Fierce Pharma

OCTOBER 15, 2024

Nearly six months after lodging a similar complaint against Pfizer and BioNTech over the partners’ COVID shot Comirnaty, GSK is targeting Moderna in a pair of lawsuits alleging the Massachusetts-ba | GSK is targeting Moderna in a pair of lawsuits claiming the mRNA specialist violated multiple patents with its vaccines Spikevax and mRESVIA. In the complaints, GSK says it hopes to recover a “reasonable royalty” tied to Moderna’s vaccine sales, plus damages.

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Vaccination Vaccine Sales 130

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.

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RNA Life Science Medicine 354

Pharmaceutical Technology

OCTOBER 25, 2024

At the Outsourcing in Clinical Trials Conference, key opinion leaders shared predictions for workflow changes due to AI.

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Pharma Companies Clinical Trials Clinical Trials Development 289

pharmaphorum

OCTOBER 30, 2024

Eli Lilly says a new starting dose regimen for its Alzheimer's disease therapy Kisunla reduces the risk of side effects that have stood in the way of approvals and reimbursement decisions for drugs in its class.Simply shifting one vial of the anti-amyloid antibody from the first infusion to the third infusion of the titration phase of dosing – the period used to achieve therapeutic levels in the body – is enough to lower the incidence of a potentially serious side effect known as ARIA-E, accordi

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Antibody Drugs 109

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

Medicine

Pharmaceutical Technology

OCTOBER 21, 2024

This trial investigated the potential of Nanoscope Therapeutics' MCO-010 to restore vision in patients with retinitis pigmentosa (RP).

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Trials 246

Pharmaceutical Commerce

OCTOBER 31, 2024

With today's pharmacy landscape shaken by unprecedented and wider disruption to healthcare support and delivery, community and independent entities strive to remain an integral cog in the mix.

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Pharmacy 123

Bio Pharma Dive

OCTOBER 16, 2024

The results provide the first clinical evidence of RNA editing, a burgeoning field that's drawn interest from biotechs and pharmaceutical companies alike.

RNA 358

RNA Trials 358

ACRP blog

OCTOBER 16, 2024

Just when it seemed as if decentralized clinical trials (DCTs) were in danger of becoming “yesterday’s news” in light of all the attention being paid lately to applications of artificial intelligence in the clinical research enterprise, the tables have turned, if perhaps only briefly, thanks to the release of finalized new U.S. Food and Drug Administration (FDA) regulatory guidance on DCTs.

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Clinical Trials Clinical Trials Trials Clinical Research 116

pharmaphorum

OCTOBER 14, 2024

Eli Lilly may invest $364m in the UK and work with the government to tackle serious public health challenges including obesity.

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Pharmaceutical Technology

OCTOBER 18, 2024

An 800% increase in licensing deal values indicates growing confidence in mRNA technology, but some vaccine producers are facing lawsuits.

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Licensing Licensing Vaccination Vaccine 278

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Clinical Supply

Outsourcing Pharma

OCTOBER 15, 2024

The big pharma company Sanofi has discontinued a phase 2 trial of U.S. partner Denali Therapeuticsâ oditrasertib for the treatment of multiple sclerosis after the drug failed to perform.

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Trials Pharma Companies Drugs Clinical Trials 110

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.

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Bio Pharma Dive

OCTOBER 4, 2024

An experimental Alzheimer’s therapy from Cassava Sciences is still being tested in two Phase 3 studies, even as the company has come under regulatory scrutiny.

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Trials 360

XTalks

OCTOBER 28, 2024

November is National Diabetes Month. This year’s theme of National Diabetes Month 2024, “Take Charge of Tomorrow: Preventing Diabetes Health Problems,” highlights how today’s actions can shape healthier futures. On National Diabetes Month 2024, healthcare organizations, policymakers and community programs are raising awareness for the nearly 29.3 million Americans with diagnosed diabetes, alongside 9.7 million undiagnosed and 115.9 million at risk with prediabetes, based on the Ameri

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Insulin FDA Approval Marketing Doctors 103

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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

Clinical Trials

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

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Drugs Protein Antibody 117

Pharmaceutical Technology

OCTOBER 14, 2024

Trends in gene therapy approvals in recent years are rapidly shaping the future of manufacturing capabilities in the pharmaceutical industry.

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Gene Therapy Manufacturing Gene 279

Outsourcing Pharma

OCTOBER 10, 2024

The big pharma company AstraZeneca has forged a licensing pact worth $2 billion with the Chinese firm CSPC Pharmaceutical Group for access to an experimental small molecule treatment for dyslipidemia.

