BioCentury This Week

A pair of high profile clinical setbacks has wiped out more than $40 billion in market cap for Novartis, most of which stemmed from the Phase III miss of antisense oligonucleotide therapy pelacarsen. On the latest BioCentury This Week podcast, BioCentury's analysts unpack the fallout for Lp(a) as a cardio target and whether issues with the target, modality or treatment setting contributed to the therapy's lack of efficacy. The analysts also review BioCentury's annual big pharma deals analysis...

Mid-sized biopharma companies are under growing pressure to accept most-favored nation drug pricing deals with the White House. On the latest BioCentury This Week podcast, BioCentury's analysts assess the trade-offs companies face, the litigation risks around mandatory Medicare MFN pricing demonstrations, and what happens to companies that don't sign on. The analysts also discuss Eli Lilly's acquisition of Merida, its thirteenth takeout of the year, Heidi Overton's nomination as FDA commissio...

China has changed the global narrative on delivering early human clinical data, with a new bar for speed and efficiency. And now drug developers and policymakers around the world have gotten the message and know that this is no time for complacency. On a special edition of the BioCentury This Week podcast, BioCentury's analysts discuss why transformational reform for early clinical development will require rethinking the risk-control paradigm for first-in-human trials. It’s the subject of the...

A Phase III win for a melanoma vaccine from Moderna and Merck & Co. has opened the door to personalized neoantigen vaccines. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the vaccine’s prospects and the broader implications. The analysts also discuss Roche/Genentech’s deal with Hanmi, which will add to the MNC’s obesity pipeline an asset that the pharma believes could be first in class, and the White House's pick of a Trump loyalist to lead FDA – a move that ha...

A baker’s dozen of biotechs shrugged off the summer haze to raise nearly $800 million in venture cash. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the financings, which included money for a potential challenger to Amgen’s blockbuster Tepezza and a new venture from immunology professor Georg Schett with backing from Deerfield Management, Boulevard Bio. The analysts also discuss new approaches to drug cancer’s “undruggable” β-catenin pathway, and whether Capricor’s...

Pressure is on FDA, policymakers and academic centers in the U.S. to respond to challenges from China, Australia, and beyond to run first in human trials faster and more efficiently. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how stakeholders in the U.S. are responding to the challenge. The analysts also discuss the next frontiers of federated learning in drug discovery and the latest crop of biotech IPOs on NASDAQ, which raised over $1.2B in strong IPO run last...

Rumors flew this weekend about a mega-merger of AstraZeneca and Bristol Myers — but would such a deal make sense? On the latest BioCentury This Week podcast, BioCentury’s analysts explain why they aren’t buying it. The team also discusses what lessons can be learned from the regulatory roller-coaster ride of Replimune’s RP1 vusolimogene oderparepvec and psychedelic therapies’ inflection point in treating depression. View full story: https://www.biocentury.com/article/660376 #BiotechMA #FDA ...

Argenx the tier-jumping European biotech, believes its proposed $2.2 billion purchase of Forte Biosciences will add a second multi-indication product upon which it can run the strategy that has made autoimmune drug Vyvgart efgartigimod alfa a blockbuster. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the deal and put it in the context of a new cohort of large-cap companies increasingly active in biotech M&A. The analysts also assess how recent releases from Ant...

The departure of U.K. Science Minister Patrick Vallance is a blow for U.K. biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what Vallance’s exit, the appointment of John Healey as Chancellor of the Exchequer and other changes arriving with the new Prime Minister could mean for life sciences in the country. BioCentury’s analysts also discuss an ambitious U.K. data initiative launched this month. The Health Data Research Service is intended to be a single front...

After nearly three years of sluggish job growth, hiring is turning a corner in the U.S. life sciences industry, while the talent pool is expanding beyond the sector’s traditional hubs. On a special episode of the BioCentury This Week podcast, Ian Anderson, senior director, head of U.S. life sciences & healthcare research at CBRE, joins BioCentury’s analysts to discuss the company’s recent report on life sciences talent trends, and how those trends are driving property demand. This episode...

