Mon.Mar 13, 2023

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‘What a mess’: How biotech startups grappled with SVB’s collapse

Bio Pharma Dive

The bank’s failure caused some companies to question whether they could pay employees, while forcing many others to take steps to calm nervous investors.

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US FDA approves Acadia Pharmaceuticals’ Rett syndrome therapy

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted approval for Acadia Pharmaceuticals ’ Daybue (trofinetide) to treat Rett syndrome in adult and paediatric patients aged two years and above. Trofinetide is a synthetic version of the tripeptide glycine-proline-glutamate (GPE) naturally occurring molecule. It increased the branching of dendrites and synaptic plasticity signals in animal trials.

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Pfizer to buy Seagen in $43B cancer drug deal

Bio Pharma Dive

The acquisition would give Pfizer control of a top-selling lymphoma drug and a pipeline of medicines that have made the Seattle-based company one of the sector’s most valuable biotechs.

Drugs 246
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Sleep Disturbances Linked With Higher Dementia Risk, Study Finds

AuroBlog - Aurous Healthcare Clinical Trials blog

If you needed another reminder of just how important quality sleep is to our health and well-being, a new study has linked three specific sleep problems with a change in risk of developing dementia.

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The New Age of Decentralized Clinical Trials

White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations

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Amylyx’s ALS drug sales impress Wall Street

Bio Pharma Dive

In its first full quarter on the market, Amylyx’s Relyvrio generated revenue just shy of $22 million, or roughly five times what some analysts were forecasting a month ago.

Sales 238
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IISc develops chemically modified nanosheets for biomedical applications like delivering drugs to diseased cells

AuroBlog - Aurous Healthcare Clinical Trials blog

The Indian Institute of Science (IISc) researchers from the Department of Organic Chemistry (DOC) and Materials Research Centre (MRC) have shown that surface modifications of two-dimensional molybdenum disulphide (2D-MoS) nanosheets can make them highly effective for applications like delivering drugs to diseased cells.

Drugs 156

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Cytovance Biologics and Phenotypeca partner for biopharmaceutical manufacturing

Pharmaceutical Technology

Cytovance Biologics has entered a collaboration deal with Phenotypeca to enhance the development of saccharomyces cerevisiae strain for biopharmaceutical manufacturing. The partnership is expected to expedite the development of high-performance yeast strains and improve the biologics production efficiency for biopharma clients. It will use the knowledge of Cytovance Biologics in microbial fermentation and the yeast strain development technology of Phenotypeca for producing high-quality expressin

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Regulators backstop SVB deposits, offer emergency lending

Bio Pharma Dive

SVB’s demise on Friday marked the nation’s largest bank failure since Washington Mutual collapsed in 2008, and sent shock waves through both the life sciences and tech sectors.

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Sanofi signs deal to buy Provention Bio for $2.9bn

Pharmaceutical Technology

Sanofi has signed an agreement to buy US-based biopharmaceutical firm Provention Bio in a deal valued at nearly $2.9bn. Under the deal, the company will start a cash tender offer to buy Provention Bio’s all outstanding shares for $25.00 per share in cash. With the acquisition, Sanofi will add a fully owned, first-in-class, disease-modifying treatment for the delay of Stage 3 type 1 diabetes (T1D), Tzield, to its core asset portfolio in General Medicines.

Medicine 130
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Sanofi acquires diabetes drug via Provention buyout

Bio Pharma Dive

The deal builds on a licensing agreement between Sanofi and Provention to market the first-of-its-kind treatment, called Tzield and approved to slow the disease’s progression.

Licensing 130
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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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Denied by AI: How Medicare Advantage plans use algorithms to cut off care for seniors in need

STAT News

An algorithm, not a doctor, predicted a rapid recovery for Frances Walter, an 85-year-old Wisconsin woman with a shattered left shoulder and an allergy to pain medicine. In 16.6 days, it estimated, she would be ready to leave her nursing home. On the 17th day, her Medicare Advantage insurer, Security Health Plan, followed the algorithm and cut off payment for her care, concluding she was ready to return to the apartment where she lived alone.

