RNA editing: emerging from CRISPR’s shadow
Bio Pharma Dive
OCTOBER 22, 2024
Early study data from Wave Life Sciences suggests how editing RNA may yield viable medicines. Large and small drugmakers say such results are just the start.
Tue.Oct 22, 2024
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EU CHMP recommends AstraZeneca and Ionis’ Wainzua for ATTRv-PN
Pharmaceutical Technology
OCTOBER 22, 2024
The European Union's CHMP has recommended the approval of AstraZeneca and Ionis Pharmaceuticals’ Wainzua to treat ATTRv-PN.
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Editas, changing course again, looks to partner lead CRISPR therapy
Bio Pharma Dive
OCTOBER 22, 2024
The gene editing company will focus on “in vivo” medicines, while seeking to license out or find a development partner for its clinical-stage treatment reni-cel.
MangoRx hits back at Eli Lilly’s weight loss drug copycat claims
Pharmaceutical Technology
OCTOBER 22, 2024
Eli Lilly sued three online vendors and medical spas earlier this week over improper copying of tirzepatide.
From Diagnosis to Delivery: How AI is Revolutionizing the Patient Experience
Speaker: Simran Kaur, Founder & CEO at Tattva 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
Starboard makes case for change at Pfizer, citing research, M&A missteps
Bio Pharma Dive
OCTOBER 22, 2024
The activist investor claims Pfizer failed to capitalize on the windfall earned from its COVID-19 vaccine and, in the process, destroyed tens of billions of dollars in market value.
October 22, 2024: Registration Opens for Pragmatic Trials Workshop at AcademyHealth–NIH Dissemination & Implementation Conference
Rethinking Clinical Trials
OCTOBER 22, 2024
The NIH Pragmatic Trials Collaboratory will offer a full-day workshop at the 17th Annual Conference on the Science of Dissemination and Implementation in Health in Arlington, Virginia. The workshop, “Dissemination & Implementation in Embedded Pragmatic Trials: Getting the Timing Right in Real-World Research,” will introduce concepts in the design, conduct, and implementation of pragmatic clinical trials embedded in healthcare systems, with a particular focus on methods relevant t
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Novo Nordisk plans label expansion for Rybelsus following Phase III win
Pharmaceutical Technology
OCTOBER 22, 2024
The oral semaglutide reduced the occurrence of major adverse cardiovascular events (MACE) by 14% in patients with type 2 diabetes.
FDA names Tarver as new head of device center
Bio Pharma Dive
OCTOBER 22, 2024
Michelle Tarver will officially replace longtime CDRH leader Jeff Shuren, who stepped down from the role earlier this year.
Cambridge University and GSK sign immunology R&D collaboration
Pharmaceutical Technology
OCTOBER 22, 2024
GSK has announced a £50m ($54.3m) investment in a partnership with the University of Cambridge to expedite R&D in immune-related diseases.
Starboard wants to hold Pfizer leadership 'accountable' for overpaid M&A deals, poor return on R&D investment
Fierce Pharma
OCTOBER 22, 2024
Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job. | Activist investor Starboard Value is baring its teeth at Pfizer management, more openly going after CEO Albert Bourla’s job in a new presentation.
How pharma leaders are approaching digital transformation
Pharmaceutical Technology
OCTOBER 22, 2024
For firms unsure about the digital transition, partnering with experienced providers like Controlant simplifies the process
Pfizer lays off 75 more workers in North Carolina in wake of late-stage DMD trial fail
Fierce Pharma
OCTOBER 22, 2024
Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. | Pfizer has told 75 employees in Sanford, North Carolina, that their positions have been eliminated. The layoffs come three months after the company axed 150 positions in Sanford following a high-profile phase 3 trial failure for its Duchenne muscular dystrophy gene therapy candidate.
Editas and Genevant team up to develop gene editing therapies
Pharmaceutical Technology
OCTOBER 22, 2024
Editas is partnering its CRISPR platform with Genevant’s LNP technology to develop novel gene editing medicines in a deal worth $283m.
CDMO Samsung Biologics bags $1.2B production contract, bringing total 2024 deal value to $3.3B+
Fierce Pharma
OCTOBER 22, 2024
With multiple high-profile production pacts already in the books for 2024, CDMO Samsung Biologics has hooked another big one. | Following a string of high-profile deals, Samsung Biologics has locked down a $1.2 billion contract with an unnamed Asia-based pharmaceutical company that’s expected to run through December 2037. Samsung did not elaborate on the identity of its new partner or the types of drugs it will help produce under the accord.
The New Age of Decentralized Clinical Trials
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White paper that delves into the complex topic of Decentralized Clinical Trials and how to master them within the confines of FDA Regulations
Navigating clinical trial disruption: growing trends and new technologies
Pharmaceutical Technology
OCTOBER 22, 2024
Disruption is a pressing problem in the pharmaceutical world; patient health depends on clinical trial organisers avoiding it
Otsuka eyes early filing of IgAN drug after phase 3 readout
pharmaphorum
OCTOBER 22, 2024
Otsuka is hoping to file for approval of its anti-APRIL antibody sibeprenlimab as a treatment for kidney disorder IgA nephropathy (IgAN) after the drug hit the target in a phase 3 trial.The Japanese drugmaker said that interim results from the 530-patient VISIONARY study showed that sibeprenlimab achieved a statistically significant and clinically meaningful reduction in 24-hour urine protein-to-creatine ratio (uPCR) – a measure of how well the kidneys are working – after nine months of treatmen
Avacta partners Tempus AI to boost cancer therapy development
Pharmaceutical Technology
OCTOBER 22, 2024
Avacta Therapeutics has entered a strategic collaboration with Tempus AI to advance the development of drugs in oncology.
