Mon.Oct 16, 2023

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The top biopharma conferences in 2024

Bio Pharma Dive

A few key meetings remain this year, like ESMO and ASH, while next year’s events are already being planned. Here’s a list of conferences to keep in mind.

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Pfizer and BioNTech face 2023 revenue hits amid Covid product write-offs

Pharmaceutical Technology

Pfizer is launching a $3.5bn cost-saving programme and BioNTech expects 2023 revenues to decrease as demand for Covid treatments wanes.

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This Protein May Protect Against Alzheimer’s, Scientists Say

AuroBlog - Aurous Healthcare Clinical Trials blog

In the search for a treatment for Alzheimer’s disease, researchers have zeroed in on a protein with protective effects. A new study reveals how cholesterol and inflammation in different types of human brain cells interact with a protein called ABCA7, which regulates how molecules pass through cell membranes.

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CHMP recommends European authorisation for seven new drugs 

Pharmaceutical Technology

Pfizer’s Elrexfio and Astellas’ Veozah are among the seven drugs recommended for approval by the European regulatory committee.

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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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MDC to call Sanofi India in next meeting before price fixation of its anti-diabetes combination

AuroBlog - Aurous Healthcare Clinical Trials blog

The Multi Disciplinary Committee (MDC) of Experts, which advices the National Pharmaceutical Pricing Authority (NPPA) on pricing related matters, has decided to call Sanofi India in its next meeting to present the company’s case with regard to its application for higher price for certain combinations of its diabetes drug Soliqua.

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US FDA grants approval for BMS’ Opdivo for melanoma

Pharmaceutical Technology

The US FDA has granted approval for Bristol Myers Squibb’s (BMS) Opdivo to treat stage IIB or IIC melanoma patients.

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More Trending

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Bristol Myers Squibb Expands Oncology Portfolio with Mirati Acquisition

Pharmaceutical Technology

On October 9, Bristol Myers Squibb announced it had an agreement to acquire Mirati Therapeutics, a targeted oncology biotech company.

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Novo adds to deal spree with blood pressure drug buy

Bio Pharma Dive

Worth up to $1.3 billion, the deal with Singapore-based KBP Biosciences builds the Ozempic maker’s armory of metabolic disease drugs.

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UCL study suggests changes to improve MRI scans for prostate cancer

Pharma Times

The research aims to make MRIs more available to men and improve treatment decisions - News - PharmaTimes

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Signal: Project NextGen continues with $500m funding for vaccine research

Pharmaceutical Technology

The US government's Covid-19 research programme has announced the vaccine candidates for its latest round of funding.

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

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5 steps to help increase the odds of clinical trial success

Bio Pharma Dive

There are many common reasons clinical trials fail, including failure to demonstrate efficacy, safety concerns, issues with inclusion and exclusion criteria and patient recruitment. Follow these five steps to increase the odds of clinical trial success.

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With COVID sales in free-fall, Pfizer slashes revenue forecast by $9B and preps for major cost cuts

Fierce Pharma

As the coronavirus outbreak has shifted to the endemic phase, drugmakers have warned of a drop in demand for COVID-19 products, with the impact coming into focus during the fall vaccination season. | Pfizer has slashed its 2023 revenue projection by $9 billion because of declining demand for COVID products. The company now expects sales to reach between $58 billion and $61 billion, down from a prior range of $67 billion to $70 billion.

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Landing a CRO that’s an extension of your team

Bio Pharma Dive

In an industry where the convergence of cutting-edge science and a human-centered approach is equally imperative, Worldwide Clinical Trials has found the sweet spot, delivering excellence in the clinical trial experience.

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Merck’s Keytruda wins coveted FDA nod around surgery for early lung cancer—with a surprise

Fierce Pharma

Up until this point, immune checkpoint inhibitors have been allowed to treat early-stage non-small cell lung cancer (NSCLC) either before or after surgery. | Thanks to a new FDA approval for Merck's Keytruda, a continuous immunotherapy regimen around surgery is now available for patients with early-stage non-small cell lung cancer. The drug's label already includes an overall survival win from a key trial.