M&A enthusiasm is carrying biotech amid tepid reception for launches. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss BioCentury’s 3Q26 Public Markets Preview, asking whether M&A momentum can carry biotech through year-end and what happens if the AI trade goes bust? Editor in Chief Simone Fishburn gives her perspective on what incoming Prime Minister Andy Burnham’s agenda means for U.K. life sciences. The analysts also discuss Ionis’ ATTR-CM miss and Takeda’s...

Novartis is deepening its antibody-drug conjugate capabilities with its $1.1 billion acquisition of U.K. biotech Myricx Pharma. On the latest episode of the BioCentury This Week podcast, BioCentury’s analysts discuss how the deal fits with the Swiss pharma’s cancer toolkit. The analysts then discuss MHRA CEO Lawrence Tallon’s Guest Commentary in BioCentury on making regulation a catalyst for U.K. life sciences and why the primary defeat of Rep. Diana DeGette (D-Colo.) is a setback for FDA ref...

New Parkinson’s disease programs aim to move beyond the historical norm of symptom management, branching into targeted therapeutics and cell therapies. On the latest BioCentury This Week podcast, BioCentury’s analysts review the most promising targets and trends shaping the Parkinson’s treatment landscape. The team then turns to AstraZeneca’s build-out of its obesity portfolio, followed by FDA’s Operation TrialBlazer and what the reforms mean for reducing the time to launch a clinical trial i...

AbbVie's $10.9 billion deal to acquire Apogee will expand its immunology pipeline by delivering assets for atopic dermatitis and asthma. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the takeout and the assets AbbVie gains. The analysts then discuss moves by FDA to reverse controversial setbacks that occurred under the agency’s former leadership and assess Acting CDER Director Michael Davis’ memo outlining how his predecessor repeatedly overruled career staff to qu...

Biotech IPOs that are getting out remain hot — but will that continue into the fall? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for fresh biotech paper on NASDAQ, including the $770 million debut by Parabilis, the largest IPO in the sector’s history. The analysts also discuss the Biosecure Act and U.S. policy toward China; the cachexia pipeline; and BioCentury’s updated Innovation Distillery. View full story: https://www.biocentury.com/article/...

Getting into the clinic fast to de-risk assets has become the name of the game in biotech, and at the academia-industry interface, too. From AI to NAMs to starting a Phase I trial in the U.S., BioCentury’s 3rd Grand Rounds-U.S. conference brought together academic innovators, biopharma leaders and early-stage investors to debate key bottlenecks in translation and how to make early-stage R&D investible. Sam Blackman, entrepreneur in residence at GV and co-founder of Day One Biopharmaceutic...

FDA’s new leadership is sailing the agency into calmer waters amid a search for a permanent commissioner and permanent center directors. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses how FDA’s new, interim leaders have changed the tone at the agency and why they are putting medicines derailed under former FDA Commissioner Marty Makary back on track. Usdin also highlights FDA’s new real-time clinical trials initiative. BioCentury’s analysts then...

Revolution Medicines continues to impress with more pancreatic cancer data, earning a standing ovation at ASCO over the weekend. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the detailed data for the company’s daraxonrasib, Akeso’s Harmoni-6 readout, as well as other results from the meeting. BioCentury’s analysts then argue that U.S. biotech executives and policymakers should embrace the challenges and opportunities that come with the rise of innovation in China ...

At ASCO among presentations focused on pancreatic cancer innovation beyond KRAS; however, abstracts for the cancer conference also highlight ADCs, bispecifics and diagnostics that are broadening the field’s approach to the cancer. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Revolution’s daraxonrasib, other readouts to watch for in pancreatic cancer and what else is on BioCentury’s radar at this year’s American Society of Clinical Oncology meeting. BioCentury’s a...

