BioSpace

BioSpace
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Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

  1. M&A Picks Up, Walmsley Moves On, Pfizer’s MFN Deal and Hope for Huntington’s

    HACE 34 MIN

    M&A Picks Up, Walmsley Moves On, Pfizer’s MFN Deal and Hope for Huntington’s

    Genmab closed out a busy third quarter for M&A in biopharma, picking up cancer biotech Merus for $8 billion. This deal—the year’s fifth largest—came just a week after Pfizer acquired rising obesity star Metsera for $4.9 billion. Just seven days later, Metsera made the New York–based pharma look like a genius with mid-stage data for one of the deal’s centerpiece therapies, MET-097i, showing 14% placebo-adjusted weight loss over 28 weeks. After months of tarrying and threats, President Donald Trump announced last week that 100% tariffs would take effect Oct. 1—with broad exceptions for companies that have taken steps to build out their domestic manufacturing footprints. One company that has answered that call—as well as a letter sent by the president to 17 of the largest pharma companies requesting action on his most-favored-nation drug pricing policy—is Pfizer. In a joint oval office announcement with Pfizer CEO Albert Bourla and HHS officials, Trump said Pfizer would offer all new medicines at MFN prices. Meanwhile, over at the FDA, CDER Director George Tidmarsh, who has flown relatively under the radar since taking the post in July, took to LinkedIn to address the subject of relying on surrogate endpoints in drug approvals. In a since deleted post, Tidmarsh called out Aurinia Pharmaceuticals’ lupus drug as an “egregious” example of this phenomenon. CDER’s sister agency, CBER, also made a splash last week, publishing three draft recommendations intended to accelerate the development of cell and gene therapies. Speaking of CGT, maybe the biggest clinical development news of the year emerged from this space last week when uniQure announced that its gene therapy for Huntington’s disease, AMT-130, slowed disease progression by 75% after three years. With these data in hand, uniQure plans to file for FDA approval of the treatment in the first quarter of 2026. If successful, AMT-130 would be the first genetic therapy for the intractable neurodegenerative disease. Finally, biopharma’s glass ceiling just got a little more tightly sealed. Emma Walmsley, the industry’s first female CEO, is stepping down after nine years at GSK, handing the reins to current chief commercial officer, Luke Miels. When Walmsley officially departs on Dec. 31, she will leave Vertex CEO Reshma Kewalramani and incoming Takeda CEO Julie Kim to represent the sisterhood at the highest ranks of the biopharma industry.

    22 min
  2. FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid, Psychedelics Revival, ACIP Confusion, More

    24 SEP

    FDA’s Autism Endeavor, Pfizer’s Obesity Comeback Bid, Psychedelics Revival, ACIP Confusion, More

    The FDA is working to reapprove GSK’s long-dormant drug Wellcovorin (leucovorin) for cerebral folate deficiency, which the agency linked to “developmental delays with autistic features.” This immediately followed a much-anticipated press conference in which President Donald Trump, flanked by Health Secretary Robert F. Kennedy Jr and other healthcare administrators, linked the use of Tylenol during pregnancy to rising rates of autism.   Meanwhile, Pfizer woke us all up Monday with the news that it had acquired breakout obesity rockstar Metsera for $4.9B. The deal should pump new life into Pfizer’s portfolio, which over the last two years has suffered three discontinued assets. Bite-sized deals—or those at or below the $5 billion mark—have defined biopharma recently, with Roche picking up metabolic dysfunction-associated steatohepatitis biotech 89bio for a potential $3.5 billion last week and Novartis putting another $5.7 billion on the line with partner Monte Rosa Therapeutics in a second molecular glue agreement.   Another therapeutic space primed for M&A action is psychedelics. After AbbVie bought Gilgamesh Pharmaceuticals’ lead depression asset for $1.2B last month, BioSpace spoke sought opinions from experts on who might be next to take the plunge. A few potential names included Eli Lilly, Bristol Myers Squibb and Merck.   On the policy front, the CDC’s revamped vaccine advisory committee convened for their first meeting to discuss COVID-19, MMRV and hepatitis B vaccine schedules. Industry watchers who spoke to BioSpace commented on the “lack of knowledge” and dearth of previous experience on the committee. And while the advisors ultimately voted to change the schedule for the MMRV vaccine, it appears unlikely to significantly affect manufacturers’ bottom lines.  Finally, in rare disease, Stealth BioTherapeutics secured its long-sought approval for elamipretide—now Forzinity—in Barth syndrome—a disorder that would fall under the purview of the FDA’s new Rare Disease Evidence Principles framework for ultra rare diseases affecting less than 1,000 people in the U.S. And we said “Bye Bye Bluebird,” as the famed gene therapy biotech—which was recently bought out by two private equity firms—returned to its original moniker, Genetix Biotherapeutics.   Lastly, make sure to sign up for Biopharm Executive here for access to a special deep dive into China biopharma.

    32 min
  3. What Do AI and Hammers Have in Common?

    18 SEP

    What Do AI and Hammers Have in Common?

