European Pharmaceutical Review

FEBRUARY 27, 2024

The Chief Executive of the Medicines and Healthcare products Regulatory Agency (MHRA), Dame June Raine, will step down in the Autumn following five years in the role. Dame June will remain in the position until then to support the new Chief Executive’s transition into the role. Leading the MHRA – a five year journey Professor Graham Cooke, interim chair of the MHRA board, remarked that Dame June’s “leadership of the MHRA over the last five years, particularly during the COVID-19 pand

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Fierce Pharma

MARCH 1, 2024

Moderna is laying off employees within its manufacturing unit, with the move tied to a resizing of its COVID production work. | Moderna is laying off some employees within its manufacturing unit after shaving COVID production costs. The company previously disclosed plans to rightsize its COVID vaccine production footprint.

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Manufacturing 316

MedCity News

FEBRUARY 26, 2024

In an interview at the Vive conference in Los Angeles, John Couris said that while he is sympathetic toward Change Healthcare’s current woes, he wants definitive answers soon.

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Healthcare Healthcare 128

Pharmaceutical Technology

FEBRUARY 29, 2024

India’s Tata Institute has developed a tablet combining resveratrol and copper that has the potential to prevent the recurrence of cancer.

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pharmaphorum

FEBRUARY 26, 2024

Sanofi gets a win for its oral BTK inhibitor rilzabrutinib in chronic hive disorder CSU, setting up a phase 3 programme as it chases after Novartis’ remibrutinib in this indication.

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Fierce Pharma

FEBRUARY 27, 2024

AstraZeneca and FibroGen have finally reached the end of the road for their U.S. collaboration on the oral anemia drug roxadustat. | More than two years after a high-profile FDA rejection, AstraZeneca has backed out of a collaboration with FibroGen for the latter’s oral anemia drug roxadustat in the U.S. Still, AZ left the partners' China pact intact.

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FDA 308

Pharmaceutical Technology

FEBRUARY 28, 2024

AGTC-501 is in Phase II development for retinitis in the SKYLINE trial (NCT03316560) and addresses unmet needs within the retinitis space

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pharmaphorum

MARCH 1, 2024

Pfizer says new oncology division will generate eight new blockbusters by 2030, in first R&D update after its $43bn takeover of Seagen.

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Fierce Pharma

FEBRUARY 26, 2024

Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” | Amgen is now open for business in Central Ohio after cutting the ribbon at its “most advanced facility to date.” Dubbed “Amgen Ohio,” the nearly 300,000-square-foot biomanufacturing plant in New Albany, Ohio, is set to employ 400 full-time employees and leverage the “latest innovation and technology.

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MedCity News

FEBRUARY 26, 2024

At the Payer Insights sessions on Day 1 of ViVE 2024, a panel on prior authorization offered compelling insights from speakers who shared the positive developments in this area after years of mounting frustration. Speakers also shared challenges as they work with providers to figure out how policy developments and technology will work in practice.

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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.

Safety

European Pharmaceutical Review

FEBRUARY 29, 2024

Eligible individuals in England and Wales can access the first licensed treatment for amyloid light-chain (AL) amyloidosis on the NHS. The National Institute for Health and Care Excellence (NICE) recommended DARZALEX ® (daratumumab) plus VELCADE ® (bortezomib), cyclophosphamide and dexamethasone (DVCd) as an option for people newly diagnosed with the systemic form of the disease.

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Pharmaceutical Manufacturing Patients 105

pharmaphorum

FEBRUARY 28, 2024

AbbVie has made another bolt-on deal in the immunology and inflammation category, paying $48 million upfront for rights to an antibody in preclinical development at OSE Immunotherapeutics. There’s another $665 million in potential milestones and a royalty tied to the deal, which focuses on OSE-230, billed as a potentially first-in-class activator of ChemR23, a G-protein coupled receptor (GPCR) found on some white blood cells.

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Fierce Pharma

FEBRUARY 27, 2024

Over-the-counter self-care specialist Perrigo is poised to leave hundreds of workers by the wayside as it embarks on the next leg of its corporate journey. | As part of a cost-cutting and restructuring initiative dubbed "Project Energize," Perrigo expects to trim roughly 6% of its total staff, the company said in a fourth-quarter earnings release Tuesday.

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MedCity News

FEBRUARY 25, 2024

The way dentistry has embraced technological innovation to make patient care both safer and more comfortable serves as an example for the rest of the healthcare sector.

