Tue.May 30, 2023

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Sacklers win appeal that shields them from opioid lawsuits, clearing way for bankruptcy settlement

STAT

A federal appeals court ruled Tuesday Purdue Pharma can shield its owners — members of the wealthy Sackler family — from thousands of lawsuits over the role the company played in the opioid crisis in exchange for a contribution of up to $6 billion to a proposed bankruptcy settlement. The Sackler family members insisted a bankruptcy deal would not be possible unless they were released from all future liability related to the harm caused by Purdue’s OxyContin painkiller.

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CVS is exiting clinical trials. Does this spell trouble for retail-based research?

PharmaVoice

Walgreens leaders are not deterred and hope to fill the holes left behind by the pharmacy giant.

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Opinion: In defense of being ‘Cali sober’

STAT

The phenomenon of being “Cali sober” is taking the recovery world by storm. It is defined as dedicating oneself to a life free of drugs and alcohol — except for cannabis and other psychedelics. (Though many consumers don’t think of cannabis as a psychedelic, policy experts often consider it one because of its effects.) Hardcore proponents of abstinence-based recovery, such as Alcoholics Anonymous, dismiss the Cali sober approach as dangerous and “not really rec

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SK Bioscience gains UK authorisation for SKYCovion Covid-19 vaccine

Pharmaceutical Technology

SK Bioscience has received marketing authorisation from the UK’s medicines and healthcare products regulatory agency (MHRA) for its Covid-19 vaccine, SKYCovion. SKYCovion is intended for the prevention of Covid-19 resulting from SARS-CoV-2 infection in individuals aged 18 years and above. The authorisation allows the distribution of the vaccine in Scotland, Wales and England.

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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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STAT wants to know your pick for a great summer read or listen

STAT

S TAT is putting together a list of books and podcasts that deal with health, medicine, and the life sciences that would be great to check out this summer. We invite our readers to fill out the form below, and you may see your pick in our upcoming annual roundup. To get a little inspiration, check out our past lists from 2022 , 2021 , and 2019.

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Amylyx’s ALS drug could face rejection in Europe

BioPharma Dive

The biotech said a committee advising the European Medicines Agency is “trending” toward issuing a negative opinion of its drug Relyvrio, which was approved in the U.S. last year.

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More Trending

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Pfizer says hemophilia drug succeeded in Phase 3 study

BioPharma Dive

The drug, called marstacimab, outperformed factor treatment in the study, and wasn’t associated with the kind of safety signals that have dogged other medicines in its class.

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Opinion: More hospitals are offering child care. But they shouldn’t have to

STAT

Since the pandemic began, thousands of child care locations have closed , exacerbating an already acute shortage. But health care worker Jada Carter was lucky. Her two children went to Hospitots, one of the few places to stay open during the early days of the pandemic, when, by one estimate , two-thirds of child care centers closed.

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US companies drive 2023 drug launches positioned for blockbuster success by 2028

Pharmaceutical Technology

According to GlobalData’s Looking Ahead to 2023 – the Future of Pharma report, five drugs set for approval in 2023 are projected to attain blockbuster status or near-blockbuster status by 2028 with US company dominance. Lecanemab by Eisai Co Ltd, a monoclonal antibody therapy marketed for Alzheimer’s disease, is predicted to achieve the most significant commercial debut.

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STAT+: Pharmalittle: Pfizer touts study data for hemophilia drug; former Novartis execs cleared of bribery in Greece

STAT

Good morning, everyone, and how are you today? We are doing fine, thank you, especially since we had an extended holiday weekend on this side of the pond. Whether you were off or not — depending upon where you may be — we hope you are feeling refreshed and energized this morning as we all prepare for the usual routines. To cope, yes, we are brewing cups of stimulation.

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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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Addressing Mental Health: A conversation with Barry Greene, CEO of Sage Therapeutics

PhRMA

As we recognize Mental Health Awareness Month, I had the opportunity to connect with PhRMA board member Barry Greene, CEO of Sage Therapeutics, about the company’s efforts to address mental health.

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STAT+: European regulatory panel weighing against approval of Amylyx’s ALS therapy, company says

STAT

LONDON — A European regulatory panel has taken a negative view of whether an ALS treatment from Amylyx Pharmaceuticals should win approval, the company said Tuesday, threatening the drug’s chances of entering the European market. In a statement, Amylyx said it had learned that a European Medicines Agency’s committee “is trending toward a negative opinion” on the drug, AMX0035, after its May meeting last week.

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AstraZeneca’s Ultomiris approved in Japan for prevention of relapses in patients with NMOSD

Pharma Times

The drug has already been approved for this indication in the EU, with regulatory reviews continuing elsewhere including in the US

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Amplo Biotechnology receives NIH-NIAMS grant for gene therapy AMP-201

Pharmaceutical Technology

Amplo Biotechnology has received a fast track phase I/II STTR grant from the NIH-NIAMS [National Institutes of Health’s National Institute of Arthritis and Musculoskeletal and Skin Diseases] for its gene therapy AMP-201. The company will receive substantial funding to advance AAV-ColQ gene therapy. AMP-201 addresses the severe congenital myasthenic syndrome (CMS) caused by collagen Q (ColQ) deficiency.

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Sun Pharma gets China NMPA approval for ILUMETRI to treat moderate-to-severe plaque psoriasis

Express Pharma

Sun Pharmaceutical Industries announced that the New Drug Application (NDA) for tildrakizumab injection under the brand name ILUMETRI has been approved by the National Medical Products Administration of the People’s Republic of China (NMPA). ILUMETRI is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy.

