Global Breakthrough: FGC2.3 Feline Vocalization Project Nears Record Reads — Over 14,000 Scientists Engage With Cat-Human Translation Research

Global Breakthrough: FGC2.3 Feline Vocalization Project Nears Record Reads — Over 14,000 Scientists Engage With Cat-Human Translation Research

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…

Tariff-Free Relocation to the US

Tariff-Free Relocation to the US

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,…

Global Distribution of the NRAs Maturity Levels as of the WHO Global Benchmarking Tool and the ICH data

Global Distribution of the NRAs Maturity Levels as of the WHO Global Benchmarking Tool and the ICH data

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…

EMA Initiates Evaluation of Sodium Oxybate for Treatment of Alcohol Dependency

EMA Initiates Evaluation of Sodium Oxybate for Treatment of Alcohol Dependency

EMA’s human medicines committee (CHMP) has started a review of medicines containing sodium oxybate used in people with alcohol dependency to treat alcohol withdrawal syndrome and…, Contact point Media enquiriesTel. +31 (0)88 781 8427E-mail: press@ema.europa.euAll other enquiriesPlease submit your request via the online formFollow…

Key Takeaways from the Committee for Medicinal Products for Human Use (CHMP) Meeting Held from June 16 to June 19, 2025

13 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its June 2025 meeting.The committee recommended granting a…, CHMP statistics Key figures from the June 2025 CHMP meeting are represented in the graphic below., CHMP statistics: Text versionJune 2025 statistics – monthly and cumulative figures for CHMP opinions and withdrawn applications:13 positive opinions on new medicines: 3 new non…, Positive recommendations on new medicines , Austedo International non-proprietary name (INN) deutetrabenazine Marketing-…, Imreplys INN sargramostim Marketing-authorisation applicant…, Ogsiveo INN nirogacestat Marketing-authorisation applicant…, Rezdiffra INN resmetirom Marketing-authorisation applicant…, Zemcelpro INN Dorocubicel / Allogeneic umbilical cord-derived CD34- cells, non-expanded…, Positive recommendations on new biosimilar medicines , Afiveg INN aflibercept Marketing-authorisation applicant…, Eiyzey INN aflibercept Marketing-authorisation applicant…, Mynzepli INN aflibercept Marketing-authorisation applicant…, Usymro INN ustekinumab Marketing-authorisation applicant…, Vgenfli INN aflibercept Marketing-authorisation applicant…, Vivlipeg INN pegfilgrastim Marketing-authorisation applicant…, Positive recommendations on new generic medicines , Emtricitabine/Rilpivirine/Tenofovir Alafenamide Viatris INN emtricitabine / rilpivirine / tenofovir alafenamide…, Nintedanib Viatris INN nintedanib Marketing-authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Benlysta INN belimumab Marketing-authorisation holder…, Cabometyx INN cabozantinib  Marketing-authorisation holder…, Darzalex INN daratumumab Marketing-authorisation holder…, Imbruvica INN ibrutinib Marketing-authorisation holder…, Nubeqa INN darolutamide Marketing-authorisation holder…, Sarclisa INN isatuximab Marketing-authorisation holder…, Start of re-examination of initial applications , Atropine sulfate FGK INN atropine  Marketing authorisation applicant…, Kisunla INN donanemab Marketing authorisation applicant…, Start of referral , Sodium oxybate-containing syrup and oral solution for alcohol dependence Marketing authorisation applicant Various…, Recommendations on extension of therapeutic indication for one medicine intended for use outside the EU , Dapivirine Vaginal Ring 25 mg INN dapivirine Marketing authorisation applicant…, Other updates Start of Union reviews adopted during the CHMP meeting of 16-19 June 2025AdoptedReference Number: EMA/202194/2025 English…

Agile in Action: Novavax Navigates Ongoing Regulatory Ambiguities

Agile in Action: Novavax Navigates Ongoing Regulatory Ambiguities

After the delayed approval of its next-generation COVID-19 vaccine, Novavax now awaits the first meeting of the recently overhauled CDC vaccine advisory committee next week. Throughout a tumultuous season, the Maryland-based company is relying on agility and a diverse pipeline to stay ahead of rapidly changing regulations.

A Revolutionary BCI Creates Speech on Demand

A Revolutionary BCI Creates Speech on Demand

By analyzing neural signals, a brain-computer interface (BCI) can now almost instantaneously synthesize the speech of a man who lost use of his voice due to a neurodegenerative disease, a new study finds.

The researchers caution it will still be a long time before such a device, which could restore speech to paralyzed patients, will find use in everyday communication. Still, the hope is this work “will lead to a pathway for improving these systems further—for example, through technology transfer to industry,” says Maitreyee Wairagkar, a project scientist at the University of California Davis’s Neuroprosthetics Lab.

