Avsnitt
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The name of the biopharma game this season is vaccines—and RFK Jr. wasted no time returning from Memorial Day Weekend before making news on this front, removing the COVID-19 vaccine from the list of recommended immunizations for healthy kids and pregnant women on Tuesday. This follows a rash of recent moves, including a new risk-based strategy for the approval of new COVID vaccines focused on adults over 65 and high-risk individuals six months to 64 years of age and a request that Moderna and partners Pfizer and BioNTech update the myocarditis risk on their vaccines’ labels.
This increased vaccine scrutiny by the FDA and Department of Health and Human Services is having a significant impact on biopharma companies, several of whom have received stop-work orders on next-gen COVID vaccines. Meanwhile, Moderna last week pulled the biological license application for its combination COVID-19/flu vaccine, anticipating a request for additional data on flu shot efficacy from the FDA, as mRNA technology continues to be scrutinized after playing the hero during the pandemic. Also last week, the White House released its Make America Healthy Again (MAHA) report, which took aim at vaccines, along with pharma lobbying and GLP-1s.
Also on the policy front, a California judge issued an order Thursday that indefinitely stops HHS’ goal of reducing its divisions from 28 to 15 and firing upwards of 10,000 employees, among other reorganization and mass layoff plans. And speaking of government plays that could receive judicial pushback, we received a couple of new updates on the Most Favored Nation (MFN) front: first, President Donald Trump appointed his CMS chief Mehmet Oz as the leader of drug pricing negotiations, calling him “one tough hombre,” and second, HHS provided new guidance for streamlining the process for states to import drugs from Canada.
In the obesity realm, Eli Lilly is calling out the Centers for Medicare and Medicaid Services. In an open letter last week, Lilly voiced its displeasure with the agency for a final ruling that left its Zepbound and Novo Nordisk’s Wegovy out of Medicare Advantage and Part D coverage in 2026.
And in the R&D realm, we returned from the long weekend to sad news from Rocket Pharmaceuticals, as the company reported that its pivotal Danon disease trial is on hold after the death of a young patient. The death—extremely sad on a human level—is also a setback for the gene therapy space, which had been buoyed earlier this month by the success of a personalized CRISPR treatment received by baby KJ.
Finally, BioSpace looks ahead to ASCO#25 where Dan Samorodnitsky will be on the ground in Chicago.
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Lori Ellis, head of insights and Ian Fisher, head of development of analytics at IQVIA, discusses the critical importance of Target Product Profiles (TPPs) for life sciences companies, especially during uncertain times with funding challenges.
Fisher emphasizes that TPPs serve as strategic guiding light which help companies articulate their development goals and demonstrate value to potential investors and partners.
This episode is presented in partnership with IQVIA.
Host
Lori Ellis, Head of Insights, BioSpace
Guest
Ian Fisher, Head of Development Analytics, IQVIA
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Saknas det avsnitt?
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Pfizer stole the headlines this week with a pact worth up to $6 billion with Chinese biotech 3SBio for a PD-1/VEGF candidate just three months after inking a clinical trials collab for a similar drug with Summit Therapeutics. It’s the largest Chinese licensing deal in recent memory, as pharmas continue to turn to the country to fill their pipelines.
Also on Tuesday, the Department of Health and Human Services offered a smidge more detail on President Donald Trump’s Most Favored Nation executive order. A press release explained that drug prices will be tied to the lowest price in certain countries with a GDP at least 60% that of the U.S. and that the effort will focus on branded drugs.
Over at the FDA, the strategy around COVID-19 vaccines is evolving. According to an editorial published in the New England Journal of Medicine Tuesday by FDA Commissioner Marty Makary and CBER director Vinay Prasad, future COVID-19 approvals will focus on adults over 65 and high-risk individuals six months to 64 years old—a strategy they say will better align the U.S. with other high-income nations. This is also in sync with the Novavax approval, which came in Friday after a few delays.
