During the first round of discussion at its two-day hearing on a World Trade Organization proposal to expand the intellectual property (IP) waiver from COVID-19 vaccines to diagnostics and therapies, the U.S. International Trade Commission (USITC) got an earful from both sides of the debate.
Are deals such as M&As between biotechs and big pharma becoming a thing of the past? That was a key question posed during the opening keynote at this year’s BIO-Europe Spring conference in Basel, Switzerland. Although Susanne Kreutz, global head of corporate and business development of Basel-based Novartis AG, doesn’t think this is the case, she told delegates that she believes M&A will increasingly focus in on “high-quality, high-impact, late-stage assets, where reimbursement is securable and where regulatory paths appear.”
Citing clinical trial data backed by real-world data, members of the U.S. FDA’s Antimicrobial Drugs Advisory Committee voted overwhelmingly, 16-1, March 16 that the overall benefit-risk assessment is favorable for the use of Pfizer Inc.’s Paxlovid to treat mild to moderate COVID-19 in adults who are at high risk for progression to severe COVID-19, including hospitalization or death.
Pfizer Inc.’s Paxlovid has become such a part of the COVID-19 treatment scene in the U.S. that it’s easy to forget it’s only authorized for emergency use. That could soon change. The FDA is convening its Antimicrobial Drugs Advisory Committee March 16 to consider Pfizer’s NDA for the co-packaged nirmatrelvir and ritonavir treatment.
Despite the new Medicare inflation rebate, the U.S. price of 27 Part B drugs grew faster than inflation in the last quarter of 2022, triggering the new rebate provision in the Inflation Reduction Act. The manufacturers of those single-source drugs will be billed for the rebates in 2025, but Medicare beneficiaries should see a drop in their coinsurance for those drugs, for the next quarter at least. According to the Biden administration, the decrease in out-of-pocket costs for those drugs will range from $2 to as much as $390 per average dose from April 1 through June 30.
Pfizer Inc.’s appetite for acquisitions shows no signs of abating as it announced this morning its plan to acquire biotech Seagen Inc. for a whopping $43 billion in a move that will double the size of its early stage oncology pipeline. Under the deal, unanimously approved by the boards of directors of both firms, Pfizer will pay Seagen $229 per share. Bothell, Wash.-based Seagen expects to amass $2.2 billion in revenue in 2023, representing 12% year-on-year-growth, royalties and collaboration and license agreements from its four, FDA-approved products for the treatment of solid tumors and hematologic malignancies, antibody-drug conjugate drugs Adcetris (brentuximab vedotin), Padcev (enfortumab vedotin) and Tivdak (tisotumab vedotin), and tyrosin kinase inhibitor Tukysa (tucatinib).
Pricing won’t be known until later for Pfizer Inc.’s Zavzpret (zavegepant), which became the first and only calcitonin gene-related peptide receptor antagonist nasal spray approved by the U.S. FDA for acute treatment of migraine with or without aura in adults. The product is slated to launch this summer. Meanwhile, Wall Street has questions about New York-based Pfizer’s performance in the migraine space.
As several key revenue-driving products fall off patent in coming years, pharmaceutical companies are increasingly focused on mechanisms by which they can draw innovation to them. What launched as the Partner of Choice organization, for example, has now become the newly named Pfizer Ignite model – an end-to-end engine designed to bring innovation to the pharmaceutical company in return for services.
Although the U.S. FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously, 12-0, March 1 that the data GSK plc presented was adequate to support the safety of its respiratory syncytial virus vaccine, several panelists cautioned the FDA against viewing the vote as a recommendation to license the vaccine before more data are available.
Safety likely will be top of mind when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee meets Feb. 28 and March 1 to advise the agency on two respiratory syncytial virus (RSV) vaccines proposed for use in adults who are at least 60 years old.