Marty Makary wasn’t the only official on the outs at FDA last week in another tumultuous turn of events for the regulatory agency. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses who’s in, who’s out and what’s next at FDA — and why the changes may mean more conservative decision-making at the agency in the near term. BioCentury’s analysts also discuss the new obesity targets that came to light at last week’s annual meeting of the European Congres...

China’s speed in generating first-in-human data has catalyzed a race across the globe to reshape regulatory requirements to compete. BioCentury’s analysts, along with special guests Detlev Mennerich, head of Boehringer Ingelheim Venture Fund, and Mehdi Ainouche, partner at Jeito Capital, discussed where Europe fits in that landscape and other takeaways from the 26th annual Bio€quity Europe conference in Prague. This special episode of BioCentury This Week has been brought to you by Jeito Capi...

Marty Makary’s hold on the top job at FDA is slipping, with White House leaks about President Donald Trump’s displeasure with the FDA commissioner shifting the question from whether he will be fired to when. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin discusses the pressures on Makary, how long he will hold onto his post, and the leading candidates to succeed him. BioCentury’s analysts then discuss solutions to AAV’s redosing problem, which could reignite industr...

UCB is the latest biopharma player to consummate a multibillion-dollar deal amid a surge in biotech M&A activity, acquiring Ken Song’s Candid Therapeutics, one of the leading T cell engager companies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $2 billion takeout and the opportunity in the TCE space. They also assess the drug development landscape for leukodystrophies and the market for biotech IPOs on NASDAQ, where a trio of biotechs exceeded expectation...

More than 175 new oncology targets surfaced at this year’s American Association for Cancer Research annual meeting in San Diego, with the focus on new ways to enhance the immune response against solid tumors and to make existing immunotherapies more effective. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the new targets identified among the thousands of abstracts at AACR, as well as emerging pan-RAS inhibiting antibody-drug conjugates. The analysts also discuss Eli...

Bispecific antibodies and dual-payload antibody-drug conjugates were in the spotlight at this year’s American Association for Cancer Research meeting in San Diego as biotechs unveiled their latest preclinical and first-in-human oncology data. On a special edition of the BioCentury This Week podcast, IQVIA Biotech CMO James Kyle Bryan joins BioCentury’s analysts to discuss what AACR revealed about modalities gaining traction, plus shares his perspective on de-risking clinical development and e...

The past week has delivered the largest M&A deal ever for a private, venture-backed biopharma, the second-largest follow-on ever for a NASDAQ-traded biotech and what could soon become the largest biotech IPO ever on NASDAQ. On the latest BioCentury This Week, BioCentury’s analysts discuss Eli Lilly's $3.25 billion takeout of in vivo CAR T company Kelonia, the market debut by obesity play Kailera and an upsized follow-on by Revolution on the back of its pancreatic cancer data. The analysts...

A pathway proposed by FDA to cut the time it takes biopharma companies to get to first-in-human trials is more ambitious than similar policies in Australia, China and the U.K. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the proposal, as well as a concession for the biopharma industry on first-in-human studies in PDUFA reauthorization negotiations with FDA. The analysts also discuss the latest pair of billion-dollar biotech deals: Gilead's $3.2 billion takeout of a...

Biotech has been resilient as the financial markets teeter under global volatility. For now, M&A and financings, if not IPOs, are continuing, but will the Mideast conflict halt biotech’s recovery? On the latest BioCentury This Week podcast, BioCentury’s Stephen Hansen breaks down the near-term and long-term outlook for a biotech industry hoping to continue the growth of 2H25. BioCentury’s analysts also discuss the impact of the Trump administration’s tariffs on the biopharma industry and ...

Biotech innovators around the world are finding speed to be the driver for investment and partnering — speed to early human data and speed to de-risk assets. The new momentum from Asia, in particular China, has added a fresh challenge for European biotech on top of falling equity and R&D investment in Europe and a complex drug pricing landscape. On a special edition of the BioCentury This Week podcast on the eve of the 26th Bio€quity Europe conference, EQT Life Sciences' Christoph Broja a...