Meanwhile, the FDA’s Oncologic Drugs Advisory Committee (ODAC) is currently in the midst of a two-day meeting, but acquiring the necessary expertise was “absolute chaos,” according to an agency insider who spoke with BioSpace. This is partly due to the decimation of an FDA office that includes staff responsible for screening scientific and therapeutic area experts for conflicts of interest.
Going back to last week—which seems like a year ago at this point—we were somewhat shocked to learn that the CEO of one of the world’s most valuable pharma companies is on his way out. Friday morning, Novo Nordisk announced that CEO Lars Fruergaard Jørgensen will be leaving the company after eight years at the helm. After peaking last June at about $155 apiece, the obesity leader’s shares are currently worth just $68. Novo said the decision for Jorgensen to leave was mutual, but Jorgensen was not made available to speak on a call following the announcement.
Finally, a couple of milestones are worth noting: First, the Alzheimer’s space got a big win on Friday when the FDA approved the first blood-based test for the disease—news that could be a boon to Eli Lilly’s Kisunla and Biogen & Eisai’s Leqembi. And second, a nine-month-old boy named KJ with a disease called CPS1 deficiency that affects just 1 in 1.3 million U.S. babies was treated with a single-use CRISPR treatment created just for him. It’s an incredible story that highlights just how far gene editing has come, but it also highlights a rare disease crisis, with these sorts of ultra- and nanorare diseases lacking the necessary financial incentive to motivate biopharma’s focus.
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President Donald Trump unveiled a sweeping drug pricing policy this week, seeking to lower drug prices in the U.S. by up to 80% through a reprisal of the Most Favored Nation rule he attempted to introduce in his first term. The rule would essentially link U.S. prices to those paid in other nations where medications are cheaper. Biopharma reaction was one of tentative relief, with BMO Capital Markets analysts suggesting the executive order had “more bark than bite.” Meanwhile, the Centers for Medicare and Medicaid Services announced that among the next 15 drugs to undergo IRA-prescripted price negotiations could be drugs payable through Medicare Part B, and not just Part D, where the first two rounds have applied.
Into all of this action steps Vinay Prasad, the outspoken oncologist and hematologist who was named last week as the next director of the FDA’s Center for Biologics Evaluation and Research. While the S&P Biotech ETF fell by more than 5% upon the news, overall reaction was fairly measured, with cell and gene therapy executive Audrey Greenberg summing up Prasad’s selection as “anything but a status quo appointment.”
Over in the weight loss and obesity space, Eli Lilly can’t seem to lose. This weekend, Lilly announced full data from a head-to-head trial showing a “superior benefit-to-risk ratio” for its Zepbound over Novo Nordisk’s Wegovy. And last week, the Indiana-based pharma won a court battle against compounders when a judge sided with the FDA, stating that tirzepatide—the active ingredient in both Zepbound and diabetes sister drug Mounjaro—was no longer in shortage. Add on a presidential shoutout during Trump’s Monday press conference for its U.S. manufacturing investments, and it really was Lilly’s week.
Flying less high are some 2,000 Bayer employees who lost their jobs in the first quarter of 2025 as part of the company’s new operating model, which is intended to make Bayer “much more agile.” On a less direct flight is Galapagos, which reversed course on plans to spin out a portion of the company and find a new CEO. Instead, CEO Paul Stoffels will make a quicker exit and the Belgian biotech could sell off its cell therapy assets as it looks to build up a new pipeline in house, having abandoned the spinout idea altogether. Stay tuned.
Finally, in ClinicaSpace this week, we took a deep dive into the HIV treatment space, where companies like Gilead and Immunocore are targeting a cure, while the Trump administration slashes funding for HIV research.
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Paul Offit, MD, Director of the Vaccine Education Center at the Children's Hospital of Philadelphia and the Maurice R. Hilleman Professor of Vaccinology, Professor of Pediatrics at the Perelman School of Medicine at the University of Pennsylvania, identifies himself as a "vaccine skeptic"–someone who demands data and evidence–which he believes is the appropriate stance for medical professionals and regulators.
