STAT

MAY 10, 2023

On the eve of the expiration date for the federally declared coronavirus public health emergency , White House Covid-19 Response Coordinator Ashish Jha warned that the pandemic is far from over. “I don’t see this as an end to the pandemic or fighting Covid,” Jha said at a STAT event in Boston on Wednesday. “I see this as a transition out of this emergency phase into a very different phase.

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PharmaVoice

MAY 10, 2023

With decades of experience in public health, Boone is leveraging RWE to move the needle within clinical development.

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STAT

MAY 10, 2023

In a highly significant move, a panel of independent experts on Wednesday voted unanimously that the Food and Drug Administration should approve the first over-the-counter birth control bill, a recommendation that holds the potential to transform the way contraception is delivered in the United States. After nearly two days of deliberations, the FDA advisory panel weighed a gamut of data and analyses to assess whether the pill — which was first approved as a prescription medicine decades

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PharmaVoice

MAY 10, 2023

After ushering a blockbuster to market, the chief development officer is channeling her experience into the rare disease space.

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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 10, 2023

Each year about 30 people make the gut-wrenching decision to leap off the Golden Gate bridge to their deaths. To address this tragedy, a Suicide Deterrent Net is being constructed — a planned $142 million project that, after years of delays, may end up costing more than $400 million, according to contractors embroiled in a lawsuit. The stainless steel barrier will undoubtedly catch people before they hit the frigid San Francisco Bay.

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BioPharma Dive

MAY 10, 2023

The companies’ personalized shot generated tumor-specific T cells that researchers hope could help prevent pancreatic cancer from returning after surgery.

Vaccines 138

Vaccines 138

Safe Biologics

MAY 10, 2023

On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). The paper is authored by IFA Secretary-General Jane Barratt and ASBM Executive Director Michael Reilly.

Biosimilars 100

Biosimilars 100

STAT

MAY 10, 2023

An international team of scientists has assembled the first human “pangenome” — an attempt to make a more representative reference genome, one that captures almost all the genetic variability residing in the DNA of humans around the globe. The technological achievement, published Wednesday in Nature , is the result of years of work by more than 100 researchers behind The Human Pangenome Project , a $30 million effort launched in 2019 and funded by the U.S.

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Safe Biologics

MAY 10, 2023

On May 9th, GaBI Journal published a whitepaper titled “Canadian prescribers’ attitudes and perceptions about ophthalmic biosimilars”, based on the recent survey of 41 Canadian ophthalmologists by ASBM and the International Federation on Ageing (IFA). The paper is authored by IFA Secretary-General Jane Barratt and ASBM Executive Director Michael Reilly.

Biosimilars 100

Biosimilars 100

STAT

MAY 10, 2023

Black people are far less likely than other Americans to receive buprenorphine , a key medication for treating opioid use disorder, according to a new study. White patients in need of addiction care were prescribed buprenorphine at more than twice the rate of Black patients in the six months preceding an addiction-related health emergency, according to the analysis.

Hospitals 240

Hospitals 240

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Pharmacy Management

BioPharma Dive

MAY 10, 2023

Sarepta has not provided “unambiguous evidence” its treatment can help patients, agency scientists wrote in documents released ahead of a crucial Friday advisory committee meeting.

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Documentation 117

STAT

MAY 10, 2023

Parents of kids who have peanut allergies have to practice constant vigilance, whether that means carefully skimming the ingredients on food packaging or warning teachers about the dangers of unexpected treats at school. A new study in the New England Journal of Medicine presents a simple treatment option for peanut allergies in kids from 1 to 3 years of age: a skin patch.

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Packaging Pharmaceutical Companies Pharmaceutical Companies 237

BioPharma Dive

MAY 10, 2023

While some see the new donanemab results as adding to a “watershed moment” in Alzheimer’s research, others say they reinforce the limitations of so-called anti-amyloid therapies.

