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For three decades, BioCentury has helped biopharma executives and investors make business-critical decisions and build larger networks with peers across the innovation ecosystem.
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Four takeouts with upfront payments north of $1 billion to close out May mark the latest run of VC exits from biotech M&A and help expand the pipelines of large biopharmas in renal, ophthalmic and immunologic indications. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how two of the takeouts -- Asahi Kasei’s buy of Calliditas and Biogen’s acquisition of HI-Bio -- showcase how the renal field is on the rise. Turning to Washington, the editors explain why the House Select Committee on the Chinese Communist Party is expanding its remit to Chinese therapeutic developers and commercial competitiveness — with an initial focus on Legend and GenScript. And, finally, they assess data from ASCO that demonstrate how immunotherapies are making progress in “cold” colorectal cancers. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652597
00:01 - Sponsor Message: Nxera Pharma
1:35 - Biotech M&A
11:40 - Biosecure Act
23:00 - ASCO
A theme among late-breaker presentations at this year’s American Society of Clinical Oncology meeting is the push by companies to move targeted therapies into earlier lines of treatment. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what they’re watching for in ASCO’s headline presentations and deliver highlights from abstracts released late last week as the oncology meeting readies to kick off on Friday. The editors also discuss the interest by FDA’s Janet Woodcock in a new approval pathway for ultrarare therapies, the Foundation for the National Institutes of Health’s initiative to support development of therapies and diagnostics for ALS, and Biogen's $1B+ acquisition of HI-Bio. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652531
0:01 - Sponsor Message: Nxera Pharma
1:43 - ASCO
6:46 - Ultrarare Diseases
14:52 - FNIH's ALS Push
20:27 - Biogen M&A
New BIO CEO John Crowley is reorganizing BIO in a bid to reshape how the organization communicates and enhance its focus on patients. BioCentury’s editors also recap the 24th annual Bio€quity Europe conference that was held in San Sebastián, Spain last week, as well as highlights from last week’s American Society of Gene and Cell Therapy conference. The editors also discuss impressive early data from Endeavor BioMedicines in idiopathic pulmonary fibrosis and Phase Ib obesity data from Roche. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652453
0:01 - Sponsor Message: Nxera Pharma
1:08 - BioEquity Europe recap
7:08 - Shake up at BIO
13:37 - ASGCT highlights
20:39 - Endeavor IPF data
22:20 - Roche obesity data
“I’m a short-term pessimist and a long-term optimist” about the potential for AI to transform drug development, Derek Lowe, author of the In the Pipeline blog, told BioCentury Washington Editor Steve Usdin on the latest BioCentury Show. Lowe's skepticism about claims that AI will rapidly transform the field is driven by a belief that the “problems that we have in the drug industry that we want to solve are almost inversely proportional to the ability of AI to solve them." Lowe also discussed the Biosecure Act and U.S. reliance on Chinese contract manufacturing and development organizations; talked about why he hopes and believes the Supreme Court will rule for FDA in litigation over the abortion drug mifepristone; and explained his view that approval of Aduhelm to treat Alzheimer’s disease was one of FDA’s worst decisions.
The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/652427
00:00 - The BioCentury Show Podcast
01:51 - Lowe’s Blog
05:30 - Biosecure Act
09:53 - AI & Drug Discovery
17:33 - FDA, The Abortion Drug, & Aduhelm
22:05 - Lessons from COVID
Lawmakers’ changes to the Biosecure Act create breathing room for U.S. biopharma companies to move on from Chinese CDMOs, Washington Editor Steve Usdin said. On the latest BioCentury This Week podcast, Usdin and his BioCentury colleagues discuss what the revisions mean for biotechs and what’s next for the legislation, plus how WuXi AppTec is defending itself against the bill’s allegations. Director of Biopharma Intelligence Paul Bonanos discusses last week’s surge in venture activity, including the largest biotech round, a $200 million series C by Lonnie Moulder’s Zenas BioPharma, as well as recent deals of note, including one for Maze Therapeutics. The biotech found a new partner for its Pompe disease program in Shionogi, months after Sanofi pulled out of a deal for the therapy amid FTC scrutiny. This week’s podcast is sponsored by Nxera Pharma.
View full story: https://www.biocentury.com/article/652402
00:01 - Sponsor Message: Nxera Pharma
03:24 - Biosecure Revisions
09:34 - WuXi AppTec Responds
14:42 - Venture Raises
19:32 - Deals of Note
It sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in companies. “We have absolute certainty that ESG is important."
The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/652294
00:00 - The BioCentury Show Podcast
02:12 - Spain’s Biotech Ecosystem
10:06 - Investment Criteria
15:03 - ESG, Diversity
28:29 - AI in Drug Development
Next week's Bio€quity Europe conference in San Sebastián will focus on how European biotechs can rise above the noise to attract investors, partners and talent. McKinsey & Co.’s Alexandra Zemp and Paula Olazábal of Ysios Capital joined BioCentury to outline the opportunities and challenges faced by Spain’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. EBD Group's Claire Macht also joined to detail what to expect in terms of attendees and one-on-one partnering meetings at the event. Bio€quity Europe 2024 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information.
View full story: https://www.biocentury.com/article/652371
00:00 - Intro
03:27 - Spanish Biotech Ecosystem
08:13 - McKinsey's Insights
12:08 - Event Preview
17:26 - BioЄquity Europe C-Level Attendees
One of the big themes of this week’s ASGCT meeting will be CAR T cells in cancer and beyond. On the latest BioCentury This Week podcast, BioCentury’s editors preview the American Society of Gene and Cell Therapy’s annual meeting. Much of the CAR T field has reoriented from cancer to autoimmune diseases over the past year. Now, researchers are looking even farther afield. According to abstracts released ahead of ASGCT, the engineered T cell modality may have new benefits to offer patients with asthma, Duchenne muscular dystrophy or HIV.
The editors also discuss a study aiming to quantify the benefits accelerated approval has had for cancer patients, and what’s next for the Biosecure Act and similar legislation seeking to rein in Chinese CDMOs and genomics companies. This week’s podcast is sponsored by Nxera Pharma.
Don’t miss BioCentury’s new podcast, The BioCentury Show, featuring BioCentury one-on-one with an industry KOL. It’s available wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.
View full story: https://www.biocentury.com/article/652335
00:01 - Sponsor Message: Nxera Pharma
01:43 - ASGCT Preview
10:37 - BioCentury Show Podcast
14:21 - Accelerated Approval
19:48 - Biosecure: What’s Next
Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan’s Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury’s Joshua Berlin joins the podcast to preview BioCentury’s upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/652273
0:01 - Sponsor Message: Jeito Capital
1:55 - Energizing Gene Therapy
6:28 - Pfizer Hemophilia Approval
11:36 - Bio€quity Europe Preview
18:03 - Arch & Foresite's AI Biotech Build
19:32 - Ono's Deciphera Takeout
A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes in the Editor’s Commentary.
BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play Metsera Inc. For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. This week’s podcast is sponsored by Jeito Capital.
View full story: https://www.biocentury.com/article/652185
0:01 - Sponsor Message: Jeito Capital
1:54 - Defending Accelerated Approval
8:44 - Endpoint Innovation
12:55 - Challenges for U.K.'s AIM
18:16 - Obesity Launch: Metsera
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