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…

AstraZeneca’s top medical executive Cristian Massacesi will replace Bristol Myers’ current chief medical officer, Samit Hirawat, on Aug. 1.

This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products

Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies

Lilly’s appeal of an earlier, negative recommendation from a key EMA committee has worked out in its favor, and puts the drug, Kisunla, one step closer to European market entry.

New research strengthens the evidence for early-life probiotic strategies, prompting supplement manufacturers to reconsider their formulations targeting infants.

The collaboration focuses on ‘molecular gates,’ a class of molecules that the startup company Gate Bioscience says can stop pathogenic proteins from leaving the cell.

Nestlé may be cutting its losses in the VMS category, selling off brands under the Bountiful Company. Nestlé acquired that company for nearly $5.75 billion.

The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne muscular dystrophy.

It’s no secret that direct sellers and multi-level marketers have suffered in recent years with the rise of social media. Last year Rodan + Fields announced plans to move away from its multi-level direct selling model and earlier this year many were shocked to hear that Modere would shut down after 23 years in business. But in this modern day, can MLMs that once thrived during the heyday of Tupperware parties decades ago survive in this modern era of social media

The strategic reprioritization comes after the company hit two major hurdles in the past year, including a clinical hold for an investigational gene therapy and an FDA rejection for its lead asset.

CBER is unanimously against Elevdiys’ return to the market without additional evidence, according to media reports citing an anonymous senior FDA official. Given Elevidys’ full approval, however, experts told BioSpace this path would set up a length legal battle between the regulator and Sarepta Therapeutics.

13 new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended 13 medicines for approval at its July 2025 meeting.The committee recommended granting a…, CHMP statistics Key figures from the July 2025 CHMP meeting are represented in the graphic below., CHMP statistics: Text versionJuly 2025 statistics – monthly and cumulative figures for CHMP opinions and withdrawn applications:13 positive opinions on new medicines: 2 new non…, Positive recommendations on new medicines , Aqneursa International non-proprietary name (INN) L-Acetylleucine Marketing…, Ekterly INN sebetralstat Marketing authorisation applicant…, Romvimza INN vimseltinib Marketing authorisation applicant…, Tryngolza INN olezarsen Marketing authorisation applicant…, Voranigo INN vorasidenib Marketing authorisation applicant…, Yeytuo INN lenacapavir Marketing authorisation applicant…, Zurzuvae INN zuranolone Marketing authorisation applicant…, Positive recommendations on new biosimilar medicines , Bildyos INN denosumab  Marketing authorisation applicant…, Bilprevda INN denosumab Marketing authorisation applicant…, Eyluxvi INN aflibercept  Marketing authorisation applicant…, Usrenty INN ustekinumab Marketing authorisation applicant…, Positive recommendations on new generic medicines , Macitentan Accord INN macitentan Marketing authorisation applicant…, Macitentan AccordPharma INN macitentan Marketing authorisation applicant…, Positive recommendation on medicine for use outside the European Union , Lenacapavir Gilead INN lenacapavir Marketing authorisation applicant…, Withdrawal of initial marketing authorisation application , Aplidin INN plitidepsin Therapeutic indication…, Ifinwil INN eflornithine Marketing authorisation applicant…, Nidlegy INN bifikafusp alfa / onfekafusp alfa  Marketing authorisation…, Negative opinions of initial marketing authorisation applications , Elevidys INN delandistrogene moxeparvovec  Marketing authorisation applicant…, Jelrix INN autologous cartilage-derived articular chondrocytes, in-vitro expanded…, Nurzigma INN pridopidine  Marketing authorisation applicant…, Positive recommendations on extensions of therapeutic indications , Alhemo INN concizumab Marketing authorisation holder…, Baqsimi INN glucagon Marketing authorisation holder…, Clopidogrel Zentiva INN clopidogrel Marketing authorisation holder…, Invokana INN canagliflozin Marketing authorisation holder…, mResvia INN single-stranded 5′ capped mRNA encoding the respiratory syncytial virus glycoprotein F stabilized in…, Sirturo INN bedaquiline Marketing authorisation holder…, Taltz INN ixekizumab Marketing authorisation holder…, Tevimbra INN tislelizumab Marketing authorisation holder…, Re-examinations of initial applications , Kisunla INN donanemab Marketing authorisation applicant…, Start of referral procedure , Tecovirimat SIGA INN tecovirimat More information…, Other updates Questions and answers on the outcome of assessment on use of Neuraceq to monitor treatment responseReference Number: EMA/310493/2020…

EMA has recommended granting a marketing authorisation in the European Union (EU) for Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) in combination with safer…, Related contentMeeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 21-24 July 2025

Ethicon Endo-Surgery is correcting the Endopath Echelon due to a potential surgical lockout that stops cutting or stapling and requires extra removal steps.

The Food and Drug Administration is advising consumers not to purchase or use X MAX Triple Shot Energy Honey, a product promoted and sold as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores.

TCG Labs Soleil, which launched in 2024 in collaboration with The Column Group, is focused on building single-drug biotechs it can position for partnerships.

A decision to possibly sell the business, which was poised to become the centerpiece of a restructuring plan, represents a shift in strategy by new company leaders.

The company didn’t share specific data for the molecule, gefurulimab, but said it hit all endpoints in the Phase III PREVAIL trial and promised to share more at an upcoming scientific meeting.

The partnership with Matchpoint Therapeutics gets Novartis global rights on all molecules for several unannounced inflammatory diseases identified through the biotech’s discovery platform.

Companies sometimes miss the mark when it comes to telling employees they’re out of a job. From accidental goodbyes to surprise meetings, there are many strange ways biopharma professionals have learned about layoffs.

Guidelines on good pharmacovigilance practices (GVP): Introductory cover note, last updated with new Addendum II to Module VI on masking of personal data in individual case safety reports submitted to EudraVigilance

At its July 2025 meeting, EMA’s Paediatric Committee (PDCO), elected Sabine Scherer from Germany as its new chair for a three-year mandate, beginning in September 2025.Dr Scherer…, She is currently involved in several PDCO initiatives and working groups, dealing with topics such as extrapolation, mechanism of action PDCO representatives in the European…, "It is a great honour to be appointed to chair EMA’s paediatric committee. My ambition is to work together with the European Medicines Regulatory Network to further advance…, The main role of the PDCO is to prospectively guide sponsors or companies on how to consider a medicine’s use in children during its development. In this context, the…

The 2025 Product of the Year winners were recently revealed during the 8th Annual NutraIngredients-USA Awards.

Second-quarter earnings come amid many high-level challenges for the biopharma industry. How will these five closely watched biotechs fare?

The new target action date for Blenrep, which GSK is proposing for the second-line treatment of relapsed or refractory multiple myeloma, is Oct. 23.

Roche obtained CT-173, a PYY mimetic, in its $2.7 billion acquisition of Carmot Therapeutics in December 2023. The company reported the change in its second quarter earnings call.

The latest round of terminations, which will take effect Sept. 15, comes after Genentech fired more than 500 employees in the last 15 months.