    In this episode, Lori Ellis and Colin Zick spend a little time further discussing some of the points brought up in the Bioprocessing Summit last month. AI is a tool, a powerful one but a tool. Understanding this, they explore the connections between hammers, AI, The Planet of the Apes and monoliths. In the end, it is all about compliance. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guest Colin Zick, Partner, Foley Hoag LLP Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    22 min
  4. China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip Flop, More

    17 SEP

    China Crackdown, UK Exit, Novo Layoffs, Adcomm Flip Flop, More

    A global shift may be underway in biopharma as the White House prepares legislation that would would place restrictions on drugs brought to the U.S. from China, and pharma companies exit the U.K. in droves. President Donald Trump is reportedly writing an executive order that would clamp down on the pharmaceutical industry’s ability to buy new molecules from biotechs based in China, while Sanofi, Merck and more have canceled or suspended investments in the U.K. following a sizeable increase in a mandatory levy in the region.  In other business news, Novo Nordisk’s newly appointed CEO Maziar Mike Doustdar hit the ground running, cutting around 9,000 employees and informing those who remained that they would need to return to the office. Novo’s headcount had climbed 81% in five years as its revenue soared—and then fell. The obesity juggernaut has been a key presence at the European Association for the Study of Diabetes’ annual meeting this week, announcing that it would seek FDA approval for a high-dose formulation of Wegovy, and presenting new data for long-acting amylin analog cagrilintide. Meanwhile, Reuters reported that Eli Lilly’s orforglipron could potentially qualify for the FDA’s recently launched Commissioner’s Priority Voucher, which could see the oral obesity candidate approved this year.   The gene therapy space was hit with more bad news as Capsida Biotherapeutics reported the death of a patient being treated with its investigational gene therapy for epileptic disorders. This follows an unfortunate trend in 2025 that has also seen deaths attributed to Sarepta’s approved Duchenne muscular dystrophy gene therapy Elevidys and a monoclonal antibody used for lymphodepletion in a study of Allogene’s CAR T cell therapy cema-cell. According to a new analyst survey, however, doctors are still prescribing Elevidys to ambulatory patients.   Meanwhile, on the regulatory front, FDA Center for Drug Evaluation and Research Director George Tidmarsh reportedly told two separate groups last week that he “would like to get away” from advisory committee meetings, but quickly appeared to walk the comments back in a statement to Endpoints News.   Finally, in BioPharm Executive, BioSpace takes a deep dive into the FDA’s new crackdown on pharmaceutical drug ads, and spotlights Akeso CEO Michelle Xia who built the biotech from a $3 million angel fundraising round to its current $15 billion valuation.

    27 min
  5. Unpacking the Latest MAHA Report, RFK’s Senate Appearance, FDA’s CRL Drop and More

    10 SEP

    Unpacking the Latest MAHA Report, RFK’s Senate Appearance, FDA’s CRL Drop and More

    The Make America Healthy Again Commission released itssecond report Tuesday, recommending, among other efforts, an investigation into a possible link between vaccines and the uptick in chronic disease. At a livestreamed MAHA commission meeting, Health Secretary Robert F. Kennedy painted a dire picture of the country’s health, saying the U.S. now has “the highest chronic disease burden of any country in the world.” Looking back to last week, all eyes were on HealthSecretary Robert F. Kennedy Jr.’s appearance before the Senate Finance Committee. The combative showdown amounted to little more than political theater, according to industry watchers, with Kennedy accusing former CDC Director Susan Monarez of lying in an op-ed published in the Wall Street Journal about his alleged request that she approve vaccine advisors’ recommendations in advance of their meeting later this month. Over at the FDA, BioSpace combed through the latest cache of publicized complete response letters (CRLs), including one for Lykos’ MDMA-based therapeutic for post-traumatic stress disorder. Going forward, the agency has promised to release CRLs in real time. The greater transparency could help companies spinning on a carousel of confusion caused by all the recent regulatory change. In other FDA news, we take a deep dive into new expert panels, which some commentators view as one-sided, and into the new rare disease approval framework, which one critic called “all wrapper and no gift.” And in the weight loss space, the FDA debuted a consumer “green list” for GLP-1 ingredients. Meanwhile, at the World Conference on Lung Cancer inBarcelona, several data readouts caught our attention. In particular, Summit Therapeutics released disappointing data for its PD-L1/VEGFa bispecific antibody ivonescimab in Western populations—a finding some analysts said could have readthroughs to Bristol Myers Squibb/BioNTech’s first ever global data readout for its L1/VEGFa bispecific. Finally, in Biopharm Executive this week, check out features on contingent value rights, which have been getting tacked on to biopharma deals more and more, Amgen’s pipeline beyond the obesity drug MariTide and Novartis’ recent deal spree, which included the $1.4B acquisition of Tourmaline on Tuesday.

