While U.S. President Donald Trump’s country-by-country reciprocal and newly negotiated tariffs go into effect today, a separate, global biopharma sector tariff of, possibly, 200% continues to loom over the sector. For many stakeholders, a biopharma sector tariff of even 25%, as first proposed by Trump, would be a disaster in the making, especially when combined with the pressures of Medicare price negotiations and the president’s escalation of most-favored-nation pricing.
After shutting down manufacturers’ efforts last year to offer the mandated 340B discounts on outpatient prescription drugs as a rebate rather than an up-front price, the U.S. Health Resources and Services Administration (HRSA) is now inching the rebate door open for drugs that were selected for the first round of Medicare price negotiations.
Agios Pharmaceuticals Inc. said the patients’ deaths tied to anemia therapy Pyrukynd (mitapivat) that were announced in a securities analyst’s Aug. 4 note to investors hasn’t changed the drug’s already established benefit-risk profile on the drug’s U.S. prescribing information.
Vertex Pharmaceuticals Inc.’s bad news from a phase II pain study and separately on the regulatory front caused shares (NASDAQ:VRTX) to close Aug. 5 at $393.83, down $78.44, or 16%. Vertex rolled out top-line results from the phase II dose-ranging study to test the safety and efficacy of its NaV1.8 pain signal inhibitor, VX-993, in tackling acute pain after bunionectomy.
Madrigal Pharmaceuticals Inc.’s long-awaited business development pact became reality by way of an exclusive global license agreement that could be worth more than $2 billion with CSPC Pharmaceutical Group Ltd., of Shijiazhuang, China, for SYH-2086. The candidate is a preclinical oral, small-molecule glucagon-like peptide-1 (GLP-1) receptor agonist and orforglipron derivative.
Good news bracketed July for Teleflex Inc. as it completed the acquisition of the vascular intervention business of Berlin-based Biotronik SE & Co. for €760 million (US$879 million) on July 1 and released stronger-than-expected second quarter results on the closing day of the month. Both bode well for the company as it proceeds through a thorough restructuring announced in February.
Negotiations for the sixth U.S. FDA device user fee agreement (MDUFA VI) are officially underway, and the Aug. 4 meeting highlighted some of the differences between the agency’s and industry’s expectations.
The FDA announced July 17 that Dexcom Inc. recalled a series of continuous glucose monitor receivers for a failure of speakers to issue an alert for out-of-specification blood glucose measures. This is a clear demonstration of the principle that greater device functionality often creates new types of risk.
The other shoe dropped on the U.S. CDC’s Advisory Committee for Immunization Practices (ACIP) when at least nine liaison organizations were informed by email late July 31 that they would no longer be involved in ACIP’s process of reviewing scientific evidence and informing vaccine recommendations.
Spine Biopharma Inc. cited an “inconsistent sham control response” among some of the sites in its phase III study testing SB-01 as an intradiscal treatment for patients with chronic low back pain associated with degenerative disc disease. The study, dubbed MODEL, fell short of statistical significance on pain intensity and pain-related function, despite showing numerical and clinically meaningful improvements.
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