pharmaphorum

JULY 23, 2021

Could virtual reality tools be effective in helping patients ‘unlearn’ their chronic pain? p harmaphorum speaks to Professor Christopher Eccleston from the University of Bath’s Centre of Pain Research to find out how digital therapeutics are shaping the future of pain management. A digital software developed by Finnish drugmaker Orion is aiming to address chronic pain conditions using virtual reality (VR) devices that provide an immersive gamified therapeutic treatment program.

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Pharma Times

JULY 22, 2021

Verquvo cleared for the treatment of symptomatic chronic heart failure in patients with reduced ejection fraction

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Outsourcing Pharma

JULY 19, 2021

A recent study indicates patients taking the cholesterol-lowering drugs prior to COVID hospitalization are far less likely to die as a result of the virus.

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Hospitals 111

Drug Patent Watch

JULY 22, 2021

Annual Drug Patent Expirations for LENVIMA Lenvima is a drug marketed by Eisai Inc and is included in one NDA. There are five patents protecting this drug and one Paragraph…. The post New patent for Eisai Inc drug LENVIMA appeared first on DrugPatentWatch - Make Better Decisions.

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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.

pharmaphorum

JULY 22, 2021

Pfizer has pledged a whopping $1 billion upfront for rights to an Arvinas drug for breast cancer from its protein degrader platform, which harnesses cells’ natural protein-denaturing machinery to remove rogue proteins associated with disease. The deal focuses on ARV-471, currently in phase 2 testing for advanced breast cancer patients whose tumours expresses oestrogen receptors – so are hormone sensitive – but test negative for HER2 receptors that would make them candidates for treatment w

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Pharma Times

JULY 23, 2021

Real-world data shows jab is effective after one dose against hospitalisation/death caused by Beta and Delta variants

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Drug Patent Watch

JULY 21, 2021

Annual Drug Patent Expirations for GOCOVRI Gocovri is a drug marketed by Adamas Pharma and is included in one NDA. It is available from one supplier. There are fifteen patents…. The post New patent for Adamas Pharma drug GOCOVRI appeared first on DrugPatentWatch - Make Better Decisions.

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pharmaphorum

JULY 23, 2021

GlaxoSmithKline has said that Brian McNamara – currently head of its three-year-old consumer health joint venture with Pfizer – will retain the top job at the business after it is hived off into a separate company next year. The appointment, which had been expected, was confirmed in a statement by GSK’s board today. McNamara has been with GSK since 2015, when he joined the company as head of consumer health for Europe and the Americas, and previously worked for 10 years at Novartis, ultima

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Pharma Times

JULY 20, 2021

A therapeutic dose of regdanvimab also reduced the viral load of the SARS-CoV-2 virus and inflammation in the lungs

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NY Times

JULY 20, 2021

Many who received the shot may need to consider boosters, the authors said. But federal health officials do not recommend second doses.

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Eye on FDA

JULY 19, 2021

It has been a regular feature of the blog to give a read on what FDA has been talking about, at least through the form of press releases. It is not always an easy task because the nature of FDA’s practice in this respect has evolved over time. But here is what we see looking at the first 6 months 2021, and comparing it to mid-years past. You may recall from the last posting on this topic at the beginning of the year, during 2020, FDA had a lot to say – a real lot, and that isn’

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Labelling Communication Vaccines 93

pharmaphorum

JULY 22, 2021

In just over a year, Celltrion Healthcare says it has identified and delivered a potential treatment for COVID-19. pharmaphorum spoke to Kwon Ki-sung, Head of Celltrion’s R&D unit, to learn more. Celltrion’s COVID-19 therapeutic, CT-P59, is a monoclonal antibody (mAb) with activity against COVID-19. It was identified as a potential treatment through the screening of antibody candidates from recovered patients and selecting those that showed the highest potency in neutralising the SARS-CoV-2

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Pharma Times

JULY 23, 2021

NHS England has set out new plans to introduce five new waiting time guarantees for mental health services

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Outsourcing Pharma

JULY 20, 2021

The pharma firm's partnership with 26 US Black colleges includes a $13.7m investment in trial and research centers at Morehouse School of Medicine.

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NY Times

JULY 21, 2021

The agreement would allow funds to begin flowing from the companies to states and communities to pay for addiction and prevention services.

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pharmaphorum

JULY 21, 2021

Think of the R&D dollars that could be saved if artificial intelligence (AI) modelling could tell you at an early stage whether a drug was likely to succeed in clinical trials, and ultimately reach the market. In 2019, a team at Massachusetts Institute of Technology (MIT) in the US came up with just such a model, and found that it was able to perform “better than random” at predicting the outcome of a clinical trial or development programme.

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Pharma Times

JULY 22, 2021

PFIC is a rare and progressive liver disease affecting young children which can lead to cirrhosis and liver failure

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Outsourcing Pharma

JULY 19, 2021

The World Health Organization hopes to encourage the development of novel therapies for tuberculosis by spotlighting key clinical study characteristics.

