Tue.Sep 03, 2024

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Why the Importer of Record (IoR) is vital in the clinical supply chain ­­

Pharmaceutical Technology

In clinical supplies, the Importer of Record (IoR) provides a critical service in facilitating logistics and easing the burden for sponsors.

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New research could ease concerns over suicide risk of obesity drugs

Bio Pharma Dive

While results from two after-the-fact analyses were “reassuring,” outside experts urged “continued vigilance” to ensure GLP-1 drugs don’t worsen problems in people with preexisting mental health conditions.

Drugs 312
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UAE MoHAP and Novo Nordisk partner for obesity management

Pharmaceutical Technology

The UAE has partnered with Novo Nordisk Pharma Gulf to develop a national scientific guide for obesity management and weight control.

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Vaxcyte’s “best-case” data for pneumococcal vaccine boost shares

Bio Pharma Dive

The company's value jumped by several billion dollars as trial results showed its experimental shot could match and, in some cases, even outperform Pfizer's market-leading Prevnar 20.

Vaccine 182
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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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Skyline wins orphan drug designation for retinitis pigmentosa gene therapy

Pharmaceutical Technology

There are currently no approved treatments that can halt or reverse photoreceptor degeneration in patients with retinitis pigmentosa.

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Sanofi finds a silver lining in mixed MS drug results

Bio Pharma Dive

Tolebrutinib, which Sanofi acquired in a $3.7 billion deal, failed two studies in people with relapsing disease, but succeeded in a type of multiple sclerosis that has no approved therapies.

Drugs 182

More Trending

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AI specialist Recursion says lead drug is safe, but efficacy less clear

Bio Pharma Dive

The Phase 2 results for Recursion’s cerebral cavernous malformation treatment are the first in a series of important trial readouts for the high-profile “techbio” company.

Drugs 173
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Ocaliva approval in Europe withdrawn following data re-assessment

Pharmaceutical Technology

Advanz Pharma, Ocaliva’s manufacturer, said thousands of patients will no longer benefit from the treatment.

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Script for success: The value of digital insights in pharma

Bio Pharma Dive

Pharma companies can thrive in 2024 by leveraging digital intelligence to anticipate trends, analyze sentiment, and engage audiences. Discover how data-driven insights drive success.

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Simcere Zaiming and TargetRx agree TGRX-326 commercial rights

Pharmaceutical Technology

Simcere Zaiming has entered a collaboration deal with Shenzhen TargetRx to bring TGRX-326 to the Chinese market.

Marketing 130
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Optimizing Clinical Supply Strategy: Navigating Challenges & Finding Your Ideal Model

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FDA advisory panels in the spotlight, as reform talks heat up

Bio Pharma Dive

Following a recent listening session hosted by the agency, current and former members have weighed in on the process and how it could be improved.

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UK NHS launches vaccine programme for RSV

Pharmaceutical Technology

The UK NHS has commenced its first-ever vaccination programme for RSV vaccine, targeting pregnant women and older adults.

Vaccine 130
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Illumina avoids fine for Grail purchase in European court victory

Bio Pharma Dive

The sequencing firm will avoid a penalty of 432 million euros after a court ruled the European Commission did not have jurisdiction to challenge the company’s Grail acquisition.

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ESC 2024: Beta blocker treatment paradigm shifts for myocardial infarction

Pharmaceutical Technology

New data provides more evidence on choosing the ideal approach for prescription of beta blockers for myocardial infarction.

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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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In Europe, shortages of Novo Nordisk's Ozempic to persist into Q4: letter

Fierce Pharma

Late last year, Novo Nordisk responded to a growing shortage of popular Ozempic with a plan to cut down on production of its older diabetes med Victoza to make room for more Ozempic. | The company and the European Medicines Agency warned European healthcare providers to continue limiting new patient prescriptions until the shortages let up.

Medicine 128
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Syntekabio and Enamine partner for AI-based drug development

Pharmaceutical Technology

Syntekabio has entered a partnership with Enamine for supply, synthesis of compounds and synthetic drug development.