After the Cutter incident in 1955, which resulted in 250 cases of polio caused by batches of polio vaccine containing live polio virus given to the public, the FDA took up this mantle in evaluating vaccines. He warns that public discourse has moved dangerously past healthy skepticism into harmful cynicism, particularly through conspiracy theorists who dismiss scientific evidence by claiming researchers are "in the pocket of Big Pharma." This cynicism threatens public health as vaccine-preventable diseases like measles and pertussis are re-emerging due to declining vaccination rates, with polio potentially following if immunization continues to decrease.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Paul Offit, MD, Director of the Vaccine Education Center, Children's Hospital of Philadelphia; Maurice R. Hilleman Professor of Vaccinology and a Professor of Pediatrics, Perelman School of Medicine, University of Pennsylvania
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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In his effort to onshore manufacturing, President Donald Trump issued an executive order on Monday afternoon ordering the FDA to ease permitting processes for new and expanded U.S. facilities. The announcement comes as more and more Big Pharma companies commit billions to expanding their U.S. footprints. Bristol Myers Squibb CEO Christopher Boerner announced this week that the company will pump $40 billion into its stateside operations over the next five years, even as the pharma executes a massive cost-cutting effort that involves shaving $3.5 billion from expenses by 2027 and cutting thousands of jobs, including another 516 in New Jersey, according to a May WARN notice.
In other policy news, the Department of Health and Human Services on Wednesday said it will require all new vaccines to be tested in placebo-controlled trials to earn FDA approval but some vaccine experts have raised concerns about this approach. Meanwhile, turmoil still envelopes the FDA, with staff cuts and rehires continuing at a dizzying pace. On Monday, several states sued HHS, saying that the cuts offload critical functions and costs onto the states and impede public health efforts.
As Q1 earnings season for Big Pharma begins to wind down, there are still headlines coming from the biotech sector. Vertex revealed last week that it is abandoning all of its adeno-associated virus vector work, while BioNTech on Monday announced that tariffs could get in the way of its ambitious plans for a closely watched PD-L1-VEGF therapy. Moderna, meanwhile, continues its fall from COVID grace, missing Q1 revenue expectations and announcing plans to reduce operating expenses by around $1.5 billion by 2027.
In the weight loss space, Novo Nordisk announced on Friday that the FDA has accepted the application for a pill version of Wegovy, with a decision expected this fall. Novo has also struck partnerships with CVS and Hims & Hers pharmacies to market injectable Wegovy, drawing the attention of Eli Lilly CEO David Ricks.
Also this week, check out BioSpace’s deep dives into advances in base editing—a technology that’s been touted as a “safer” CRISPR—and Summit Therapeutics’ push to bring closely watched PD-1/VEGF immunotherapy ivonescimab to the U.S. market after its recent approval in China.
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Policy issues—particularly tariffs—loom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizer’s call, CEO Albert Bourla called the Trump administration’s national security concerns “legitimate,” but objected to the proposed tariffs in general. Meanwhile, Novartis CEO Vas Narasimhan brushed off the tariff risk but expressed concern over President Donald Trump’s desire to bring back the ‘Most Favored Nations’ rule.
Meanwhile, cancer conference season is in full swing, with the American Association for Cancer Research’s annual event continuing in Chicago. Merck, GSK, Boehringer Ingelheim, Roche and others have presented highly anticipated data from some of their cornerstone cancer drugs and other candidates.
Turning to the latest news out of the FDA, newly minted Commissioner Marty Makary gave his first two big press interviews last week, making statements that both jibed with and contradicted recent reporting. And in the midst of the ongoing Novavax vaccine saga, many have raised concerns that the FDA could become politicized under the watch of HHS Secretary RFK Jr.
Finally, check out this week’s BioPharm Executive stories, including a deep dive into the trend toward mining innovative therapies from China and BioSpace’s annual report on pharma CEO-to-employee pay ratios.
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This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine emphasizing the need for collaboration to improve women's health.
This discussion features Lori Ellis, Martin Hadosi, and Melissa Laitner, who emphasize the need for collaborative effort across multiple sectors including industry, healthcare organizations, researchers, and patient advocacy groups. Regarding investment challenges, they acknowledge the current difficult economic environment affects all biomedical research, not just women's health specifically.
