Sat.Jul 22, 2023 - Fri.Jul 28, 2023

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AstraZeneca buys Pfizer’s early gene therapy work for up to $1B

Bio Pharma Dive

The British pharma is deepening its investment in genetic medicine through a deal for a group of Pfizer’s gene therapy delivery tools, while the New York giant cuts back.

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NS Pharma scores breakthrough therapy status for DMD therapy

Pharmaceutical Technology

NS Pharma’s candidate would be the first to target Duchenne Muscular Dystrophy (DMD) patients amenable to exon 44 skipping therapy.

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July 27, 2023: NIH Collaboratory Hosts Onboarding Session for Newest Demonstration Projects

Rethinking Clinical Trials

Leaders of the NIH Pragmatic Trials Collaboratory hosted an onboarding meeting for the program’s 3 newest Demonstration Projects. The projects joined the program under the UG3 cooperative agreement mechanism to support a 1-year planning phase in preparation for potential transition to a UH3 implementation phase. Access the complete materials from the onboarding session.

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ABPI reacts to new vital vaccination report

Pharma Times

New HSCC document deems the UK’s vaccination position to be at risk - News - PharmaTimes

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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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Gene editing biotech Homology hits reset and seeks a sale

Bio Pharma Dive

The company will lay off 87% of its workforce and halt further research, including for a gene editing therapy to treat the rare disease PKU.

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Boehringer, Lilly secure EC approval for Jardiance to treat adults with CKD

Pharmaceutical Technology

Boehringer Ingelheim and Eli Lilly have secured approval from the EC for Jardiance to treat adults with chronic kidney disease (CKD).

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More Trending

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AstraZeneca links up with Qureight on lung disease research

Pharma Times

The company will utilise Qureight’s AI technology to undergo studies across a variety of complex lung diseases - News - PharmaTimes

Research 107
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Biogen to acquire rare disease drugmaker Reata for $7.3B

Bio Pharma Dive

The deal is a major bet by Biogen and its new CEO Chris Viehbacher, who’s reorganized R&D, cut costs and laid off staff since becoming company head last year.

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Verrica gains FDA approval for Verrica’s YCANTH to treat molluscum

Pharmaceutical Technology

Verrica has received approval from the US FDA for its YCANTH to treat molluscum in adult and paediatric patients aged two years and above.

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Biogen, amid layoffs, ponies up $7.3B for rare disease specialist Reata and potential blockbuster Skyclarys

Fierce Pharma

On Monday during a quarterly earnings call, when Biogen CEO Chris Viehbacher was asked about the company’s potential to execute M&A, he randomly offered “we’ve got, I think, about $7.3 billion | Biogen has revealed a proposal to acquire Reata Pharmaceuticals for $7.3 billion. The Texas-based rare disease specialist brings newly approved Skyclarys, the first treatment for the neurologic disorder Friedreich’s ataxia with peak sales potential of $1.5 billion.

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

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MSD’s HCV report calls for key elimination boosts

Pharma Times

The advice includes a national rollout of the HCV GP champion programme and further testing - News - PharmaTimes

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Moderna, Merck advance cancer vaccine into late-stage test

Bio Pharma Dive

The companies are enrolling people with melanoma in a Phase 3 trial aimed at testing whether the shot can prevent disease recurrence.

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Eli Lilly extends tender offer for $2.4bn Dice acquisition

Pharmaceutical Technology

Eli Lilly has extended the tender offer expiration date for the acquisition of all Dice Therapeutics in a deal valued at $2.4bn.

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1000Farmacie Secures $25 Million in Series A Funding

pharmaphorum

1000Farmacie Secures $25 Million in Series A Funding Nicole.

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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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Vantage Biosciences launched to take on diabetic eye disease

Pharma Times

The new company’s core mission is to boost patient access to disease-modifying treatments - News - PharmaTimes

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GSK confident in RSV vaccine launch, but sets expectations for ‘steady build’

Bio Pharma Dive

GSK expects its respiratory syncytial virus vaccine will be a multibillion dollar product. But at the beginning it’s predicting a slower launch than for its fast-selling shingles shot.

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Bavarian Nordic falls by RSV vaccine wayside after Phase III failure

Pharmaceutical Technology

Shares in the company dropped by 29% despite assurances the failure would not harm its 2023 financial outlook.

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Biovian Makes $55 Million investment in Finland Manufacturing Facility

Pharmaceutical Commerce

CDMO’s Turku addition will span over 69,000 square feet and support the production of ATMPs.

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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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First dose completed in phase 1 cannabinoid study

Pharma Times

OCTP aims to demonstrate the lead candidate’s safety, tolerability and pharmacokinetic profile - News - PharmaTimes

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Bavarian Nordic to scrap RSV vaccine after study setback

Bio Pharma Dive

The shot failed to meet a key goal of Bavarian Nordic’s Phase 3 study, a finding that separates it from marketed vaccines developed by Pfizer and GSK.

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GSK reports rise in profit in Q2 2023

Pharmaceutical Technology

GSK has reported an adjusted operating profit of £2.17bn in Q2 2023, which is an almost 8% increase from the £2.

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New patent expiration for Astrazeneca drug SYMBICORT

Drug Patent Watch

Annual Drug Patent Expirations for SYMBICORT Symbicort is a drug marketed by Astrazeneca and is included in one NDA. It is available from three suppliers. There are eleven patents protecting… The post New patent expiration for Astrazeneca drug SYMBICORT appeared first on DrugPatentWatch - Make Better Decisions.

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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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TVM and Tillotts form company to take on ulcerative colitis

Pharma Times

Mage Biologics aims to progress a novel, orally administered monoclonal antibody - News - PharmaTimes

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Hunting Host Cell Proteins (HCPs) with mass spectrometry

Bio Pharma Dive

Regulators are recognizing mass spectrometry as a powerful tool in Host Cell Protein analysis. Are you ready to implement HCP-MS?

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Bernie Sanders plans more drug price caps as big pharma fights back

Pharmaceutical Technology

Senator Bernie Sanders has proposed price caps on drugs developed with federal funds, following a political career battling against high drug prices.

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Merck's challenge to Pfizer's Prevnar grows

pharmaphorum

Merck's challenge to Pfizer's Prevnar grows Phil.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Crescendo widens pivotal solid tumour therapy trial

Pharma Times

The CB307 study expansion involves the addition of a new pembrolizumab combination cohort - News - PharmaTimes

Trials 99
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Cell and gene therapy is coming of age

Bio Pharma Dive

Outsourcing in the cell and gene therapy industry is booming and no longer considered just a “trend.

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Inflationary pressure causes drop-off in contract manufacturing M&A

Pharmaceutical Technology

As several economies deal with inflation, there has been a reduction in deals involving contract manufacturing organisations.

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After cutbacks, Biogen adds new drug with $7.3bn Reata buy

pharmaphorum

After cutbacks, Biogen adds new drug with $7.3bn Reata buy Phil.

Drugs 98
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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.