Sat.Mar 02, 2024 - Fri.Mar 08, 2024

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AstraZeneca Loses Lawsuit Challenging Drug Price Negotiation by Medicare

MedCity News

A federal judge disagreed with AstraZeneca’s claims that the Inflation Reduction Act causes harm by disincentivizing innovation and violates its constitutional rights to due process. Blockbuster AstraZeneca drug Farxiga is one of 10 medications selected for the Medicare drug price negotiation program created by the law.

Medical 129
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Novo's obesity superstar Wegovy wins FDA nod to cut cardio risks in key label expansion

Fierce Pharma

Novo Nordisk’s fast-growing weight loss med Wegovy just added a new cardiovascular FDA approval to its label, likely enabling the med's superstar status to reach new levels. | The drug is the first weight loss treatment to win FDA approval to reduce the risk of severe cardiovascular outcomes, giving it an edge over rival Zepbound from Eli Lilly.

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Cannabinoids show promise in acute migraine clinical trial

pharmaphorum

Inhaled cannabinoids have been shown to perform better than placebo in providing pain relief for people suffering from acute migraine in a clinical trial

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Oncology emerges as dominant therapy area for CRISPR technology

Pharmaceutical Technology

In late 2023, the Medicines and Healthcare products Regulatory Agency approved Vertex’s Casgevy, which became the inaugural clustered regularly interspaced short palindromic repeats (CRISPR)-based drug for the haematological indications beta thalassemia and sickle cell disease (SCD).

Medicine 111
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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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Answering 7 Key Questions About Change Healthcare’s Cyberattack

MedCity News

The aftermath the cyberattack on Change Healthcare remains messy, with patients across the country still struggling to obtain their prescriptions. The federal government has even stepped in to help address the fallout of the attack, urging payers to quickly alleviate the digital bottlenecks that providers and pharmacies are facing.

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AstraZeneca pledges £650M in UK investments to boost vaccine capabilities, expand near HQ

Fierce Pharma

AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing a big chunk of money into the Big Pharma’s home country. | AstraZeneca CEO Pascal Soriot, who has been critical of the U.K.’s business environment for the life sciences industry, is directing £650 million into the Big Pharma’s home country.

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Navigating the Current Funding Slowdown While Securing Capital

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, discusses the biggest roadblocks to the widespread adoption of novel modalities, and how new biotech companies can navigate the current funding slowdown while securing the capital crucial for their success.

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How the Nursing Educator Shortage Has Created a Tipping Point for Virtual Reality Simulations

MedCity News

Immersive scenarios in VR allow nursing education programs to enhance and scale the hands-on experiences they provide learners for developing and practicing critical skills.

Education 118
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Pfizer stops buildout of $350M Seagen plant, leaving 120 workers' roles in question

Fierce Pharma

When Pfizer completed its $43 billion buyout of Seagen in December | Less than three months after completing its $43 billion acquisition of Seagen, Pfizer has confirmed a report that it is shutting down construction of a $350 million manufacturing facility in Everett, Washington. The decision will affect 120 employees working on the initial setup of the site, the company said.

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NICE backs frontline use of Jemperli in endometrial cancer

pharmaphorum

GSK’s PD-1 inhibitor Jemperli has been cleared for use by the NHS as a first-line treatment for a specific type of endometrial cancer, making it an option for around 580 women across England, Wales and Northern Ireland.

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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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How Long Will the Current Slowdown in Biotech Investment Last?

Pharmaceutical Commerce

In this Pharmaceutical Commerce video interview, Emma Banks, CEO of ramarketing, discusses how the balance between onshoring and outsourcing will evolve, how long will the current slowdown in biotech investment likely last, and what factors might influence its duration.

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Blue Shield of California CEO on PBM Shakeup: ‘It’s Going to Become the Norm’

MedCity News

During a fireside chat hosted by MedCity News at ViVE, Blue Shield of California CEO Paul Markovich discussed the company’s decision to largely move away from CVS Caremark as its PBM and partner with several other companies.

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Boehringer Ingelheim cuts monthly out-of-pocket inhaler prices to $35 for US patients

Fierce Pharma

As one of Boehringer Ingelheim's asthma competitors catches scrutiny over pricing and access concerns, the company itself is taking steps to cut patient costs in the U.S. | Starting on June 1, patients will only have to shell out a maximum of $35 per month for Boehringer Ingelheim inhalers in the U.S.

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Cellares Innovates With Automated Cell and Gene Therapy Platform

PharmaTech

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

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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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UK Chancellor trumpets £650m AstraZeneca investment

pharmaphorum

A £650 million investment package by AstraZeneca in the UK has been held up by Chancellor Jeremy Hunt as a “vote of confidence” in the country’s life sciences sector. AZ is preparing to invest £450 million at its manufacturing site in Speke, Liverpool, to boost research, development and manufacturing of vaccines, including the construction of a new plant that will be powered by renewable energy, according to a government statement.

