Sarepta’s Elevidys is back on the market for ambulatory patients with Duchenne muscular dystrophy, Health Secretary Robert F. Kennedy Jr. reportedly plans to dissolve the U.S. Preventive Services Task Force and “fix” the vaccine injury compensation program, Merck, AstraZeneca and more report Q2 earnings, Novo names a new leader and Roche’s trontinemab impresses at AAIC25.
Among the problems cited were cat hair, bacterial contamination and instrument defects.
Washington has had notable life sciences job growth over the past 10 years, according to a Life Science Washington report. The association’s CEO and a biopharma CEO discuss what makes the state stand out, including its talent pool, AI leadership and entrepreneurship support.
In this episode presented by Cresset, BioSpace’s head of insights Lori Ellis discusses clinical trial fail rates and AI’s potential to reduce preclinical costs with Mutlu Dogruel, VP of AI and Mark Mackey, CSO of Cresset.
Stealth BioTherapeutics originally submitted elamipretide for approval in January 2024, only to receive a rejection in May of this year. In addition to accepting the biotech’s resubmission, the FDA has promised to take action on the candidate by Sept. 26.
President Donald Trump first threatened pharma tariffs in February and recently said they were imminent. Johnson & Johnson’s new investment adds to a $55 billion pledge made by the company in March.
Hundreds of HHS Staffers Accuse RFK Jr. of ‘Sowing Public Mistrust’ Against CDC After Shooting at HQ
In an open letter, Health and Human Services employees asked the Secretary to stop and disavow the spread of health misinformation, particularly about vaccines, infectious diseases and federal health agencies.
FEATURED STORIES
Sage Therapeutics discontinued development of its lead candidate dalzanemdor after a third clinical failure, leading analysts to question the biotech’s future profitability.
With two decisions originally scheduled for this week already announced, including BridgeBio’s approval in ATTR-CM, the regulator has just one PDUFA on its plate this holiday week.
ADC Therapeutics, Sutro Biopharma and Zai Lab are among those developing antibody-drug conjugates to address payload and toxicity challenges of current ADCs—and rapidly grow the multibillion-dollar market.
RFK Jr. as HHS head is perhaps President-elect Donald Trump’s most controversial Cabinet pick now that Matt Gaetz has withdrawn as nominee for Attorney General. With Dr. Oz tapped to lead CMS and maybe Marty Makary at the FDA, it’s going to be quite the show.
While the full impact of the Supreme Court decision remains unknown, the new regulatory landscape could be a net positive for drug developers.
A handful of billion-dollar deals in the rare disease space highlights the uptick in Big Pharma’s investment, but it’s still extremely low compared to the money flowing to more common indications.
LATEST PODCASTS
In this episode we dive into regulation, real-time management, and AI’s various applications and how it can streamline different processes with guests from Microsoft and IQVIA.
In this episode, hear from senior leaders at Microsoft and IQVIA to get their take on how generative AI is impacting productivity, employee engagement and how to mitigate risks.
This week we discuss ups and downs in the weight loss and ADC markets - including Altimmune, Pfizer setbacks, AbbVie’s ImmunoGen buy and more.
Job Trends
Building upon their partnership announced last year, digital health leader Dawn Health and global pharmaceutical company Novartis are proud to announce the launch of Ekiva PNH, an innovative digital solution designed for people living with Paroxysmal Nocturnal Hemoglobinuria.
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SPECIAL EDITIONS
In this deep dive, BioSpace investigates China’s rise as a biotech powerhouse.
In this deep dive, BioSpace explores the next big thing in obesity.
BioSpace did a deep dive into biopharma female executives who navigated difficult markets to lead their companies to high-value exits.
DEALS
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IFM Therapeutics announced Wednesday its subsidiary IFM Due has been acquired by Novartis. The acquisition provides the Swiss pharma with full rights to IFM Due’s portfolio of STING antagonists targeting inflammation-driven diseases. -
The early-stage oncology startup filed for an initial public offering on Wednesday, seeking funds to help develop its novel cancer therapies targeting extrachromosomal DNA. -
Follow along as BioSpace keeps you up to date on the latest pharma and biotech M&As, from announcements to closings. -
Companies inked 204 deals in the fourth quarter of 2023 with venture capital funding slipping to $6.3 billion from $7.8 billion in the third quarter last year, according to market data firm Pitchbook. -
After oncology and neuroscience headlined biopharma investment in 2023, experts anticipate increased interest in the autoimmune and obesity spaces this year.
