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By PharmaCompass
2025-06-12
Impressions: 812 (Article) || 7 (Video)
This week, US Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. dismissed all 17 members of the US Centers for Disease Control and Prevention’s vaccine advisory committee. This unprecedented move has sparked intense debate about the politicization of vaccine science and its potential impact on public health.
Merck’s oral cholesterol drug, enlicitide decanoate, successfully met primary endpoints in two late-stage trials for treating hyperlipidemia (abnormally high amount of fat in the blood). The company also secured US Food and Drug Administration (FDA) approval for Enflonsia, an antibody that prevents illness due to respiratory syncytial virus (RSV) in newborns.
In other trials, Otsuka’s kidney disease treatment sibeprenlimab showed remarkable results by reducing protein in urine by 51.2 percent in patients with Immunoglobulin A Nephropathy (IgAN), a chronic kidney disease. And FDA placed clinical holds on five HIV trials being conducted by Gilead due to concerning drops in immune system markers.
In deals, Bristol-Myers Squibb’s subsidiary RayzeBio signed a US$ 1.35 billion deal to secure exclusive rights to a promising radiopharmaceutical for prostate cancer.
Meanwhile, European regulators warned of a rare but serious eye condition affecting up to 1 in 10,000 long-term users of Novo’s semaglutide-based drugs like Ozempic.
RFK Jr fires all 17 members of CDC’s vaccine advisory committee, sparks backlash
Robert F. Kennedy Jr. dismissed all 17 members of the CDC’s Advisory Committee on Immunization Practices (ACIP), a panel that has guided US vaccine policy for over 60 years. Kennedy cited concerns over conflicts of interest and a desire to restore public trust in vaccine science as reasons for the overhaul.
The move has sparked significant backlash from the medical community and public health experts. Former CDC Director Thomas Frieden warned that politicizing the ACIP could lead to reduced vaccine access. The American Medical Association has urged for immediate reversal of the decision and has also passed a resolution urging the Senate Committee on Health, Education, Labor and Pensions to investigate Kennedy’s actions.
Meanwhile, RFK Jr. has appointed eight new members to the ACIP. The slate includes Robert Malone, known for early mRNA research and for later criticizing Covid‑19 vaccine; Martin Kulldorff, a critic of pandemic shutdowns; and Vicky Pebsworth, linked to vaccine-harm advocacy.
Champions faster path for breakthrough genetic treatments: RFK Jr. has expressed strong support for regulatory flexibility in the approval process of cell and gene therapies, particularly those targeting rare diseases. During an FDA roundtable, Kennedy emphasized the need to eliminate barriers that hinder the development and market entry of these therapies.
CDC restores jobs of 450 sacked workers: The CDC is reinstating over 450 employees laid off under the Trump administration’s massive drive to reduce workforce. Many of these employees were part of the mass layoff announced in April.
Merck’s oral cholesterol drug meets goals in two late-stage trials
Merck announced that its investigational oral PCSK9 inhibitor, enlicitide decanoate, successfully met primary and key secondary endpoints in two pivotal phase 3 trials, targeting adults with hyperlipidemia who were already on statins. Both trials demonstrated statistically significant and clinically meaningful reductions in LDL cholesterol. If approved, enlicitide could unlock a multi‑billion‑dollar opportunity, supporting Merck’s post‑Keytruda transition.
FDA approves RSV prevention drug for newborns: FDA has approved Merck’s long‑acting monoclonal antibody, Enflonsia (clesrovimab), to prevent severe RSV illness in newborns and full‑term or pre‑term infants entering their first RSV season.
Novavax’s Covid-flu, flu jabs score in phase 3 trials: In a late-stage trial, Novavax’s experimental Covid-19-influenza combination vaccine and standalone influenza vaccine candidates generated strong immune response in adults aged 65 and older.
Nuvation Bio’s lung cancer drug approved: FDA has approved Nuvation Bio’s drug — Ibtrozi (taletrectinib) — for patients with a rare and aggressive form of lung cancer. This once-daily oral drug, is approved to treat ROS1-positive non-small cell lung cancer (NSCLC), which results from changes in the ROS1 gene leading to uncontrolled cell growth.
Label expansion for AbbVie’s Mavyret: FDA has approved a label expansion for AbbVie’s Mavyret (glecaprevir/pibrentasvir). It is now approved for the treatment of adults and pediatric patients three years and older with acute or chronic hepatitis C virus (HCV) infection without cirrhosis or with compensated cirrhosis.
BMS’ RayzeBio in US$ 1.35 bn deal with Philochem for novel prostate cancer med
Bristol‑Myers Squibb subsidiary RayzeBio has secured exclusive worldwide rights to OncoACP3, a radiopharmaceutical agent for both therapeutic and diagnostic applications in prostate cancer. The molecule — developed by Philochem — targets Acid Phosphatase 3 (ACP3), an enzyme primarily found in the prostate gland. Under the definitive agreement, BMS will pay Philochem US$ 350 million upfront, with up to an additional US$ 1 billion contingent on achieving development, regulatory, and sales milestones.
Novo in US$ 812 mn deal with Deep Apple: Novo Nordisk is joining hands with biotech Deep Apple Therapeutics to develop drugs for cardiometabolic diseases, including obesity. The deal is worth up to US$ 812 million. Deep Apple discovers drug candidates using its AI-based platform.
Users of Novo’s Ozempic face 1-in-10,000 risk of sudden vision loss, says EMA
The EMA has issued a warning that semaglutide-based treatments — Ozempic, Wegovy, and Rybelsus — may in very rare cases cause non-arteritic anterior ischemic optic neuropathy (NAION), a condition that can lead to sudden, painless vision loss in one eye. NAION is the second most common optic-nerve-related cause of blindness after glaucoma. The EMA estimates that the condition affects up to 1 in 10,000 users who have been on semaglutide for at least one year.
Meanwhile, Novo has launched a new late-stage trial for its experimental next-generation obesity drug candidate, CagriSema (cagrilintide/semaglutide).
Otsuka’s new kidney med cuts protein in urine by 51% in phase 3 trial
In
a phase 3 trial, Otsuka Pharmaceutical’s investigational therapy — sibeprenlimab — cut severe levels of protein in the
urine by 51 percent in patients with life-threatening kidney disease (known as
IgAN). This data was released a few days after Vera Therapeutics announced results from a separate study on its drug atacicept, which reduced protein in urine by 46 percent.
FDA halts Gilead’s HIV trials over safety concerns: FDA has placed a clinical hold on five trials of a combination of Gilead Sciences’ two experimental HIV treatments, GS-1720 and GS-4182. This decision follows the observation of low levels of a type of white blood cell known as CD4+ T-cell, which is a crucial part of the human body’s immune system.
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