Sat.Aug 29, 2020 - Fri.Sep 04, 2020

article thumbnail

MHRA publishes guidance on medicine regulation after Brexit

pharmaphorum

The UK’s medicines regulator has published long-awaited guidance on regulation of medicines and medical devices as the UK approaches the end of its Brexit transition period at the end of the year. This would see the UK mirroring decisions made by the European Medicines Agency, while also laying out a process should companies wish to file for a separate approval in the UK.

article thumbnail

COVID-19 treatment study predicts adverse drug events

Outsourcing Pharma

Innovative research by Tabula Rasa Healthcare uses simulation technology to analyze potential adverse drug events of potential therapies for the virus.

98
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Medical Device Innovation Summit: India is poised to be a manufacturing hub for medical equipments and devices

Pharma Mirror

The first digital session of Medical Device Innovation Summit concludes on a positive note with industry leaders addressing burning topics to promote innovation in the medical equipment industry. From challenges like lack of regulatory systems to its new found potential of manufacturing indigenous products on a large scale, the summit successfully addressed discussions on new.

80
article thumbnail

UK launch for Novo's new diabetes pill

Pharma Times

Rybelsus is the world’s first and only oral GLP-1 receptor agonist

59
article thumbnail

From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

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

article thumbnail

Mobio closes $1.8m seed fund to develop meditation app

pharmaphorum

Digital health firm Mobio Interactive has closed a $1.8 million seed fund to advance development of its meditation app Am Mindfulness. Mobio said that the app, known as Am for short, is the first and only meditation app to outperform placebo in randomised controlled trials. MI’s Seed raise was led by the Singapore-based Verge HealthTech Fund along with Atlas Asset Management , Creative Ventures and VC giant SOSV.

122
122
article thumbnail

Front-line physicians offer COVID-19 insights

Outsourcing Pharma

A recent study from healthcare insights company Sermo shares information and perspectives that trial and pharma professionals could learn from.

96

More Trending

article thumbnail

Immunotherapies could target aggressive pancreatic cancer, research indicates

Pharma Times

Scientists have discovered that hard-to-treat pancreatic cancer hijacks a key immune system response

article thumbnail

Compass plans $100m IPO to fund magic mushroom depression drug

pharmaphorum

UK biotech Compass Pathways is planning a $100 million US IPO as it seeks to further develop its depression treatment based on psilocybin – an active ingredient that can be found in magic mushrooms. In a filing with the US financial regulator Compass laid out its plans to develop the drug known as COMP360, which is a crystalline formulation of psilocybin in phase 2b clinical development in patients who have not responded to standard therapy for depression.

article thumbnail

COVID-19 report shares insights on potential therapies

Outsourcing Pharma

A new scientific report offers a comprehensive review of protein targets, associated COVID-19 drug candidates to date and other revealing information.

79
article thumbnail

Jacobson Pharma Collaborates with Fosun Pharma Group to Supply Potentially 10 Million Doses of BioNTech SE’s COVID-19 Vaccine Candidate in Hong Kong and Macau

Pharma Mirror

Jacobson Pharma Corporation Limited (“Jacobson Pharma” or the Group”; Stock Code: 2633.HK), a leading company engaged in the research, development, production, marketing and sale of essential medicines and branded healthcare products in Hong Kong, announced the signing of a letter of intent (“Letter of Intent”) with Fosun Industrial Co.

article thumbnail

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.

article thumbnail

Janssen disappointed with second NICE no for Spravato

Pharma Times

NICE has concerns with the evidence submitted but Janssen insists the nasal spray is a cost-effective use of NHS resources

52
article thumbnail

NICE rejects Janssen’s depression spray Spravato for second time

pharmaphorum

NICE has rejected regular NHS funding for Janssen’s depression spray Spravato (esketamine) for a second time, although the company says it could salvage the situation by providing further data and “additional discussions”. This will likely see the company drop its price further after already offering a commercially confidential discount to the NHS following European approval late last year.

