Sat.Aug 14, 2021 - Fri.Aug 20, 2021

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F.D.A. Aims for Full Approval of Pfizer Covid Vaccine on Monday

NY Times

Federal regulators are winding down the process of licensing Pfizer’s two-dose coronavirus vaccine, setting up an approval possibly by Monday and possibly kicking off a wave of new mandates.

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Beckley Psytech raises $80m for psychedelic meds development

pharmaphorum

UK psychedelic medicine specialist Beckley Psytech has raised an impressive £58 million (around $80 million) in an oversubscribed second-round financing that will help fund clinical development of its psilocybin-based therapies. The Oxford-based company had originally hoped to raise $50 million from the series B, and the scale of the financing is further evidence that repurposing psychedelic compounds as potential therapies for neuro-psychiatric disorders is a hot topic in biopharma.

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Upcoming workshop on generic portfolio management

Drug Patent Watch

I’ll be leading a workshop on generic portfolio management, and also giving a talk, at the 14th annual Marcus Evans event on Portfolio Planning and Partnerships for Generics. The event…. The post Upcoming workshop on generic portfolio management appeared first on DrugPatentWatch - Make Better Decisions.

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Welireg approved in US for rare VHL-associated cancers

Pharma Times

VHL is a rare genetic disease which puts patients at risk of developing benign blood vessel tumours and several cancers

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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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Covid Vaccines Produced in Africa Are Being Exported to Europe

NY Times

Johnson & Johnson is sending shots from South Africa to other parts of the world. African countries are waiting for most of the doses they’ve ordered.

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Merck kicks off oral COVID-19 antiviral filing in Canada

pharmaphorum

Health Canada has started a rolling review of Merck & Co’s molnupiravir, an oral antiviral therapy treatment for COVID-19 partnered with Ridgeback Biotherapeutics. The Canadian regulator will start reviewing early safety, quality and efficacy data for the drug while late-stage clinical trials are still underway, in the hope of approving the drug quickly of results are positive.

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More Trending

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NICE’s health technology assessment methods and processes to be evaluated

Pharma Times

Public consultation launches on proposed changes aiming to provide earlier access to new treatments

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SAVE THE DATE: PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 – Sep. 16th

Pharma Marketing Network

SAVE THE DATE – PMN Fall 2021 Summit: Pharma-Marketing Innovations & Trends of 2021 | SEP. 16th, 12:00PM – 1:30PM EST. SAVE YOUR SEAT TODAY. Telehealth: Is It Here to Stay? Once considered a novelty, over the past 18 months, Telehealth has risen to a prominent position in the continuum of care. Pharmaceutical brands must adapt to this new modality and pivot their promotional efforts to ensure that they can leverage the Telehealth channel effectively.

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NICE says yes to Novartis’ Rydapt for rare blood disorder

pharmaphorum

Novartis’ Rydapt has become the first and only licensed treatment for rare and life-threatening blood disorder systemic mastocytosis (SM) to be cleared for routine NHS use, after getting a green light from NICE. The decision means around 170 people with advanced SM in England and Wales will be eligible for treatment with oral, twice-daily drug, which since 2018 has also been cleared for NHS treatment of a form of acute myeloid leukaemia.

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New patent for Boehringer Ingelheim drug GLYXAMBI

Drug Patent Watch

Annual Drug Patent Expirations for GLYXAMBI Glyxambi is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are eleven patents…. The post New patent for Boehringer Ingelheim drug GLYXAMBI appeared first on DrugPatentWatch - Make Better Decisions.

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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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Accenture survey reflects changing patient experiences

Outsourcing Pharma

The check-in with nearly 1,800 US healthcare consumers reflects how COVID-19 and other factors have impacted patient access, equity, experience and trust.

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GSK, CureVac’s COVID-19 vaccine candidate shows promise in preclinical study

Pharma Times

Preclinical study shows high protective efficacy in primates for Beta, Delta and Lambda variants

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Global regulators seek permanent working group on AI

pharmaphorum

Rapid advances in the use of artificial intelligence (AI) in healthcare and medicines development are at risk of outstripping current regulatory frameworks, according to a new report. The International Coalition of Medicines Regulatory Authorities (ICMRA) has recommended that a new permanent working group be set up to keep tabs on the use of AI and make sure that regulations can accommodate new developments.

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Sacklers Threaten to Pull Out of Purdue Pharma Opioids Settlement

NY Times

In a rare court appearance, David Sackler said he and his family would withdraw their pledge to pay $4.5 billion, unless they are granted broad legal immunity.

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Trial complexity, info explosion driving data management evolution

Outsourcing Pharma

A leader from Veeva Systems shares perspective on what factors are impacting clinical trial data management, and how the industry can adapt to the changes.

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MHRA nod for Moderna’s COVID-19 vaccine for 12- to 17- year-olds

Pharma Times

UK regulator confirms vaccine is “safe and effective” in this age group

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Organicell on regenerative medicine: the pharmaphorum podcast

pharmaphorum

In the latest episode of the podcast Dominic Tyer speaks with Dr Maria Ines ‘Mari’ Mitrani, chief science officer at the clinical-stage biopharmaceutical company Organicell Regenerative Medicine. They looked at the development of regenerative medicine and where Organicell hopes to add to that field. Then, with the company pivoting to try and help tackle Covid, they also discussed how that change was made possible and where Organicell’s focus will be.