This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Martin Hodosi, Partner, Kearney
Melissa Laitner, Director of Strategic Initiatives, National Academy of Medicine
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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While much of the country was off celebrating Easter and Passover this weekend, the FDA—and its new leader Marty Makary—were busy making news. Makary, who was confirmed as FDA commissioner last month, gave his first major interview, where he unveiled a new regulatory pathway for rare disease therapies and addressed the “epidemic of distrust” he feels is imperiling the agency. Makary also shared his thoughts on the conflicts of interest he sees between the FDA and pharma industry, highlighting a new directive to ban industry representatives from serving on the agency’s advisory committees—a move experts believe will have minimal impact in reducing COIs.
Makary also touched on vaccines and what he believes to be the cause of autism. On this, he was more restrained than his boss, HHS Secretary Robert F. Kennedy Jr., who continues to insist on re-investigating what he believes is a link between autism and vaccines. The interview comes as more former FDA officials sound the alarm about the changes happening within the agency.
Elsewhere on the policy front, President Donald Trump continues to threaten tariffs on pharma products. In response, two more companies, Roche and Regeneron, are committing billions of dollars to enhance their U.S. footprints. They join Novartis, J&J and Eli Lilly in this regard, with the latter additionally promising to manufacture its investigational oral obesity drug orforglipron in the U.S.
That announcement followed the news that orforglipron generated “injectable-like efficacy” in a Phase III diabetes trial. Lilly intends to submit for approval of the pill for weight management by the end of this year and diabetes in 2026. Not to be outdone, chief rival Novo Nordisk revealed Saturday that it has already filed for FDA approval of an oral formulation of its own blockbuster, semaglutide, for overweight and obesity.
Finally, make sure to check out this week’s edition of BioPharm Executive where we take a deep dive into another sizzling space—transthyretin amyloid cardiomyopathy (ATTR-CM)—and find out which pharma CEO has the biggest golden parachute.
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It’s all about tariffs again this week. No sooner had Donald Trump announced that “major” tariffs on the pharmaceutical industry would be coming “very shortly”—sending stocks spiraling—the president announced a 90-day pause on most taxes for imports from countries not named China. But this respite was not to last. On Sunday, Secretary of Commerce Howard Lutnick told ABC News that tariffs would be coming for pharma in the next month or two, according to Leerink.
A Federal Register Notice revealing an investigation into pharmaceutical product imports and the associated potential national security threats additionally signaled that tariffs might be imminent. Accordingly, tariffs were a major theme as Johnson & Johnson kicked off Q1 earnings season on Tuesday, where CEO Joaquin Duato urged President Donald Trump to consider tax policy changes instead. Last week, Novartis joined J&J and Eli Lilly in preparing for said tariffs with a $23 billion pledge to expand its own U.S. R&D and manufacturing. And amid all of these trade tensions, the National Security Commission on Emerging Biotechnology released a report warning that China is “dangerously close” to overtaking U.S. biotech.
Meanwhile, after unprecedented cuts to its workforce, the FDA is looking toward a future of drug review delays and increased executive oversight, according to experts. Industry watchers have also expressed concern that the cuts could trigger a little-known mechanism built into the Prescription Drug User Fee Act that could potentially cost the FDA nearly half of its funding and set the agency—and U.S. patients—back 35 years.
Also fighting for headlines on Monday morning was Pfizer’s announcement that it is ending development of its lead obesity candidate danuglipron after detecting a potential case of drug-induced liver injury. Pfizer’s loss could be Viking Therapeutics’ gain, however, as analysts immediately floated the idea of a marriage between the two companies. Viking has long been a top takeover target, and the biotech’s shares rose 13% upon Pfizer’s announcement.
Finally, it’s that time of year again: In BioPharm Executive this week, BioSpace looked at the top paid CEOs in biopharma. Who is this year’s highest paid CEO? Click here to find out.
