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By PharmaCompass
2026-01-29
Impressions: 1,526 Article || 168 Video || 3 Listen
Public health suffered several setbacks over the last week. First, the United States formally exited the World Health Organization (WHO). It used to be one of the biggest sources of funding for the agency.
Second, Moderna CEO Stephane Bancel said the company does not plan to invest in new late-stage vaccine trials due to growing opposition to immunizations from US officials.
Additionally, Kirk Milhoan, chair of the CDC’s Advisory Committee on Immunization Practices (ACIP), questioned broad vaccine recommendations in a podcast interview. The American Medical Association said it was “deeply alarmed” by his comments.
Amid rising geopolitical tensions, the European Union and India agreed to a free trade deal that should promote trade in pharmaceuticals through tariff reductions.
In drug approvals, the US Food and Drug Administration (FDA) has approved Johnson & Johnson’s Darzalex Faspro as part of a four-drug treatment regimen for adults with newly diagnosed multiple myeloma who are ineligible for an autologous stem cell transplant.
In deals, Boehringer Ingelheim licensed a preclinical inflammatory bowel disease (IBD) drug from China’s Simcere in a pact worth up to US$ 1.25 billion.
Meanwhile, India granted regulatory approval to Sun Pharma and Zydus Lifesciences to manufacture and sell generic semaglutide in India, the active ingredient in Novo Nordisk’s Wegovy and Ozempic.
US formally exits WHO, cuts all ties with organization it helped shape
The US has officially withdrawn from the WHO, ending its long-standing membership that began in 1948, when the UN health agency was founded. The US, which used to be one of the biggest sources of funding for the WHO, has cut all ties with the organization it helped shape. The move follows an executive order signed by President Donald Trump a year ago, triggering the mandatory one-year withdrawal process. According to WHO officials, the US still owes over US$260 million in unpaid dues for 2024 and 2025. The US government said the decision was driven by concerns over the WHO’s handling of the Covid-19 pandemic, a lack of reforms, and what it called political influence from member states.
Moderna won’t invest in new vaccine trials due to immunization pushback in US
Moderna CEO Stephane Bancel said the company does not plan to invest in new late-stage vaccine trials because of growing opposition to immunizations from US officials. Speaking to Bloomberg TV at the World Economic Forum in Davos, Bancel said regulatory delays and limited government support have reduced the market size and made it difficult to generate a return on investment without access to the US market. Over the last year, the US Health Secretary Robert F Kennedy Jr has taken steps to change the vaccination policy, including dropping recommendations for Covid-19 shots for pregnant women and children.
CDC’s ACIP head questions childhood vaccine recommendations: Kirk Milhoan, chair of the CDC’s ACIP, questioned broad vaccine recommendations for diseases such as polio and measles in a podcast interview. He said the panel aims to prioritize individual autonomy over public health and that vaccine decisions should be made by patients and doctors rather than through mandates. The American Medical Association said it was “deeply alarmed” by Milhoan’s comments.
EU, India ink free trade deal; India to eliminate 11% tax on European drugs
The European Union and India have agreed to a free trade agreement after years of negotiations. The agreement is expected to mostly eliminate India’s 11 percent tariff on EU pharmaceuticals. This is likely to be done over five to seven years. The European Commission said Europe exported about €1.1 billion (US$ 1.3 billion) worth of pharmaceuticals to India in 2024, and the total annual EU-India trade exceeds €180 billion (US$ 214.6 billion). The Commission must still move the deal through European lawmakers before it can take effect.
Next 15 drugs for Medicare price negotiations: The US Centers for Medicare & Medicaid Services (CMS) announced the next 15 high-spend medicines selected for Medicare price negotiations under the Inflation Reduction Act. The list includes first-time negotiations for drugs such as GSK’s Anoro Ellipta (umeclidinium/vilanterol), Gilead’s Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), AbbVie’s Botox and Botox Cosmetic, Takeda’s Entyvio (vedolizumab), and Johnson & Johnson’s Erleada (apalutamide).
FDA okays J&J’s Darzalex Faspro four-drug combo for newly diagnosed multiple myeloma
Johnson & Johnson said the FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) as part of a four-drug treatment regimen for adults with newly diagnosed multiple myeloma who are ineligible for an autologous stem cell transplant. The newly approved combination includes Darzalex Faspro with Velcade (bortezomib),Revlimid (lenalidomide) and dexamethasone. Darzalex Faspro is the subcutaneous version of Darzalex.
The approval also marks Darzalex Faspro’s 12th indication overall and its fifth in the newly diagnosed setting. In 2025, the Darzalex franchise brought in sales worth US$ 14.4 billion.
Boehringer licenses Chinese drugmaker Simcere’s preclinical IBD drug
Boehringer Ingelheim will license SIM0709, an experimental IBD treatment from China’s Simcere Pharmaceutical Group. Boehringer will pay €42 million (US$ 50 million) upfront and up to €1.016 billion (US$ 1.211 billion) more if development, regulatory, and sales milestones are achieved, for a total potential value of about €1.05 billion (US$ 1.25 billion).
Sun Pharma, Zydus bag approval for generic versions of Wegovy, Ozempic in India
Sun Pharmaceutical Industries and Zydus Lifesciences have received approval from India’s regulator to manufacture and sell generic versions of semaglutide, the active ingredient in Novo Nordisk’s Wegovy and Ozempic. Semaglutide is set to face patent expiry in March 2026. Dr Reddy’s has also received approval to sell a generic version of Ozempic.
FDA lifts clinical hold on Intellia’s gene therapy trial, but heart study remains paused
Intellia Therapeutics said FDA has allowed it to restart a late-stage study of its gene-editing treatment for a rare nerve disease known as ATTRv-PN. FDA had paused two related studies in October after a patient developed severe liver-related side effects. However, a separate trial testing the same therapy in patients with cardiomyopathy remains on hold.
Places Regenxbio’s gene therapy trials on clinical hold: Regenxbio said FDA has placed a clinical hold on two of its experimental gene therapy programs — RGX-111 and RGX-121 — for rare childhood diseases. RGX-111 was put on hold after a brain tumor was found in one trial participant during a routine brain scan, the company said. The patient was a five-year-old child suffering from Hurler syndrome (an inherited lysosomal disorder). RGX-121 is being developed for a similar condition known as Hunter Syndrome. It was put on clinical hold owing to similarities and potential shared risks between the two programs.
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