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The Federal Trade Commission’s increased scrutiny of mergers has now hit IQVIA, whose proposed acquisition of Propel Media has been challenged by the watchdog agency.
Following several clinical failures for its candidates Roxadustat and pamrevlumab, FibroGen CEO Enrique Conterno is stepping down for “personal reasons,” the company announced Tuesday.
Embattled SQZ Biotechnologies announced Tuesday that the Swiss biotech will not exercise its option for HPV 16 positive solid tumors under the SQZ-APC-HPV program.
The biotech’s “Fit for Growth” program, which includes the headcount reduction, is expected to generate a net savings of $700 million on operating expenses by 2025.
While chemo drugs remain in shortage, Congress asks for answers from the FDA to find solutions to the supply chain disintegration.
Late-stage data, which showed significant overall and progression-free survival benefits in unresectable hepatocellular carcinoma patients, supports Elevar’s New Drug Application filed in May 2023.
The license and option deal, for an undisclosed amount, seeks to develop potentially first-in-class antibody-drug conjugate candidates against different oncology targets.
Following two BLA rejections for its Humira biosimilar, Alvotech is expanding its partnership with Teva Pharmaceuticals, which will enable the latter to have greater involvement with quality and control.
Company shares fell over 50% after two late-stage studies failed to demonstrate vision improvements in patients with diabetes macular edema.
The Danish vaccine maker’s respiratory syncytial virus candidate did not meet all primary endpoints in a late-stage study in older adults and the company is discontinuing the program.
James Ellis, an authority on employer branding for small businesses and biotechs, weighs in on the best ways to earn candidates’ trust.
With an upfront payment of $310 million in cash, Roche is partnering with Alnylam to develop the latter’s RNA interference candidate zilebesiran for hypertension patients with high cardiovascular risk.
Despite the lifting of the FDA’s partial clinical hold, Gilead will discontinue magrolimab’s development in higher-risk myelodysplastic syndromes after a Phase III study met the bar for futility.
The infectious diseases market is expected to reach $150 billion in sales by 2029, with three pharma giants reaping most of its benefits, according to data analytics and consultancy GlobalData.
The U.S. Supreme Court recently declared an end to race-conscious admission programs into colleges and universities, which could have a trickle-down effect on hiring.
The company continues to repair the damage caused by the July 19 storm in hopes of restoring ample supplies of drugs produced at the Rocky Mount facility.
The Federal Trade Commission released new draft guidelines for assessing mergers, while an Alzheimer’s conference yielded promising data and J&J kicked off Q2 earnings season with a sound beat.
CSL’s AEGIS-II trial and cell and gene therapy expansion highlight the significant global expansion within the company over the past five years.
FDA
The FDA’s CBER approved nine novel therapies in the first half of 2023, with several more high-profile decisions on deck for the second half of the year.
FDA
After being rejected by an FDA advisory panel four years ago, Vanflyta is now approved across three phases of treatment for acute myeloid leukemia patients with the FLT3 gene mutation.