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EU regulator recommends revoking approval for Novartis’ sickle cell disease drug

Pharma Times

The EMA's human medicines committee concluded that the benefits of Adakveo did not outweigh its risks

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How do you solve a problem like community pharmacy IT systems?

The Pharmacist

The NHS primary care recovery plan promised ‘interoperable digital solutions’ to support pharmacists to deliver clinical services and ‘significantly improve’ the digital infrastructure between general practice and community pharmacy. This would include streamlined referral processes, giving community pharmacy additional access to relevant clinical information from GP records, and allowing community pharmacy to update GP records […] The post How do you solve a problem like community pharmac

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Sun Pharma, Philogen sign pact to commercialise specialty product, NIDLEGY in Europe, Australia and New Zealand

Express Pharma

Sun Pharmaceutical Industries and Philogen have entered into a licensing agreement for commercialising Philogen’s specialty product, Nidlegy (Daromun) in the territories of Europe, Australia and New Zealand. Nidlegy, currently in Phase III clinical trials, is a new anti-cancer biopharmaceutical which is being developed by Philogen for the treatment of melanoma and non-melanoma skin cancers.

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NHS workforce plan ‘delayed again due to cost concerns’

The Pharmacist

The government’s long-awaited NHS workforce plan appears to have been delayed as rumours circulate that it is too expensive. According to deputy chief executive of NHS Providers Saffron Cordery, the plan, which was expected for publication imminently, has been delayed further. Speaking on BBC Radio 4’s Today programme, Ms Cordery said the plan will require ‘a very […] The post NHS workforce plan ‘delayed again due to cost concerns’ appeared first on The Pharmacist.

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Factors Contributing to Hospital Readmission Rates

cureatr

When a patient is discharged from the hospital, it is under the assumption their condition has improved enough that they can safely return home. According to the Agency for Healthcare Research and Quality (AHRQ) , more than 70% of patients who have been hospitalized are able to return home without being closely supervised. Another 10% of patients are discharged home with healthcare supervision.

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ValGenesis, Life Science Consulting partner to provide technical and regulatory support for life sciences companies in North America, Europe, and Asia

Express Pharma

ValGenesis and Life Science Consulting have partnered to provide digital validation solutions to enhance compliance and quality across life sciences disciplines such as production, quality control and assurance, information technology, and research and development (R&D). Life Science Consulting is a CONVAL Group company with industry experience and success stories in deployment of eQMS and eBR, computer system validation for enterprise systems like ERP, MES, LIMS, DMS, laboratory systems (CD

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Men’s Health Month at Your Pharmacy

Digital Pharmacist

Men’s Health Month is upon us and we are thrilled to be raising awareness with you. The goal of this week is to focus on encouraging boys, men, and their families to practice and implement healthy living decisions, such as exercising and eating plenty of fruits and vegetables. Focusing on men’s health and raising awareness is imperative as we strive to keep our communities healthy.

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Akebia says FDA will give its once-rejected anemia pill a second chance

BioPharma Dive

The regulator denied an appeal of its decision to turn back vadadustat, but outlined a path forward for the company to resubmit an application without running another clinical trial.

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The benefits of adopting a truly digital mindset for pharmaceuticals

pharmaphorum

The benefits of adopting a truly digital mindset for pharmaceuticals Mike.

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Overcoming common pitfalls in lentiviral cell and gene therapies

BioPharma Dive

See how ddPCR technology can take your lentiviral cell and gene therapies to the next level.

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Purdue can shield wealthy Sackler family from opioid lawsuits, court rules

The Guardian - Pharmaceutical Industry

The ruling cleared the way for the pharma company to settle cases tied to the epidemic that caused more than 500,000 deaths The billionaire family behind Purdue Pharma , the maker of the powerful and highly addictive prescription painkiller OxyContin, can be protected from lawsuits related to their company’s role in the opioids crisis, a federal appeals court ruled on Tuesday.

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Parkinson’s wearable matches experts in clinical trial

pharmaphorum

Parkinson’s wearable matches experts in clinical trial Phil.

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Novartis Purchases Cystinosis Gene Therapy from AVROBIO

PharmaTech

The $87.5 million purchase grants Novartis rights to an investigational gene therapy program intended for treatment of cystinosis.

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UK funds extended reality projects for mental health

pharmaphorum

UK funds extended reality projects for mental health Phil.

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Rain Oncology to cut workforce by 65% after study failure

BioPharma Dive

The biotech, which went public in 2021 to develop a cancer drug licensed from Daiichi Sankyo, may try to acquire a different tumor-targeting medicine to grow its pipeline.

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Elizabeth Holmes due to start prison sentence today

pharmaphorum

Elizabeth Holmes due to start prison sentence today Phil.

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Lexicon Receives FDA Stamp of Approval for New Heart Failure Treatment

PharmExec

Inpefa to support multiple cardiovascular issues.

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Short-term crucial to future of AI drug discovery

pharmaphorum

Short-term crucial to future of AI drug discovery Mike.

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Drug Channels News Roundup, May 2023: 340B Shame, OptumRx vs. Humira Biosimilars, ICER on White Bagging, Hospitals vs. Taxes, and Dr. G

Drug Channels

Summer unofficially began over the weekend. Check out these noteworthy delicacies, seared to perfection on the Drug Channels grill: Fresh evidence of 340B abuses by hospitals and contract pharmacies OptumRx rewrites its biosimilar Humira strategy ICER discovers channel markups Tax-exempt hospitals are not holding up their end of the bargain Plus, Dr.

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Unlocking the Synergistic Potential of Methylene Blue for Alzheimer’s Disease

Welltopia Pharmacy

Discover the wide range of medical applications of Methylene Blue, from treating methemoglobinemia to potential Alzheimer's disease treatments. Learn more in our comprehensive guide.