Allergies 145
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Got muscle pain from statins? A cholesterol-lowering alternative might be for you

NPR Health - Shots

New evidence shows bempedoic acid works to lower cholesterol and reduce the risk of heart attacks, without the muscle pain that some people suffer when taking statins. (Image credit: Digital Vision.

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STAT+: Veterans Health Administration will cover the newest Alzheimer’s drug

STAT News

In an unexpected move, the Veterans Health Administration decided that it will widely cover a new Alzheimer’s treatment , even as Medicare has decided to wait for additional data about the medicine before taking the same step. The VA will provide coverage to veterans who meet agency criteria for using the medicine — called Leqembi — as well as stipulations on the product labeling, according to a statement from Eisai, which is partnering with Biogen to market the treatment.

Medicine 105
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A veterinarian says pets have a lot to teach us about love and grief

NPR Health - Shots

Karen Fine says "I feel like I learn from my patients all the time. They really have skills and senses that we don't." Her new memoir is The Other Family Doctor.

Doctors 136
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The New Age of Decentralized Clinical Trials

This new white paper defines and details the impact of Decentralized Clinical Trials on the Pharmaceutical industry and how the impact can be measured along with steps companies can take to ensure adoption.

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Opinion: The second age of psychedelic therapies for mental health

STAT News

Psychedelics like psilocybin and ketamine are being touted as the next generation of treatment for depression, anxiety, and other mental health issues. There’s no question that a next generation is needed. But it’s not like flipping a switch: These therapies involve a novel administration paradigm, acceptance by regulatory bodies, and public appreciation of their unique medicinal value.

Medicine 105
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Can you catch a hidden virus from a dog kiss or a cat cuddle?

NPR Health - Shots

What's the risk of contracting a virus from your Fido or Kitty? It's not a frivolous question, as one cat-owning virologist explains. And there's another question: Can you give a virus to your pet?

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STAT+: Pfizer buys Seagen, maker of targeted cancer drugs, for $43 billion

STAT News

Pfizer said Monday it is acquiring Seagen, a maker of targeted cancer drugs, for $43 billion. The deal helps Pfizer, flush with cash but in need of new sources of revenue due to declining sales of Covid treatments, by adding a lineup of cancer drugs called antibody-drug conjugates that work by delivering chemotherapy directly to tumors.

Drugs 105
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Mediterranean diet associated with decreased risk of dementia

Medical Xpress

Eating a traditional Mediterranean-type diet—rich in foods such as seafood, fruit, and nuts—may help reduce the risk of dementia by almost a quarter, a new study has revealed.

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Accelerating Clinical Supply Through Integrated Drug Development

As the development pipeline for new drugs continues to grow, biopharmaceutical companies are re-evaluating how to best manage and balance resources across an increasing number of development projects and complex clinical trials. There are two approaches that can be used to speed a drug from development to clinic faster: timeline compression and parallel processing, but only one that considers the benefits of integrating clinical supply into the overall drug development process.

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STAT+: Buyer’s remorse: How a Medicare Advantage business is strangling one of its first funders

STAT News

When NaviHealth began building a business around using algorithms to scrutinize the care of older patients a decade ago, one of the country’s largest chains of inpatient rehab and long-term care hospitals was among the first to invest. Select Medical cut a check of about $5 million — a rounding error for a conglomerate that generates more than $6 billion of revenue every year.

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What Do Patients Have to Say about Gene Therapy Trials? An Upcoming FDA Public Meeting to Hear from Patients and Caregivers

FDA Law Blog

By Larry J. Bauer, Senior Regulatory Drug Expert & James E. Valentine — Incorporating patient and caregiver experiences into every phase of drug development has become increasingly prioritized during both development and review ( see, e.g. , previous coverage here ). Who better than people living with a condition to inform drug companies, physicians, academics, and the FDA on what it is like to live with their condition, what symptoms most impact their lives, what goes into their decision ab

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STAT+: Illumina has been ignoring its investors, but it can’t ignore Carl Icahn

STAT News

Illumina, the DNA sequencing giant whose stock has fallen 40% in two years, already had problems. Now it has to contend with Carl Icahn. The granddaddy of activist investors announced Monday morning that he’s taken a stake in Illumina and wants three handpicked directors added to the company’s board. The message Illumina’s management should hear is this: Icahn usually gets much of what he wants.

