STAT

MAY 24, 2023

Over the last few years, Daniel Cleggett Jr. appeared to be living a charmed life. The founder of a small Boston-area   addiction treatment empire knew he was under scrutiny; the Globe and STAT News  published investigations  in 2017 and 2019 into his questionable business dealings, and the Massachusetts attorney general’s office announced   shortly after that   it was examining alleged scams involving addiction treatment.

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ALiEM - Pharm Pearls

MAY 24, 2023

A young boy is brought to the pediatric emergency screaming at the top of his lungs by his parents. His penile skin is trapped in the zipper of his jeans. On a busy shift, you want a simple way to handle zipper injuries that minimizes pain, doesn’t require resource-intensive procedural sedation, and is quick. Background The 4 most common types of zippers are nylon coil zip, plastic mold zip, metal zip, and invisible zip.

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STAT

MAY 24, 2023

Every day, it seems, is mental health awareness day. In the U.S., there’s Eating Disorders Awareness Week in February. May is National Mental Health Awareness Month, which includes National Children’s Mental Health Awareness Day. September is Suicide Prevention Awareness Month and in October we go global, with  World Mental Health Day.

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PharmaVoice

MAY 24, 2023

As CEO of the neurogenerative company, Ricciardi is applying her decades of “human capital” to advance Alzheimer’s and dementia treatments.

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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.

STAT

MAY 24, 2023

When seriously depressed patients don’t respond to antidepressants, the alternatives are limited. Now a new study has found that ketamine performs at least as well as the current gold standard for such patients, electroconvulsive therapy (ECT), suggesting it deserves consideration as a frontline response for people with treatment-resistant depression.

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PharmaVoice

MAY 24, 2023

Vizgen’s CEO discusses the potential of spatial genomics in the life sciences and the company’s role in the movement.

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BioPharma Dive

MAY 24, 2023

The agency will extend its review of Sarepta’s treatment by roughly one month as it weighs limiting an initial OK only to children with Duchenne aged 4 to 5 years old.

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STAT

MAY 24, 2023

LONDON — The promise of immunotherapies to treat cancer has yet to reach brain tumors. It’s difficult to deliver medicines into the brain for a host of reasons. In particular, brain tumors are able to suppress the body’s immune activity and have comparably few genetic vulnerabilities that cancer drugs can target. They’re considered immunologically “cold.

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Immunity Immunization Vaccines 235

BioPharma Dive

MAY 24, 2023

The drug, called Xacduro, will be made available later this year by Innoviva Specialty Therapeutics, a new company formed from antibiotic developers Entasis and La Jolla.

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Hospitals 110

STAT

MAY 24, 2023

The Food and Drug Administration is delaying by one month a decision on the approval of a gene therapy for Duchenne muscular dystrophy, the treatment’s maker, Sarepta Therapeutics, said Wednesday. Sarepta said the FDA expects to complete the review of its gene therapy called SRP-9001 by June 22. A decision had been expected on or before May 29.

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Pharmacy Management

BioPharma Dive

MAY 24, 2023

The biotech is giving up on early-stage gene therapy research as part of a restructuring meant to cut costs and redirect resources toward therapies most likely to succeed.

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STAT

MAY 24, 2023

WASHINGTON — The Biden administration wants to help states control Medicaid prescription drug costs by making prices more transparent and curbing the practice of so-called spread pricing. The goal is to give states more leverage in price negotiations by forcing drugmakers to share and publish details about their pricing data. The government would collect specific drug pricing information from makers of up to 10 particularly high-cost drugs.

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Drug Pricing 215

The Pharmacist

MAY 24, 2023

The Labour party has pledged to improve care for patients with multiple medications and conditions by bringing primary care teams together, including by co-locating services in one site where possible. In its ‘Mission for Public Services’, the opposition party said that it aimed to give patients one point of contact for appointments with a range […] The post Labour promises more joined-up primary care teams appeared first on The Pharmacist.