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In this bonus episode, BioSpace’s vice president of marketing Chantal Dresner and careers editor Angela Gabriel take a look at job market performance in the first quarter of 2025.
They discuss job posting trends, application rates and layoffs. Also discussed are recent decisions of the Trump administration and how they are impacting the workforces of the private sector, HHS and academia.
Want to receive our latest quarterly job market reports? Subscribe to Career Insider for our job market updates, job trends, career advice and more.
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This discussion features BioSpace's head of insights Lori Ellis, Kearney partner Martin Hadosi, and Melissa Laitner, director of strategic initiatives at the National Academy of Medicine examining the underrepresentation of women in clinical trials.
They stress that rather than waiting for regulatory guidance, the industry should proactively improve trial accessibility and inclusivity, as there's mutual benefit in faster enrollment and more diverse participation.
This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Martin Hodosi, Partner, Kearney
Melissa Laitner, Director of Strategic Initiatives, National Academy of Medicine
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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Pushback against the Trump administration’s massive government cuts exploded this weekend across America—and biopharma is no exception. Taking a deep dive into the leadership cuts, we found that more than half of the senior FDA leaders from six months ago are no longer there, and that’s just the leadership. Across the Department of Health and Human Services, some 20,000 people will be leaving—of their own accord or otherwise—amounting to a 25% reduction in headcount that would leave HHS with around 62,000 employees. With many of these people likely destined for biopharma, does this pose an ethical problem?
Meanwhile, the escalating tariff war is beginning to ring alarm bells for the economy, with Goldman Sachs now predicting a 45% chance of a recession happening in the next 12 months. While pharma has historically been considered resistant to the challenges of a recession—people always need medicines—this time around could be different, in part because of the consumer-led obesity market. Thanks to the Trump administration’s decision to nix a Biden era proposal to cover GLP-1s under Medicare Part D—at least for now—these drugs will continue to cost consumers a pretty penny.
Even without a recession being declared, Eli Lilly’s and Novo Nordisk’s stocks are falling significantly with the rest of the market. Lilly has lost more than $95 billion in market value in one month. Novo’s value has declined $72 billion.
The drugmakers are also still battling makers of knockoff versions of their drugs. Most recently, Lilly filed a lawsuit against a med spa in Indianapolis for allegedly taking vials of tirzepatide and splitting them up into single doses that are sold to patients without the packaging inserts.
Of course, Lilly and Novo aren’t the only pharma drug rivalry out there. There’s also Keytruda vs. Opdivo, Leqembi vs. Kisunla and more.
Finally, we take a look at seven late-stage MASH candidates that could hit the market in the next few years, following the FDA’s 2024 approval of Madrigal’s Rezdiffra, the first treatment for the metabolic disorder.
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Biopharma’s reaction to the forced resignation of venerable CBER director Peter Marks has been swift and furious, with former FDA Commissioner Robert Califf saying on LinkedIn that “the FDA as we’ve known it is finished.” Analysts, meanwhile, called Marks’ exit “arguably biotech investors’ greatest fear,” as company shares across the industry tumbled.
Marks’ announcement added insult to injury for the agency, which was already reeling from the announced cuts of 10,000 employees across the Department of Health and Human Services, including 3,500 FDA staffers. Those layoffs began to roll out on Tuesday as some employees showed up to work only to discover they no longer had a job. Amid all this chaos, Cantor Fitzgerald analysts called for Kennedy himself to get the axe, saying in part that he was “undermining the trusted leadership of health care in this country.”
Despite the turmoil, drug development continues in the obesity space, with Novo Nordisk presenting mixed data from its semaglutide franchise at the American College of Cardiology’s annual conference last weekend. While an oral version of the blockbuster drug showed cardiovascular benefits for some patients, it failed to change the trajectory of other major adverse cardiovascular events. Meanwhile, Novo continues its battle against compounding pharmacies manufacturing copycat versions of semaglutide—as multiple players scramble for a piece of this massive pie.
On the Alzheimer’s front, Eli Lilly’s Kisunla failed last week to win the recommendation of the EU’s Committee for Medicinal Products for Human Use. This decision is consistent with CHMP’s recent stance on anti-amyloid antibodies, as Biogen and Eisai have also struggled to get Leqembi approved in Europe.
