The life sciences industry’s impressive response to the COVID-19 was made possible by unprecedented collaboration between the pharmaceutical, medical diagnostics, and medical devices industries. This spurred a massive influx of capital that is still buoying the market, despite recent bumps and […]
Early-Stage Biopharma Financing in 2022
In an article from earlier this year, Richard Ramko of Life Science Leader laid out the current landscape of early-stage biopharma financing. The unprecedented levels of investments throughout 2020 and early 2021 began to dip in the latter half of the year and early 2022. However, Ramko argues that […]
European Medicines Agency Recommends Suspension of 100 Drugs Due to CRO Data Concerns
Data integrity issues at Synchron Research Services spurred the European Medicines Agency to recommend the suspension of 100 drugs. Synchron, an India-based CRO, runs quality control tests for generics from several manufacturers. The firm has faced similar critiques from the US Food and Drug […]
Top Pharma Companies Form Coalition to Increase Access to Cancer Therapies in Developing Countries
Less than half of the cancer therapies deemed essential by the World Health Organization are available in low- and lower-middle-income countries (LLMICs). The newly formed Access to Oncology Medicines (ATOM) Coalition seeks to address this issue. The coalition, led by the Union for International […]
Draft CADTH Recommendation for Spinraza™ (nusinersen) Fails Adults in Need of Treatment for Spinal Muscular Atrophy (SMA)
CADTH does not accept new evidence demonstrating SPINRAZA™'s effectiveness and safety for treating SMA – a progressive, life-altering neurodegenerative disease SMA treatment access remains unequal across Canada , with only Quebec funding SMA care for patients over 18 Implementing the draft […]
Global Vital Signs Monitoring Devices Market Size is Estimated to Reach USD 8,126.0 Million by 2030, at a CAGR of 5.8%: Astute Analytica
NEW DELHI , May 20, 2022 /PRNewswire/ -- The study undertaken by Astute Analytica foresees a tremendous growth in revenue of the market for global vital signs monitoring devices market from US$ 4,960.0 Million in 2021 to US$ 8,126.0 Million by 2030. The market is anticipated to grow at a CAGR of […]
Bayer Backs Out of Atara CAR-T Partnership
Following a pause in a CAR-T cell mesothelioma therapy caused by a patient death, Bayer has pulled out of a $670 million partnership with Atara. The two partnered to advance two therapeutic candidates through clinical and pre-clinical development, with Bayer paying Atara $60 million upfront. The […]
Voluntary Recall Guidance Released by FDA
The US Food and Drug Administration (FDA) issued its final guidance in April on initiating voluntary recalls for drugs, biologics, and medical devices. Although largely in line with the previous draft guidance issued in April 2019, the agency made changes based on public comments. The non-binding […]
Pfizer and Headlands Health Partner to Increase Clinical Trial Diversity
Clinical trial participants are often far less diverse than the populations they represent, as clinical trial sites are often located in wealthier urban areas. To help solve this problem, Pfizer and Headlands Research have partnered to initiate research sites in more diverse areas. The first such […]
Gilead Places Restrictions on 340B Drug Pricing for Hepatitis C Treatments
The drugmaker Gilead cut off 340B discounts for certain hepatitis C drugs to some hospitals if they do not provide claims data to their specifications. The drugs, which include Epclusa, Solvadi, Vosevi, and Harvoni, previously qualified for 340B pricing discounts, but the manufacturer accuses […]
Webinar – May 21st – Addressing the Intersection Between LGBTQ+ and Parkinson’s Disease Communities
LGBTQ+ identity is a social determinant of health (SODH) associated with limited access to healthcare and worse health outcomes. In an upcoming online symposium hosted in coordination between the Parkinson’s Foundation and the Medical College of Georgia, the intersection of LGBTQ+ identity and […]
AJMC Video: Dr Miruna Sasu Discusses the Transformative Power of Real-world Data
In a new video interview from AJMC, Miruna Sasu PhD, President and CEO of COTA Healthcare explains how real-world data (RWD) can empower the drug discovery and development processes. RWD can be used in tandem with wet-lab data to help propel drug candidate or biomarker identification. Once a […]
Martin Shkreli Released Early; Transferred to Halfway House
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 […]
