Sat.Oct 15, 2022 - Fri.Oct 21, 2022

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CAR-T pioneer Carl June on founding biotech startups and cell therapy’s next act

Bio Pharma Dive

The University of Pennsylvania immunologist and inventor of Kymriah spoke with BioPharma Dive about working with pharma, starting companies and the future of the cell therapy field.

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Lilly agrees to acquire gene therapy developer Akouos for $610m

Pharmaceutical Technology

Eli Lilly and Company has signed a definitive agreement for the acquisition of all outstanding shares of precision genetic medicine firm Akouos for a total deal value of up to nearly $610m or up to $15.50 for each share in cash. The deal comprises an acquisition value of $12.50 for each share in cash payable at closing along with one non-tradeable contingent value right per share (CVR) of up to another $3 in cash.

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Mouse Study Reveals How to Help Speed Up The Liver’s Self-Regeneration Process

AuroBlog - Aurous Healthcare Clinical Trials blog

The liver is known for its ability to regenerate. It can completely regrow itself even after two-thirds of its mass has been surgically removed. But damage from medications, alcohol abuse, or obesity can eventually cause the liver to fail. Currently, the only effective treatment for end-stage liver disease is transplantation. However, there is a dearth […].

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Kite’s Yescarta to receive European marketing authorisation

Pharma Times

First treatment in 30 years to improve second-line treatment of DLBCL

Marketing 158
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From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience

Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.

The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven

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‘In vivo’ cell therapy: expanding beyond CAR-T

Bio Pharma Dive

At least five startups have emerged with new ways to genetically modify immune cells within the body, an approach that, if successful, could widen the field of CAR-T treatment.

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Hookipa partners with Roche for cancer immunotherapy development

Pharmaceutical Technology

Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinical development through Phase Ib for HB-700 to treat KRAS-mutated cancers. On concluding this trial, Roche will gain the right to develop and market the licenced products across various indications, contingent on approval.

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AlzeCure gets new Alzheimer's abstract accepted

Pharma Times

Therapy is based on ACD856's indicative disease modifying effects against the condition

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Prime Medicine raises $175M in one of the year’s largest biotech IPOs

Bio Pharma Dive

The gene editing startup is one of less than two dozen biotech companies to debut on Wall Street this year, as the pace of IPOs remains far off last year’s trajectory.

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Novel CSF biomarkers signal new avenues for Parkinson’s therapeutics

Pharmaceutical Technology

A new study identifies a novel cerebrospinal fluid biomarker for Parkinson’s disease, expanding the scope of possible drug targets. Last week, Nature magazine published a paper detailing an in-situ study of Parkinson’s disease (PD), showing protein structural changes in cerebrospinal fluid (CSF) between healthy individuals and Parkinson’s patients. There is potential that these structural changes could allow for a new method of differentiating different disease subtypes, thus expanding the scope

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Eating Late at Night Is Not a Good Idea. This Experiment Reveals Why

AuroBlog - Aurous Healthcare Clinical Trials blog

It’s long been popular advice for people looking to lose weight to avoid late night snacking. It’s no wonder, with a host of research showing that late night eating is linked to greater body weight and increased risk of obesity. But until now, few studies have actually investigated precisely why late night eating is linked […].

Research 242
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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Parliament square set for ME research demonstration

Pharma Times

Demonstrators will demand hundreds of millions of pounds ‘missing’ from ME research

Research 154
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Pfizer planning steep price hike for COVID-19 vaccine

Bio Pharma Dive

The company is considering charging as much as between $110 and $130 per dose — roughly four times the vaccine’s current price — once sales transition to the private market.

Vaccine 349
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Novo Nordisk acquires Forma Therapeutics for $1.1bn

Pharmaceutical Technology

Novo Nordisk has concluded the acquisition of all outstanding shares of common stock of clinical-stage biopharmaceutical company Forma Therapeutics for $20 for each share in cash or a deal totalling $1.1bn. In September, Novo Nordisk entered a definitive agreement to acquire Forma. With the conclusion of the merger, Forma became Novo Nordisk’s fully-owned subsidiary. .

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Researchers Have a New Theory About What Causes Alzheimer’s, And It’s Not Plaque

AuroBlog - Aurous Healthcare Clinical Trials blog

In 1906, Alois Alzheimer, a psychiatrist and neuroanatomist, reported “a peculiar severe disease process of the cerebral cortex” to a gathering of psychiatrists in Tübingen, Germany. The case was a 50-year-old woman who suffered from memory loss, delusions, hallucinations, aggression, and confusion – all of which worsened until her untimely death five years later.

Research 239
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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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Grifols’ Tavlesse receives NICE recommendation

Pharma Times

Therapy treats refractory chronic immune thrombocytopenia and is available across UK

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5 questions facing drugmakers as third quarter earnings begin

Bio Pharma Dive

The newly enacted drug pricing law, along with Eisai and Biogen’s Alzheimer’s study success, will bring questions for many of the industry’s top companies.

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AbbVie announces acquisition of DJS Antibodies for $255m

Pharmaceutical Technology

AbbVie has announced the acquisition of UK-based biotechnology firm DJS Antibodies for nearly $255m in cash at closing. DJS focuses on the discovery and development of antibody therapies that act on difficult-to-drug disease-causing proteins, such as G protein-coupled receptors (GPCRs). The company leverages its HEPTAD platform to facilitate the antibody discovery of GPCRs and other difficult targets. .