A flurry of deals, several with sizable upfront payments, has energized the biotech sector in March. On the latest BioCentury This Week podcast, BioCentury’s Paul Bonanos assesses last week’s deals by Merck, which is laying out $6.7 billion to acquire Terns, and Gilead, which is buying Ouro for about $1.7 billion up front. Gilead’s deal comes as the Foster City, Calif.-based biotech is looking to defend its position in HIV while resetting in inflammation and immunology and growing its oncolog...

After 20 years of platform building and resets, Arrowhead Pharmaceuticals is making a bid to become a large-cap biotech. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the company has built a pipeline and set of enabling technologies that could enable a steep period of value creation based on RNAi. The team then analyzes the $2 billion deal between Synnovation and Novartis for a pan-mutant-selective PI3Kα inhibitor. The analysts also assess where AI is integrati...

Biotechs have been pricing follow-ons at a steady pace, with some companies parlaying data into upsized deals, and others even beginning to debut on NASDAQ — but will geopolitical tensions and war in the Middle East scuttle the forward momentum? On the latest BioCentury This Week podcast, BioCentury’s analysts take the temperature of the markets for biotech." They also discuss last week’s late-stage epilepsy data from Xenon Pharmaceuticals, which revived the biotech’s stock and the Kv7 target...

Biotechs in South Korea and other regions of Asia outside of China need to lean into innovation to distinguish themselves from their Chinese counterparts. On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by industry guests Ya-Ting Lei and Luther (Ruizhe) Zhao to discuss why the best path for biotechs in Korea and Japan is to lean into target, biology and modality risk, as well as other takeaways from the fifth BioCentury-BayHelix Biopharma Summit, whi...

The second ousting of Vinay Prasad from FDA in the past eight months won’t lead to major changes at the agency, other than selecting a successor tasked with keeping FDA out of the news ahead of the coming midterm elections. On the latest BioCentury This Week podcast, Washington editor Steve Usdin lays out why the former CBER director was pushed out at FDA and what’s next for the agency following his departure. BioCentury’s editors also discuss the next wave of therapies for idiopathic pulmona...

Can a strong U.S. biopharma industry be reconciled with the successful emergence of China? And can China be a catalyst of positive change across the global industry, even if this implies some level of rebalancing away from the U.S.? On the latest BioCentury This Week podcast, BioCentury’s analysts discuss a Guest Commentary by McKinsey Senior Partner Emeritus Franck Le Deu, who argues that a multipolar biopharma world in which the U.S. continues to thrive even as China becomes meaningfully st...

Gilead is acquiring Arcellx for $7.8 billion up front three years after forging a partnership with the biotech around a cell therapy for multiple myeloma. On the latest BioCentury This Week podcast, BioCentury’s analysts assess what the deal does for the Foster City, Calif.-based biotech’s pipeline. The analysts also discuss the case for using ctDNA as a surrogate endpoint for early cancer trials. Turning to Washington, Steve Usdin offers his takeaways from last week’s PhRMA Forum, which foc...

As targeted protein degradation gains momentum, oral selective estrogen receptor degraders are emerging as one of its most advanced proving grounds. On the latest BioCentury This Week podcast, BioCentury’s Lauren Martz assesses how the oral SERD landscape is evolving. Washington Editor Steve Usdin then discusses setbacks at FDA for an orphan therapy from Disc Medicine and a vaccine from Moderna, and why he is calling on life sciences industry leaders to publicly demand the dismissal of Vinay ...

2025 marked the end of a four-year slide in series A financings for biotechs, with 144 biotechs raising an aggregate of $8 billion, up $1 billion from the prior two years. On the latest BioCentury This Week podcast, BioCentury’s Danielle Golovin assesses which companies VCs backed last year and what their investments say about where technology is headed. Washington Editor Steve Usdin offers a perspective on why compounded Wegovy is an assault on the biopharma industry and also explains how th...

