraZeneca and Johnson & Johnson.

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Vertex eyes controllable genetic drugs with $1.3bn Obsidian alliance

pharmaphorum

Vertex Pharma has ramped up its involvement in gene-editing medicines for the second time in a week, paying Obsidian Therapeutics $75 million upfront to access its technology platform. . Vertex is also offering up to $1.3 billion in milestone payments in the deal, which will focus on using small-molecule compounds to “fine tune” the effects of genetic medicines in the body.

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FDA approves under-pressure GSK’s Jemperli for endometrial cancer

pharmaphorum

The FDA has approved GlaxoSmithKline’s Jemperli (dostarlimab) immunotherapy, a drug acquired through its $5.1 billion acquisition of Tesaro, for certain patients with endometrial cancer. . With Jemperli , a PD-1 class drug, GSK is a latecomer to the immunotherapy party with a host of other competitors already on the market in various cancers. Merck & Co’s Keytruda (pembrolizumab) is the top seller and while it’s unlikely Jemperli will generate the level of blockbuster revenues, GSK needs to

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Calliditas eyes 2022 approval in EU for rare kidney disease drug Nefecon

pharmaphorum

Calliditas Therapeutics is on course to launch its first product, Nefecon for rare disease primary IgA nephropathy (IgAN), in the first half of 2022 after getting the green light for an accelerated review by the EMA. . The Swedish biotech is planning to file Nefecon for approval in the second quarter to the EU regulator, which will review the dossier in 150 days rather than the usual 210, as Nefecon could become the first ever approved therapy for IgAN.