Sat.Aug 07, 2021 - Fri.Aug 13, 2021

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Gene therapy specialist bluebird exits “untenable” European market

pharmaphorum

Europe market has proved so hostile to gene therapies when it comes to pricing and reimbursement for gene therapies that bluebird bio has decided to quit the market altogether, according to Andrew Obenshain, president of its severe genetic diseases unit. On the firm’s second-quarter results call, Obenshain said the biotech will start “an orderly wind-down” of its activities in Europe and seek “strategic alternatives” to make its therapies available to patients there

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Virtual reality technology transforming COVID-19 drug discovery

Outsourcing Pharma

Nanomeâs virtual reality tech is being put to use by Oak Ridge National Laboratory and top pharma firms to study COVID-19 and explore drug candidates.

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Trending Sources

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Health Canada’s proposed amendments to the Food and Drug Regulations and the Medical Devices Regulations

Pharma in Brief

On July 31, 2021, Health Canada published a Notice of Intent outlining its plan to amend the Food and Drug Regulations ( FDR ) and the Medical Devices Regulations in the spring of 2022. The proposed amendments are intended to modernize the Canadian therapeutic product regulatory system at every stage of products’ lifecycles from authorization to post-market.

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Ep. 014 – RJ Lewis and Diane Bartoli of ePocrates Discusses the State of eCME – August 9, 2021

Pharma Marketing Network

Tune in with the Pharma Marketing Network for an insightful conversation with R.J. Lewis and Diane Bartoli, VP and General Manager of epocrates, as she shares her background with eCME, how COVID-19 has been driving it’s rapid growth, the other digital channels that have come into play, the term “snackable eCME” and how we can expect eCME to trend in a post-COVID sense.

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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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Sensyne, Oxford University deploy AI to find asthma targets

pharmaphorum

Oxford University and UK clinical artificial intelligence (AI) company Sensyne Health will partner on a project to find new drug targets for people with hard-to-treat asthma. It’s estimated that almost one in five people with asthma find it difficult to control symptoms using current therapies, while around 4% have particularly severe forms that puts them at risk of life-threatening attacks.

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Philip Morris acquires another inhaled-drug pharma firm

Outsourcing Pharma

The US-based company continues its move away from smoking products with the purchase of drug developer OtiTopic, as part of its Beyond Nicotine initiative.

More Trending

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Michael Pollan’s ‘Trip Report’

NY Times

The author discusses his psychedelic journey and why the government embraces some drugs while waging a war against others.

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BioNTech says repeat doses may be better than modified COVID-19 jab

pharmaphorum

BioNTech has suggested that giving booster doses of its current Comirnaty (BNT162b2) COVID-19 vaccine may be a preferable strategy to modifying the Pfizer-partnered shot. The comments came on the German biotech’s second-quarter results call, during which BioNTech raised its forecasts for revenues it will book from sales of the vaccine to €15.9 billion (almost $19 billion), on the back of contracts to deliver 2.2 billion doses this year with more than 1 billion already booked in for 2022.

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Importance of achieving true patient centricity in clinical trials

Outsourcing Pharma

A leader from Longboat by Advarra outlines what it really means for a study to be patient centric, and how to succeed in achieving patient-centric trials.

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bluebird bio re-evaluates gene therapy strategy in ‘untenable’ European market

Pharma Times

US biotech company says European payers have ‘not yet evolved their approach to gene therapy’

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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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F.D.A. Approves GHB, a ‘Date Rape’ Drug, for Rare Sleeping Disorder

NY Times

Jazz Pharmaceuticals brought in more than $1.7 billion last year selling GHB to narcolepsy patients. With the new approval, sales could soar.

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Social Health: The Future of Healthcare Marketing

pharmaphorum

With advertisers preparing to spend up to $15 billion on influencer marketing by 2022, pharmaceutical and biotech companies are increasingly (and carefully) engaging trusted health social influencers to connect more authentically with consumers. As pharma starts to leverage a multitude of high-engagement channels like influencer marketing, online communities and virtual health services, the industry finds itself in a unique position to reimagine traditional direct-to-consumer (DTC) efforts and p

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UIC studying IV drug as potential COVID-19 treatment

Outsourcing Pharma

The University of Illinois at Chicago has been given $6m from the US Department of Defense to develop a potential treatment for severe cases of COVID-19.

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FDA approves Keytruda plus Lenvima for advanced kidney cancer

Pharma Times

Combination treatment reduced the risk of disease progression or death by 61% versus Sutent

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Part B Update: Hospitals Keep Displacing Physicians—And More Practice Acquisitions Loom

Drug Channels

The Medicare Payment Advisory Commission (MedPAC), the independent agency that advises Congress on the Medicare program, recently released its latest Health Care Spending and the Medicare Program databook. This annual report is a treasure trove of useful and fascinating data. The July 2021 edition provides us with the latest pre-pandemic details on the buy-and-bill market in Medicare Part B.

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AZ gets European approvals for Forxiga in chronic kidney disease

pharmaphorum

AstraZeneca’s Forxiga has become the first SGLT2 inhibitor to be approved in Europe for use in people with chronic kidney disease, extending its lead over rival drugs in the class. The European Commission has cleared Forxiga (dapagliflozin) for CKD in adults with or without diabetes, and the drug becomes the first new drug treatment for these patients in more than two decades.

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Current FDA COVID-19 related actions and advice

Outsourcing Pharma

The US Food and Drug Administration has kept its staff busy with approvals, authorizations, and warnings related to various coronavirus-centered products.

