News & Updates

MIAMI, FL — The FGC2.3: Feline Vocalization Classification and Cat Translation Project, authored by Dr. Vladislav Reznikov, has crossed a critical scientific milestone — surpassing 14,000 reads on ResearchGate and rapidly climbing toward record-setting levels in the field of animal communication and artificial intelligence. This pioneering work aims to develop the world’s first scientifically grounded…

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…

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of Propofol Injectable Emulsion (containing benzyl alcohol), 100mL Single Patient Use Glass Fliptop Vial; lot EA7470, to the user level due to visible particulates observed in two vials during annual examination of retention samples.

Lawrence, Kansas – Plastikon Healthcare, LLC is voluntarily recalling one (1) lot of Milk of Magnesia 2400 mg/10 mL Oral Suspension, one (1) lot of Milk of Magnesia 2400 mg/30 mL Oral Suspension, eleven (11) lots of Magnesium Hydroxide 1200 mg/Aluminum Hydroxide 1200 mg/Simethicone 120 mg per 30 mL

Annual Reports published by requirement of FDASIA Section 705

The FDA issued a complete response letter for Regeneron's lymphoma drug odronextamab. Elsewhere, Bristol Myers raised its guidance and analysts saw progress in Biogen’s turnaround.

Delays in the decision dates for high-dose Eylea are linked to issues at a Catalent-owned facility. Once these are resolved, Regeneron expects “to receive favorable action” on these applications, CEO Leonard Schleifer told investors.

A U.K. Court of Appeals ruling confirms the validity of a patent covering modifications of mRNA used in Moderna’s vaccines.

Manufacturers may face increased pressure to align with technical labeling requirements amid rising retailer accountability, as evidenced by the recent advancement of a class-action lawsuit against Amazon.

It’s not often that a CEO outright dismisses M&A prospects, but Moderna CEO Stéphane Bancel says the mRNA biotech has enough programs on its hands.

Trends are always a hot topic, but what about reasoning behind those trends? What motivations, social dynamics and experiences shape our decisions when we purchase products like creatine or ashwagandha

Research indicates that nut consumption has the potential to reduce cardiometabolic risk factors and the incidence of cardiovascular disease. Walnut (Juglans regia L.), containing a balanced lipid profile and a significant concentration of bioactive antioxidant and anti-inflammatory compounds, has demonstrated potential health benefits.

The FDA has denied that it plans to combine the Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research into one entity.

In its first commercial quarter for ATTR-cardiomyopathy, Alnylam’s Amvuttra reached roughly 1,400 patients and made more than $490 million.

Merck has characterized its cost-cutting initiative as more of a reallocation of resources to support other, higher-growth areas of its business.

FDA is Requiring Opioid Pain Medicine Manufacturers to Update Prescribing Information Regarding Long-Term Use. Class-Wide Action Will Further Emphasize and Characterize Risks of Long-Term Use to Help Patients, Health Care Professionals Make Informed Treatment Decisions: Drug Safety Communication

An executive order President Trump signed Thursday codifies rates for over 60 trading partners, including Switzerland. A probe into pharmaceuticals that’s expected to result in sectoral tariffs remains ongoing.

The White House set a 60-day deadline for drugmakers to agree on “most favored nation” prices for Medicaid as well as for newly launched drugs.

The 17 advisers fired last month by Robert F. Kennedy Jr. urged alternatives to ACIP be organized to limit further degradation in vaccine guidelines.

A potentially billion-dollar acquisition of Gilgamesh Pharmaceuticals suggests big pharma may finally be willing to place significant bets on psychedelics.

In 17 identical letters posted to his Truth Social account, the president said companies must lower their prices or the government ‘will deploy every tool in our arsenal to protect American families from continued drug pricing practices.’

FDA is requiring safety labeling changes for opioid pain medicines to further emphasize and characterize the risks associated with long-term use.

Despite battling drugs from BridgeBio and Pfizer, Amvuttra beat Wall Street expectations with results CEO Yvonne Greenstreet claimed were “not a flash in the pan.”

The FDA greenlit multiple new drugs this month and issued some notable label expansions including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.

Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.

For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU.

Move over Humira, Skyrizi and Rinvoq are expected to beat the former megablockbuster’s peak sales by the end of this year.

Rumors of Biogen’s disagreements with Eisai have been greatly exaggerated, CEO Chris Viehbacher said during a second quarter earnings call. The partnered Alzheimer’s drug Leqembi saw sales climb 20% for the period.

The announced reduction of hundreds of staff came a day ahead of Moderna’s Q2 earnings report.

While Eli Lilly’s diabetes blockbuster was non-inferior to its older incretin therapy Trulicity in a highly anticipated Phase III cardiovascular outcomes trial, analysts had hoped for statistical significance in reducing major events such as cardiovascular death, heart attack and stroke.

Employed biopharma professionals are highly likely to look for new jobs in the next 12 months, although not quite as likely as their unemployed counterparts, according to a BioSpace LinkedIn poll. Three recruitment experts discuss the findings and what’s driving job searches.

In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the concerns and opportunities of patient data driving AI tasks with Louise Molloy, associate director medical information and pharmacovigilance.