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By PharmaCompass
2023-09-14
Impressions: 1168
In this week’s Phispers, the US Department of Health and Human Services (HHS) has attacked Merck over the lawsuit it had filed in June pertaining to the provisions in the Inflation Reduction Act. In a court filing, HHS has argued that it can’t be sued by Merck as the drugmaker isn’t the primary manufacturer of Januvia.
In deals, Moderna and Immatics have inked a research and development collaboration for developing cancer vaccines and therapies with high unmet medical need. And Sandoz has partnered with Samsung Bioepis for the development and commercialization of its biosimilar to Johnson & Johnson’s blockbuster anti-inflammatory med Stelara.
In regulatory news, a group of external experts to the US Food and Drug Administration (FDA) has declined to endorse the efficacy of over-the-counter (OTC) medicines containing phenylephrine, a commonly used active pharmaceutical ingredient (API) found in cold and cough syrups. The agency has also issued warnings to eight companies cautioning them against manufacturing or marketing unapproved eye products.
And in trial news, AstraZeneca’s cancer drug Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38 percent compared to Tagrisso alone in a late-stage trial.
Merck can’t sue US govt over drug pricing plan, HHS argues in new court filing
Merck, the first drugmaker to sue the US government over Medicare’s price negotiation provisions in the Inflation Reduction Act (IRA), was assailed by the US Department of Health and Human Services (HHS). In a new filing, HHS has said Merck can’t sue the US government as the drugmaker isn’t the primary manufacturer of the diabetes med Januvia—one of 10 medications up for the first round of price negotiations in 2026.
It merely markets Januvia, HHS has said, pointing out that Merck’s subsidiary — Merck Sharp & Dohme (MSD) — is the company set to face the legal obligations “that Merck supposedly fears”.
The agency said the price negotiation program does not constitute a physical taking of property in violation of the American constitution. “If a manufacturer is unwilling to sell its selected drugs to Medicare at the price that the government is willing to pay, it is free to withdraw from the Medicare program,” the motion says.
After Merck sued the US government in June, several other drugmakers and trade groups had filed similar lawsuits. The pharmaceutical industry was concerned that the drug pricing plan might lead to reduced profits, potentially causing them to scale back their efforts in developing innovative treatments and imposing excessive fines on those that don’t negotiate.
Moderna partners Immatics for cancer jabs; its flu shot succeeds late-stage trial
Moderna and Immatics have inked a research and development collaboration for cancer vaccines and therapies with high unmet medical need. The deal will combine Immatics’ TCR platform with Moderna’s mRNA technology. Under the terms, Immatics will receive an upfront payment of US$ 120 million and milestone payments that could exceed US$ 1.7 billion. Moderna will also explore the potential combination of its own cancer vaccine with Immatics’ cancer therapy, IMA203.
In other news from Moderna, its flu vaccine has generated a stronger immune response against all four A and B strains of the influenza virus in a late-stage trial, when compared with traditional flu shots. The Moderna flu shot was effective in all age groups, and was found to be safe and tolerable even in older people.
Meanwhile, Moderna has scaled down the manufacture of its Covid 19 vaccine whose updated version was approved by the US regulators this week, to keep pace with decreased demand post-pandemic.
AbbVie’s Skyrizi beats J&J’s Stelara in head-to-head phase 3 Crohn’s disease trial
In a late-stage, head-to-head trial in patients with Crohn’s disease, AbbVie’s Skyrizi (risankizumab-rzaa) outperformed Johnson & Johnson’s blockbuster arthritis therapy Stelara (ustekinumab).
For the first primary endpoint of clinical remission at week 24, the remission rates stood at 59 percent and 40 percent for those who received Skyrizi and Stelara, respectively. For the second primary endpoint of endoscopic remission, the remission rates for the two groups reached 32 percent and 16 percent, respectively, indicating statistically significant superiority for Skyrizi over Stelara at week 48.
Sandoz-Samsung Bioepis tie-up for Stelara copycat: Novartis’ Sandoz unit announced a partnership with Samsung Bioepis to develop and commercialize its biosimilar to J&J’s Stelara. This agreement will provide Sandoz exclusive rights to commercialize the biosimilar SB17 ustekinumab in the US, Canada, and almost all European countries. With Stelara’s patent exclusivity expiration nearing, there is currently no approved biosimilar for ustekinumab.
FDA panel terms popular nasal decongestant used in OTC cough syrups ineffective
A group of external experts advising the FDA declined to endorse the
efficacy of over-the-counter (OTC) medicines containing phenylephrine, a commonly used API in cold and cough
syrups. The panel unanimously rejected the notion that orally administered phenylephrine is effective as a nasal decongestant and stated that further trials were unnecessary to establish this fact.
FDA issues warning letters to eight firms over eye products: FDA has issued warnings to eight companies, including CVS Health Corp, Boiron, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance, cautioning them against manufacturing or marketing unapproved eye products. As per the warning letter, these eye products are being marketed illegally for the treatment of conditions such as conjunctivitis, cataracts, and glaucoma.
CDC okays broad use of updated Covid-19 vaccines: The US Centers for Disease Control and Prevention (CDC) has okayed broad use of updated Covid-19 vaccines from Pfizer-BioNTech and Moderna, that were approved by the FDA. The shots are part of a push by public health officials to align the next Covid vaccines more closely with the actual circulating variant of the virus.
Astra’s Tagrisso-chemo combo reduces risk of death by 38% in lung cancer
In May, AstraZeneca’s blockbuster cancer drug Tagrisso in combination with chemotherapy showed promise in a late-stage clinical trial in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). This week, the trial details were shared at a conference in Singapore. The trial showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38 percent compared to Tagrisso alone. Tagrisso is already established as the trusted first-line standard of care for EGFRm NSCLC.
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