    32 min
  6. The 'Research Safety Net' Saving Scientists from Funding Crisis

    4 SEP

    The 'Research Safety Net' Saving Scientists from Funding Crisis

    In this episode, Mike Garrett, CEO of Taconic Biosciences, discusses how preclinical research companies are helping drug developers navigate the current challenging funding environment. He explains that investors now demand more robust translational data showing real potential to impact human health, rather than just basic in vitro results, forcing researchers to generate better evidence packages earlier in development. This episode is presented in partnership with ⁠⁠Taconic Biosciences. Host ⁠⁠⁠⁠⁠⁠⁠⁠⁠Lori Ellis⁠⁠⁠⁠⁠⁠⁠⁠⁠, Head of Insights, BioSpace Guest Mike Garret, CEO, Taconic Biosciences Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.

    17 min
  7. CDC Faces Critical Meetings Amid COVID Vaccine Uncertainty, Plus Deals, FDA Approvals, More

    3 SEP

    CDC Faces Critical Meetings Amid COVID Vaccine Uncertainty, Plus Deals, FDA Approvals, More

    We returned from the Labor Day holiday to a spate of intriguing deals, including two that could surpass $2 billion: Vertex’s new pact with Enlaza for autoimmune disease—which the Casgevy maker hopes could ease conditioning for the sickle cell/beta thalassemia gene therapy—and Novartis’ agreement with Arrowhead for neurodegenerative diseases such as Parkinson’s.    But as we look ahead, Thursday’s Senate Finance Committee will be the focus this week, as Health and Human Services Secretary Robert F. Kennedy Jr. will answer questions after the ousting of CDC Director Susan Monarez. Her departure is reportedly linked to changes to the regulation of COVID-19 vaccines, for which the FDA last week issued restricted approvals to Moderna, Pfizer/BioNTech and Novavax and rescinded the emergency use authorizations. The next ACIP meeting—where COVID-19 vaccines will be on the agenda—is set for Sept. 18 and 19.     In the weight loss arena, Novo Nordisk presented results from a real-world study this weekend at the European Society of Cardiology Congress in Madrid showing that Wegovy cut the risk of heart attack, stroke or death by 57% compared to Eli Lilly’s tirzepatide in people with obesity and cardiovascular disease. The company also continues to throw money into the space, last week inking a $550 million deal with Replicate for RNA-based treatments for obesity and diabetes. Meanwhile, Lilly is dropping studies of one oral obesity candidate as another nears a regulatory filing. Finally, the FDA greenlit the first GLP-1 generic for obesity.     We also discuss reactions to the FDA’s new guidance on radiopharma drug development, four recent approvals for rare diseases, and everything you ever wanted to know about SPACs.

    31 min
  8. Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change

    27 AGO

    Lilly’s Obesity Pill Heads to the FDA, AbbVie Bets on Psychedelics, HHS Unveils More Change

    Eli Lilly posted data Tuesday from a second Phase III trial of its oral weight loss therapy orforglipron, providing the company with all it needs to head to the FDA with a new drug application. For more in-depth discussion on the oral weight-loss space, check out a special episode of The Weekly. And stay tuned to BioSpace for more unique coverage of this market as we learn which investigational assets will make it across the regulatory finish line and which will join the weight-loss wasteland.  On the business side of biopharma, AbbVie turned back to neuropsychiatric therapies this week, acquiring partner Gilgamesh Pharmaceuticals’ lead depression candidate for $1.2 billion. The deal is a display of resilience for AbbVie in the neuropsychiatric space as well, after the stunning failure last November of schizophrenia asset emraclidine—picked up in its nearly $9 billion acquisition of Cerevel Therapeutics. And is the cooler late summer weather thawing the IPO market? Neuropsych-focused LB Pharma revealed in an SEC filing on Friday that it plans to take the plunge, ending a six-month stalemate in biotech IPOs.   Finally, the Department of Health and Human Services (HHS) has been busy this past week. On Monday, the CDC named Retsef Levi—a known vaccine critic—to head the agency’s COVID-19 immunization working group, just as reports surfaced that the Trump administration could be “within months” of banning the COVID-19 vaccine in the U.S. Meanwhile, the FDA issued new draft guidance for cancer drug developers that prioritizes the use of survival data, and the agency began publishing drug-related adverse event reports daily.     HHS itself has also been the subject of recent headlines, announcing that it will no longer recognize employee unions, and last week, hundreds of HHS staffers penned an open letter calling on Secretary Kennedy to tone down what they called “dangerous and deceitful statements” that have fostered distrust against federal health workers, exposing them to physical harm. This followed the Aug. 8 shooting at CDC headquarters in Atlanta.     Finally, multinational pharmaceutical companies spent more than $48 billion on partnerships with China in the first half of 2025 alone, according to a new report from IQVIA—more than in all of 2024.

    23 min
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Unravel the business of science with BioSpace. We dive into biopharma's top stories and biggest challenges, whether it’s layoffs, pipeline shake-ups, acquisitions, new FDA approvals or how to regulate AI in drug development.

Información

  • Creador
    BioSpace
  • Años de actividad
    2023 - 2025
  • Episodios
    167
  • Clasificación
    Apto
  • Copyright
    © BioSpace
  • Mostrar sitio web
    BioSpace

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