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STAT

MAY 10, 2023

Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday. The FDA documents, released ahead of an advisory committee hearing Friday, found that Sarepta’s clinical studies “conducted to date do not provide unambiguous evidence” that the therapy, known as SRP-9001, is “li

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Documentation 225

Pharmacy Joe

MAY 10, 2023

In this episode, I’ll discuss a randomized controlled trial about delayed sequence intubation. Episode 816: Delayed Sequence Intubation With Ketamine RCT Results Subscribe on iTunes , Android , or Stitcher In a typical rapid sequence intubation, there is a period of time referred to as “pre-oxygenation” where the patient needs to breath 100% oxygen for 3 minutes in order to extend the safe apnea time and maximize the chance of successful intubation without hypoxic injury.

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Inpatient 105

STAT

MAY 10, 2023

A Senate hearing on high insulin costs billed as a blockbuster showdown with drugmakers and middlemen turned out to be a familiar case of political theater that appeared to satisfy no one. The nation’s three biggest insulin makers, Eli Lilly, Novo Nordisk, and Sanofi, and the trio of middlemen known as pharmacy benefit managers, Express Scripts, OptumRx and CVS Health, testified Wednesday in a three-hour hearing before the Senate Health, Education, Labor, and Pensions Committee.

Packaging 225

Packaging Drug Pricing 225

Pharmaceutical Technology

MAY 10, 2023

Gilead Sciences has emerged victorious in a legal battle with the US government over patents surrounding the HIV pre-exposure prophylaxis (PrEP) drugs Descovy and Truvada following a federal jury’s verdict on May 9. A jury in the Delaware District Court gave a favourable verdict to the Foster City, California-headquartered company, concluding that Gilead did not infringe any of the US government’s patents.

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Pharmaceutical Companies Pharmaceutical Companies 105

STAT

MAY 10, 2023

On Friday, the Food and Drug Administration’s Cellular, Tissue and Gene Therapies Advisory Committee will meet to discuss the Biologics License Application for Sarepta Therapeutics’ gene therapy delandistrogene moxeparvovec for the treatment of Duchenne muscular dystrophy. The late decision by the FDA to reverse course and hold an advisory committee to get expert input into the drug’s review occurred after concerns were apparently raised that the FDA was leaning toward rejec

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Pharmaceutical Technology

MAY 10, 2023

Synlogic has received orphan drug designation (ODD) from the US Food and Drug Administration (FDA) for SYNB1934 to treat phenylketonuria (PKU), a rare inherited metabolic disease. The orally administered, non-systemically absorbed drug candidate SYNB1934 has been designed for reducing blood phenylalanine (Phe) levels in PKU patients. SYNB1934 consumes Phe in the gastrointestinal (GI) tract by leveraging genetic engineering of the drug or drug-carrying capsule, probiotic escherichia coli (E coli)

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STAT

MAY 10, 2023

Brigham and Women’s Hospital will launch a new institute focused on immunology and inflammation, thanks to a $100 million gift, the largest in the hospital’s history. The donation, from Gene Lay, founder and CEO of San Diego-based company BioLegend, will establish the Gene Lay Institute of Immunology and Inflammation. The institute will be led by Brigham immunologist and principal investigator Vijay Kuchroo, who will lead teams dedicated to studying chronic inflammation and discove

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Immunity Immunization Hospitals Diabetes 224

PharmExec

MAY 10, 2023

According to the latest State of Revenue survey of c-suite executives, pharma manufacturers are prioritizing digital transformation while struggling with inflation and supply chain disruptions.

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STAT

MAY 10, 2023

Hello, everyone, and how are you this fine, sunny morning? The middle of the week has arrived, as you may know, so why not celebrate with a delicious cup of stimulation? After all, you made it this far, which is a likely sign of surviving another few days. And of course, no prescription is required, which is a good thing. And while you indulge, you can peruse some of the tidbits we have assembled to help you start the day.

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Pharmaceutical Companies Pharmaceutical Companies 200

Drug Channels

MAY 10, 2023

Yesterday’s reflections on Asembia’s Specialty Pharmacy Summit included a link to the general session slides. My portion of the deck included an updated mapping of vertical integration among insurers, PBMs, specialty pharmacies, and providers within U.S. drug channels. Many readers asked for a standalone version of this infamous chart. So, for your viewing and slide making pleasure, below you’ll find my latest illustration of the major vertical business relationships among the largest companies.