Licensing 111

Licensing Licensing Pharma Companies Drugs 111

Fierce Pharma

OCTOBER 18, 2024

After a prior rejection, Astellas can head into the weekend celebrating a class-first FDA approval for its new gastric cancer med Vyloy. | Astellas' Vyloy won an FDA approval to treat gastric or gastroesophageal junction adenocarcinoma patients whose tumors are CLDN18.2 positive. The drug was rejected earlier this year thanks to observations raised during the agency's inspection of a third-party manufacturing facility.

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FDA Approval Manufacturing Drugs 127

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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.

Clinical Trials

Bio Pharma Dive

OCTOBER 17, 2024

Vyalev’s clearance is the second victory for AbbVie in Parkinson’s this year, following an April readout for a drug acquired through its Cerevel buyout.

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Drugs 331

XTalks

OCTOBER 25, 2024

Shields Health Solutions, a specialty pharmacy owned by Walgreens, has partnered with Sutter Health to expand access to specialty medications across the US. This collaboration aims to support patients with chronic and complex conditions, particularly in oncology, rheumatology and dermatology. Nearly 3,000 healthcare providers will benefit, as Shields’ broad payer network and access to limited distribution drugs will offer patients more treatment options and cost-saving support.

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Pharmacy Dermatology Cardiology Drugs 104

pharmaphorum

OCTOBER 9, 2024

Advancing Precision Care For All with Hakim Yadi from Closed Loop Medicine. Listen to the latest podcast episode featuring insights from a leader in the healthcare industry.

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Medicine 122

Pharmaceutical Technology

OCTOBER 7, 2024

The CD7 CAR)-T cell therapy has demonstrated potential in treating patients with relapsed or refractory T-cell leukaemia.

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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.

Clinical Research

Velocity Clinical Research

OCTOBER 21, 2024

At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. It was our third time receiving the award, which recognizes the fastest-growing mid-market businesses in the state. For a clinical trials organization to achieve this level of scale is notable. The clinical trials sector in the US is typically made up of small independent businesses that collectively play an important role in trialing new protocols and aiding drug development.

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Clinical Trials Clinical Trials Trials Clinical Research 105

Fierce Pharma

OCTOBER 23, 2024

With an expanded recommendation from the Center for Disease Control and Prevention (CDC)’s Advisory Committee on Immunization Practices (ACIP), pneumococcal conjugate vaccines (PCV) from Pfizer and | The CDC's immunization committee voted to expand the recommendation for pneumococcal conjugate vaccines, including both Pfizer’s Prevnar 20 and Merck’s newer Capvaxive.

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Vaccination Vaccine 126

Bio Pharma Dive

OCTOBER 24, 2024

Newly published data show the therapy reduced the rate of swelling attacks in people with hereditary angioedema, but didn't silence questions about its commercial outlook.

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FDA Law Blog

OCTOBER 27, 2024

By Deborah L. Livornese & John W.M. Claud & Charles D. Snow — On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA.

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Drugs Marketing Production Compliance 100

Advertiser: FourKites

A research study conducted by The Journal of Commerce and FourKites surveyed hundreds of international shippers, exploring how their usage of global supply chain visibility technology has evolved since the onset of global disruptions caused by COVID-19. For international shippers, ocean freight visibility has evolved from optional to essential and satisfaction with visibility varies greatly depending on how it is obtained and delivered.

Research

pharmaphorum

OCTOBER 18, 2024

Sanofi invests €300m in Orano Med's lead-based radioligandsSanofi has firmed up its position in the red-hot area of radiopharmaceuticals for cancer with the purchase of a €300 million ($325 million) stake in Orano Med, a subsidiary of French nuclear fuel company Orano.The transaction builds on a three-way partnership between Sanofi, Orano Med, and RadioMedix – signed in September with a €100 million upfront payment – to develop a radioligand therapy (RLT) for rare neuroendocrine tumours (NETs) c

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Development 117

Pharmaceutical Technology

OCTOBER 2, 2024

Exscientia detailed how its robotics lab in Oxfordshire, UK is increasing productivity and efficiency in developing new molecules at ELRIG 2024.

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Production Drugs Development 275

JAMA Internal Medicine

OCTOBER 13, 2024

This multicenter randomized clinical trial investigates the efficacy and safety of acupuncture compared with sham acupuncture in patients with chronic sciatica from herniated disk.

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Clinical Trials Clinical Trials Trials 111

Fierce Pharma

OCTOBER 1, 2024

Johnson & Johnson is laying off 231 employees in New Jersey and Bayer is cutting 57 positions in the state, according to separate Worker Adjustment and Retraining Notification (WARN)

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Speaker: Steve Goldstein, Sales Leader

Are you currently in sales, or involved in a business that depends on strong sales results? What about the extremely competitive world of medical device sales? What are some of the top challenges your customers face and how do you approach understanding what’s most important to them? Join Steve Goldstein, Sales Success Coach, Motivational Speaker and Medical Device Sales Leader from Gold Selling LLC., to discover critical strategies and approaches you can take to engage your customers, achieve g

Sales