WEIGHT LOSS
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A day after Eli Lilly’s obesity and weight-loss therapies were removed from the regulator’s database, Novo Nordisk also made strides in boosting the supply of all but one of semaglutide’s shortages. -
The company is projecting that future growth will be driven by geographic and label expansions for its rare disease assets, as well as potential approvals in obesity. -
All doses of Eli Lilly’s type 2 diabetes medication Mounjaro and weight-loss drug Zepbound are now available, according to an update on Friday to the FDA’s drug shortage database. -
Eli Lilly on Thursday released late-stage data showing a 38% reduction in the risk of heart failure outcomes, as it plays catch-up with Novo Nordisk’s semaglutide which won the FDA’s cardio nod in March. -
Second-quarter earnings season continues with Big Pharma beating Wall Street expectations, the author of an encrypted email sent to BioSpace has a proposal for Moderna and Merck, Roche and Viking seek quicker entry to the obesity market, and AAIC is in full swing.
POLICY
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Less than a day into his second term, President Donald Trump ordered a freeze on communications at major public health agencies, among other moves that have sent waves through the biopharma industry. -
The settlement is the largest deal to date with the people primarily who played an “instrumental role” in driving the opioid crisis, according to the office of Massachusetts Attorney General Andrea Joy Campbell. -
Robert F. Kennedy, Jr.’s recent disclosures have revealed several potential conflicts of interest, including investments in two biopharma companies. -
The U.S. Court of Federal Claims ruled that Vanda cannot claim a breach of confidentiality for specifications that it did not develop itself. -
At J.P. Morgan, most biopharma executives expressed a neutral stance on the incoming administration, but just days later, President Trump issued multiple executive orders that concern the industry.
Maryland has become a key part of the strategy for Kite, a Gilead company, and its mission to find a cure for cancer.
As your organization continues with hiring efforts, interviewers will face new questions from candidates that they’ve never been asked before.
If you are looking for a new job, it is crucial to have an ATS friendly resume. Let’s discuss how to do this and why they’re so popular with hiring managers.
Do you have soft skills but don’t know how to show them on your resume? Here are 6 of the most popular soft skills for resume and tips on how to make sure they get noticed.
Here are some of the top questions you should consider asking during an interview regarding COVID-19.
If you’re struggling to figure out how, exactly, to back up your accomplishments with facts, think about your impact, and then ask yourself some of these questions.
HOTBEDS
REPORTS
In this Employment Outlook report, BioSpace explores current workforce sentiment, job activity trends and the prospective job and hiring outlook for 2025, particularly as it compares to the previous year.
BioSpace’s third report on diversity, equity, inclusion and belonging in life sciences examines dramatic shifts in attitude around diversity initiatives.
CANCER
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Opdivo showed a 52% progression-free survival advantage over Adcetris in newly diagnosed Hodgkin’s lymphoma, according to a Phase III study that combined either therapy with doxorubicin, vinblastine and dacarbazine. -
Thursday’s agreement with Orano Med is the second in as many months. Sanofi in September made its first foray into the radioligand space with a $110 million licensing deal with Orano Med and Texas biotech RadioMedix. -
Jazz Pharmaceuticals contends that its alkylating agent Zepzelca significantly improved both overall survival and progression-free survival in patients with extensive-stage small cell lung cancer, when used as a front-line maintenance therapy with Roche’s Tecentriq. -
Sales of Johnson & Johnson’s oncology drugs jumped nearly 19% in the third quarter, driven by cancer treatment Darzalex which brought in more than $3 billion. -
The FDA is looking at four events for the remainder of October, one of which is an advisory committee meeting for a dual SGLT inhibitor for use alongside insulin in type 1 diabetes and chronic kidney disease.
NEUROSCIENCE
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The European Medicines Agency’s Committee for Medicinal Products for Human Use found that Leqembi’s benefits do not outweigh the risks of severe side effects associated with the treatment. -
Biogen and Sage Therapeutics’ investigational neuroactive steroid did not significantly improve upper limb tremors in patients with essential tremor, the companies announced Wednesday. -
While supportive of Amylyx’s acquisition of a GLP-1 drug, analysts say the company’s future hinges on key upcoming readouts from multiple products in its pipeline. -
After a long and challenging journey for its stem cell therapy NurOwn, BrainStorm Cell Therapeutics has aligned with the FDA on the parameters of a Phase IIIb ALS trial that is expected to begin by the end of 2024. -
While type 2 diabetes and obesity are the primary conditions currently treated with blockbuster GLP-1 drugs, Novo Nordisk and Eli Lilly aim to enter additional markets.
CELL AND GENE THERAPY
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At a Thursday ASGCT 2024 session, CBER Director Peter Marks made the case for a better, “more convergent” global framework on cell and gene therapies, especially for rare diseases. -
An autologous and personalized regulatory T cell therapy is safe in patients with type 1 diabetes, but does not help preserve β-cell function. -
Launched in 2021, the public-private consortium on Wednesday updated ASGCT attendees on its efforts to bring adeno-associated virus gene therapies to more rare disease patients. -
We are in an unprecedented time in neurotherapeutics. Medicines that address the causative disease biology underlying central nervous system -
In a fireside chat at the American Society of Gene & Cell Therapy conference, CBER Director Peter Marks spoke with Takeda’s Kristin Van Goor about how the regulator is approaching the exploding gene therapy space.
