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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"âsomeone who demands data and evidenceâwhich 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
â â â â â Lori Ellisâ â â â â , 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 SquibbâŻCEO 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 BioSpaceâs deep dives into advances in base editingâa technology thatâs been touted as a âsaferâ CRISPRâand Summit Therapeuticsâ 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 issuesâparticularly tariffsâloom large as Q1 2025 earnings season rolls on, with Pfizer , Novartis, AstraZeneca and many more all reporting this week. On Pfizerâs call, CEO Albert Bourla called the Trump administrationâs national security concerns âlegitimate,â but objected to the proposed tariffs in general. Meanwhile, Novartis CEO Vas Narasimhan brushed off the tariff risk but expressed concern over President Donald Trumpâs desire to bring back the âMost Favored Nationsâ rule.
Meanwhile, cancer conference season is in full swing, with the American Association for Cancer Researchâs 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 weekâs BioPharm Executive stories, including a deep dive into the trend toward mining innovative therapies from China and BioSpaceâs 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 â DIAâ , in support of their â 2025 Global Annual Meetingâ taking place June 15-19 in Washington DC.
Host
â â â â â Lori Ellisâ â â â â , Head of Insights, BioSpace
Guests
â Martin Hodosiâ , Partner, Kearney
â Melissa Laitnerâ , 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 FDAâand its new leader Marty Makaryâwere 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 âepidemic of distrustâ 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 agencyâs advisory committeesâa 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 âinjectable-like efficacyâ 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 weekâs edition of BioPharm Executive where we take a deep dive into another sizzling spaceâtransthyretin amyloid cardiomyopathy (ATTR-CM)âand find out which pharma CEO has the biggest golden parachute.
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Itâs all about tariffs again this week. No sooner had Donald Trump announced that âmajorâ tariffs on the pharmaceutical industry would be coming âvery shortlyââsending stocks spiralingâthe 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 âdangerously closeâ 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 agencyâand U.S. patientsâback 35 years.
Also fighting for headlines on Monday morning was Pfizerâs announcement that it is ending development of its lead obesity candidate danuglipron after detecting a potential case of drug-induced liver injury. Pfizerâs loss could be Viking Therapeuticsâ 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 biotechâs shares rose 13% upon Pfizerâs announcement.
Finally, itâs that time of year again: In BioPharm Executive this week, BioSpace looked at the top paid CEOs in biopharma. Who is this yearâs highest paid CEO? Click here to find out.
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In this bonus episode, BioSpaceâs vice president of marketing â Chantal Dresnerâ and careers editor â Angela Gabrielâ 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? â Subscribeâ 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 â DIAâ , in support of their â 2025 Global Annual Meetingâ taking place June 15-19 in Washington DC.
Host
â â â â â Lori Ellisâ â â â â , Head of Insights, BioSpace
Guests
â Martin Hodosiâ , Partner, Kearney
â Melissa Laitnerâ , 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 administrationâs massive government cuts exploded this weekend across Americaâand 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 thatâs just the leadership. Across the Department of Health and Human Services, some 20,000 people will be leavingâof their own accord or otherwiseâamounting 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 recessionâpeople always need medicinesâthis time around could be different, in part because of the consumer-led obesity market. Thanks to the Trump administrationâs decision to nix a Biden era proposal to cover GLP-1s under Medicare Part Dâat least for nowâthese drugs will continue to cost consumers a pretty penny.
Even without a recession being declared, Eli Lillyâs and Novo Nordiskâs stocks are falling significantly with the rest of the market. Lilly has lost more than $95 billion in market value in one month. Novoâs 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 arenât the only pharma drug rivalry out there. Thereâs 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 FDAâs 2024 approval of Madrigalâs Rezdiffra, the first treatment for the metabolic disorder.
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Biopharmaâs 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 âthe FDA as weâve known it is finished.â Analysts, meanwhile, called Marksâ exit âarguably biotech investorsâ greatest fear,â as company shares across the industry tumbled.
Marksâ 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 âundermining the trusted leadership of health care in this country.â
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 Cardiologyâs 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 semaglutideâas multiple players scramble for a piece of this massive pie.
On the Alzheimerâs front, Eli Lillyâs Kisunla failed last week to win the recommendation of the EUâs Committee for Medicinal Products for Human Use. This decision is consistent with CHMPâs 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 âfragile.â The firm urged companies to be bold and embrace cutting edge technology like gene therapy and AI. These returns canât 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
â â â â Lori Ellisâ â â â , 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 âat some point,â per CNBC. Meanwhile, Johnson & Johnson became the latest big pharma to respond to Trumpâs warning of potential tariffs if companies donât 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 Lillyâs 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 Sareptaâs 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 Pfizerâs tafamidisâmarketed as Vyndaqel and Vyndamaâand BridgeBioâs Attruby. Next up is Milestone Therapeuticsâ CARDAMYST in paroxysmal supraventricular tachycardia, which has a PDUFA date of March 27.
Finally, the saga of Cassava Sciencesâ Alzheimerâs 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 Sareptaâs gene therapy Elevidys has died of acute liver failure, possibly related to a recent viral infection. Sarepta, which said it will update Elevidysâ 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 presidentâs 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 Weldonâs nomination âa positive sign for reigning in vaccine criticism.â
In the weight loss arena, BioSpace takes deep dives into the tendency for biopharma to develop fast-followers, or me-too drugsâfollowing a pattern seen with PD-1 checkpoint inhibitors after the approvals of Merckâs Keytruda and Bristol Myers Squibbâs 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. Theyâre also making other moves to differentiate themselves, including focusing on overall health outcomesâin areas like cardiovascular, sleep apnea and kidney disease.