A major potential application for brain-computer interfaces is restoring the ability to communicate to people who can no longer speak due to disease or injury. For instance, scientists have developed a number of BCIs that can help translate neural signals into text.

However, text alone fails to capture many key aspects of human speech, such as intonation, that help to convey meaning. In addition, text-based communication is slow, Wairagkar says.

Now, researchers have developed what they call a brain-to-voice neuroprosthesis that can decode neural activity into sounds in real time. They detailed their findings 11 June in the journal Nature.

“Losing the ability to speak due to neurological disease is devastating,” Wairagkar says. “Developing a technology that can bypass the damaged pathways of the nervous system to restore speech can have a big impact on the lives of people with speech loss.”

Neural Mapping for Speech Restoration

The new BCI mapped neural activity using four microelectrode arrays. In total, the scientists placed 256 microelectrode arrays in three brain regions, chief among them the ventral precentral gyrus, which plays a key role in controlling the muscles underlying speech.

“This technology does not ‘read minds’ or ‘read inner thoughts,’” Wairagkar says. “We record from the area of the brain that controls the speech muscles. Hence, the system only produces voice when the participant voluntarily tries to speak.”

The researchers implanted the BCI in a 45-year-old volunteer with amyotrophic lateral sclerosis (ALS), the neurodegenerative disorder also known as Lou Gehrig’s disease. Although the volunteer could still generate vocal sounds, he was unable to produce intelligible speech on his own for years before the BCI.

The neuroprosthesis recorded the neural activity that resulted when the patient attempted to read sentences on a screen out loud. The scientists then trained a deep-learning AI model on this data to produce his intended speech.

The researchers also trained a voice-cloning AI model on recordings made of the patient before his condition so the BCI could synthesize his pre-ALS voice. The patient reported that listening to the synthesized voice “made me feel happy, and it felt like my real voice,” the study notes.

Neuroprosthesis Reproduces a Man’s Speech UC Davis

In experiments, the scientists found that the BCI could detect key aspects of intended vocal intonation. They had the patient attempt to speak sets of sentences as either statements, which had no changes in pitch, or as questions, which involved rising pitches at the ends of the sentences. They also had the patient emphasize one of the seven words in the sentence “I never said she stole my money” by changing its pitch. (The sentence has seven different meanings, depending on which word is emphasized.) These tests revealed increased neural activity toward the ends of the questions and before emphasized words. In turn, this let the patient control his BCI voice enough to ask a question, emphasize specific words in a sentence, or sing three-pitch melodies.

“Not only what we say but also how we say it is equally important,” Wairagkar says. “Intonation of our speech helps us to communicate effectively.”

All in all, the new BCI could acquire neural signals and produce sounds with a delay of 25 milliseconds, enabling near-instantaneous speech synthesis, Wairagkar says. The BCI also proved flexible enough to speak made-up pseudo-words, as well as interjections such as “ahh,” “eww,” “ohh,” and “hmm.”

The resulting voice was often intelligible, but not consistently so. In tests where human listeners had to transcribe the BCI’s words, they understood what the patient said about 56 percent of the time, up from about 3 percent from when he did not use the BCI.

Computer screen displaying neural signal data in multiple graph plots. Neural recordings of the BCI participant shown on screen.UC Davis

“We do not claim that this system is ready to be used to speak and have conversations by someone who has lost the ability to speak,” Wairagkar says. “Rather, we have shown a proof of concept of what is possible with the current BCI technology.”

In the future, the scientists plan to improve the accuracy of the device—for instance, with more electrodes and better AI models. They also hope that BCI companies might start clinical trials incorporating this technology. “It is yet unknown whether this BCI will work with people who are fully locked in”—that is, nearly completely paralyzed, save for eye motions and blinking, Wairagkar adds.

Another interesting research direction is to study whether such speech BCIs could be useful for people with language disorders, such as aphasia. “Our current target patient population cannot speak due to muscle paralysis,” Wairagkar says. “However, their ability to produce language and cognition remains intact.” In contrast, she notes, future work might investigate restoring speech to people with damage to brain areas that produce speech, or with disabilities that have prevented them from learning to speak since childhood.

Beyond a Single Talent: Lilly Invests in the Biotech Sector’s Success

Beyond a Single Talent: Lilly Invests in the Biotech Sector’s Success

On the sidelines of BIO2025, Julie Gilmore, head of Lilly Gateway Labs, shares her thoughts on the $1.3 billion Verve Therapeutics buy, where Lilly’s therapeutic puck is potentially going and how the company is leveraging its unprecedented success in obesity to support young biotechs.