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BioNTech Founders Predict Cancer Vaccine Is Only Years Away

AuroBlog - Aurous Healthcare Clinical Trials blog

The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade. “Yes, we feel that a cure for cancer, or to changing cancer patients’ lives, is in our grasp,” said […].

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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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Boston University researchers’ testing of lab-made version of Covid virus draws government scrutiny

STAT News

Research at Boston University that involved testing a lab-made hybrid version of the SARS-CoV-2 virus is garnering heated headlines alleging the scientists involved could have unleashed a new pathogen. There is no evidence the work, performed under biosecurity level 3 precautions in BU’s National Emerging Infectious Diseases Laboratories, was conducted improperly or unsafely.

Research 145
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AbbVie to buy UK biotech DJS for $255M

Bio Pharma Dive

The deal gives AbbVie an experimental medicine for idiopathic pulmonary fibrosis, as well as a platform for designing antibody drugs that can target proteins known as GPCRs.

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Immediate steps are needed to reduce the ‘twindemic’ impact in Europe and the US

Pharmaceutical Technology

Recent reports show that influenza cases are rising in the US and the UK. The intensity of the flu season in North America and Europe can be predicted by Australia’s flu season, having occurred months before the northern hemisphere’s winter period. This year, Australia experienced its worst flu season in five years. At its height, more than 30,000 cases were reported each week, according to the Australian Government Department of Health and Aged Care.

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Karnataka embarks on inspections to ensure quality of four cough syrups that led to death of 66 children in Gambia

AuroBlog - Aurous Healthcare Clinical Trials blog

The Karnataka drugs control department is insisting that all the cough syrup manufacturers dealing in ethylene glycol and diethylene glycol will now need to procure solvents like glycerin and propylene glycol complying to pharmacopeia standards directly from manufacturers as required under para 10 of the Schedule M of the Drugs & Cosmetics Act, 1945.

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

Speaker: Dr. Ben Locwin - Biopharmaceutical Executive & Healthcare Futurist

What will the future hold for clinical research? A recent draft from the FDA provides valuable insight. In "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases," the FDA notes that "targeted therapies demonstrate different dose-response relationships compared to cytotoxic chemotherapy, such that doses below the Maximum Tolerated Dose (MTD) may have similar efficacy to the MTD but with fewer toxicities.

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STAT+: European Prosecutor’s Office confirms it’s investigating European Union Covid vaccine contracts

STAT News

In an unusual step, the European Public Prosecutor’s Office (EPPO) confirmed it has opened an investigation into the Covid-19 contracts signed by the European Union, a move that comes shortly after numerous members of the European Parliament harshly criticized a lack of transparency surrounding an agreement with Pfizer. The EPPO is an independent public prosecution office that is responsible for investigating, prosecuting, and bringing to judgment crimes such as fraud, money laundering an

Vaccine 144
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Biogen expects longer wait on ALS drug decision from FDA

Bio Pharma Dive

The agency has requested more information about tofersen, a closely watched medicine that Biogen is seeking approval of despite a failed Phase 3 trial.

Medicine 317
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A game of two halves for Roche’s recently approved wet AMD assets

Pharmaceutical Technology

Of late, it seemed that all the stars had aligned well for Roche in the wet age-related macular degeneration (wAMD) space. With Susvimo (ranibizumab sustained release) winning US FDA approval last year, followed by an FDA approval for Vabysmo (faricimab) this year, Roche had all the right assets to take the game to the current market leader, Regeneron and Bayer’s Eylea (aflibercept), at an accelerated pace.

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Five states yet to report formation of Appropriate Authority under ART, Surrogacy Regulation Acts

AuroBlog - Aurous Healthcare Clinical Trials blog

With less than ten days to meet the deadline mandating the registration of Assisted Reproductive Technology (ART) clinics, ART banks and Surrogacy Clinics to be eligible to conduct counselling and procedures, five more States are yet to report to the Centre on appointment of appropriate authority. In a relief to the Centre, 12 out of […].

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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CDC: Signs point to an early start for flu season, with cases already ticking up in parts of the U.S.

STAT News

Before the Covid-19 pandemic emerged, influenza trackers would begin reading tea leaves around this time of the year, looking for signs of whether there would be an early start to the flu season in the northern hemisphere and which of the various flu viruses might be responsible for the most cases over the coming winter. Flu transmission has been low since the start of the pandemic , but an odd spurt of activity in April, May, and even early June of 2022 — which coincided with the onset o

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A startup plans an IPO to give a shelved Lilly drug another shot

Bio Pharma Dive

Acrivon Therapeutics is looking to fund a development approach it claims could improve the prospects of a cancer drug Lilly scrapped after testing it in clinical trials.

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New dawn for the EU’s joint procurement crisis response

Pharmaceutical Technology

The European Union (EU) is on the cusp of approving clearer rules governing the joint procurement of medicines and medical devices by member states at the EU level. The imminent rule changes will apply to crisis-relevant supplies of medical countermeasures, including both vaccines and therapeutics, where the threshold of a 'serious cross-border threat to health' is met.

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PETA India urges CPCSEA to withdraw recommendation for using stray dogs for vaccine testing

AuroBlog - Aurous Healthcare Clinical Trials blog

Animal rights organisation People for Ethical Treatment of Animals (PETA) India has urged the Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) to withdraw its recent recommendations for using stray dogs for vaccine testing in favour of superior, human-relevant, animal-free research methods, which are more effective and don’t cause suffering […].

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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.