DNA 98
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Scientists reveal a potential new approach to treating liver cancer

Medical Xpress

Scientists at the National Institutes of Health and Massachusetts General Hospital in Boston have uncovered a potential new approach against liver cancer that could lead to the development of a new class of anticancer drugs. In a series of experiments in cells and mice, researchers found that an enzyme produced in liver cancer cells could convert a group of compounds into anticancer drugs, killing cells and reducing disease in animals.

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How Machine Learning Drives Clinical Trial Efficiency

Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.

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STAT+: Pharmalittle: Biogen exec who quarterbacked Aduhelm leaves; Pfizer to buy Seagen for $43 billion

STAT News

Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of online meetings and deadlines has returned. But you knew this would happen, yes? After all, the world continues to spin no matter how we try to slow it down. So to cope, we are firing up the coffee kettle and brewing cups of stimulation.

Drugs 98
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From grave robbing to giving your own body to science—a short history of where medical schools get cadavers

Medical Xpress

In 1956, Alma Merrick Helms announced that she was bound for Stanford University. But she would not be attending classes. Upon learning that there was a "special shortage of women's bodies" for medical students, this semiretired actress had filled out forms to donate her corpse to the medical college upon her death.

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STAT+: French pharma Sanofi buys maker of diabetes treatment for $2.9 billion

STAT News

Sanofi said Monday that it is acquiring Provention Bio, makers of a diabetes treatment, for $2.9 billion. The Provention drug at the centerpiece of the deal, called TZield, was approved in the U.S. last November as the first and only treatment to prevent the onset of symptomatic Type 1 diabetes. Sanofi was already co-marketing the drug under a prior licensing deal signed between the two companies.

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Yoga may help to prevent frailty in older adults

Medical Xpress

A systematic review of 33 randomized controlled trials (RCTs) found that yoga improved gait speed and lower extremity strength in inactive older people. However, yoga did not seem to offer a benefit for frailty markers over activities like exercise or tai chi. The review is published in Annals of Internal Medicine.

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The New Clinical Trial Supply Chain: Resilient, Flexible, and Patient-Centric

The global landscape of clinical trials is rapidly changing as studies become more complex. An increasing number of sponsors are seeking enhanced flexibility in their supply chains to address a variety of clinical supply challenges, including patient demand and reducing delays. Demand-led supply and direct-to-patient distribution are next-generation solutions that are helping to meet these growing needs, allowing for more streamlined processes and patient-centric studies.

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STAT+: 102 hours of chaos: How SVB’s collapse rattled the biotech industry

STAT News

Paul Rennert was surprisingly energized after deplaning a transatlantic flight in Boston Thursday evening. He had just wrapped up weeks of international travel and investor meetings, and was pleased that even though the biotech industry was in the midst of one of the worst financing environments in years, venture capitalists had seemed receptive to the idea of investing in his startup, Aleta Biotherapeutics.

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Providing clinicians with an AI sidekick to help to identify cirrhosis

Medical Xpress

There is power and value in a highly skilled detective. Sherlock Holmes and his trusty sidekick, Watson, are famous for sifting through enormous amounts of data—identifying patterns and making predictions to uncover a mystery with ease. In the medical world, clinicians are detectives, making diagnoses and drawing conclusions based on their clinical judgment and available patient data.

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IIH headaches could be treated with exenatide

Pharma Times

The type 2 diabetes therapy is being tested on patients in a phase 2 clinical trial

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COVID-19 can cause 'face blindness,' according to new study

Medical Xpress

COVID-19 can cause difficulty recognizing faces and navigational problems, according to a new Dartmouth study in Cortex.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.