RNAi and exon-skipping therapies headline the list of regulatory and pivotal data catalysts in 2026, while new lipid-lowering mechanisms, modalities, and precision medicines define cardiovascular disease catalysts this year. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the most important milestones of the year in new modalities, CV and renal diseases. The analysts also discuss a new regulation in China introducing orphan drug exclusivity that could incentivize dev...

New rules in China will accelerate the country’s cell and gene therapy sector by reshaping how investigator-initiated trials are conducted and commercialized. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the new framework and why it will create a powerful incentive for deploying new gene and cell therapies. Executive Editor Selina Koch discusses which milestones she is watching in neurology in the year ahead, from psychedelics to Alzheimer's disease. Finally, Seni...

The biotech bull is back, and buysiders believe this market has staying power for the first time in nearly five years. On a special episode of the BioCentury This Week podcast, Director of Biopharma Intelligence Stephen Hansen and colleagues discuss Hansen’s 2026 Public Markets Preview, which found interest rates, policy in Washington and fundamentals finally aligning and a wave of launches and M&A that could keep capital flowing into the sector. View full story: https://www.biocentury.c...

Next-generation induced proximity technologies are coming of age after a decade of industry focus on PROTACs. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Senior Biopharma Analyst Danielle Golovin’s four-part analysis of how next-generation targeting chimeras (TACs) are evolving. The analysts assess the $2.2 billion takeout of Rapt Therapeutics by GSK, which gave the pharma an allergy asset that the biotech sourced in China in 2024, and movement in Washington on p...

The J.P. Morgan Healthcare Conference kicked off this week with sunny skies over San Francisco and more financial momentum than the biotech industry has seen in years. On a special “on the road” edition of the BioCentury This Week podcast, recorded on the sidelines of the annual JPM conference, special guests joined BioCentury’s analysts to discuss the biotech ecosystems in Asia. The wide-ranging conversation spans dealmaking, including the pricing dynamics of assets in China and RNAi’s prosp...

Riding the tailwind of a strong 2H25, the days leading up to biotech’s annual kickoff meeting in San Francisco delivered billions in capital raised and more than two dozen deals announced. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss two of the largest deals announced at the start of the J.P. Morgan Healthcare Conference, a partnership for a bispecific between AbbVie and RemeGen and the launch of “NewCo” AirNexus Therapeutics by Haisco Pharmaceutical and a syndica...

The New Year begins with biotech running along parallel storylines. There’s cause for optimism as the industry’s financing gears have begun to churn again and innovation remains as strong as it has ever been, while there's cause for concern as the world’s most stable, progressive, science-based regulatory system has become unpredictable amid new leadership at HHS, FDA, and NIH. On the first episode of the BioCentury This Week podcast’s seventh year, BioCentury’s analysts assess the state of p...

This past year was an inflection point for biotech: The markets woke up, M&A and China had strong showings, drug development offered key trends, and new leadership at FDA shuffled the regulatory deck. On the latest BioCentury This Week podcast, BioCentury’s analysts make their picks for the biggest biopharma readouts, deals and regulatory and policy moves of 2025 and what they are forecasting for the year ahead. The analysts also recap biotech highlights of the past two weeks, including t...

Obesity readouts continue to be hot for biotech with new top-line data from both injectable and oral therapies pushing the boundaries on efficacy. On the latest BioCentury This Week podcast, BioCentury’s analysts break down last week’s readouts from Eli Lilly, Structure and Wave Life Sciences, and discuss a deal in the space by Pfizer. Lilly reported the latest for its triple agonist contender retatrutide for best-in-class weight loss, while strong Phase IIb data put Structure back in t...

Fueled by cancer, obesity and cardiovascular deals, $1 billion-plus takeouts in biotech are at their highest level in a decade with three weeks to go in the year. On the latest BioCentury This Week, BioCentury’s analysts discuss the rise in large M&A deals and what the trends among the 37 acquisitions say about biopharma dealmaking. The analysts assess first-in-human in vivo CAR T data at the American Society of Hematology meeting from Kelonia Therapeutics, which showcase the promise of t...