On a positive note, pharma R&D returns grew again in 2024, but Deloitte warned that this progress is “fragile.” The firm urged companies to be bold and embrace cutting edge technology like gene therapy and AI. These returns can’t help everyone, however, as the past week has seen an uptick in layoffs across biopharma, including at Carisma Therapeutics, Organon and Tenaya Therapeutics.
Finally, as April kicks off cancer conference season, BioSpace took a deep dive into the recent action in the always-hot in radiopharmaceuticals space.
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Martin Hodosi, partner at Kearney and Melissa Laitner, director of strategic initiatives, National Academy of Medicine, join Lori Ellis, head of insights, to discuss the evolution of women's inclusion in clinical trials.
They note that while overall representation has improved, significant challenges remain. They highlight how industry mindset has evolved from being protectionist to inclusion.
This episode is presented in partnership with DIA, in support of their 2025 Global Annual Meeting taking place June 15-19 in Washington DC.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Martin Hodosi, Partner, Kearney
Melissa Laitner, Director of Strategic Initiatives, National Academy of Medicine
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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President Donald Trump doubled down on tariff threats targeting pharma, saying additional levies on pharmaceuticals will come “at some point,” per CNBC. Meanwhile, Johnson & Johnson became the latest big pharma to respond to Trump’s warning of potential tariffs if companies don’t reshore their manufacturing, announcing a massive $55 billion U.S. manufacturing and R&D investment. Not all companies are on board, however: AstraZeneca is looking eastward, pumping $2.5 billion into a new research facility in Beijing.
Also on the policy front, Trump nominated acting CDC director Susan Monarez for the top job after pulling his first nominee, Dave Weldon, days before his senate hearing was expected to begin. If confirmed, Monarez would be the first CDC director since 1953 to not have a medical degree; she holds a Ph.D. in microbiology and immunology from the University of Wisconsin.
In weight loss news, Novo Nordisk is paying China-based United Laboratories $200 million upfront to license a triple agonist of the GLP-1, GIP and glucagon receptors that could one day compete with Eli Lilly’s retatrutide. And BioSpace examines the next great challenge for GLP-1s: oral formulation manufacturing.
Two more therapeutic spaces in focus last week are Duchenne muscular dystrophy and spinal muscular atrophy, where companies including Dyne Therapeutics, REGENXBIO and Novartis presented new data on their respective candidates. And the Duchenne community continued to react to news of the death of a patient taking Sarepta’s approved gene therapy Elevidys.
In cardiovascular news, Alnylam won a much-anticipated approval for Amvuttra as the first RNAi silencer for transthyretin amyloid cardiomyopathy, setting up a three-way race with Pfizer’s tafamidis—marketed as Vyndaqel and Vyndama—and BridgeBio’s Attruby. Next up is Milestone Therapeutics’ CARDAMYST in paroxysmal supraventricular tachycardia, which has a PDUFA date of March 27.
Finally, the saga of Cassava Sciences’ Alzheimer’s hopeful simufilam is over, as the company announced it has ended development of the controversial candidate.
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A patient with Duchenne muscular dystrophy taking Sarepta’s gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidys’ label to reflect the new safety signal, saw its shares drop 22% on the news but analysts still seem positive on the drug, as treatment options for Duchenne remain limited.
Meanwhile, both AstraZeneca and Taiho Pharmaceuticals announced acquisitions worth up to $1 billion or more in two sizzling therapeutic spaces, cell therapy and antibody-drug conjugates, respectively.
Despite canceling a vaccine advisory committee late last month, the FDA on Thursday selected flu strains to be targeted in the upcoming 2025-2026 flu season. And at another federal agency, the Centers for Disease Control and Prevention, employees will have to wait a bit longer to see who will take the helm under Donald Trump, as the president’s nominee, Dave Weldon, was pulled hours before he was set to appear before a Senate committee on Thursday. Like HHS Secretary Robert F. Kennedy Jr., Weldon has expressed anti-vaccine views in the past, particularly his continued suggestion of the link between vaccines and autism. Guggenheim Partners called the move to revoke Weldon’s nomination “a positive sign for reigning in vaccine criticism.”
