| Companies large and small dread an FDA warning letter. But along with the immediate actions required to re-enter compliance—plus a public airing of manufacturing faults—the letters can also serve as a learning opportunity for the industry. And while it’s not meaningful to simply rank the worst offenders, we can list the ones we feel are the most significant due to their impact. Meanwhile, the coronavirus continues its spread, leading to travel restrictions at several Big Pharmas and canceled conferences, but also hope in repurposed drugs. Read on below for our top stories of the week. | |
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Featured Story | | | Wednesday, March 4, 2020 Some patients infected with the novel coronavirus can develop uncontrolled immune response, leading to potentially life-threatening damage to lung tissue. After seeing promising results in clinical practice, Chinese authorities now recommend Roche's blockbuster arthritis drug Actemra to tackle that rampage. |
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Top Stories Of The Week Monday, March 2, 2020 The takeover will give Gilead control of midphase anti-CD47 antibody magrolimab that delivered data that impressed investors late last year. Warning letters issued by the FDA in 2019 ran the gamut from small companies to large and OTC drugs to finished pharmaceuticals, but some were significant for a variety of reasons. We present those here. Friday, February 28, 2020 As COVID-19 continues to spread globally, fears of its impact on employee health have led several pharma majors to either outright prohibit travel to and from China—including one that just added Korea and Italy to the restriction list—or advise their employees to reschedule business meetings in affected areas. Tuesday, March 3, 2020 A special issue of the Journal of the American Medical Association spotlights three studies questioning whether pharma companies are hiking drug prices to boost their own profitability at the expense of patients. But Merck CEO Kenneth Frazier has some bones to pick with how the research was conducted, and he's worried it will exacerbate the ongoing political debate about drug pricing. Friday, February 28, 2020 A year ago, Sangamo’s shares sank after it posted lackluster data for its genome-editing therapy; 12 months down the line, and it’s a complete reversal for the biotech as Biogen lays down a major upfront and biobucks pact for several of its CNS meds. Wednesday, March 4, 2020 The forecast cost of AstraZeneca’s new headquarters in Cambridge, U.K., has ballooned to $1.3 billion (£1 billion), more than three times the original target. AstraZeneca blamed the overspend on the complexity of the build, construction cost inflation and other factors. Tuesday, March 3, 2020 While eyes have been on China for signs that COVID-19 might result in drug shortages, India has come up with a surprise of its own. The country, which accounts for about 40% of U.S. generic drugs, has halted exports of more than two dozen APIs and drugs. Tuesday, March 3, 2020 After months of a public back-and-forth over a potential acquisition, Thermo Fisher Scientific President and CEO Marc Casper said he and Qiagen’s leadership finally had a “meeting of the minds” on how to move forward—and $11.5 billlion later, they’ve set a target date for the first half of 2021. Wednesday, March 4, 2020 Scientists at City of Hope have designed a novel chimeric antigen receptor (CAR) based on chlorotoxin (CLTX), a toxin found in scorpion venom. The novel CAR-T cell therapy successfully killed glioblastoma tumors with minimal off-target events and will now be ushered into clinical testing. Monday, March 2, 2020 To launch its new rheumatoid arthritis pill Rinvoq into an already crowded therapy area, AbbVie is leading with a DTC campaign meant to empower patients to “take on” the disease. A newly debuted TV ad from the campaign shows active patients with a voice-over advising them to “make it your mission” to fight the debilitating disease. Enrollment Showcase | | | Presented by: Global EMBA for Healthcare & the Life Sciences, University of Toronto Prepare to step up in your career, build the expertise you need to reshape your organization, and explore opportunities worldwide. |
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