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Entry closing next month for the 2021 Communications Awards

Pharma Times

The 2021 Communications Awards will be closing its doors for entry on the 10th of September.

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Three Factors to Determine the Best e-Support Services Provider for Your Brand

Drug Channels

Today’s guest post comes from Stacey Little, Senior Vice President of Business Development and Marketing at AssistRx. Stacey discusses how a patient support vendor can help specialty pharmacy patients attain prior authorizations and access critical therapies. She offers three criteria that manufacturers can use to evaluate e-support services providers.

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UK cues up more Pfizer/BioNTech vaccines as price row looms

pharmaphorum

The UK government has started ordering COVID-19 vaccines for a 2022 booster campaign, including a 32 million-dose order for the Pfizer/BioNTech shot, even before third doses for 2021 have been given the go-ahead. A report in The Times claims that the government is paying £22 a dose – up from an earlier price of £18 – for the Pfizer/BioNTech vaccine as part of a £1 billion deal for additional supplies, which is needed because existing stocks will be depleted next year.

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WHO COVID-19 trial moves ahead with three drug candidates

Outsourcing Pharma

The World Health Organizationâs Solidarity PLUS trial will kick off in 52 countries, trialing three drugs to treat patients hospitalized with COVID-19.

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Entry closing in 1 month for the 2021 Marketer of the Year

Pharma Times

The 2021 Marketer of the Year competition will be closing for entry on the 10th of September.

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New patent for Boehringer Ingelheim drug PRADAXA

Drug Patent Watch

Annual Drug Patent Expirations for PRADAXA Pradaxa is a drug marketed by Boehringer Ingelheim and is included in two NDAs. It is available from three suppliers. There are five patents…. The post New patent for Boehringer Ingelheim drug PRADAXA appeared first on DrugPatentWatch - Make Better Decisions.

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FDA starts speedy review of Keytruda for adjuvant kidney cancer

pharmaphorum

Merck & Co is looking at a decision from the FDA in December on its application to market Keytruda as a post-surgery treatment for people with kidney cancer, after a priority review. The drugmaker – known as MSD outside the US and Canada – is seeking approval of Keytruda (pembrolizumab) as an adjuvant treatment for renal cell carcinoma (RCC) patients who have undergone surgery for the cancer and are at risk of relapse.

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BMS joins with Black colleges to increase pharma talent diversity

Outsourcing Pharma

The pharma firm is working with five US colleges and universities onto create programming designed to boost recruitment of Black talent in the industry.

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Enhertu improves progression-free survival in breast cancer trial

Pharma Times

Trial compared Enhertu with T-DM1 in patients with HER2-positive breast cancer

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New patent expiration for Genzyme Corp drug CAPRELSA

Drug Patent Watch

Annual Drug Patent Expirations for CAPRELSA Caprelsa is a drug marketed by Genzyme Corp and is included in one NDA. It is available from one supplier. There are four patents…. The post New patent expiration for Genzyme Corp drug CAPRELSA appeared first on DrugPatentWatch - Make Better Decisions.

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Telstra buys MedicalDirector, plugging gap in its digital health range

pharmaphorum

Australian telecommunications giant Telstra has reached a deal to acquire MedicalDirector, a company specialising in software used by GPs to manage their practices. Telstra Health – the Australian group’s digital health arm – is paying A$350 million ($257 million) to buy MedicalDirector from investment company Affinity Equity Partners, which bought the company from former owner Healius for A$155 million in 2016.

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Study examines long-term effects of COVID-19 on athletes' hearts

Outsourcing Pharma

The Heart of Athletes study, using Deloitteâs ConvergeHealth MyPath for Clinical platform, aims to examine heart inflammation in athletes with the virus.

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New joint venture aims to 'open' funding opportunities for early medicines discovery

Pharma Times

Collaboration will drive medicines discovery in areas of unmet patient need

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Sunny White

Pharma Marketing Network

Sunny drives the promotion of global brands for pharmaceutical, biotech and medical. device. She founded Xavier Creative House (XCH), a healthcare marketing agency that. builds BOLD and EVOCATIVE designs, pushing the edge of creativity. Sunny is the point person for positioning your brand into a “Powerhouse.” As, CEO, she leads Operations and Client Management utilizing a wealth of experience gained from her roles in communications, compliance, and sales in rapid-growth companies.

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Shaping the future of ovarian cancer diagnosis with femtech

pharmaphorum

Israeli femtech start-up GinaLife is developing a platform of biomarker strategies supported by artificial intelligence and data science for the early detection of problems in women’s health. CEO and co-founder Inbal Zafir-Lavie tells pharmaphorum more. Six years ago, research scientist Inbal Zafir-Lavie tragically lost her 38-year-old sister Hava Zafir to colorectal cancer.

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New patent for Genentech Inc drug XOFLUZA

Drug Patent Watch

Annual Drug Patent Expirations for XOFLUZA Xofluza is a drug marketed by Genentech Inc and is included in two NDAs. It is available from two suppliers. There are six patents…. The post New patent for Genentech Inc drug XOFLUZA appeared first on DrugPatentWatch - Make Better Decisions.

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FDA approval for Xywav for idiopathic hypersomnia in adults

Pharma Times

First and only FDA-approved treatment for the neurological sleep disorder

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Understanding placebo response, patient personality vital

Outsourcing Pharma

A leader from Tools4Patient discusses the importance understanding ties between the two in reducing the impact of the placebo response in clinical trials.

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