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Specialty Pharmacies 92

STAT

MAY 10, 2023

From medical note-taking to analyzing X-rays and mammograms , new artificial intelligence tools are swiftly gaining traction in the world of science and medicine. STAT is reporting on the use of generative AI — content-creating technology that includes models like ChatGPT and its rivals  — in health care and scientific research. We want to hear your questions about how the technology works, its potential in science and medicine, and the risks that it carries.

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Hospitals 200

Pharma Times

MAY 10, 2023

Transfer marks start of vital development stage as company expands its range of synthesized DNA

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STAT

MAY 10, 2023

Alex Rosenblat is particularly careful when it comes to her digital privacy. She requests to fill out paper forms instead of digital ones; she documents and tracks what she signs. But even her diligence can’t always save her. Rosenblat recently spent months retracing her digital steps after Phreesia, a company that collects demographic information, claimed to have her authorization to share her data — authorization she knew she hadn’t consented to.

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Documentation 197

Pharma Times

MAY 10, 2023

Patients living with the debilitating impacts of migraine attacks will be able to access Vydura

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Express Pharma

MAY 10, 2023

The Competition Commission of India (CCI) has cleared Edelweiss Alternative Asset Advisors and ESOF III Investment Fund’s subscription to certain compulsorily convertible debentures of Biocon Biologics. The deal has been cleared under the green channel route. Edelweiss Alternative Asset Advisors is a Sebi-registered alternative asset advisor, while ESOF III Investment Fund is a Sebi-registered Alternative Investment Fund (AIF).

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World Pharma News

MAY 10, 2023

Bayer AG announced the inauguration of its new life science incubator dubbed "Co.Lab Cambridge" located in Kendall Square in Cambridge, U.S. Bayer's Co.Lab Cambridge is specifically designed to support cutting-edge cell and gene therapies (CGT) entrepreneurs with access to Bayer's enterprise wide expertise in addition to state-of-the art laboratory and office space.

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PhRMA

MAY 10, 2023

Today, the U.S. Senate Committee on Health, Education, Labor and Pensions (HELP) will examine the cost of insulin and how to make this lifesaving medicine more affordable for patients. The nation’s largest pharmacy benefit managers (PBMs) are expected to testify. These are the middlemen that insurance companies use to determine what’s covered and what patients pay out of pocket at the pharmacy.

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European Pharmaceutical Review

MAY 10, 2023

Sandoz has announced it is investing €25 million in its manufacturing site in Holzkirchen, Germany, to expand its biosimilar development capabilities. The company intends to grow its Biopharma Technical Development (BioTD) capabilities and transform the lab building into a state-of-the-art biotech lab by the last quarter of 2023. The financing is intended to bring together these highly advanced laboratories and analytical expertise at one site.

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Biosimilars 83

PharmExec

MAY 10, 2023

BCG’s 2022 benchmark study uncovers new competencies needed for pharma access leaders in enterprise-wide business strategy, where thoughtfully designed approaches and goals focused on shared priority and responsibility are increasingly important.

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The Pharmacist

MAY 10, 2023

The NHS England primary care recovery plan, released yesterday focuses on increasing access to primary care – by freeing up GPs and making the most of other roles, such as practice and community pharmacists. But Graham Stretch, president of the Primary Care Pharmacy Association (PCPA) and chief pharmacist and partner at Argyle Health Group, told […] The post Primary care recovery plan: Five things clinical pharmacists need to know appeared first on The Pharmacist.

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Big Molecule Watch

MAY 10, 2023

In October 2022, we reported that Biogen was seeking a preliminary injunction in its BPCIA case brought in the District of Delaware against Sandoz relating to Sandoz’s proposed multiple sclerosis biosimilar of TYSABRI (natalizumab). The parties completed their briefing on Biogen’s motion in April, and Judge Williams has scheduled a hearing for May 17 at 1 pm EST.

Biosimilars 80

Biosimilars 80

Express Pharma

MAY 10, 2023

Sandoz announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE. The agreement covers the development and manufacture of multiple biosimilar medicines with an option for expansion. Access to Just – Evotec Biologics’ drug substance development platform and manufacturing technology complements Sandoz capabilities, supporting expansion of the current pipeline from 15+ to 24 assets and the continued development of its early-stage biosimil

Biosimilars 82

Biosimilars Drug Development 82