Fierce Pharma
JUNE 26, 2024
In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate (ADC) patritumab deruxtecan. | In the second setback for the HER3 field in days, the FDA has rejected Daiichi Sankyo’s Merck & Co.-partnered antibody drug conjugate patritumab deruxtecan.
MedCity News
JUNE 24, 2024
Multiple stakeholders are to blame for prescription drug costs, including pharmaceutical companies and PBMs, according to Merith Basey, executive director of Patients for Affordable Drugs. The post Who Is Responsible for the High Cost of Prescription Drugs? One Advocate Weighs In appeared first on MedCity News.
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European Pharmaceutical Review
JUNE 25, 2024
The European Commission has approved the first twice-yearly injection for relapsing and primary progressive multiple sclerosis (RMS and PPMS). Roche highlighted that as a 10-minute injection, OCREVUS ® (ocrelizumab) subcutaneous has the same twice-yearly schedule as the intravenous (IV) infusion, which was the first therapeutic to be approved for both RMS and PPMS.
Pharmaceutical Technology
JUNE 26, 2024
AstraZeneca has received Japanese approval for Tagrisso plus chemotherapy as first-line treatment for non-small cell lung cancer (NSCLC).
Fierce Pharma
JUNE 26, 2024
Thirteen years after his passing, Sir David Jack still looms as an innovative force in healthcare. | Verona Pharma has earned an FDA approval for Ohtuvayre, a potential blockbuster with a novel mechanism of action, to treat patients with chronic obstructive pulmonary disorder (COPD). It is the first novel treatment advancement in the indication in more than a decade.
MedCity News
JUNE 26, 2024
The American Hospital Association sent letters to the Senate and House urging them to support legislation that would prevent the CMS from enforcing its final rule on minimum staffing requirements for long-term care facilities. The organization argued that the mandate could lead nursing homes to reduce capacity or close altogether. The post AHA Urges Congress to Stop CMS from Enforcing Minimum Staffing Requirements for Nursing Homes appeared first on MedCity News.
Pharma Rep Focus brings together the best content for pharma rep professionals from the widest variety of industry thought leaders.
Pharmaceutical Technology
JUNE 24, 2024
The osteoporosis market is expected to grow at a compound annual growth rate of 5.4% from 2023 to 2032, reaching $17.9bn across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) by the end of this forecast period, according to leading data and analytics company GlobalData’s recent report: Osteoporosis: Seven-Market Drug Forecast and Market Analysis.
Fierce Pharma
JUNE 24, 2024
After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. | After losing round one of its respiratory syncytial virus (RSV) vaccine bout with GSK, Pfizer is rallying. And what better way to do it than to win a major contract in your rival’s home country? The U.K. government has selected Pfizer to supply 5 million doses of its RSV shot Abrysvo over the next two years.
MedCity News
JUNE 24, 2024
Argenx’s Vyvgart Hytrulo is now approved to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a rare autoimmune disease that affects nerves and impairs muscle function. The drug, an FcRn inhibitor, is the first in its class to win FDA approval in CIDP. The post FDA Approves Argenx Drug as First New Treatment in Decades for Rare Nerve Disease CIDP appeared first on MedCity News.
PharmaVoice
JUNE 27, 2024
Neuroscience pipelines are reawakening as biotechs prove to the pharma giants that the field is still worth the investment.
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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.
pharmaphorum
JUNE 26, 2024
Fresh from reporting encouraging results with its obesity drug candidate petrelintide, Zealand Pharma has raised an impressive $1 billion from a new share offering.The Danish biotech started the fundraising process earlier this week with an expectation of raising $900 million but easily overshot that target, evidence once again of huge investor interest in companies developing a new generation of obesity drugs.
Fierce Pharma
JUNE 28, 2024
After scoring approval as the world’s first pneumococcal disease vaccine made specifically for adults earlier this month, Merck’s Capvaxive passed the next test in its bid to take on Pfizer an | The recommendation sets up Merck's new pneumococcal disease vaccine to potentially capture some of Pfizer's market share.
MedCity News
JUNE 26, 2024
The 2024 Benefit Consultant Sentiment Index published by MedCity News and sponsored by Quantum Health, now in its second year, is based on a survey of more than 100 seasoned healthcare benefits consultants who represent a cross-section of employer size. A few shared their impressions of some of the report findings. The post Amidst High Healthcare Costs Benefits Consultants See Growing Interest in Pharmacy Spend, GLP-1 drugs, AI and Navigation Platforms appeared first on MedCity News.