DOJ challenges Johnson & Johnson's talc bankruptcy attempt in Texas
Fierce Pharma
OCTOBER 22, 2024
With Johnson & Johnson sweetening the pot and mustering up the support of 83% of those who claim that the company’s talc products caused their cancer, it had
World Osteoporosis Day calls for urgent action to prevent fragility fractures
Pharmaceutical Technology
OCTOBER 22, 2024
The IOF highlights the importance of collaborative efforts in treating osteoporosis, ensuring appropriate care globally.
France warns of penalties if Opella production goes offshore
pharmaphorum
OCTOBER 22, 2024
Sanofi is now in exclusive talks with private equity company Clayton Dubilier & Rice over the sale of a controlling stake in its consumer health business Opella, as the French government seeks guarantees it will keep production and jobs in France.
Gilead and MSD to advance once-weekly HIV treatment to Phase III
Pharmaceutical Technology
OCTOBER 22, 2024
The companies have presented positive Phase II data during an oral session at IDWeek 2024, in Los Angeles, US.
MacroGenics passes off struggling breast cancer med Margenza to TerSera for $40M plus milestones
Fierce Pharma
OCTOBER 22, 2024
MacroGenics’ first commercial product, breast cancer drug Margenza, is heading off to TerSera Therapeutics through a $40 million hand-off. | The 2020-approved breast cancer med booked $17.9 million in 2023 sales as it struggled to make a mark in the crowded market.
The New Age of Decentralized Clinical Trials
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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.
Seven pillars of GenAI for enterprise-level value generation
pharmaphorum
OCTOBER 22, 2024
Discover the seven essential pillars of GenAI for generating value at an enterprise level and leveraging artificial intelligence to drive innovation and growth.
Telix unveils radiopharmaceutical spinoff Rhine Pharma following string of nuclear medicine acquisitions
Fierce Pharma
OCTOBER 22, 2024
There’s no denying it: the radiopharmaceuticals boom is here to stay. | Telix on Tuesday unveiled the spin-off of Rhine Pharma—a new entity born from a collaboration between Telix and Germany’s Heidelberg University Hospital—which is setting out on a mission to expand access to radiopharmaceuticals for cancer treatment and imaging.
Canadian CDMO OmniaBio Launches New Cell and Gene Therapy Manufacturing Facility
XTalks
OCTOBER 22, 2024
Canadian contract development and manufacturing organization (CDMO) OmniaBio has debuted its new state-of-the-art facility focused on cell and gene therapy (CGT) manufacturing. The facility, located in Hamilton, Ontario, spans 120,000 square feet and is designed to support the development and production of cell and gene therapies through AI-enabled technologies.
The 340B Program Reached $66 Billion in 2023—Up 23% vs. 2022: Analyzing the Numbers and HRSA’s Curious Actions
Drug Channels
OCTOBER 22, 2024
Reality has again failed to support the spin surrounding the 340B Drug Pricing Program. For 2023, discounted purchases under the 340B program reached a record $66.3 billion—an astounding $12.6 billion (+23.4%) higher than its 2022 counterpart. The gross-to-net difference between list prices and discounted 340B purchases also grew, to $57.8 billion (+$5.5 billion). 340B purchases are now almost 40% larger than Medicaid’s prescription drug purchases.
Unlocking Excellence: How Catalent Is Transforming Japan’s Clinical Research
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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
FDA Approves Gastric Cancer Drug Vyloy, First-In-Class Approval for Astellas
XTalks
OCTOBER 22, 2024
Astellas Pharma has won approval from the US Food and Drug Administration (FDA) for Vyloy (zolbetuximab) as a first-line treatment for adults with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma. The drug is specifically indicated for patients whose tumors are HER2-negative and express claudin 18.2 (CLDN18.2). Vyloy is a first-in-class monoclonal antibody that targets the CLDN18.2 transmembrane tight junction protein, which is commonly found in some gastric and GEJ cancers.
Starboard spells out its concerns with Pfizer's direction
pharmaphorum
OCTOBER 22, 2024
Starboard Value CEO Jeff Smith pulls no punches in his assessment of Pfizer failings, which he claims have resulted in at least $20bn in lost value
Obesity Clinical Trials: Combining Patient-Centric Care with Scientific Rigor
XTalks
OCTOBER 22, 2024
Obesity remains one of the most significant public health challenges of the 21st century, not only due to its alarming prevalence but also because of its vast implications on individual and societal health. Recent statistics from the World Health Organization (WHO) reveal that worldwide obesity has nearly tripled since 1975. The latest reports indicate that over 650 million adults and an increasing number of children and adolescents are classified as obese, highlighting a global epidemic that sp
AZ, Ionis get CHMP backing for ATTR polyneuropathy drug
pharmaphorum
OCTOBER 22, 2024
AstraZeneca and Ionis are on track for EU approval of ATTR polyneuropathy therapy Wainzua after the CHMP backs the drug
How Machine Learning Drives Clinical Trial Efficiency
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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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