Novo Nordisk’s highly anticipated data for semaglutide in Alzheimer’s dashed hopes that the GLP-1 therapy could become a game changer in the disease. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses the Phase III readout including what it says about the mechanism’s use in the neurodegenerative disease, Novo’s decision to skip Phase II and enroll a large patient group in a later stage trial, and what other datasets for GLP-1s in the indication have shown. Wash...

A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other g...

There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury’s Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development. The group also dis...

Voyager CEO and former head of R&D at Biogen Al Sandrock is more optimistic than ever about the prospect of bringing clinically meaningful solutions to patients with Alzheimer’s disease and other neurodegenerative disorders. The threads of progress are finally coming together, he said in a special episode of the BioCentury This Week podcast. From the first disease-modifying therapies for Alzheimer’s disease, to a growing biomarker toolkit, to an expanding set of genetically validated targ...

Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs. BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy o...

Today’s South Korean biotechs have a risk-on mentality, a willingness to partner, and strategies focused on globalization. On a special edition of the BioCentury This Week podcast recorded at Venture Café Cambridge, BioCentury is joined by a quartet of investors and executives with deep knowledge of Korea’s life sciences ecosystem to discuss Korea biotech’s push to globalize and the opportunities in the country for Western companies. The four guests joining BioCentury were Aram Hong, CEO of K...

With ObesityWeek yielding eye-catching amylin data and a bidding war that ran to $10 billion for Metsera, weight loss companies were center stage in biotech last week. On the latest edition of the BioCentury This Week podcast, BioCentury’s analysts explained why Pfizer's victory for the start-up over European rival Novo Nordisk doesn’t necessarily mean a broader U.S. policy shift against foreign acquisitions of domestic biotechs. Turning to ObesityWeek readouts, they discuss Eli Lilly's data ...

Novo Nordisk’s unsolicited $8.5 billion bid for Metsera has thrown a wrench into Pfizer’s plans to return to the obesity race via its acquisition of the New York-based start-up. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the details of the competing bids and what’s at stake for the pair of suitors. The analysts also assess the reasons behind the abrupt departure of Center for Drug Evaluation and Research Director George Tidmarsh from FDA and a surge in activity ...

China is setting a new bar for the speed of clinical development and redefining the time it takes an asset to get to the clinic. On a special edition of the BioCentury This Week podcast recorded on stage at the 12th BioCentury BayHelix China Healthcare Summit in Shanghai, BioCentury's Simone Fishburn argued that China’s emerging new standard for swift entry to the clinic could upend the bottleneck of translational development and usher in a new paradigm that could have a “massive impact globa...

Novartis’ biggest deal in more than a decade gives the Swiss pharma three programs for muscular dystrophies that are close to the finish line. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $12 billion deal for Avidity in the context of Novartis’ recent acquisitions and the antibody-oligonucleotide conjugate platform it is gaining. The team dives into RNA versus DNA modalities, noting antisense and siRNA approaches appear to be gaining traction with major pharma...

Next-generation platforms and technologies are getting closer to cracking one of biopharma’s biggest problems: delivering medicines, and mAbs in particular, to the brain. On the latest BioCentury This Week podcast, BioCentury’s Selina Koch details the latest innovations in blood-brain-barrier shuttles and how the technologies could transform the treatment of neurological diseases. BioCentury’s Lauren Martz discusses her conversation with Tony Wood, CSO of GSK, which included the pharma’s stra...

It’s been a tough year for cell and gene therapy — patient deaths, high-profile companies pulling out of the space, and sour investment sentiment. But the field has had some promising readouts in the clinic recently, and it continues to mature, showing steady progress despite challenging market conditions. On the latest BioCentury This Week podcast, Evotec’s Bernd Mühlenweg joins BioCentury’s analysts to give his view of the field and offer takeaways from this month’s Cell & Gene Meeting ...

