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Two important oncology drugs for AstraZeneca have returned with trial wins in early-stage non-small cell lung cancer (NSCLC). | AstraZeneca reported two trial wins in early-stage non-small cell lung cancer. For the immunotherapy Imfinzi, the detailed data will feed into an increasingly fierce market showdown. → Read More
Already approved in breast, stomach and lung cancers, AstraZeneca and Daiichi Sankyo’s Enhertu has delivered a trial win across many other tumor types that express the HER2 protein biomarker. | Already approved in breast, stomach and lung cancers, AstraZeneca and Daiichi Sankyo’s Enhertu has delivered a trial win across many other tumor types that express the HER2 protein biomarker. → Read More
After several market withdrawals, the FDA’s scrutiny around the PARP inhibitor class of cancer drugs doesn't seem to be abating. | After several market withdrawals, the FDA’s scrutiny around the PARP inhibitor class of cancer drugs doesn't seem to be abating. The agency will gather an advisory committee to review AstraZeneca and Merck & Co.’s application for Lynparza in prostate cancer. → Read More
Under a new analysis, ICER says Eisai should take 19% to 66% off Leqembi’s current list price of $26,500. → Read More
Thanks to cancer drugs Brukinsa and tislelizumab, BeiGene nearly doubled its global sales in 2022. But the most important launches for the meds either have just begun or are yet to come. | Thanks to cancer drugs Brukinsa and tislelizumab, BeiGene nearly doubled its sales in 2022. But the most important launches for the meds have either just begun or are yet to come. → Read More
Contract biopharma manufacturer Catalent has reportedly drawn buyout interest as COVID-related declines weigh on its outlook and stock performance. → Read More
Even as Roche’s pharma group prepares for further biosimilar erosion, a decline in COVID-19 product revenues and key readouts, it’s welcoming a new leader. | Roche has found its new pharma CEO from within. She’ll lead a group that’s preparing for further biosimilar erosion, plus a decline from COVID-19 products and key clinical readouts. → Read More
It’s unusual to have the FDA chase down a pharma company and ask them apply for a new drug indication. | In an unusual move, the FDA requested an expanded approval of breast cancer drug Ibrance from Pfizer. And the New York pharma won the go-ahead without additional clinical efficacy data. → Read More
CAR-T therapies have shown impressive results in acute lymphoblastic leukemia. | Bristol Myers Squibb aims to make Breyanzi the first CAR-T therapy for chronic lymphocytic leukemia. But without specifics, it remains unclear whether Breyanzi will bring meaningful advancement in this indication. → Read More
The push for a business separation at Bayer just got more personal. | The push for a business separation at Bayer just got more personal. Joining the chorus calling for a more focused Bayer, Union Investment portfolio manager Markus Manns criticized Bayer Chairman Norbert Winkeljohann. → Read More
Armed with a new FDA approval in chronic lymphocytic leukemia (CLL), BeiGene is readying an all-out assault against AbbVie and Johnson & Johnson’s entrenched Imbruvica. | Armed with a new FDA approval in chronic lymphocytic leukemia, BeiGene is readying an all-out assault against AbbVie and Johnson & Johnson's entrenched Imbruvica. → Read More
By BMS’ estimates, about 50% of its revenue in 2030 will come from acquisitions, including its Celgene takeover. → Read More
Thanks to the FDA’s expedited reviews, an RSV prevention market battle between several pharma giants may kick off in 2023. | Thanks to the FDA’s expedited reviews, an RSV prevention market battle between several pharma giants may kick off in 2023. → Read More
Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements. | Novartis has decided to end a classic generic pay-for-delay legal battle with a series of settlements. The lawsuit centered on an agreement Novartis and Endo's Par signed in 2011 that allegedly pushed back the launch of a copycat to Novartis' Exforge. → Read More
Despite five years of collective experience making and selling engineered human cell products, CAR-T companies are still having trouble ensuring smooth and timely access. For this report, Fierce Pharma talked to cell therapy leaders at three top cancer centers to understand how recent CAR-T launches are progressing in the real world. → Read More
As Big Pharma companies face growing competitive pressures for their existing businesses, they’ve been increasingly drawn to rare disease M&A. | Rare disease drug maker Horizon Therapeutics said it has drawn buyout interest from pharma juggernauts Amgen, Johnson & Johnson and Sanofi, all of which arguably have good reasons to make an M&A move. → Read More
BeiGene has shared detailed results from a Brukinsa head-to-head trial, and it’s bad news for rival Imbruvica from AbbVie and Johnson & Johnson. The latest update makes Brukinsa the first BTK inhibitor to top Imbruvica on a hard efficacy endpoint. → Read More
A top candidate to succeed Biogen CEO Michel Vounatsos is reportedly out of the running. | The talks over whether Johnson & Johnson veteran Mathai Mammen would become Biogen's next CEO have reportedly fallen through. The R&D exec demanded influence over Biogen's board, a proposal that was met with cold shoulder by current Chairman Stelios Papadopoulos, Stat reports. → Read More
Tens of millions of doses of Bharat Biotech's Covaxin could expire in early 2023 because of low demand. | Tens of millions of doses of Bharat Biotech's Covaxin could expire in early 2023 because of low demand. BioNTech's third-quarter revenues fell 43% year over year. Plus more. → Read More
The FDA has granted an accelerated approval for Tecvayli, or teclistamab, for relapsed or refractory multiple myeloma. → Read More