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…

Winrevair yielded significant and meaningful clinical benefits for patients with combined post- and precapillary pulmonary hypertension, an indication that, according to BMO Capital Markets, has few treatment options.

Only one clinical-stage asset from the ProfoundBio acquisition remains in development: The antibody-drug conjugate Rina-S, in late-stage studies for ovarian and endometrial cancer.

On September 18 and 19, 2025, the U.S. Food and Drug Administration (FDA) is hosting a virtual public workshop to discuss methodological challenges related to patient experience data encountered, including the submission and evaluation of patient experience data in the context of the benefit-risk assessment and product labeling, as well as other ar

The deal gives J&J access to a pipeline of drugs designed to “hold and kill” tumors, led by a prostate cancer medicine that’s shown promise in early-stage testing. 

Halda Therapeutics is developing oral assets for prostate and lung cancer. The deal comes after Johnson & Johnson set an ambitious goal for its oncology sales by 2030.

The companies have yet to disclose how many programs they plan to collaborate on or what indications they will prioritize.

Sarepta must also run a post-marketing study for Elevidys to better assess the risk of serious liver injury in patients dosed with the gene therapy.

Artios Pharma is working on a pipeline of oncology assets, led by alnodesertib, currently being tested for second-line pancreatic cancer and third-line colorectal cancer.

EMA’s Emergency Task Force (ETF) is improving its approach to scientific advice for the most promising medicines and vaccines under development for public health threats.Under…, “With this new approach, developers will receive clear input on the design of clinical trials to allow generation of adequate evidence, and how these trials should be…, The approach will be crucial to enhance the rapid development and approval of medicines ahead of and during public health emergencies. The overall goal is to ensure alignment…

Priority voucher awardees and regulators could feel pressure to “meet the moment” as FDA watchers question the intent and feasibility of the Commissioner’s National Priority Voucher program.

The new fund will mostly support biotechs making new drugs, with investments spanning from initial financings to follow-on rounds. 

Now in a tug of war with Lundbeck, Alkermes could either lose out on a marketed sleepiness drug or end up paying significantly more than it had hoped.

FDA’s Office of Generic Drugs (OGD) ensures, through a scientific and regulatory process, that Americans have access to safe, effective, and high-quality generic drugs.

Milvexian’s failure in acute coronary syndrome dampens the outlook for other anticoagulants like it and is the latest in a series of clinical setbacks this year for Bristol Myers.

Significant changes from the 2017 version include additional recommendations related to IRB review; informed consent, including a template; and new requirements established by the Cures Act and FDARA related to sponsors making their expanded access policies public and readily available.

Bristol Myers Squibb and Johnson & Johnson will continue to test the asset in stroke and atrial fibrillation.

Bayer has let go of about 13,500 employees, including around 5,000 managers, since implementing a new operating model in early 2024. CEO Bill Anderson said in a recent earnings call that he expects a slower rate of headcount reduction moving forward.

Pfizer quickly consummated the $10 billion buyout after one-upping Novo Nordisk. Elsewhere, Lundbeck submitted a rival offer for Avadel Pharmaceuticals and Zealand Pharma dropped an obesity drug.

Healthcare is rapidly evolving with a growing reliance on portable medical devices in both clinical and home-care environments. These devices—used for diagnostics, monitoring, and life-support functions like ventilators—improve accessibility and outcomes by enabling continuous monitoring and timely interventions. However, their mobility and usage in high-impact environments demand rugged, compact, and high-speed components, particularly reliable internal connectors that can withstand shock, vibration, and physical stress.

This white paper highlights how the growth of portable and in-home medical devices has pushed the need for miniaturized, high-performance connectors. It explores how connector technology must balance reduced size, high data speeds, rugged durability, and simplified assembly to support modern healthcare demands.

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A day after Pfizer closed its hotly contested Metsera deal, Lundbeck has made an unsolicited offer to steal Avadel Pharmaceuticals away from Alkermes.

Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use

Gilead’s investigational drug combo bic/len could help lower the pill burden in patients with virologically suppressed HIV who are on complex treatment regimens, according to BMO Capital Markets.