Biotech’s fourth quarter began with a familiar feeling, with indicators pointing toward an improving public market even as political and regulatory uncertainty has buysiders reluctant to say industry has returned to sustainable growth. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the state of biotech’s public markets. The analysts discuss the Senate’s move to limit access to Chinese CDMOs, the latest developments in the White House’s “most favored nation” drug pric...

The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent. On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what’s next in wrangling over drug pricing between industry and the Trump administration. The analysts also discuss PDUFA ...

Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms. The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under i...

AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset’s chance for success. On a special edition of the BioCentury This Week podcast, IQVIA’s Greg Lever joins BioCentury’s analysts to discuss agentic AI’s short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biot...

Is this the U.K.’s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury’s analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference. Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting’s m...

A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state o...

Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country’s life sciences policies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon’s plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of ...

Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the legacy of Baltimore, who passed away this past weekend at 87. The analysts also discuss Atlas Venture’s new $400 million opportunity fund, the clinical development...

Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease. The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule...

There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong. The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulat...

BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends. The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disea...

Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut. These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special editio...

Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market. They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-...

The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA. The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for...

A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery. Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition ...

This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers. On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innova...

Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and di...

Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, a...

There are many reasons why it may be the European biomedical ecosystem’s moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference. On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive direc...

Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics. Special Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’B...

Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells’ unique profile. The team also explores the biotech sector’s ongoing struggle to c...

The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury’s analysts assess who the winners and losers are likely to be as FDA changes shape. The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy,...

Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s ne...

The tragic death of a second non-ambulatory DMD patient treated with Sarepta's Elevidys gene therapy marks a turning point for the field and should drive all stakeholders to come together to figure out how to safely treat patients with this new modality. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the opportunity FDA, companies and patient advocates have to share data and identify a safe path forward for the gene therapy field, both in DMD and beyond. The analyst...

With federal funding at risk and VCs increasingly focused on de-risked assets, academia is facing unprecedented headwinds despite rapid advancements in innovation. One potential bright spot: Pharma, which is turning to academia to access first-in-class innovation. But many in pharma complain it is difficult to work with academia. On a special Grand Rounds edition of the BioCentury This Week podcast, BioCentury analysts and special guests discuss a new way of thinking and a new era of collabo...

Translational trends at this year’s ASCO meeting featured new and selective ways to target cell surface receptors on solid tumors. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the findings from Executive Director of Biopharma Intelligence Lauren Martz’s deep dive into first-in-human studies at the American Society of Clinical Oncology meeting, including how immunocytokines, solid tumor CAR Ts and Chinese innovation are thriving in early trials. The analysts also e...

Dealmaking by a pair of pharmas has given the biotech industry its best day of transactions in months, tallying nearly $13 billion in guaranteed payments across two deals. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the takeout of Blueprint Medicines for $9.1 billion up front gives Sanofi a drug for a rare immunological disorder and bolsters the French pharma’s already strong presence in immunology. The analysts also assess the $3.5 billion partnership betwe...

Dutch biotech Merus’ EGFR x LGR5 bispecific antibody has caught investors’ attention in the run-up to ASCO as a new approach to block EGFR signaling. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Phase II data from Merus for petosemtamab as they preview the American Society of Clinical Oncology’s upcoming annual meeting. The analysts also assess a setback in a gene therapy trial for Rocket Pharmaceuticals, renewed interest in cancer target EpCAM, and a flurry of bi...

Political and market turmoil has raised questions whether the U.S. can retain its biopharma leadership position, and in turn presents Europe with an opportunity to attract talent back to the continent with an offer of a more stable biomedical funding and regulatory environment. Jeito Capital’s Ksenija Pavletic and Cambridge Innovation Capital’s Anne Horgan join BioCentury’s analyst to wrap up the 25th annual Bio€quity Europe conference in Bruges, Belgium, by discussing their key takeaways fro...

The turbulence that has come with the Trump administration’s policies related to the U.S. biopharmaceutical industry is creating an opening for Europe to bolster its life sciences industry. On the latest BioCentury This Week podcast, BioCentury’s editors look at how Europe can capitalize on staffing cuts at FDA and NIH and an uncertain policy environment to lure back talent to bolster regulatory agencies and biotech R&D engines and attract assets and partners from China. The editors also ...