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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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Synaffix partners with SOTIO Biotech in deal worth up to $740m

Pharma Times

SOTIO will gain access to Synaffix’s three ADC technologies - News - PharmaTimes

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Quotient Sciences Appoints Thierry Van Nieuwenhove as New CEO

Pharma Mirror

Van Nieuwenhove succeeds Mark Egerton, who retires after 18 years in the role Wayne Hewett also joins Quotient Board of Directors as Non-Executive Chairman NOTTINGHAM, UK: Quotient Sciences (“Quotient” or the “Company”), a leading global pharmaceutical drug development and manufacturing accelerator, is pleased to announce the appointment of Thierry Van Nieuwenhove as its new Chief Executive Officer (CEO), effective 16th October 2023.

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CHMP affirms Mundipharma and Cidara’s candidiasis therapy

Pharmaceutical Technology

Mundipharma and Cidara Therapeutics have received a positive opinion from EMA CHMP for rezafungin to treat invasive candidiasis.

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mRNA Drugs: Pros, Cons, and Prospects

Pharma Mirror

by Carrie Taylor, Director of Research & Development of BOCSCI. Globally, the COVID-19 pandemic has significantly accelerated the development of mRNA technology platforms and mRNA industry chains. The first mRNA drug (BNT162b2 vaccine) was granted emergency use authorization by the FDA in December 2020 and approved for marketing in August 2021. mRNA drugs mRNA drugs encode mRNA based on the selection of targets or antigens and enter the cytoplasm through specific delivery systems (such as LN

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Sterling Pharma acquires contract services provider NewChem

Pharmaceutical Technology

Sterling Pharma Solutions has concluded the acquisition of UK-based contract services provider NewChem Technologies for an undisclosed sum.

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Patient Centricity to Integration: Enhancing Cancer Outcomes

pharmaphorum

Patient Centricity to Integration: Enhancing Cancer Outcomes Mike.

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Pfizer gains FDA approval for ulcerative colitis therapy VELSIPITY

Pharmaceutical Technology

Pfizer has received approval from the US FDA for its VELSIPITY to treat adults with moderately to severely active ulcerative colitis (UC).

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Bayer adds QR code to pack to help blind patients

pharmaphorum

Bayer adds QR code to pack to help blind patients Phil.

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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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How the life sciences sector can defend against the top five data protection challenges

Pharmaceutical Technology

Pharma and healthcare organisations use patient data to deliver personalised treatments and efficient care, but the digitalisation of the industry raises new privacy and cybersecurity concerns. We explore how the life sciences industry can address these challenges to create a secure and compliant health data ecosystem.

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AI/ML-enabled Medical Devices Have Everyone’s Attention, Including FDA’s

FDA Law Blog

By Gail H. Javitt & Steven J. Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. The first article—“Is the Eye the Window to Alzheimer’s?

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EMA rejects Amylyx’s ALS drug MAA following reevaluation

Pharmaceutical Technology

The EMA gave a negative approval decision for Amylyx’s Albrioza due to concerns surrounding Phase II results.

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The UK market: A land of new opportunities for medical device manufacturers

pharmaphorum

The UK market: A land of new opportunities for medical device manufacturers Mike.

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Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research

Planning on running clinical trials in Japan? How can you reliably supply these studies? Discover Catalent’s clinical supply packaging facility in Shiga, Japan. Strategically located between Tokyo and Osaka, and one of largest in Japan, this 6,000 square meter facility offers comprehensive services including primary and secondary clinical packaging and labelling, comparator sourcing, cold chain storage, local and global distribution, local language support and white glove service to support stud

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Illumina vows to challenge European Commission order to give up GRAIL

Pharmaceutical Technology

Illumina has said that it intends to challenge the European Commission’s ruling calling for the company to divest itself of its newly acquired cancer detection firm, GRAIL

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AZ’s Tagrisso plus chemo get fast FDA review for lung cancer

pharmaphorum

AZ’s Tagrisso plus chemo get fast FDA review for lung cancer Phil.

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Bristol Myers Squibb's Opdivo reign expands with new earlier-stage melanoma nod

Fierce Pharma

Bristol Myers Squibb’s star Opdivo now can lay claim to an earlier melanoma stage with a new approval that “reinforces the company’s legacy” in treating the cancer type, it said. | Bristol Myers Squibb's Opdivo can now treat completely resected stage 2B or 2C melanoma, adding to its existing approvals in stages 3 and 4 tumors and setting up an expanded market battle with Merck & Co.'s star Keytruda.

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Novo Nordisk cuts $1.3bn deal for KBP blood pressure drug

pharmaphorum

Novo Nordisk cuts $1.3bn deal for KBP blood pressure drug Phil.

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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.