Pharmaceutical Technology
JUNE 25, 2024
Novavax has sought EMA approval for its updated JN.1 Covid-19 vaccine, NVX-CoV2705, for people aged 12 years and above.
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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
PharmaVoice
JUNE 24, 2024
With a career focused on striking deals, Kaan Cartel is hoping to lead the Flagship-backed biotech with an mRNA platform into its next phase of growth.
Fierce Pharma
JUNE 25, 2024
A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established fo | A little over a year after being slapped with an FDA rejection, AbbVie has hit another regulatory wall in its bid to debut a more convenient Parkinson’s disease successor to its established formulation of carbidopa and levodopa.
MedCity News
JUNE 27, 2024
While it it’s too early to judge the success of Kaiser Permanente’s Risant Health, the company’s first two acquisitions show a commitment to adjoining organizations with a strong focus on population health — as well as a dedication to spreading Kaiser’s value-based care delivery models across the country. The post What Do Experts Make of Risant Health’s Newest Acquisition?
Pharmaceutical Technology
JUNE 26, 2024
In this issue: UK’s new Netflix-style funding model for antibiotics, the Swiss biotech ecosystem recuperates from financial instability of 2023, how patient advocacy can lead to more successful clinical trials, and more.
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.
pharmaphorum
JUNE 28, 2024
The House Ways and Means Committee in the US voted in favour of a new bill which would end a two-decade-long restriction on the coverage of drugs to treat obesity under Medicare.The Treat and Reduce Obesity Act of 2023 (TROA) was originally intended to overturn the restriction completely, but has been hugely scaled back in its scope.
Fierce Pharma
JUNE 26, 2024
The loss of patent protection on Amarin’s sole commercial product Vascepa in 2020 has led to a roller coaster ride for the Dublin-based company over the past few years. | Amarin is getting a fresh shot to challenge Hikma Pharmaceuticals’ generic version of its fish oil-derived heart med in the lower courts. But the legal development comes after a patent loss on Vascepa eviscerated its U.S. business.
MedCity News
JUNE 28, 2024
A new report from JPMorgan Chase showed that small businesses are struggling with the cost of health insurance. The post JPMorgan Chase: Health Insurance Premiums Are Burdening Small Businesses appeared first on MedCity News.
Pharmaceutical Technology
JUNE 28, 2024
On 17 June, Amylyx acquired the rights to Eiger Biopharmaceutical’s experimental GLP-1 receptor antagonist, avexitide, for $35.1m.
pharmaphorum
JUNE 28, 2024
Amazon’s strategy in telehealth has coalesced around a pay-per-visit and subscription-based model under a new brand – Amazon One Medical.
Fierce Pharma
JUNE 24, 2024
In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events in patient | In one of the most closely watched biotech trial readouts of the year, Alnylam Pharmaceuticals said its RNA interference drug reduced the risk of death or recurrent cardiovascular events.
MedCity News
JUNE 23, 2024
Telehealth advocates are calling on Congress to act quickly on Medicare telehealth flexibilities, which are set to expire at the end of the year. Doing so would help key healthcare stakeholders prepare. The post Medicare Telehealth Flexibilities Will Expire In December. Congress Needs To Act Swiftly, Experts Say appeared first on MedCity News.
Pharmaceutical Commerce
JUNE 24, 2024
A study examines the economical validity of using this therapy as a treatment for unresectable stage III non–small cell lung cancer.
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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
pharmaphorum
JUNE 27, 2024
Verona Pharma has claimed FDA approval for its chronic obstructive pulmonary disease (COPD) drug ensifentrine, which has been tipped as a future blockbuster.The first-in-class dual phosphodiesterase (PDE) 3/4 inhibitor – now given the somewhat tongue-twisting brand name of Ohtuvayre – is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, according to Verona.
Fierce Pharma
JUNE 27, 2024
Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court. | Years of negotiations and legal proceedings surrounding a high-dollar opioid settlement for Purdue Pharma have reached a dead end at the U.S. Supreme Court.
MedCity News
JUNE 25, 2024
Liquid biopsy company Grail is now an independent, publicly traded company. While the separation from Illumina ends a protracted antitrust battle, Grail is still in the early stages of a long-term strategy to win regulatory validation and payor coverage for its multi-cancer early detection test. The post Illumina Spin-Off Now Complete, Grail Sets Out on Its Own on the Public Markets appeared first on MedCity News.
Pharmaceutical Technology
JUNE 27, 2024
Data showed that Ohtuvayre significantly improved dyspnea compared to placebo in as little as six weeks and maintained this over 24 weeks.
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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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