Martin Shkreli, known as “Pharma Bro,” has been released from federal prison early. Shkreli, known for his smug demeanor, was convicted of securities fraud after becoming a target of near-universal scorn for price-gouging the life-saving HIV drug, daraprim, by over %4,000. Shkreli’s early release […]
Bridging the Innovation Gap with Biopharma Partnerships
With impending patent expirations and increased drug development times, the biopharma industry faces an innovation gap. Bridging this gap and maintaining or increasing the pipeline replenishment rate is essential for revenue growth. However, this rate is also falling, with the 25 top biopharma […]
Japan Drug Lobby Asserts Pricing Scheme Driving Drug Crisis
For the first time in the week starting May 16th, Japan’s three major pharmaceutical trade associations joined forces to call for changes to the government’s drug pricing structure in order to prevent missing out on new drug innovation and expansion. While American and European drug companies have […]
Learning from Big Pharma to Optimize Psychedelic Drug Development
During a post-earnings conference call yesterday, May 17th, executives Atai Live Sciences N.V. explained what they’ve learned from Johnson & Johnson’s Spravato launch. The launch of Spravato, an esketamine treatment, was marred by its high price, inpatient delivery, and addiction potential, […]
How Investing in Public Health Will Strengthen America’s Health
Introduction and summary Most of the gains in life expectancy achieved in the 20th century came not from medical progress. Rather, they resulted from public health advances such as cleaner air and water, improved sanitation and food safety, safer environments and thus fewer injuries, and vaccines to […]
Under-the-radar Chinese biotech scores $47M upfront in secretive Merck deal around cancer drug
During his most recent investor call, Merck CEO Rob Davis promised to be “appropriately aggressive in pursuing compelling external innovation.” But as it turns out, that doesn’t necessarily mean they would be loud about it. China’s Kelun Pharmaceutical said the pharma giant has licensed a certain […]
PhRMA Report: More than 500 medicines in development to treat disorders of the blood | Nachricht
WASHINGTON, May 18, 2022 /PRNewswire/ -- Today, the Pharmaceutical Research and Manufacturers of America released a new report covering 549 medicines in development to potentially treat disorders of the blood, including blood cancers. These conditions pose a significant and ongoing unmet medical […]
GlobalData Plc: Big Data Crucial for Business Strategy Across the Pharma Value Chain
GlobalData Plc The global data and analytics market in the pharmaceutical sector was valued at $1.4 billion in 2020 LONDON, May 18, 2022 (GLOBE NEWSWIRE) -- The healthcare and pharmaceutical industry generates data in abundance in the form of physician notes, pathology reports, EHR, patient […]
Merck snaps up cancer drug from China’s Kelun in $1.4bn deal
Merck & Co has quietly added another drug to its immuno-oncology pipeline via an agreement with China’s Sichuan Kelun Pharmaceutical, and is keeping the details close to its chest. The US pharma group is paying $47 million in upfront payments to license rights to the undisclosed drug outside […]
Cerner Collaboration to Increase Access to Cancer Clinical Trials
The company's Learning Health Network t eams with Elligo Health Research and Freenome to Advance Early Cancer Detection KANSAS CITY, Mo. Cerner Corporation (NASDAQ: CERN ), Elligo Health Research ® and Freenome are collaborating to enable a clinical trial through the Learning Health Network to help […]
Roche and Bluebird Bio Reach Sickle Cell Gene Therapy Trademark Settlement
The trademark infringement lawsuit between Roche and Bluebird Bio has been settled. The case surrounded Bluebird’s “Be the Spark,” advertising campaign for its sickle cell gene therapy. Roche claimed this name was similar to its own gene therapy division, Spark Therapeutics, and therefore infringed […]
Survey: Pharma Drives Innovation in Digital Health but Doesn’t Always Stick the Landing
A recent survey of 450 healthcare executives found that 92% agreed that pharma-sponsored digital health solutions can add value to patients and providers. However, only 4% of respondents believed that digital project launches are usually successful. This doubt was paired with a deprioritization of […]
FDA Seeks to Promote Lactation and Pregnancy Real-World Data Efforts
There is limited information regarding the use of many common medications during pregnancy or lactation. This confusion results in parents overestimating the risks of many otherwise safe medications. In a recent workshop hosted by Johns Hopkins Center of Excellent in Regulatory Science and […]
UCB’s Psoriasis Drug’s FDA Application on Pause Due to Facility Inspection Issues
The US Food and Drug Administration (FDA) has temporarily halted the approval process for UCB’s psoriasis drug bimekizumab on concerns with facility inspections. This is the second delay UCB has faced thus far related to inspections, with the agency postponing the company’s application last October […]
The Present and Future State of Clinical Trial Staffing
Clinical trial staffing is a growing market, with demand beginning to outstrip the supply of qualified clinical research associates (CRA’s). This leaves contract research organizations (CROs), the traditional providers of clinical research services, in a bind. Increased competition has driven up […]