In the weight loss arena, BioSpace takes deep dives into the tendency for biopharma to develop fast-followers, or me-too drugs—following a pattern seen with PD-1 checkpoint inhibitors after the approvals of Merck’s Keytruda and Bristol Myers Squibb’s Opdivo. One key difference between these two markets, however, is that when it comes to GLP-1s for weight loss, patients are not staying on these medicines. Drug developers are trying several approaches to improve treatment persistence, including titration, combinations and even secondary drugs that address side effects. They’re also making other moves to differentiate themselves, including focusing on overall health outcomes—in areas like cardiovascular, sleep apnea and kidney disease.
Following on BioSpace’s coverage of the major patent cliffs that many Big Pharma companies are facing in coming years, we also take a look back at some of the companies that have already weathered such loss of exclusivity. It’s rarely a straightforward story of sales crashing off patent, as companies take various tacks to extend their blockbuster sales.
Finally, the cardiovascular space is expecting some movement this week. First, Alnylam is anticipating a decision on its RNAi silencer Amvuttra in ATTR-CM. An approval—which is widely expected—would make three companies on the market in this rapidly expanding space after Pfizer’s tafamidis was approved in May of 2019, and BridgeBio’s Attruby got the greenlight in November last year. And second, Milestone Pharmaceutical has a PDUFA coming up for etripamil in paroxysmal supraventricular tachycardia.
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On the sidelines of this year’s J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Mark McKenna, CEO of Mirador Therapeutics, a member of BioSpace’s NextGen Class of 2025. Their discussion here focused on the company’s two-pronged approach to developing therapies for inflammatory and fibrotic diseases, as well as the importance of operating under stealth at this time for the biotech.
This is the second episode in a special series of The Weekly focused on how NextGen companies are navigating the current business environment.
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Miruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this episode, she discusses the challenges of stringent inclusion and exclusion criteria of clinical trials. She also dives into her main takeaways from this year's JP Morgan Healthcare Conference and Scope Summit around exits and investment in women's health.
Host
Lori Ellis, Head of Insights, BioSpace
Guests
Miruna Sasu, President and CEO, COTA
Disclaimer: The views expressed in this discussion by guests are their own and do not represent those of their organizations.
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As we mark five years since the World Health Organization officially declared the COVID-19 pandemic, the BioSpace editorial team reflects on the health crisis of a generation and how it changed us—and the biopharma industry. While companies like Pfizer, BioNTech and Moderna raked in billions from their vaccines, J&J and Novavax struggled to capture a significant piece of the market.
Five years later, much has changed. A substantial number of us now work from the comfort of our homes—though that may be changing for some in the life sciences—and biopharma has a new obsession: obesity. In this space, Novo Nordisk has had a rough week, reporting lower-than-expected results from a second straight trial of its next-gen weight loss drug CagriSema. And in an effort to protect revenues from its blockbuster weight-loss drug Wegovy, Novo jumped into the legal battle between the FDA and compounding pharmacies over the regulator’s decision to declare the shortage of Wegovy over. Viking Therapeutics had a better week, securing “multiple metric tons” of its investigational obesity medication VK2735 in a deal with CordenPharma. Meanwhile, companies continue to tackle adverse events associated with GLP-1s.
Another space that has seen its fair share of failures in the past couple of years is depression. The latest flop comes from J&J, which announced it would discontinue its a kappa opioid receptor blocker aticaprant after a disappointing Phase III readout. J&J joins Biogen and Sage Therapeutics, Relmada Therapeutics and Alto Neuroscience, all of whom have suffered regulatory misses or trial flops.
Finally, two of Donald Trump’s healthcare nominees, Marty Makary and Jay Bhattacharya, sailed through their confirmation hearings in the Senate last week. Both are up for confirmation on Thursday.
- Visa fler