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Patients Healthcare Healthcare 119

Advertiser: ZoomInfo

Marketing technology is essential for B2B marketers to stay competitive in a rapidly changing digital landscape — and with 53% of marketers experiencing legacy technology issues and limitations, they’re researching innovations to expand and refine their technology stacks. To help practitioners keep up with the rapidly evolving martech landscape, this special report will discuss: How practitioners are integrating technologies and systems to encourage information-sharing between departments and pr

Competition

European Pharmaceutical Review

FEBRUARY 27, 2024

Amgen has opened a new biomanufacturing plant in Central Ohio, US. It is the company ’s most advanced manufacturing facility to date. The new facility, known as Amgen Ohio, “was designed with the latest innovation and technology to deliver safe, reliable medicines for ‘every patient, every time,'” stated Robert Bradway, Chairman and Chief Executive Officer at Amgen. “As part of Amgen’s global biomanufacturing network, Amgen Ohio will play an important role in helping us

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Manufacturing Food and Drug Administration Food Networking 105

pharmaphorum

FEBRUARY 26, 2024

GSK has reported topline results from a phase 3 trial of its novel antibiotic gepotidacin that could spell the end of a decades-long drought in new oral therapies for gonorrhoea.

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Fierce Pharma

FEBRUARY 26, 2024

Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million- | Bristol Myers Squibb’s first drug substance facility outside the United States is now set to become the company’s inaugural sterile drug product (SDP) facility in Europe, thanks to a multi-million-dollar expansion expected to add hundreds of new jobs in the coming years.

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MedCity News

MARCH 1, 2024

The Pharmacy Guild recently launched and aims to create the first national pharmacy union in the U.S. But it has a difficult road ahead going up against giants like Walgreens and CVS. Still, its organizers expect the union to be successful.

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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.

FDA

Pharmaceutical Technology

FEBRUARY 29, 2024

LUT014 is being investigated in an ongoing Phase II trial as a first-line treatment for EGFR inhibitor-induced acneiform rash, for which there is no approved drug.

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FDA 105

pharmaphorum

FEBRUARY 27, 2024

The FDA has approved Allecra Therapeutics' Exblifep, a combination antibiotic for complicated urinary tract infections (cUTIs) that will now launch later this year, but turned down a rival product from Venatorx.

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FDA 108

Fierce Pharma

FEBRUARY 26, 2024

Not even one year after becoming a commercial biotech, Krystal Biotech has blockbuster dreams for its flagship product. | In its first six months of commercial availability, Krystal's topical gene therapy Vyjuvek raked in more than $50 million. Now, the company is looking toward bringing the drug to Europe and Japan and testing a new eye-drop formulation.

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MedCity News

FEBRUARY 28, 2024

There are several misconceptions when it comes to mental healthcare, including that AI means fully automated therapy chatbots and that mental health and physical health are separated, according to Dr. Mimi Winsberg, chief medical officer of Brightside Health.

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Healthcare Healthcare Medical 111

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Pharmaceutical Technology

FEBRUARY 26, 2024

Bayer’s oral tyrosine kinase inhibitor is currently in a Phase I trial estimated to enrol 460 patients.

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FDA Patients 132

pharmaphorum

MARCH 1, 2024

Rare Disease Day saw the debut of a film that aims to raise awareness of cerebral adrenoleukodystrophy (cALD), a devastating and fatal condition with no pharmacological treatments available.

Pharmacology 105

Pharmacology 105

Fierce Pharma

FEBRUARY 28, 2024

After a busy 2023 marked by multiple drug approvals, UCB isn’t resting on its laurels. | After an initial FDA approval came later than anticipated, UCB is looking to quickly grow Bimzelx. The company is eying four new indications and potential peak sales of 4 billion euros.

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MedCity News

FEBRUARY 26, 2024

Epic’s Payer Platform is being integrated with Highmark’s claims data on Google Cloud, the companies announced Monday at ViVE. This will give providers better insight into patients’ health.

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Patients 111

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Safety

European Pharmaceutical Review

MARCH 1, 2024

Technology trends Current technology trends are influencing consumer behaviour and reshaping the way industry operates. Although pharma companies are working steadily to leverage the power of data and become more agile and resilient, there is still room for improvement. The post 2024 Pharmaceutical industry trends – discover the latest pharma quality and manufacturing trends appeared first on European Pharmaceutical Review.

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Manufacturing Pharmaceutical Pharma 98

pharmaphorum

FEBRUARY 28, 2024

Peterson Health Technology Institute will review the clinical effectiveness and economic impact of digital health technologies (DHTs) for hypertension and mental health.

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Fierce Pharma

MARCH 1, 2024

It’s time to add another vaccine to the shortage list in the U.S. | It’s time to add another vaccine to the shortage list in the United States as the CDC has urged healthcare providers to conserve their supply of tetanus shots. The warning from the national public health agency comes after one of the two providers of tetanus shots in the U.S., MassBiologics, discontinued production of its tetanus and diphtheria vaccine.

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Healthcare Provider Healthcare Healthcare 300

MedCity News

FEBRUARY 29, 2024

While the past several decades have seen progress in early detection, recent innovations in metastatic breast cancer—or cancer that has spread to distant parts of the body, including the bone, brain, or lungs—continues to cause excitement.

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Biopharma 110

Advertiser: ZoomInfo

In times of economic uncertainty, account-based strategies are essential. According to several business analysts and practitioners, ABM is a necessity for creating more predictable revenue. Research shows that nearly three-quarters of marketers (74%) already have the resources needed to build successful ABM programs.

Marketing