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NY Times

JULY 19, 2021

Though some of its own senior officials said there was little evidence of benefit for patients, the F.D.A. nonetheless greenlighted Biogen’s Aduhelm, or aducanumab.

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Labelling 73

pharmaphorum

JULY 20, 2021

EPG Health’s Allen Wellings assesses future symposia and congress models, outlining some learnings about content and reach. COVID-19 had a huge, and very obvious, initial impact on medical congresses and symposia when 2020’s lockdowns took effect, with many events struggling to move quickly enough to a purely digital format. While many did succeed in creating digital learning environments during those difficult early months of the pandemic, there are some clear learnings for pharma companies in

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Pharma Times

JULY 23, 2021

Microbiome-based therapeutic failed to improve clinical remission rates among mild-to-moderate ulcerative colitis patients

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Pharma Mirror

JULY 23, 2021

Immunotherapy and Tyrosine Kinase Inhibitor Combination Approved for the Treatment of Patients With Advanced Endometrial Carcinoma Study Results Demonstrated Statistically Significant Improvements in Overall Survival, Progression-Free Survival and Overall Response Rate, Helping to Address a Significant Unmet Need in Advanced Endometrial Carcinoma TOKYO and KENILWORTH, N.J. – (JCN Newswire) – Eisai Co., Ltd. and Merck & Co., Inc., Kenilworth, N.J., U.S.A.

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NY Times

JULY 20, 2021

The agreement would end thousands of lawsuits against the three largest distributors and Johnson & Johnson and require them to pay billions for addiction treatment and prevention.

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pharmaphorum

JULY 19, 2021

America’s biopharmaceutical industry says it is “ready to do its part” in building a stronger, more resilient, affordable, and equitable health care system for all. COVID-19 highlighted both the challenges of the US healthcare system and the huge change potential of the country’s pharmaceutical industry. Now, as vaccination continues at pace, the sector has pledged to help “build back better”, by lowering barriers between medical innovations and the patients who need them.

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Pharma Times

JULY 22, 2021

Pemazyre recommended for the treatment of cholangiocarcinoma, a rare type of liver cancer that forms in the bile duct

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Drug Patent Watch

JULY 23, 2021

Annual Drug Patent Expirations for AVYCAZ Avycaz is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. There are eight patents protecting…. The post New patent expiration for Allergan drug AVYCAZ appeared first on DrugPatentWatch - Make Better Decisions.

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NY Times

JULY 23, 2021

Research into these often mysterious and debilitating disorders has languished. That’s changing.

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pharmaphorum

JULY 20, 2021

The FDA has taken a longer than usual look at Ardelyx’ regulatory submission for tenapanor, a drug for high blood phosphate levels associated with chronic kidney disease (CKD), and found it wanting – sending the biotech’s shares into a tailspin. The US regulator had extended its review of the drug by three months – setting back its action date from April to 29 July – but now says that deficiencies in the marketing application “preclude discussion” of labelling and post-ma

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Pharma Times

JULY 21, 2021

The new fund will build upon the Cancer Drugs Fund to fast-track access to promising new treatments

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Drug Patent Watch

JULY 23, 2021

Annual Drug Patent Expirations for ABILIFY Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. It is available from two suppliers.…. The post New patent expiration for Otsuka drug ABILIFY appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma Mirror

JULY 23, 2021

On 9 November 2021, the 18th Annual CPhI Pharma Awards will take place in Milan, Italy at the Stella Polare Convention Centre. The CPhI Pharma Awards celebrate innovators and thought leaders breaking new ground in the pharma and biopharma industries, and their commitment to advancing new approaches, processes and technologies. Held as part of CPhI Worldwide (9-11 November 2021), the world’s largest pharma exhibition, these prestigious awards recognise the individuals, teams and companies who tur

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pharmaphorum

JULY 20, 2021

Bayer subsidiary BlueRock Therapeutics has been granted a fast-track review by the FDA for DA01, its stem cell-based therapy for Parkinson’s disease which is currently in early-stage clinical testing. The FDA designation allows for benefits such as more frequent meetings and communication with the regulator during clinical development, and a truncated six-month review time.

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Pharma Times

JULY 20, 2021

No new safety signals identified with longer-term Hemlibra treatment in adult and adolescent patients

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Drug Patent Watch

JULY 22, 2021

Annual Drug Patent Expirations for COSELA Cosela is a drug marketed by G1 Therap and is included in one NDA. There are nine patents protecting this drug. This drug has…. The post New patent for G1 Therap drug COSELA appeared first on DrugPatentWatch - Make Better Decisions.

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Pharma in Brief

JULY 22, 2021

Health Canada has issued a notice explaining a policy change to the review of applications for COVID-19 medical devices. As of July 16, 2021, Health Canada is no longer accepting applications for certain categories of medical devices under Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 ( IO No. 2 ) if there is no longer an urgent public health need ( UPHN ) for those devices.

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