Sat.Feb 24, 2024 - Fri.Mar 01, 2024

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MHRA Chief Executive to step down

European Pharmaceutical Review

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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Perrigo plots hundreds of job cuts as it embarks on restructuring initiative

Fierce Pharma

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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India’s Tata Institute develops tablet for cancer recurrence prevention

Pharmaceutical Technology

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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Tampa General Hospital CEO on Change Healthcare Breach: They Are Going To Have To Give an Update Soon

MedCity News

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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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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NICE recommends first licenced treatment for AL amyloidosis

European Pharmaceutical Review

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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Moderna lays off parts of manufacturing team after resizing COVID footprint

Fierce Pharma

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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Viking Therapeutics Obesity Drug’s Data Raise Best-in-Class Expectations

MedCity News

The weight loss achieved by Viking Therapeutics’ obesity drug tops results posted by Eli Lilly’s Zepbound in its pivotal test. But Viking still needs to show its results can hold up in a larger Phase 3 clinical trial.

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Pfizer’s new cancer unit sees eight new blockbusters by 2030

pharmaphorum

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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With Sanofi left as the lone supplier of tetanus shots in the US, CDC warns of shortage

Fierce Pharma

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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Lutris wins FDA orphan drug tag for EGFR inhibitor-induced rash candidate

Pharmaceutical Technology

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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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.

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At ViVE 2024, Panelists Share Prior Authorization Progress and Frustration in Payer Insights Program [Sponsored]

MedCity News

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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Amgen opens its most advanced manufacturing facility to date

European Pharmaceutical Review

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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Bristol Myers blueprints $400M Ireland expansion with plans to add sterile drug firepower and hire 350

Fierce Pharma

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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Bayer wins FDA breakthrough therapy designation for NSCLC candidate

Pharmaceutical Technology

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

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How to Stay Competitive in the Evolving State of Martech

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

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Inside One Organization’s Efforts To Create the First National Pharmacy Union

MedCity News

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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Sanofi trumpets win for oral BTK drug in chronic hives

pharmaphorum

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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AstraZeneca finally drops roxadustat US rights after FDA rejection, trial failure

Fierce Pharma

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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Trademarks on the rise: applications recover in 2023 after a dip in 2022

Clarivate

When global trademark filing activity fell in 2022 , questions rose around what this signified. Would 2023 data show a second year of decline, indicating uncertain economic outlooks? Or would filing activity recover? To answer this question, we dove into curated trademark data from CompuMark to analyze application and filing history. With access to over 147 million trademark records, including application and filing history gathered directly from Patent and Trademark Offices (PTOs) such as the E

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What the FDA's New Dosage Guidance Means for the Future of Clinical Research

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.

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Dentistry’s Technological Revolution Is Transforming Patient Trust

MedCity News

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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New film aims to raise awareness of rare disease cALD

pharmaphorum

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.

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Amgen boots up Ohio 'smart facility' where it plans to employ 400—and a trio of robots, too

Fierce Pharma

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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Preventing Toxic Productivity and Toxic Positivity

ALULA

Re cen t global increases in e mployee engagement have been music to the ears of hard-working, mindful leaders. But here’s the thing about a good thing – it merits vigilance.

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Roles and Responsibilities of Specialized Clinical Supply Experts

When selecting a clinical supply provider, consideration often focuses upon the manufacturing, packaging, storage and distribution capabilities available that will, at face-value, be sufficient to meet the needs of the sponsor and their trial. However, there are human-based and knowledge-driven factors that are often overlooked that go beyond these basic physical capabilities and are integral to the development and delivery of high performing clinical supply chains.

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The Future of Innovation Metastatic Breast Cancer: 2024 Outlook

MedCity News

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.

Biopharma 108
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AbbVie inks $713m deal for OSE chronic inflammation drug

pharmaphorum

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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With global expansion planned, Krystal lays out blockbuster ambitions for topical gene therapy

Fierce Pharma

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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Green granulation: Tracking energy efficiency in pharmaceutical granulation

Pharmaceutical Technology

Experts say that dry granulation is 10x more efficient than wet granulation, which could make substantial progress towards making this pharmaceutical process greener.

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Deliver Fast, Flexible Clinical Trial Insights with Spotfire

Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.

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Highmark Health Collaborates with Epic, Google Cloud To Improve Payer/Provider Coordination

MedCity News

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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GSK antibiotic gepotidacin clears phase 3 gonorrhoea trial

pharmaphorum

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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In atypical Big Pharma-VC pact, Gilead secures $210M from Abingworth to fund Trodelvy trials

Fierce Pharma

Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. | Venture capital firms pitching in on drug development isn’t exactly a new way of doing business for the biopharma industry. But a new funding pact between Carlyle’s Abingworth and Gilead Sciences is somewhat unconventional.

Biopharma 274
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Merck’s Keytruda regimen gains positive EMA CHMP opinion

Pharmaceutical Technology

Merck's KEYTRUDA has received a positive opinion from the EMA CHMP for use in combination with chemotherapy for non-small cell lung cancer.

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ABM Evolution: How Top Marketers Are Using Account-Based Strategies

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.