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Illumina avoids hefty EU fine over Grail merger

pharmaphorum

EU had no grounds to probe Illumina's takeover of Grail, says ECJ, but while spinoff has already taken place Illumina can now avoid a €432m fine

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Scilex's Semnur Pharmaceuticals to go public through $2.5B SPAC merger as it advances sciatica prospect

Fierce Pharma

Semnur Pharmaceuticals, which is working on a non-opioid prospect for sciatica, has agreed to merge with special purpose acquisition company Denali Capital Acquisition Corp. | Semnur Pharmaceuticals is following in its parent company Scilex's footsteps with a special purpose acquisition company (SPAC) merger.

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European Clinical Supply Planning: Balancing Cost, Flexibility and Time

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Unpacking the High Cost of GLP-1 Drugs

Pharmaceutical Commerce

How can industry stakeholders ensure the quality and supply chain security of existing product?

Drugs 111
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Data builds behind Valneva, Pfizer's Lyme disease vaccine

pharmaphorum

New data for Valneva and Pfizer's Lyme disease vaccine bolsters the case for the shot as the results of a phase 3 programme are awaited.

Vaccine 110
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Dr. Reddy's banned from China's drug procurement program after inspectors turn up manufacturing problems

Fierce Pharma

Dr. Reddy’s has been cut off from China’s bulk-buy drug procurement program after an inspection turned up “serious defects” in the company’s manufacturing operations. | Following a remote inspection of a Dr. Reddy’s formulations production plant, China’s National Medical Products Administration has suspended the import, sale and use of the Indian drugmaker’s atomoxetine hydrochloride capsules for ADHD.

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HDA 2024 Traceability Seminar: Legal Advice for DSCSA Compliance Teams

Pharmaceutical Commerce

In an interview with Pharma Commerce Editor Nicholas Saraceno, Ilisa B.G. Bernstein, President of Bernstein Rx Solutions, LLC, highlights the hard-hitting points that she anticipated will be covered during her session at the 2024 HDA Traceability Seminar.

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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 to Scale Your Business with a CDMO

Drug Patent Watch

Scaling your business with a Contract Development and Manufacturing Organization (CDMO) is crucial for biopharmaceutical companies seeking to expedite the transition from preclinical development to clinical manufacturing. CDMOs play a vital role in providing expertise in process development and scale-up manufacturing, allowing biotech companies to adapt to changing market dynamics and client needs.

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Pharma Pulse 9/3/24: CrowdStrike VP to Testify on IT Outage, Embracing FSPs & more

Pharmaceutical Commerce

The latest news for pharma industry insiders.

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Digital NHS health checks will start in England next year

pharmaphorum

A digital version of the NHS Health Check offered to older people in the UK will be piloted in some areas of England early next year, according to the government.The Department of Health and Social Care (DHSC) has said the digital alternative to the current system of in-person health checks will be ready for testing in early 2025, with pilots planned for Norfolk, Medway, and Lambeth in London.

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Metagenomics revolution: Empress Therapeutics on drug discovery breakthroughs

Outsourcing Pharma

Dr Dawn Thompson has over 20 years of experience in building technology platforms that leverage genomics at scale to produce novel products.

Genome 93
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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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Advanz Pharma's bid to keep Ocaliva on EU market fails

pharmaphorum

EU follows through on plan to revoke approval for Advanz Pharma's Ocaliva for rare disease primary biliary cholangitis (PBC)

Marketing 101
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FDA grants expanded approval for Emergent Bio’s mpox vaccine

BioPharma Reporter

The U.S. company Emergent BioSolutions recently announced the FDA approval of its application to expand the indication for ACAM2000 â previously approved for smallpox â to include the prevention of mpox in high-risk individuals.

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Vaxcyte's pneumococcal vaccine win points to Prevnar battle

pharmaphorum

Vaxcyte's new pneumococcal vaccine may only have phase 1/2 results behind it, but analysts are already predicting it could be a major competitor to rival shots from Pfizer and MSD.Just-reported data from that study has shown that Vaxcyte's VAX-31 shot was able to stimulate a strong immune response against all 31 serotypes of Streptococcus pneumoniae included in the formulation, in adults aged 50 and over.

Vaccine 90
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Reimagine Care and Memorial Hermann boost cancer care engagement

Outsourcing Pharma

Reimagine Care, the leading provider of on-demand cancer care, and Memorial Hermann Health System, one of Texas's largest not-for-profit health systems, have announced an ambitious multi-year expansion of their pioneering partnership.

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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.