On the day Donald Trump was sworn in as the 47th President of the United States, there was a deluge of some 200 measures, which included an order to withdraw the country from the World Health Organization (WHO). Trump also directed federal health agencies to pause all external communications. Both these measures have raised concerns within the public health community.In its last days, the Biden administration chose 15 new drugs for Medicare price negotiations under the Inflation Reduction Act (IRA). This second batch includes Novo Nordisk’s blockbuster diabetes drugs, Ozempic and Rybelsus, and its weight-loss treatment Wegovy. Novo also revealed that a high dose of Wegovy led to an average weight loss of over one-fifth of the body weight in a late-stage trial.The week also saw its fair share of drug approvals. FDA approved Johnson & Johnson’s ketamine-derived nasal spray, Spravato, as the first and only standalone treatment for adults suffering from treatment-resistant depression. AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate (ADC), Datroway, was approved for HR-positive, HER2-negative breast cancer. Amgen’s combination therapy for colorectal cancer also bagged FDA approval.In deals, ArriVent BioPharma inked a US$ 1.2 billion
license agreement with Lepu Biopharma for a promising ADC targeting
gastrointestinal cancers.Trump signs order withdrawing
US from WHO, accuses agency of mishandling CovidThe US President Donald Trump has signed an executive order to withdraw the US from the
WHO, stating that “World Health ripped us off”. The executive order accuses WHO of mishandling the Covid-19 pandemic, failing to act independently from the “inappropriate political influence of WHO member states”, and requiring “unfairly onerous payments” from the US that are disproportionate to the sums provided by larger countries like China. The US has been the biggest contributor to the WHO’s budget, providing 18 percent of the current biennium budget for 2024-2025, which is set at US$ 6.8 billion.The US is set to leave the United Nations’ health agency in 12 months. Trump has also rescinded an executive order issued by the Biden
administration that aimed to establish safeguards for the development and use of AI, including its applications
in healthcare and drug development.US health agencies to cease
external communication: In a surprising move, the Trump administration
has directed federal health agencies, including the FDA, the Centers for
Disease Control and Prevention (CDC) and Department of Health and Human
Services (HHS), to pause all external communications, a
report in the Washington Post said. This directive affects regular scientific reports, health advisories, updates to websites, and social media posts. The pause has raised concerns within the public health community, as these agencies routinely release critical information on food recalls, drug and medical device approvals, and updates on public health threats, such as infectious diseases and natural disasters.Novo’s Ozempic, Wegovy among 15 new drugs chosen for price negotiations under IRAThe outgoing Biden administration announced that it has selected 15 drugs targeted for Medicare price
negotiations under the IRA. This marks the second batch of prescription drugs for
negotiations aimed at reducing costs for Medicare beneficiaries.Novo Nordisk’s blockbuster diabetes drugs Ozempic, Rybelsus, and weight-loss treatment Wegovy (all semaglutide) are among the drugs
identified. The selected drugs, which also include Pfizer’s cancer drugs Ibrance (palbociclib) and Xtandi (enzalutamide), GSK’s asthma and COPD treatment Trelegy Ellipta, and AbbVie’s irritable bowel syndrome
drug Linzess (linaclotide) and major depressive
disorder (MDD) treatment Vraylar (cariprazine), accounted for about US$ 41
billion in Medicare Part D gross spending between November 2023 and October
2024.Novo touts increased weight
loss results for high-dose Wegovy: Novo Nordisk has announced phase 3 trial results that point to
increased efficacy of a high
dose Wegovy in attaining weight loss. In 72 weeks, the 7.4 mg dose of Novo’s obesity drug led to an average weight loss of over one-fifth of the body weight (20.7 percent). In comparison, the 2.4 mg
dose resulted in 17.5 percent reduction in body weight, while the
placebo resulted in 2.4 percent weight reduction. Additionally, 33.2 percent of
patients on the highest dose achieved a weight loss of at least 25 percent,
compared to 16.7 percent on the 2.4 mg doseJ&J’s Spravato becomes first FDA-approved standalone med for treatment-resistant depressionFDA has
approved J&J’s nasal spray, Spravato (esketamine), as a standalone treatment for adults suffering from treatment-resistant depression (TRD), a severe form of major depressive disorder (MDD)
where patients do not respond to at least two
different antidepressants.In a pivotal study, 22.5 percent of patients using Spravato
achieved remission by week four, compared to just 7.6 percent in the placebo
group. Patients experienced rapid and significant improvements in depressive symptoms, with some reporting relief within just 24 hours. Due to the potential risk of misuse, the drug will only be available through a restricted program.Allergic reactions to MS
drugs: FDA
has warned of the risk of a rare, but serious,
allergic reaction caused by the use of some multiple
sclerosis drugs. These drugs now require a new boxed warning. Teva’s Copaxone is among the drugs impacted by the US agency’s warning.Key AstraZeneca-Daiichi
ADC wins its first US approval for breast cancerFDA has approved Datroway (datopotamab
deruxtecan or Dato-DXd), an ADC developed by AstraZeneca and Daiichi Sankyo, for the treatment of adult patients with unresectable
or metastatic hormone receptor
(HR)-positive, HER2-negative breast cancer. Datroway is the second ADC
developed under the collaboration between AstraZeneca and Daiichi Sankyo, following the success of
Enhertu (trastuzumab deruxtecan). The approval comes after a tough year with Dato-DXd failing multiple trials in 2024.Amgen’s Lumakras combo greenlit for colorectal cancer: FDA has approved
Lumakras (sotorasib) in combination with Vectibix (panitumumab) for the treatment of adult patients with KRAS G12C-mutated
metastatic colorectal cancer (mCRC). This approval is for patients who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy.ArriVent gains ex-China
rights to gastro cancer ADC in US$ 1.2 bn deal with Lepu BiopharmaArriVent BioPharma made strides in its ADC pipeline by securing an exclusive license agreement with Lepu Biopharma for MRG007, a preclinical
ADC targeting gastrointestinal
cancers. This deal, valued at US$ 1.2 billion, includes US$ 47 million in upfront and near-term milestone payments. It grants ArriVent the rights to develop and commercialize MRG007 outside of Greater China.
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