Endpoints News Event at #BIO22 – Managing a Biotech in Turbulent Times
The biotech industry experienced a boom in the last 2 years, with investor money pouring into startups of all kinds. However, this bubble appears to be bursting and taking out several new companies in its wake. For this reason, understanding how to navigate the rapidly changing biotech industry is […]
How Real-World Data and Evidence Propelled Boehringer Ingelheim
The Germany-based pharma company Boehringer Ingelheim has experienced major growth in recent years, with 2020 net sales reaching EUR 19.6 billion. This expansion has been supported by increased reliance on real-world data (RWD) and real-world evidence (RWE) at every level of clinical […]
Moderna’s Ousted CFO may Lose $700,000 Severance
Days after the end of Jorge Gomez’s one-day stint as CFO of Moderna, the company has announced that Gomez has agreed to return his $700,000 severance package if found guilty in an ongoing internal probe at his former employer, Dentsply Sirona. Gomez stepped down one day after taking the position […]
Lack of Funding and COVID Outbreaks Sank Chinese Drugmaker’s Alzheimer’s Phase III Trial
Green Valley Pharma has ended its Phase III clinical trial for its Alzheimer’s drug due to funding issues and new COVID outbreaks in several major cities in China. Two years ago, the drugmaker won approval to market its Alzheimer’s drug in China. It hoped that its novel oral drug would gain […]
Real-World Data and the Benefits of External Control Arms
The expansion of real-world data (RWD) in regulatory decision-making, spurred on in the US by the 21st Century Cures Act, has caused a sea change in clinical trial design. More and more, researchers and organizations have shifted from the classic randomized clinical trial (RCT) design to newer […]
FDA Approves Eli Lilly Diabetes Drug
The US Food and Drug Administration (FDA) has given the green light to Eli Lilly’s new type II diabetes therapy Mounjaro. The injectable drug is hailed as a potential blockbuster for Lilly, which has seen its stocks jump by 50% in the past year. Clinical trial data showed that the drug reduced A1C […]
OMNY Health Unveils New Real-World Data Platform for Ophthalmology
OMNY Health has announced its new ophthalmology real-world data (RWD) platform. Created in partnership with community-based ophthalmology clinics, the platform takes electronic health record (EHR) data to drive research, empower treatment decisions, and discern the impact of social determinates of […]
Positive Results Announced for Bristol Meyer Squibb’s Plaque Psoriasis Trial
Bristol Meyer Squib (BMS) has released promising two-year results for deucravacitinib, its psoriasis therapeutic. The results show the drug was efficacious for adults with moderate to severe plaque psoriasis and was well-tolerated by patients. Psoriasis is a chronic immune-mediated skin condition […]
Podcast: Live Biologics & the Microbiome with 4D Pharma’s Duncan Peyton
Live biotherapeutics are key early-stage clinical candidates of 4D Pharma, building on increasing knowledge of the microbiome. In the latest episode of Business of Biotech, 4D Pharma’s CEO Duncan Peyton explains how new insights into the microbiome are driving innovations that could impact patients […]
Roche Takes Second Hit this Week with Launch of $0 Copay Esbriet Copycat
Just days after the failure of Roche’s massive TIGIT Phase III trial, Sandoz has released the first generic of Esbriet, the company’s blockbuster IPF drug Esbriet. Adding insult to injury for Roche, Sandoz’s version has a $0 copay for some patients, all but ensuring its future market dominance. […]
Life Science Leader: 5 Trends to Watch
As clinical research begins to pivot back from a single-minded focus on COVID-19 therapeutics and vaccines, the life sciences field is adapting to the new research landscape. In a recent Life Science Leader article, Denise Juliano lays out five important trends to watch in therapeutic development […]
Cytel Announces Free Statistical Programming Ebook
When submitting data to the US Food and Drug Administration, maintaining a steady line of communications is essential. Frequent technical discussions can help ensure sufficiently thorough guidance from the agency and reduce snags in the process made by time-consuming corrections. In a […]
RWJ Foundation Study Reveals Unhealthiest County US State
Health disparities in the US exist on the state and county level, with several rural areas experiencing significantly higher levels of negative health outcomes like stroke and heart attacks. This year’s County Health Rankings report by the University of Wisconsin Population Health Institute and […]
CSL’s Acquisition of Vifor Pharma Hits Antitrust Snags
The multinational biotech CSL’s planned purchase of Vifor Pharma has been put on pause due to antitrust concerns. The $11.7 billion deal was set to close in June of this year, but CSL reported yesterday, May 11th, 2022, that the regulatory approval process with several agencies will take longer than […]
A Quarter of Medicare Recipients Experience Harm During Hospitalization
A newly released report from the US Department of Health and Human Services (HHS) finds that 25% of Medicare beneficiaries were harmed during hospitalization. The report is based on data covering 770 Medicare patients who were discharged from a hospital for acute care in October 2018. […]