115
115
article thumbnail

Elligo: increasing diversity can elevate trials

Outsourcing Pharma

A company leader outlines the importance of increasing diversity in clinical trial patient populations, and how researchers can improve their results.

68
article thumbnail

Video: A Major Driver of U.S. Digital Display Ad Spending Growth in 2020 and Beyond

Pharma Marketing Network

Despite the COVID-19 pandemic, digital display advertising will continue to grow this year with more investments in video ads. According to eMarketer, U.S. advertisers will increase investments in video by 11.3% this year to $35.45 billion, making it the only digital ad format to grow at a double-digit rate this year. For the first time ever, video will account for more than a quarter of all U.S. digital ad spending.

52
article thumbnail

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.

article thumbnail

EU OKs paediatric use of Gilead's Epclusa

Pharma Times

The decision allows use of the therapy in the EU in children as young as six years of age

52
article thumbnail

GSK opens £10m AI hub in London

pharmaphorum

GlaxoSmithKline is opening a £10 million artificial intelligence (AI) research hub in King’s Cross, London, according to a press report. The area is being reimagined as a life sciences and technology hub and is already home to the Francis Crick Institute biomedical research organisation. King’s Cross is also home to Google’s DeepMind artificial intelligence company, which has already been involved in life sciences projects such as using the technology to predict acute kidney injury.

114
114
article thumbnail

IntelGenx, ATAI partner on film-based psychedelics

Outsourcing Pharma

The companies will join forces to use IntelGenxâs polymeric film technologies for development of pharmaceutical-grade psychedelic drug treatments.

63
article thumbnail

Not All Statins Interact With Grapefruit Juice

Med Ed 101

Drug food interactions are common and there can be significant negative consequences from these interactions. A common misconception amongst healthcare professionals who may not have as much experience with drug interactions is that ALL statins interact with grapefruit juice. I have heard and read this type of comment before, and it is not true. Grapefruit […].

40
article thumbnail

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.

article thumbnail

Janssen's lead coronavirus vaccine shows preclinical promise

Pharma Times

The findings have validated confidence in the experimental vaccine, the firm noted

article thumbnail

Highlight Therapeutics trials second-line melanoma combo after immunotherapy fails

pharmaphorum

Cancer immunotherapy has set new standards in care, with some impressive responses in those patients lucky enough to respond. But many patients still do not respond to therapies such as Merck & Co’s anti PD-1 therapy Keytruda (pembrolizumab), or go on to develop progressive disease, and pharma companies are looking for new second-line therapies.

article thumbnail

Thermo Fisher expands cryo-EM access

Outsourcing Pharma

The company intends to enable pharma and biotech companies to have greater access to cryo-electronic microscopy for their research projects.

59
article thumbnail

Paroxetine in Pregnancy – Why not?

Med Ed 101

If you are a healthcare professional, inevitably, questions about the use of antidepressants in pregnancy come up in clinical practice. Why is paroxetine generally avoided in pregnancy? The primary reason that paroxetine is avoided in pregnancy is that it has demonstrated fetal risks. Through the previous FDA rating system, it was considered an FDA pregnancy […].

FDA 40
article thumbnail

BMS bags US approval for Onureg

Pharma Times

The oral therapy can be used as continued treatment for adults in first remission with acute myeloid leukaemia (AML)

51
article thumbnail

Sanofi and GSK begin clinical trials of coronavirus vaccine

pharmaphorum

Sanofi and GlaxoSmithKline have begun clinical trials of their coronavirus vaccine, as AstraZeneca expanded studies of its rival into Japan. The French pharma in April joined forces with the UK’s GSK to produce the vaccine, with Sanofi contributing an antigen that produces the immune reaction. Meanwhile GSK is producing the booster that reduces the amount of active ingredient necessary to produce an effect.

Vaccines 106
article thumbnail

People on the Move: September 2020

Outsourcing Pharma

Learn about the latest appointments, acquisitions, awards and other news in life sciences, involving Florence, Nanoform and other notable companies.

