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Congress, the Federal Trade Commission and the U.S. Patent and Trademark Office are all targeting Big Pharma’s practice of filing multiple, overlapping patents that stifle generic and biosimilar competition.
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The record-setting government shutdown was just the latest blow to the U.S. biopharma industry. When science funding becomes a casualty of political gridlock, we lose valuable talent, erode public trust and jeopardize our position as a global leader in innovation.
At one point in merger negotiations with Novartis, Avidity CEO Sarah Boyce and her team walked, cutting off access to a data room and moving on to a capital raise.
Previous mega blockbusters took years to reach their peak sales. Lilly’s tirzepatide franchise is on course to exceed them just a few years in.
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AbbVie announced it has submitted a marketing authorization application to the European Medicines Agency for atogepant for the prophylaxis of migraine in adult patients who have at least four migraine days per month.
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Read our takes on the biggest stories happening in the industry.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
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A federal judge in New Jersey has agreed to hear legal challenges from BMS, J&J, Novartis and Novo Nordisk to the Inflation Reduction Act’s Drug Price Negotiation Program during the same March 7 hearing.
This week Lori, Greg and Tyler discuss the Accelerated Approval of Amtagvi, the first one-time cell therapy for solid tumors and the first TIL therapy; the FTC and HHS probe into generic drug shortages and some recent ADC-focused raises from ProfoundBio and Firefly Bio.
Mergers and acquisitions are trending upward as Novo Nordisk, Gilead, and Johnson & Johnson kick off the year with big deals. AI and other scientific advances will likely be the focus of M&As yet to come.
The regulator has placed a clinical hold on RAPT Therapeutics’ drug zelnecirnon, which was being investigated in atopic dermatitis and asthma, after a patient experienced liver failure.
Two surprise companies, Vertex Pharmaceuticals and Regeneron Pharmaceuticals, made GlobalData’s list with 41.4% and 21.8% market capitalization growth, respectively.
While AstraZeneca discontinued its Phase IIb trial for tozorakimab, the pharma’s zibotentan—if approved—could be “an optimal treatment of choice” for patients with diabetic kidney disease, finds a new report from GlobalData.
The European Commission granted marketing authorization in the EU to treat patients 16 years of age and older with moderately to severely active ulcerative colitis.
With the investment in the plant, Daiichi Sankyo is looking to create new laboratories for its antibody-drug conjugates used to develop and manufacture therapies for breast, lung and stomach cancers.
In a late-stage study, Tagrisso induced a “statistically significant and highly clinically meaningful improvement” in progression-free survival in patients with unresectable stage III, EGFR-mutated non-small cell lung cancer.
A week after Britain’s debut of the four-week Kwikpen, a European Medicines Agency panel is slated to review Eli Lilly’s multi-dose, pre-filled pen injector for diabetes drug Mounjaro.