Biopharmas developing therapies for obesity are looking to a future where the quality of weight loss matters as much as the quantity — what targets and programs could help realize that vision? On the latest BioCentury This Week podcast, BioCentury’s editors discuss the signaling pathways that may exclusively target fat mass while preserving, or even increasing, lean mass — and which companies are playing in the space. The editors also assess what Vinay Prasad’s past comments say about how he ...

This year’s Bio€quity Europe conference — the 25th edition of the event — will focus on what’s next for Europe amid biotech’s current complex moment, Editor in Chief Simone Fishburn said on a special edition of the BioCentury This Week podcast previewing the meeting, which kicks off May 12 in Bruges, Belgium. McKinsey & Co.’s Alexandra Zemp and Henk Joos, an investment specialist at Medvia, which fosters health innovation in Flanders, joined BioCentury to discuss the state of Belgium’s bi...

Among the formerly undruggable targets gaining translational momentum, SMARCA2 has intrigued researchers for its potential to treat challenging solid tumors. On the latest BioCentury This Week podcast, BioCentury's editors zero in on preclinical research supporting different degraders of SMARCA2 at this year’s American Association for Cancer Research (AACR) annual meeting. They also discuss takeaways from Editor in Chief Simone Fishburn’s conversation with David Baker, the Nobel-prizewinning ...

Belief in tau — both as a target and surrogate endpoint — for Alzheimer’s is building among leaders in the field. On the latest BioCentury This Week podcast, Executive Editor Selina Koch discusses how tau could be reaching a tipping point. Also on this week’s episode, Washington Editor Steve Usdin details how political moves have begun to intrude into the Trump administration’s regulation of vaccines, a topic that’s also taken up by Phil Krause and Luciana Borio in a BioCentury Guest Commenta...

Biopharma companies are vying to dethrone Vyvgart as a leading therapy for myasthenia gravis, with the latest data for therapies treating the rare autoimmune neuromuscular disease coming at this month’s American Academy of Neurology. On a special episode of the BioCentury This Week podcast, BioCentury’s editors discuss the landscape for MG therapies, including anti-BLyS and APRIL therapy telitacicept from Remegen. Joining BioCentury’s editors are Qing Zuraw, chief development officer of podca...

The academia-industry interface is more important than ever for sustaining biomedical innovation’s forward momentum, even as the Trump administration injects turbulence into academic funding for universities. On a special edition of the BioCentury This Week podcast, BioCentury’s Simone Fishburn and Karen Tkach Tuzman preview Grand Rounds, BioCentury’s second annual R&D conference, along with special guests. Spots are filling up for the Grand Rounds U.S. Presenting Company Class of 2025. F...

The biotech community is reeling, fearful and furious about the fallout of tariff, FDA and NIH policies, according to BioCentury’s newly released Risk Sentiment survey. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from the survey, which polled 328 biopharma stakeholders during April 10-14. The editors dissect the latest from Washington, including comments from FDA Commissioner Marty Makary on a new pathway for ultrarare drugs and his plans to reform advis...

FDA’s plan to move away from animal toxicity testing could expedite INDs and cut costs for biopharma companies, while helping the U.S. maintain its position as a clinical research hub. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the agency’s new three-year road map to reduce animal safety studies for mAbs. The editors then discuss the deepening morale crisis at FDA after HHS Secretary Robert F. Kennedy Jr. accused the agency of corruption, encouraged staff to repo...

Loss of leadership, cuts to staffing and a proposed reorganization at FDA have heightened biotech risk amid an already turbulent macroeconomic climate, according to BioCentury’s Washington editor Steve Usdin. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how the turmoil at FDA could affect a sector already grappling with the uncertainty brought by the Trump administration’s trade war. The editors also explore the growing pipeline of VEGF-targeted bispecifics in a pr...