Following on BioSpaceâs 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. Itâs 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 approvalâwhich is widely expectedâwould make three companies on the market in this rapidly expanding space after Pfizerâs tafamidis was approved in May of 2019, and BridgeBioâs 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 yearâs 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 BioSpaceâs NextGen Class of 2025. Their discussion here focused on the companyâs 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
â â â Lori Ellisâ â â , Head of Insights, BioSpace
Guests
â Miruna Sasuâ , 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 usâand 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 homesâthough that may be changing for some in the life sciencesâand 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 regulatorâs decision to declare the shortage of Wegovy over. Viking Therapeutics had a better week, securing âmultiple metric tonsâ 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 Trumpâs healthcare nominees, Marty Makary and Jay Bhattacharya, sailed through their confirmation hearings in the Senate last week. Both are up for confirmation on Thursday.
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Donald Trumpâs tariffs have headlined myriad news stories this weekâincluding at BioSpace, where we reported Pfizer CEO Albert Bourlaâs claim that his company is prepared to reshore manufacturing if the president makes good on threats made last month. Eli Lilly also appears to be preparing, commiting $27 billion to boost its U.S. manufacturing capacity.
Meanwhile, another regulatory meeting has been canceled under new HHS Secretary Robert F. Kennedy Jr. Reuters revealed last week that an upcoming meeting of the FDAâs external advisers for vaccine policy on March 13 has been canceledâjust a week after the CDC Vaccine Advisory Boardâs first meeting of 2025 was postponed. Also on the policy front, BioSpace took a deep dive into priority review vouchers (PRVs) after Congress failed to reauthorize the rare pediatric disease PRV program at the end of 2024. Our reporting shows this will be painful for many biopharma companies who rely on funds from the sale of PRVs.
Speaking of money, AbbVie and Eli Lilly struck a pair of mid-size deals in hot spaces. AbbVie made a late obesity play this week, inking a licensing deal worth up to $2.2 billion with service provider Gubra to bring a long-acting amylin drug to the market, while Lilly hopped onto the hot molecular glue train, paying more than $1.2 billion in a licensing deal with Magnet Biomedicine.
Finally, we examined the somewhat lethargic immuno-oncology space, which has companies, including BMS, Roche, Summit Therapeutics and BeiGene, targeting TIGIT, VEGF, RAS and more in their quest to bring the next Keytrudaâwhich led the way in 2024 as the worldâs best-selling drugâto the market.
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On the sidelines of this yearâs J.P. Morgan Healthcare Conference in San Francisco, BioSpace Senior Editor Annalee Armstrong sat down with Kevin Marks, CEO of Delphia Therapeutics, a member of BioSpaceâs â NextGen Class of 2025â . Their discussion here focused on the companyâs novel science of activation lethality, which involves forcing cancer cells to overactivate and thereby overload cell stress pathways, as well as Delphia's relatively smooth path to a $67 million series A raise thanks to contributions from Google Ventures (GV), where Marks was previously employed.
This is the second episode in a special series of The Weekly focused on how NextGen companies are navigating the current business environment.
Host
â Annalee Armstrongâ , Senior Editor, BioSpace
Guest
â Kevin Marksâ , President and CEO, Delphia Therapeutics
For a complete list of NextGen 2025 companies, â click hereâ .
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Miruna Sasu, CEO of COTA, has been labeled as a disrupter in the industry. In this discussion, she highlights the challenges of investing in the life sciences industry. She also suggests how the investor mindset needs to change as well as offer solutions that benefit both investors and developers seeking investment.
Host
â â Lori Ellisâ â , 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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There was a high point this week for employees riding the rollercoaster that is currently the FDA, as 300 recently fired employees are reportedly being asked to return. This could serve to boost spirits at the agency, which is reeling from unpredictable and seemingly âindiscriminateâ layoffsâand low morale as a result.
Trump made additional waves over the weekend, threatening to enact tariffs on the largest pharmaceutical companiesâunless they relocate their manufacturing operations to the U.S. And the early impacts of the new administration continue to be felt, as the CDCâs vaccine advisory board postponed its first meeting of 2025âjust a week after RFK Jr.âs confirmation as HHS secretary.
In weight loss news, the Outsourcing Facilities Association (OFA), which represents compounders, is suing the FDA after the agency declared an end to the shortage of semaglutide, marketed by Novo Nordisk as Ozempic and Wegovy. This followed a similar OFA lawsuit last fall, filed after the FDA removed Eli Lillyâs tirzepatideâ Zepbound and Mounjaroâfrom its shortage list. In a possible attempt to protect Zepbound from compounder competition, Lilly announced Tuesday that it will expand single dose vials options of the blockbuster weight loss drug at a reduced price. This all comes as a new study compares physician wishlists with investment in the obesity spaceâand reveals key indicators for drug developers.
And itâs been a good news/bad news kind of week in gene therapy, as Pfizer discontinued hemophilia B drug Beqvez worldwide, Regeneron reported more positive data from its gene therapy for genetic deafness and, facing a cash crunch, bluebird bio elected to go private in an acquisition by global investment firms Carlyle and SK Capital Partners.
Finally, let us leave you with a ghost storyâthe story of so-called âghost assetsâ that have found a new home, and a new purpose.
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