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STAT

MAY 24, 2023

We’ve all had the experience of a doctor or other health care worker staring at screen while asking us sensitive questions to fill out our electronic health records. But that frustrating experience is made even worse by a new trend in health care. As Sanjay Basu wrote in a recent First Opinion, hospitals are using so-called “screen and refer” systems to identify people with social needs, like those who are experiencing domestic violence or hunger.

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Hospitals 201

Quality Matters

MAY 24, 2023

World Health Assembly: Building a medicines supply chain to meet the needs of patients everywhere Hundreds of global public health experts converged in late May 2023 in Geneva, Switzerland for the 76th meeting of the World Health Assembly (WHA), the decision-making body of the World Health Organization (WHO). The engaging dialogue made clear that ensuring medicines supply chain resilience is integral to key priorities WHA has set forth to promote public health.

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STAT

MAY 24, 2023

On Thursday Illumina, the largest and most important maker of DNA sequencing technology, whose innovations have changed medicine and have been crucial in our battles with diseases from Covid to cancer, will face a day of reckoning. A catch-up: Illumina is holding a meeting during which investors will vote on who should be on its board of directors. Carl Icahn, the embodiment of activist investing, has proposed adding three new directors to the board.

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European Pharmaceutical Review

MAY 24, 2023

The US Food and Drug Administration (FDA) has approved the first-ever redosable gene therapy for the rare skin disease dystrophic epidermolysis bullosa (DEB). VYJUVEK (beremagene geperpavec-svdt) is authorised for DEB patients six months of age or older. The gene therapy is a topical gel that restores functional copies of the COL7A1 gene to provide wound healing and sustained functional COL7 protein expression with redosing.

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STAT

MAY 24, 2023

Matt Eyles, CEO of America’s Health Insurance Plans, is leaving by this October, the lobbying group said Wednesday. Eyles has led AHIP for the past five years — a historically profitable time for health insurers — and his departure surprised some in the industry, according to three executives and lobbyists. In 2018, Eyles took over for Marilyn Tavenner , who became CEO of AHIP right after serving as the top administrator of Medicare and Medicaid under President Obama.

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PharmaTech

MAY 24, 2023

Process development methods & analytical requirements are integral parts of gene therapy manufacturing. This whitepaper explores the analytical and development approaches needed for success.

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STAT

MAY 24, 2023

Boston Scientific is scrapping its $230 million plan to buy a majority stake in M.I. Tech, a Korean company that builds surgical tools, the company confirmed to STAT. Instead, it will purchase a minority stake of around 10%. That purchase will go through later this year. “Our agreement to purchase the majority stake of M.I.Tech Co., Ltd, from Synergy Innovation Co., Ltd, required global regulatory approvals that we were not able to obtain in some countries,” said Boston Scientific

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Pharmaceutical Technology

MAY 24, 2023

Forge Biologics has joined the public-private collaboration, the Bespoke Gene Therapy Consortium (BGTC), to expedite the development and manufacture of new AAV [adeno-associated virus] gene therapies to treat patients with rare diseases. The BGTC is part of the accelerating medicines partnership (AMP) programme and is managed by the Foundation for the National Institutes of Health (FNIH).

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STAT

MAY 24, 2023

Annexon Biosciences said Wednesday that its experimental treatment for an eye disease called geographic atrophy had no effect on the growth of retinal lesions that eventually lead people with the disease to lose their vision. The result means Annexon’s drug failed to achieve the primary goal of a mid-stage clinical trial. The company has a more optimistic view of the study results, pointing to other data showing that injections of its drug, called ANX007, preserved vision compared to sham

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Express Pharma

MAY 24, 2023

Express Pharma – Nutrify Today Boardroom series offers a platform for meaningful dialogues on the vast ocean of opportunities for the Indian pharma sector to be reaped in nutraceuticals, provided the right course is set for long and sustainable growth. In this video, Rahul Adakmol, COO – International Operations & Business Development at Bharat Serums and Vaccines, speaks on the trends shaping the pharma and nutra sectors, ethical and responsible approaches for the pharma industry to

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Vaccines 96

PharmaTech

MAY 24, 2023

Alvotech and Advanz Pharma have signed a strategic partnership agreement for the supply and commercialization of five biosimilar candidates in Europe.