At $9.2 billion, the Cidara acquisition lands among the top 5 largest deals of the year.

A BioNTech spokesperson downplayed the news, insisting that the two companies remain “close” and have a “strong collaboration.”

Ten new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended ten medicines for approval at its November 2025 meeting.The committee recommended…, CHMP statistics , CHMP statistics: Text…, Positive recommendations on new medicines, Dawnzera International non-proprietary name (INN) donidalorsen Marketing authorisation applicant Otsuka Pharmaceutical Netherlands B.V. Therapeutic indication…, GalenVita International non-proprietary name (INN) Germanium (68Ge) chloride / Gallium (68Ga) chloride Marketing authorisation applicant Curium Romania S.R.L.…, Inluriyo International non-proprietary name (INN) imlunestrant Marketing authorisation applicant Eli Lilly Nederland B.V. Therapeutic indication Monotherapy…, Teizeild International non-proprietary name (INN) teplizumab Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication To delay the…, VacPertagen International non-proprietary name (INN) pertussis vaccine (recombinant, acellular, component, adsorbed) Marketing authorisation applicant BioNet…, Waskyra International non-proprietary name (INN) Autologous CD34+ haematopoietic stem cells transduced ex vivo with a lentiviral vector encoding human Wiskott-…, Positive recommendations on new hybrid medicines, Enzalutamide Accordpharma International non-proprietary name (INN) enzalutamide Marketing authorisation applicant Accord Healthcare Therapeutic indication…, Positive recommendations on new biosimilar medicines, Ondibta International non-proprietary name (INN) insulin glargine Marketing authorisation applicant Gan & Lee Pharmaceuticals Europe GmbH Therapeutic…, Osqay International non-proprietary name (INN) denosumab Marketing authorisation applicant Theramex Ireland Limited Therapeutic indication Treatment of…, Positive recommendations on new generic medicines, Teduglutide Viatris International non-proprietary name (INN) teduglutide Marketing authorisation applicant Viatris Limited Therapeutic indication Treatment of…, Positive recommendations on extensions of therapeutic indications , Koselugo International non-proprietary name (INN) selumetinib Marketing authorisation holder AstraZeneca AB Orphan designation This medicine was designated an…, Minjuvi International non-proprietary name (INN) tafasitamab Marketing authorisation applicant Incyte Biosciences Distribution B.V. More information Minjuvi…, Veyvondi International non-proprietary name (INN) vonicog alfa Marketing authorisation holder Baxalta Innovations GmbH More information Veyvondi : pending EC…, Xerava International non-proprietary name (INN) eravacycline Marketing authorisation holder PAION Pharma GmbH More information Xerava : pending EC decision, Negative recommendations on extensions of therapeutic indications, Hetlioz International non-proprietary name (INN) tasimelteon Marketing authorisation holder Vanda Pharmaceuticals Netherlands B.V. More information Hetlioz, Outcome of re-examination on recommendation for new medicine, Aqneursa International non-proprietary name (INN) levacetylleucine Marketing authorisation applicant Intrabio Ireland Limited Therapeutic indication Chronic…, Start of re-examination on recommendation for new medicine, Rezurock International non-proprietary name (INN) belumosudil Marketing authorisation applicant Sanofi Winthrop Industrie Therapeutic indication Treatment of…, Withdrawal of initial marketing authorisation application, Insulin Aspart Injection International non-proprietary name (INN) insulin aspart Market authorisation applicant Masuu Pharma Europe Limited Therapeutic…, Nurzigma International non-proprietary name (INN) pridopidine Market authorisation applicant Prilenia Therapeutics B.V. Therapeutic indication Treatment of…, Ohtuvayre International non-proprietary name (INN) ensifentrine Market authorisation applicant Verona Pharma Ireland Limited Therapeutic indication…

The European venture firm raised 500 million euros, or about $579 million, for its latest fund, which follows a flurry of recent buyout deals involving portfolio companies like Merus and Vicebio.

Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.

The U.S. Food and Drug Administration today made public filing checklists used internally by Center for Drug Evaluation and Research (CDER) staff to determine if a submitted application is complete and reviewable.

Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028.