52
article thumbnail

A sea-change for pharma? Pandemic commercial models and launch

pharmaphorum

Sarah Rickwood looks at how COVID-19 is changing pharma’s commercial models and launch strategies. The terrible pandemic crisis we’ve had as our daily companion for six months is far from over, in part because it is in fact not one crisis, but three. There’s the initial pandemic crisis, which wreaked havoc on communities and stretched urgent care systems to the brink; the consequent healthcare system crisis, where the knock-on effects of the pandemic are still playing out in non-COVID patients a

article thumbnail

Gilead licenses Jounce immunotherapy for $800m

pharmaphorum

Gilead has joined forces with biotech Jounce Therapeutics to licence its immunotherapy JTX-1811 in a deal worth more than $800 million. The drug, JTX-1811, is a monoclonal antibody designed to selectively deplete immunosuppressive tumour-infiltrating T regulatory (TITR) cells. . The drug targets CCR8, a chemokine receptor enriched on TITR cells. When JTX-1811 binds to CCR8, it targets TITR cells for depletion by an enhanced antibody-dependent cellular cytotoxicity mechanism. .

article thumbnail

How a flock of birds can help solve complex healthcare market research challenges

pharmaphorum

Bilal Babar from THE PLANNING SHOP tells us how the movement of birds and Swarm Technology have helped develop multiple market research tools. Flocks of birds wheeling, swooping and gliding in unison, as if choreographed, are a wonderful sight. The benefit to members of the flock are many including safety from predators, more eyes to spot food and natural selection – those that can’t keep up or fly in a very densely populated flock and make such sharp turns without colliding don’t survive.

article thumbnail

AZ expands phase 3 trials of COVID-19 vaccine frontrunner into US

pharmaphorum

AstraZeneca has expanded development of COVID-19 vaccine AZD1222 into the US, beginning a phase 3 clinical trial across all adult age groups. The UK pharma said that the trial will recruit up to 30,000 adults aged 18 years or over to assess the safety, efficacy and immune response. AZ already has late-stage trials ongoing in the UK, Brazil and South America, with trials planned to start in Japan and Russia, recruiting up to 50,000 patients globally.

article thumbnail

Rises in non-submissions to NICE: do they matter?

pharmaphorum

Leela Barham asks why companies may choose to not submit their drugs to NICE and keep them off routine commissioning – a trend that appears to be on the rise. Appraisal of a treatment by the National Institute for Health and Care Excellence (NICE) is voluntary; companies can simply choose not to submit, resulting in a statement from NICE that the appraisal was terminated due to non-submission.

64
article thumbnail

Novo launches type 2 diabetes pill in UK after NICE waives review

pharmaphorum

Novo Nordisk has launched its type 2 diabetes pill Rybelsus (semaglutide) in the UK, after cost-effectiveness watchdog NICE decided that there was no need to review it. After EU approval in April Novo said it had priced Rybelsus at parity with rival GLP-1 drugs in the UK, and NICE will not perform a single technology appraisal as a result, allowing the company to begin negotiations in England and Wales to get the drug included on NHS formularies.

article thumbnail

Canada signs deals for J&J, Novavax COVID vaccines

pharmaphorum

The Canadian government has reached agreements in principle with J&J and Novavax to buy their coronavirus vaccine candidates. Under the agreement with J&J, Canada would purchase up to 38 million doses of Janssen’s Ad26.COV2.S vaccine candidate on a not-for-profit basis for emergency pandemic use. Meanwhile, Novavax has agreed to supply up to 76 million doses of its candidate in the event of the vaccine gaining approval in the country.

article thumbnail

In the precision medicine era, the line between products and services is blurred

pharmaphorum

Personalized and precision medicines are exciting fields that focus on the development of treatment and prevention strategies for a single patient or patient group. The treatments are developed using cutting- edge technologies such as genomic sequencing and genetic engineering, helping to account for the individual variability in both patient and disease characteristics.