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Why GoodRx—Not Amazon—May Be the True PBM Disrupter

Drug Channels

The generic prescription market is being disrupted—but not by the big, bad spaceman from Seattle. Instead, consider how GoodRx is affecting patients, payers, and PBMs. Below I summarize the latest financial results for GoodRx’s discount card business. We estimate that the company accounted for $4.1 billion in U.S. prescription revenues for 2021. That’s about six times its 2016 figure.

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Secure pharma supply chain requires connections, information

Outsourcing Pharma

A representative from Clarivate explains how supply chain vulnerabilities can hurt stakeholders, including patientsâand how one solution can close the gap.

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US approval for Boehringer Ingelheim, Lilly's heart failure drug Jardiance

Pharma Times

Jardiance reduced risk of death or hospitalisation by 25% for adults with heart failure with reduced ejection fraction

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Health Innovators: PureTech Health’s Daphne Zohar

pharmaphorum

In latest episode of our Health Innovators video interview series, Dr Paul Tunnah speaks to Daphne Zohar, the co-founder and CEO of PureTech Health. They discuss the publicly-listed biotech’s pipeline projects and focus on the BIG (brain-immune-gut) axis as well as PureTech’s interest in digital therapeutics. Daphne explains how she built an impressive team of board advisors for her company, plus the challenges and experience of fund raising.

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What to Know About Boosters if You Got the Johnson & Johnson Vaccine

NY Times

Health experts say that boosters are likely to be needed eventually and that more data should be available in the next several weeks.

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Paige, Perspectum forge AI-centered clinical trial alliance

Outsourcing Pharma

The digital pathology firm and image-analysis software developer will partner on artificial intelligence based solutions to improve trial decision making.

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FDA fast tracks breast cancer candidate samuraciclib

Pharma Times

Carrick Therapeutics’ oral CDK7 inhibitor may improve patient outcomes

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Does draft RCT guide set the scene for future trials?

pharmaphorum

A common set of standards for randomised clinical trials (RCTs) aims to help researchers develop the drugs and interventions of the future – no matter what they do or where they are based. The Good Clinical Trials Collaborative (GCTC) has published a draft guidance document, and is asking for the life sciences sector to make its views known. The publication, which is out for public consultation until 15 September, said RCTs played a central role in generating the evidence needed to inform the de

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Richard Sackler Says Family and Purdue Bear No Responsibility for Opioid Crisis

NY Times

In a rare courtroom appearance, the former Purdue Pharma president and board member was evasive and defiant.

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3D tablet printing needs the right excipient: DFE Pharma

Outsourcing Pharma

The excipients specialist shares findings from its research into the ins and outs of 3D powder bed printed tablets and how it can benefit drug development.

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Beckley Psytech raises £58m to advance psychedelic medicines pipeline

Pharma Times

The funding will be used to complete an ongoing Phase Ib trial with low-dose psilocybin

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BMS buys into AI-designed immune drug from Exscientia

pharmaphorum

Bristol Myers Squibb has exercised an option on an immune-modulating drug candidate developed by UK artificial intelligence specialist Exscientia, paying $20 million for the buy-in as part of their $1.2 billion alliance. The unnamed drug candidate acts on an immunological kinase enzyme, which has proven hard to target using conventional drug discovery techniques because challenges relating to “potency, selectivity, and overall drug-like properties,” according to the partners.

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Living With O.C.D. in a Pandemic

NY Times

Covid made things worse for many people with obsessive-compulsive disorder. But it also came with a silver lining.

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Orally disintegrating tablets offer range of patient benefits: Roquette

Outsourcing Pharma

A leader from the excipients firm discusses how ODTs appeal to seniors and patients on the go, and the formulation-related challenges with such tablets.

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Accelerated FDA approval for GSK’s Jemperli

Pharma Times

Indicated for the treatment of of dMMR recurrent or advanced solid tumours

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Amid Actemra shortage, WHO asks Roche to ensure equitable access

pharmaphorum

Roche’s arthritis drug Actemra has become a key treatment for people with severe COVID-19, leading to shortages, and the World Health Organisation (WHO) wants the company to ensure that supplies don’t just go to wealthy countries. Earlier this week Roche’s Genentech unit said it was facing unprecedented demand for Actemra (tocilizumab) – known as RoActemra in some markets – caused by the highly-transmissible spread of the delta variant of SARS-CoV-2.

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Leveraging Mobile Patient Support to Boost Adherence

Drug Channels

Today’s guest post comes from Ian Ocilka, Senior Vice President of Client Solutions at ConnectiveRx. . Ian discusses how mobile platforms like mobileCare Manager can boost patient adherence to specialty therapies. To learn more, register for ConnectiveRx's free panel discussion on September 15, 2021, at 1:00 p.m. ET. Email inquiries@ConnectiveRx.com with any questions.

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New patent for Astrazeneca Ab drug BYDUREON PEN

Drug Patent Watch

Annual Drug Patent Expirations for BYDUREON+PEN Bydureon Pen is a drug marketed by Astrazeneca Ab and is included in one NDA. It is available from one supplier. There are twenty-two…. The post New patent for Astrazeneca Ab drug BYDUREON PEN appeared first on DrugPatentWatch - Make Better Decisions.

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