EU, China, and more are now in the crosshairs. How’s next? It’s time to act. The Trump administration has announced sweeping tariff hikes, as high as 50%, on imports from the European Union, China, and other major markets. Affected industries? Pharmaceuticals, Biotech, Medical Devices, IVD, and Food Supplements — core sectors now facing crippling costs,…
This study presents the GDP Matrix by Dr. Vlad Reznikov, a bubble chart designed to clarify the complex relationships between GDP, PPP, and population data by categorizing countries into four quadrants—ROCKSTARS, HONEYBEES, MAVERICKS, and UNDERDOGS depending on National Regulatory Authorities (NRAs) Maturity Level (ML) of the regulatory affairs requirements for healthcare products. Find more details…
The study presents the innovative GDP Matrix method created by Dr. Vlad Reznikov for business development and market entry corporate decisions. When making a decision on market entry based on limiting factors such as the complexity of regulatory policies, estimated marketing costs, preliminary determination of the target consumer base, language barriers, or any other critical…
The deal gets NextCure the rights to Simcere’s novel ADC for solid tumors outside of China.
At a satellite kickoff event to the annual BIO meeting, investment bankers and VCs gave reasons for optimism amid a ‘volatile’ period for the industry.
As GLP-1 weight loss drugs become more common, managing side effects has emerged as key to adherence. A Kerry Group consumer perception study suggests its BC30 Probiotic may help reduce digestive discomfort linked to these medications.
Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots is part of an overall FDA effort to make demographic data more available and transparent.
The 2025 BIO International Convention (BIO2025), the world’s largest annual biotech event, will take place from June 16 to 19 (U.S. time) at the Boston Convention & Exhibition Center. This year, Taipei City Government is partnering with six Taipei-based biotech companies, including PanCAD.ai Co., Ltd., Instant NanoBiosensors Co., Ltd., Bened Biomedical Co., Ltd., Cancer Free Biotech Ltd., Xantho Biotechnology Co., Ltd., and Energenesis Biomedical Co., Ltd., to showcase their innovations at the Taiwan Pavilion (Booth #1645) in the Taipei Exhibition Area.
AstraZeneca, Pfizer and more are leveraging the computational power of AI to better design trials, predict the potential efficacy and safety profiles of their molecules and synthesize massive multi-omic information to gain a more complete understanding of challenging cancers.
This page contains the PCAC roster, which lists the current members and the current number of vacancies for the committee.
Office of New Drugs Custom Medical Queries (OCMQs) are standardized groupings of similar adverse event terms intended to assist with the identification of potential safety issues during review of adverse event data.
The Standard Safety Tables and Figures (ST&Fs) are designed to reduce clinical reviewers’ time in generating safety review content and to ensure consistency in the safety review of products across Divisions.
The Danish drugmaker, which is grappling with a share decline and competition from Eli Lilly, unveiled planned trials of an obesity medication that works differently than its popular Wegovy.
The agency’s decision to clear Moderna’s shot for use in certain younger adults is a much-needed win for a company that’s been significantly impacted by the recent changes in FDA and HHS leadership.
Non-cystic acne may significantly improve by consuming either a synbiotic supplement or an herbal-based supplement, underscoring the gut microbiome’s relationship to skin health.
Management Board meets the African Medicines Agency Governing BoardThe Management Board welcomed the African Medicines Agency (AMA) Governing Board and heads of African national…
AstraZeneca could spend up to $5.3 billion in a deal to develop oral medicines with CSPC Pharmaceutical. Elsewhere, Insmed cashed in on a stock surge and Third Harmonic kicked off a drug auction.
EMA has issued a positive opinion for the approval of a vaccine named Biobhyo, indicated to protect pigs from swine dysentery, a disease that causes dysenteric diarrhoea in pigs.…
Later this month, HHS Secretary Robert F. Kennedy Jr.’s revamped CDC vaccine advisory committee will discuss RSV vaccination guidelines for the newly approved patient group, high-risk adults 18 through 49. Analysts and other experts have warned that the new panel includes some who have documented anti-vaccine sentiments as well as those who have spoken out against mRNA technology specifically.
The Committee re-elected Dr Frida Hasslung Wikström from Sweden as its Vice-chair for a further 3-year mandate.CVMP opinions on veterinary medicinal productsThe Committee adopted…
This news announcement was revised on 13 June 2025 to delete the reference to the European Commission issuing a legally binding decision on the procedure., EMA’s safety committee (PRAC) has concluded its review of medicines containing semaglutide following concerns regarding a possible increased risk of developing non-arteritic…
Friday’s deal with CSPC fits neatly within AstraZeneca’s business development strategy of upping investments in AI and in China.
Martin Kulldorff and Robert Malone, both outspoken vaccine skeptics, have received compensation for their expert participation in various vaccine-related cases against Merck.
The FDA’s Oncologic Drugs Advisory Committee narrowly voted against the approval of Zusduri, citing the lack of a completely randomized study to back up the application.
Nipro recalls bicarbonate dialysate concentrate due to contamination. Learn about potential serious injuries, fatality risks and essential steps for healthcare providers and patients for this Class I recall.
Sensorized Guidewire Issue from Centerline Biomedical
GDUFA III includes several enhancements to the ANDA assessment process to maximize the efficiency and utility of each assessment cycle. These enhancements aim to reduce the number of assessment cycles and facilitate timely access to safe, effective, high-quality, and affordable generics.
Valued at $1.25 billion, the deal expands BioNTech’s cancer drug portfolio and heads off royalty costs it could have owed CureVac in ongoing patent litigation.
Days after firing all 17 members of the CDC's Advisory Committee for Immunization Practices, the HHS Secretary named a small new committee that includes multiple vaccine critics.
Scientists and analysts express concern that the newly appointed ACIP members—which include known anti-vaxxers—could relitigate recommendations that have already been made. Many are imploring Sen. Bill Cassidy to step up.
Pep19 reduced visceral fat by 25% in a clinical trial, and participants also saw a reduction in systolic blood pressure.
Infants and young children taking probiotic supplements may be at a lower risk of being overweight and obese when they get to preschool age, says a new study.
The biopharma job market failed to turn around in May, but employers were still hiring, especially in Indiana and California, based on BioSpace data. The two states had the most job postings live on BioSpace last month, with Indiana showing a 108% year-over-year increase.