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. […]
Webinar – June 6th: Improve Tech Transfer through Digital Transformation
Life sciences companies depend on smooth tech transfer for success, but inefficiencies in several areas needlessly complicate the process. In particular, most companies still use processes that are document-driven and require significant manual input to transfer methods. In a new webinar hosted by […]
With help of a Petersburg factory, a nonprofit drugmaker is taking aim at high insulin prices
Guest Column May 11, 2022 12:39 am High insulin prices are leaving some people who need the drug without access. (Erik McGregor/LightRocket via Getty Images) By Jing Luo, University of Pittsburgh Health Sciences Doctors have been treating diabetes with insulin since 1922 . A century later, about 1 […]
Takeda Focuses on Reducing Debt as Vyvanse Patent Loss Looms
The drugmaker Takeda has ramped up its efforts in reducing its debt burder, with plans to pay off another 500 billion yen of debt by the end of the year. While the company had pivoted its efforts towards cutting its debt since its acquisition of Shire, the new focus comes as its ADHD drug Vyvanse is […]
FDA Roundup – Week of May 10th
In the latest weekly FDA roundup, the agency has approved the immunomodulatory COVID-19 drug for use in hospitalized adult patients needing external oxygen. This adds to the drug’s current indications, which include use in hospitalized children with COVID-19. In other news, the agency just posted a […]
Real World Evidence (RWE) Solutions Market Regional Survey and SWOT Analysis till 2030
The Real World Evidence (RWE) Solutions Market is expected to be around US$ 3.13 Billion by 2027 at a CAGR of 14% in the given forecast period. Market Research Engine has published a new report titled as “ Real World Evidence (RWE) Solutions Market Size by Component (Services, Data Sets, Clinical […]
Novo Nordisk forges close ties with biotech VC Flagship
Danish drugmaker Novo Nordisk has traditionally generated its pipeline mainly from internal R&D, but a new alliance with venture capital firm Flagship Pioneering signals another departure from that strategy. The partnership with Flagship will bring Novo Nordisk into closer contact with the […]
Report: HEOR Services Market 2022-2028
The health economics and outcomes (HEOR) research market has seen a massive expansion in recent years, and it appears this trend will continue over the next six years. Learn more about these trends and how to navigate the upcoming landscape of HEOR and clinical outcome services in a new market […]
AbbVie and Teva Seek $5 Billion Opioid Litigation Settlements
Abbvie and Teva are looking towards an exit from their opioid litigation woes that could cost the two upwards of $5 billion. The legal challenges come from state, local, and indigenous tribal governments that would use the payments to fund addiction services, law enforcement, and other services. […]
Moderna CFO Steps Down After First Day as Investigation is Announced
Jorge Gomez, Chief Financial Officer at Moderna, has resigned one day after taking the position. Gomez resignation comes after his former employer Dentsply Sirona Inc announced an internal investigation into financial reporting. The company probe will center on the use of incentives for deals with […]
Alternate Payment Models to Increase Equity for Dually Eligible People
Medicare beneficiaries that are dually enrolled in Medicare (duals) are more likely to have social determinants of health (SODH) that are associated with poorer outcomes and decreased access to healthcare than non-duals. In addition, they have less access to novel accountable care organizations […]
Abortion Draft Opinion Reignites Push for Over-the-counter Birth Control
The leaked US Supreme Court draft opinion on abortion rights has spurred additional urgency in efforts to gain FDA approval for over-the-counter birth control. All forms of hormonal birth control have been prescription-only despite several decades of deliberations between pharma companies and the […]
Webinar – May 19th: Breaking Down Research Data Silos for Accelerated Innovation
Although taking full advantage of biomedical data assets is essential to accelerating innovation in pharma, many organizations silo their data and leave it unused and disorganized. In a new Fierce Biotech Webinar, experts from Flywheel and Intuitive Ventures break down how pharma companies can fully […]
Pfizer Purchases Biohaven; Gains Rights to Leading Migraine Drug
Pfizer has announced an $11.6 billion deal to acquire the biotech Biohaven. This deal gives Pfizer rights to Nurtec, a leading migraine drug in the US and abroad. The pharma giant purchased Biohaven at $148.50 per share, a price that jumped over 70% since the announcement. The purchase also includes […]
Emergent was Aware of COVID Vaccine Problems Six Weeks Before Alerting FDA
Contrary to what it told the US Food and Drug Administration (FDA), a new US House committee revealed that Emergent BioSolutions was aware of contamination problems at its Bayview plant. The company waited six weeks to tell the agency that about contamination of 15 million COVID vaccine doses. The […]
Johnson & Johnson Backs Out of Bavarian Nordic HPV and HBV Vaccine Collaborations
J&J has announced that it is pulling out of hepatitis B virus (HBV) and human papillomavirus (HPV) vaccine development partnerships with Bavarian Nordic. The companies, which began their collaborations in 2014 with Ebola vaccine development, will continue their work on other projects. This […]
Intra-Cellular Launches New Bipolar Ad Campaign for Calypta
Intra-Cellular’s schizophrenia drug Calypta has recently gained FDA approval for bipolar depression. In response, the company has launched a aggressive new direct-to-customer (DTC) ad campaign for the newly-added indication. In April alone, Intra-cellular has spent over $13 million marketing the […]
Nonprofit Promises $1 a Day Insulin
Many Americans living with diabetes are forced to ration the insulin they need, potentially worsening their condition. Efforts to tackle the high price of insulin have met with limited success, but not all patients benefit from price caps. The nonprofit generic drugmaker Civica Rx has announced […]
Biotech Predicts Reduced COVID Sales and Signals Potential M&As
Despite tripling their sales last quarter, BioNTech’s CFO Jens Holstein signaled to investors that mergers and collaborations may be in the company’s future in a Q1 call on Monday, May 9th. The expected reduction in sales is a result of the pandemic seemingly transitioning to an endemic state, which […]
Webinar – June 1st: Decentralized Clinical Trials in the Real World
Decentralization and digitization have accelerated changes in the clinical trials landscape. Uncertainty still surrounds this process, leaving sponsors and clinical research organizations scratching their heads over the current best practices for remote study operations. In a new webinar, experts […]
Endpoints Peer Review: Biogen Searches for a CEO, Roivant Selects Srini Ramanathan as CDO
In the latest Endpoints Peer Review, Biogen looks for a new head to replace its CEO, Michel Vounatsos. The company intends to replace Vounatsos before March 2023. In other news, Roivant has announced their new chief development officer, Srini Ramanathan, former senior vice president of R&D […]
Asembia Specialty Pharmacy 2022: The Future of Specialty Pharmacy
Adam J. Fein, PhD, CEO, Drug Channels Institute forecasted future trends in specialty pharmacy in a general session at Asembia’s Specialty Pharmacy Summit 2022. In the session, Fein noted that PBMs are still on top in specialty dispensing, as 4 of the 5 top grossing specialty pharmacies are PBMs. […]