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Biosimilars 105

Drug Channels

MAY 24, 2023

In The Top Pharmacy Benefit Managers of 2022: Market Share and Trends for the Biggest Companies , I shared Drug Channels Institute's analysis showing that three pharmacy benefit managers (PBMs)—the Caremark business of CVS Health, the Express Scripts business of Cigna, and the OptumRx business of UnitedHealth Group—accounted for about 80% of total equivalent prescription claims in 2022.

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Pharmaceutical Manufacturing 93

The Pharmacist

MAY 24, 2023

As part of our pharmacist in practice series, The Pharmacist speaks to Shivani Patel, lead clinical pharmacist for a GP federation in north central London. How long have you been working in general practice and what were you doing before? I went into general practice around 2017 and that's where I've been ever since. I […] The post Pharmacist in practice: ‘I get to learn something new every day’ appeared first on The Pharmacist.

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European Pharmaceutical Review

MAY 24, 2023

Alvotech and Advanz Pharmaceutical have extended their partnership, regarding the supply and commercialisation of five proposed biosimilars in Europe. “We are very excited to extend our existing partnership with Advanz Pharma into additional therapeutic areas… to provide better patient access to more affordable biologics,” stated Robert Wessman, Chairman and CEO of Alvotech.

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Biosimilars Pharmaceutical Companies Pharmaceutical Companies 89

The Pharmacist

MAY 24, 2023

Decision support tools to help clinicians and patients decide whether or not valproate is the right option for them have been launched by NHS England (NHSE), in efforts to curb inappropriate prescribing of valproate during pregnancy. The tools are aimed at women, girls and anyone who could become pregnant, aged between 12 – 55, who […] The post NHSE launches valproate decision support tools for women appeared first on The Pharmacist.

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Pharma Times

MAY 24, 2023

Vital data supports early intervention in order to treat chronic obstructive pulmonary disease

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Express Pharma

MAY 24, 2023

A group of researchers led by Prof Arun K Shukla in the Department of Biological Sciences and Bioengineering at the Indian Institute of Technology Kanpur (IIT-K) has unravelled a previously unknown mechanism that regulates an important class of drug targets known as G protein-coupled receptors. The discovery has important implications for not only understanding the fundamental mechanism of cellular signaling in our body but it also has the potential to facilitate novel drug discovery for several

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Communication 87

Pharma Times

MAY 24, 2023

Celadon will sell a minimum of £3m worth of the high-THC product over the next three years

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European Pharmaceutical Review

MAY 24, 2023

Research proposing a digital twin (DT) based approach has outlined the types of information required for components in a laboratory automation plug & play (LAPP) framework. This system provides overall recommendations for integrating robots into life science laboratories. The paper stated that the framework aims to simplify the integration and set-up process for these types of robots by removing the requirement for manual configuration by the user in addition to teaching of the robots.

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Express Pharma

MAY 24, 2023

The sixth edition of the Pharma Project & Portfolio Management was held at Fairfield by Marriott near the Mumbai International Airport from April 26-28, 2023. The programme comprised various discussion topics for project and portfolio management teams. The conference started with a Keynote address from the Managing Director of Eminence Business Media, welcoming everyone and setting the expectations for the three-day programme.

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Biosimilars Communication Drug Development 77

Big Molecule Watch

MAY 24, 2023

FDA’s Purple Book provides a searchable database of licensed biological products and includes the patent information provided to biosimilar applicants during the BPCIA patent dance. As we previously reported , a patent list for Regeneron’s EYLEA (aflibercept) was added to the Purple Book in April 2022. That original list contained 29 patents, including the 24 patents that Regeneron later asserted against Mylan in a BPCIA lawsuit filed in August 2022.

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Biosimilars 70

World Pharma News

MAY 24, 2023

Taking a daily multivitamin supplement can slow age-related memory decline, finds a large study led by researchers at Columbia University and Brigham and Women's Hospital/Harvard.

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Hospitals 72