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How Food-as-Medicine Execs Are Responding to Kellogg CEO’s ‘Let Them Eat Flakes’ Remarks

MedCity News

Kellogg CEO Gary Pilnick recently encouraged families struggling to put food on the table to turn to cereal as their go-to dinner option. Food-as-medicine executives are none too thrilled about his comments — they argue that the remarks underscore the dire need to increase public education about affordable, healthy meal planning.

Food 115
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PhRMA seeks to revive Medicare price negotiations lawsuit, blasts Biden's request for IRA expansion

Fierce Pharma

As President Joe Biden doubles down on the price negotiation meas | As President Joe Biden doubles down on the price negotiation measures in the Inflation Reduction Act, prominent industry lobbying group the Pharmaceutical Research and Manufacturers of America isn’t letting its legal challenge go down without a fight.

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AD/PD 2024: TauRx’s HMTM promising despite lacking primary endpoint data

Pharmaceutical Technology

Participants cannot remain blind to their treatment arm due to the properties of TauRx's drug, which causes urinary discoloration.

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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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Gilead and MSD say weekly oral therapy controls HIV

pharmaphorum

Gilead and MSD showcase once-weekly oral HIV regimen at CROI congress, as ViiV presents new data on injectable Cabenuva in patients with low adherence to daily oral therapy

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Novo Nordisk Obesity Pill Flashes the Potential to Beat Wegovy in Weight Loss

MedCity News

Novo Nordisk reported its weight loss pill amycretin led to greater weight loss measured at 12 weeks compared to clinical trial results for its blockbuster obesity drug Wegovy. But these results are from a small Phase 1 study and more testing is needed.

Biopharma 112
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Novo Nordisk's success with Ozempic in diabetes and kidney disease patients isn't enough for investors

Fierce Pharma

A trial of Novo Nordisk's Ozempic on diabetes and kidney disease patients found that it reduced the risk of disease progression and death by 24%.

Patients 306
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The growing uses of medicinal cannabis

Pharmaceutical Technology

Demand for medicinal cannabis is increasing globally to treat a range of illnesses and conditions.

Medicine 136
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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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GSK scores again with Blenrep in multiple myeloma

pharmaphorum

GSK continues to build the case for its multiple myeloma therapy Blenrep, which was pulled from the US market last year, with another positive phase 3 trial. The BCMA-targeted antibody-drug conjugate (ADC), given in a regimen with pomalidomide plus dexamethasone (PomDex), was shown to be more effective at preventing disease progression or death than Johnson & Johnson’s $10 billion-a-year anti-CD38 antibody Darzalex (daratumumab) with PomDex in the head-to-head DREAMM-8 trial.

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An Attack on Patients’ Right to Informed Consent

MedCity News

This case, about the claim that Merck failed to warn patients about the risk of typical femoral fracture, reaches past this suit to potentially change pharmaceutical companies’ relationship with the FDA.

Patients 112
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Perrigo's over-the-counter birth control launch takes flight in the US

Fierce Pharma

A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.” | A little more than half a year after winning a historic over-the-counter nod, Perrigo’s nonprescription birth control pill Opill is set to hit store shelves in the “coming weeks.

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UK manufacturing and R&D to benefit from new £360m investment

European Pharmaceutical Review

On 4 March, ahead of the Spring Budget , the UK Chancellor of the Exchequer, Jeremy Hunt, announced a significant investment package for the UK life sciences and manufacturing sectors. A total of £360 million is set to boost UK manufacturing and R&D. Joint government and industry investment of £92 million will help to expand facilities to manufacture life-saving medicines and diagnostics products.

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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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CCC to Host Publisher Panel on Copyright and AI at 2024 London Book Fair

Copyright Clearance Center

March 5, 2024 – Danvers, Mass. – CCC , a leader in advancing copyright, accelerating knowledge, and powering innovation, will host, “ Publishers, Copyright & AI: Taking Action ” at the 2024 London Book Fair on Tuesday, 12 March, 10:30 – 11:00am GMT in the Tech Theatre. An international panel of executives from leading scholarly publishers, including Claire Harper , Head of Global Rights & Licensing, Sage , and Sarah Fricker , Group Head of Legal, IOP Publishing , will address questions s

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Reducing Burnout Requires Giving Health Care Workers More Control Over Their Time

MedCity News

One way that we can address this root cause of burnout is by supporting health care workers in using their time most effectively. That involves deploying technologies that make their lives easier.

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Vanda's jet-lag approval hopes for Hetlioz quashed with FDA hearing rejection

Fierce Pharma

Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. | Vanda has been waiting years for an FDA hearing to contest the agency’s 2019 rejection of its sleep drug Hetlioz in jet lag disorder. Now, following a lawsuit and a protracted back-and-forth with the U.S. regulator, the FDA has crushed Vanda’s bid.

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Semaglutide could provide novel dual benefit in diabetes and kidney disease

European Pharmaceutical Review

Headline results from Novo Nordisk AS’s kidney outcomes FLOW trial reveal that injectable semaglutide 1.0mg demonstrated a statistically significant and superior reduction in kidney disease progression as well as cardiovascular and kidney death of 24 percent. This was based on treatment policy estimand: treatment effect regardless of treatment adherence, Novo Nordisk confirmed.

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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.