| Today's Big NewsNov 17, 2022 |
| By Nick Paul Taylor Pfizer and BioNTech have opened another front in their push to develop a better COVID-19 vaccine. After moving a shot with an enhanced spike protein design into the clinic, the partners have now set out to turn another arm of the immune system against the virus by trialing a T-cell enhancing vaccine prospect. |
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By Angus Liu The FDA is dealing one more blow to Clovis Oncology. Just as the PARP player warns of a possible imminent bankruptcy, the U.S. regulator is looking to narrow Rubraca's use with a market restriction request. |
By Paige Minemyer This includes bringing its senior-centric care model to new states including Indiana, Virginia and Mississippi and continuing to expand in markets where it currently operates clinics. |
By Andrea Park Just a few weeks after beginning a voluntary recall of the remote-control devices used with some of its insulin pumps—and warning that the safety action would take a multimillion-dollar hit to its bottom line—Insulet has received an FDA ruling on the matter. |
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Tuesday, December 6, 2022 | 12pm ET/9am PT Biopharma customers are now demanding that the vendor industry work collaboratively to connect their scientific workflows. This webinar will provide valuable insights for biopharmaceutical scientists, lab directors, IT professionals, and life science vendors. Register now. 
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By Gabrielle Masson GSK is doubling down on a retreat from the land of T-cell receptors, terminating a partnership with Immatics that held the potential for up to $600 million in biobucks. |
By Kevin Dunleavy Takeda reported a phase 3 trial of blood cancer drug Iclusig plus reduced-intensity chemotherapy performed better than Novartis’ Gleevec chemotherapy in patients with newly-diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL). |
By Max Bayer Editas is struggling to keep pace with its counterparts in the gene-editing field, announcing its lead asset would be shelved while it searches for a partner. Updated data from the company's phase 1/2 trial for EDIT-101 found that it was most effective in a very small population with little market upside. |
By Conor Hale The FDA cleared an AI program to screen for the early signs of diabetic retinopathy, a major cause of blindness among people with Type 1 or Type 2 diabetes. |
By Robert King A new survey shows a majority of adults in a family with Medicaid enrollees could lose eligibility when states start coverage redeterminations. |
By Joseph Keenan GSK continues to grow its manufacturing footprint in Singapore with the opening of a new $33 million (S$44 million) plant that will be focused on producing key ingredients used for cancer treatments. |
By Andrea Park The thin plastic tubing of infusion sets that connect insulin pumps to the body typically need to be changed every two or three days—but a new version in the U.S. more than doubles that timespan. |
By Nick Paul Taylor Astellas Pharma’s $1.3 billion oncology bet has delivered a phase 3 win. The clinical trial linked the anti-CLDN18.2 antibody zolbetuximab to improved progression-free survival, moving Astellas a step closer to filing for approval. |
By Dave Muoio Alongside the release of its twice-annual hospital grades, the patient safety watchdog celebrated its 10th anniversary with a look through its historical data. |
Fierce podcasts Don't miss an episode |
| This week on “The Top Line,” we share some highlights from Fierce Biotech's Cell and Gene Therapy Forum in case you missed it. |
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Tuesday, November 29, 2022 | 2pm ET / 11am PT Process development of RNA-LNPs can be time consuming, cost prohibitive and require deep expertise in a field that is very dynamic and accelerating fast. Outsourcing gives you direct access to infrastructure, experience, and a team who has done this before and can quickly generate meaningful data taking the guesswork out of process development. Register now. 
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