Market Place
Novartis sues US govt over Medicare drug price regulation; FTC okays Amgen-Horizon deal
Novartis has sued the US government in a bid to halt the Medicare drug-price negotiation program. The first list of drugs for price negotiation was released last week, and included Novartis’ heart failure treatment Entresto.
The Federal Trade Commission (FTC) has given its approval to Amgen’s US$ 27.8 billion acquisition of Horizon, albeit with anti-competition restrictions.
In trial news, Roche announced promising findings from a late-stage study evaluating Alecensa (alectinib) as an adjuvant treatment for patients with early lung cancer. Similarly, J&J’s Janssen unit has announced positive topline results from a late-stage study that evaluates Rybrevant in combination with chemotherapy in patients with a type of non-small cell lung cancer (NSCLC).
Viatris has secured tentative FDA approval for a fixed-dose combination (FDC) of three drugs for the treatment of HIV-1 infection in pediatric patients.
Sage Therapeutics plans to reduce its workforce by 40 percent after the US Food and Drug Administration (FDA) rejected its drug in a larger indication while approving it as the first postpartum depression pill. And CSL Vifor, the merged entity after CSL acquired Vifor Pharma last year, will be laying off 85 staff members.
Post release of first list, Novartis sues US govt over Medicare drug price regulation
Novartis has sued the US government over Medicare drug price negotiations. This is the first lawsuit that has been filed by a drugmaker after the Biden administration released the first list last week. The list includes 10 drugs that will be subject to price negotiations and includes Novartis’ blockbuster heart-failure medication, Entresto.
Through this lawsuit, Novartis joins companies such as Bristol Myers Squibb, J&J, and Merck that had filed lawsuits in July, aiming to block the Medicare drug-price negotiation program. In a statement, Novartis said the negotiations are unconstitutional.
Meanwhile, Japanese drugmaker Astellas Pharma has withdrawn its lawsuit against the US government after its prostate cancer drug got spared from the first list.
Roche touts positive late-stage results for its targeted early-stage lung cancer drug
Roche’s unit Genentech has announced promising findings from a late-stage study on people with early non-small cell lung cancer (NSCLC) that was driven by a well-known cancer gene, known as anaplastic lymphoma kinase (ALK). The patient population was given Roche’s Alecensa (alectinib) as an adjuvant treatment. Compared to chemotherapy, Alecensa successfully achieved its primary goal of improving disease-free survival. This makes Alecensa the first and only ALK inhibitor to demonstrate a decreased risk of recurrence or mortality in early-stage ALK-positive NSCLC.
Seagen-Genmab’s drug for cervical cancer: An antibody-drug conjugate (ADC) co-developed by Seagen and Genmab — Tivdak (tisotumab vedotin-tftv) — has successfully achieved its primary goal of overall survival in a late-stage trial involving patients with recurrent or metastatic cervical cancer who had experienced disease progression following front-line therapy as compared to chemotherapy alone. Tivdak is the first and only approved ADC for the treatment of this patient population. It received accelerated approval in 2021.
GSK invests in Belgium plant: GSK plans to invest over €250 million (US$ 273 million) in constructing a new facility at its Wavre site in Belgium, set to become operational in 2027. The new unit will manufacture freeze-dried vaccines, including GSK’s new RSV jab Arexvy, shingles vaccine Shingrix and malaria vaccine Mosquirix.
FTC okays Amgen-Horizon deal, albeit with anti-competition restrictions
The Federal Trade Commission (FTC) in the US has granted approval to Amgen’s US$ 27.8 billion acquisition of Horizon Therapeutics. However, the commission has imposed restrictions that seek to prevent Amgen from using anti-competitive tactics to extend its control over two drugs owned by Horizon. This agreement clears the uncertainty surrounding the deal, which stemmed from FTC taking legal action in May over concerns that Amgen may leverage rebates from its successful drugs to exert influence over insurance companies and pharmacy benefit managers.
Viatris bags FDA’s tentative approval for treatment of HIV in pediatric patients
Viatris has secured tentative FDA approval for a fixed-dose combination (FDC) of abacavir 60 mg, dolutegravir 5 mg, and lamivudine 30 mg tablets in oral suspension form for the treatment of HIV-1 infection in pediatric patients weighing at least 6 kg. This approval is anticipated to lessen the medication burden for children with HIV.
Sage lays off 40% staff after FDA rejects its major depressive disorder drug
Sage Therapeutics plans to reduce its workforce by approximately 188 employees, which constitutes around 40 percent of its staff. This decision comes shortly after FDA declined to approve Sage and Biogen’s drug for the treatment of major depressive disorder last month, while approving it as the first postpartum depression (PDD) pill.
Meanwhile, CSL Vifor, the merged entity created after CSL acquired Vifor Pharma for US$ 11.7 billion in August last year, is laying off 85 staff members based in California.
J&J posts positive data from late-stage lung cancer trial; stops hypertension trial
Johnson & Johnson’s Janssen unit has announced positive topline results from a late-stage study that evaluates Rybrevant (amivantamab-vmjw) and chemotherapy (carboplatin-pemetrexed) in combination with and without lazertinib, in patients with previously treated EGFR-mutant NSCLC. The drug combination plus chemo met its dual primary endpoint of progression-free survival as opposed to chemotherapy alone. Rybrevant is currently approved for subset of NSCLC. These results could move the drug to a larger area of NSCLC.
Meanwhile, J&J has decided to stop a late-stage study that tests its experimental drug — macitentan — on patients with chronic thromboembolic pulmonary hypertension, a type of hypertension. Janssen has also pulled out of its deal with Idorsia to develop an experimental hypertension drug, known as aprocitentan. Janssen has returned the rights for aprocitentan to Idorsia. It had licensed rights to the drug in 2017.
FDA rejects Astra’s Ultomiris for use in rare autoimmune disorder
FDA has handed AstraZeneca a complete response letter (CRL) for its Ultomiris application in a rare autoimmune disease affecting the central nervous system, known as neuromyelitis optica spectrum disorder (NMOSD). While the rejection didn’t raise safety or efficacy concerns, it has asked AstraZeneca to make modifications to its proposed Ultomiris risk evaluation and mitigation strategy (REMS).
BioCardia’s cell therapy for heart failure fails to meet its primary endpoint
In July, an independent data safety monitoring board had recommended pausing enrollment in a late-stage trial involving BioCardia’s CardiAMP cell therapy for heart failure. And now, the company says it has reported disappointing interim efficacy findings from this late-stage trial. BioCardia says the therapy did not meet its primary endpoint.
The PharmaCompass Newsletter – Sign Up, Stay Ahead
Feedback, help us to improve. Click here
Image Credit : Phisper Infographic by PharmaCompass license under CC BY 2.0
“ The article is based on the information available in public and which the author believes to be true. The author is not disseminating any information, which the author believes or knows, is confidential or in conflict with the privacy of any person. The views expressed or information supplied through this article is mere opinion and observation of the author. The author does not intend to defame, insult or, cause loss or damage to anyone, in any manner, through this article.”
