The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
The patient, who was being treated with an investigational gene therapy for limb-girdle muscular dystrophy, died of acute liver failure, the same complication responsible for the deaths of two boys taking Sarepta’s Duchenne muscular dystrophy treatment Elevidys.
In advance of CMS’ negotiated price for the blood thinner taking effect next year, partners Bristol Myers Squibb and Pfizer pitched the direct-to-consumer program as a way to allow uninsured, underinsured and self-pay patients to pay less out of pocket.
Sarepta Therapeutics appears to have right-sized itself after laying off over a third of its staff, announcing a significant pipeline shift and adding a black box warning to its Duchenne muscular dystrophy gene therapy Elevidys.
In this episode presented by IQVIA, BioSpace’s head of insights Lori Ellis discusses the evolving role of local qualified persons for pharmacovigilance with Ana Pedro Jesuíno, global head local QPPV network at IQVIA.
In its Q2 earnings call Thursday, Novartis said it is moving quickly to reshore its drug manufacturing operations, but CEO Vas Narasimhan told reporters that for most medicines, it typically takes three to four years to completely relocate production.
FEATURED STORIES
Sanofi looks to follow a deep history of Big Pharma offloading their consumer healthcare businesses.
Analysts expect the partners’ first-mover advantage, clinical data and existing presence in lung disease to translate into significant sales, with GlobalData predicting Dupixent’s COPD revenues will top $6.5 billion within 10 years.
Since its inception in 1992, the FDA’s accelerated approval pathway has helped shepherd nearly 300 new drugs to the market. However, recent years have seen a number of high-profile market withdrawals and failed confirmatory trials.
As companies roll out data showing the power and improved safety profile of antibodies that target two antigens, analysts say the class could overtake monoclonal antibody Keytruda as the “immunotherapy backbone” of solid tumor treatment.
Large pharmaceutical companies were out in force at this week’s 2024 Cell & Gene Meeting on the Mesa, as they look to expand their presence in the industry.
Eli Lilly CEO David Ricks is confident his company and peer Novo Nordisk are years ahead in the weight loss space, as biotechs press on with compelling data.
LATEST PODCASTS
In this episode presented by PII, BioSpace’s head of insights discusses with guests Oliver Eden and Travis Webb how autoinjectors offer opportunities to improve delivery systems, patient compliance and clinical trial processes.
M&A headlined for a second straight week as Genmab acquired Merus for $8 billion; Pfizer strikes most-favored-nation deal with White House; CDER Director George Tidmarsh caused a stir with a now-deleted LinkedIn post; GSK CEO Emma Walmsley will step down from her role; and uniQure’s gene therapy offers new hope for patients with Huntington’s disease.
The FDA is hoping to repurpose GSK’s Wellcovorin for cerebral folate deficiency; Pfizer acquired fast-moving weight-loss startup Metsera for nearly $5 billion after suffering a hat trick of R&D failures; psychedelics are primed for M&A action and Eli Lilly may be next in line; RFK Jr.’s revamped CDC advisory committee met last week with confounding results; and Stealth secured its Barth approval.
Job Trends
Alexion Pharma Canada Corp., AstraZeneca’s Rare Disease group, is pleased to announce the appointment of Karen Heim as Vice President and General Manager, Canada, effective April 1st, 2024.
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SPECIAL EDITIONS
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.
BioSpace data show biopharma professionals faced increased competition for fewer employment opportunities during the second quarter of 2025, with increased pressure from further layoffs.
DEALS
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Nearly two decades in the making, the companies expect to close the deal in the first half of 2024, after which Taro Pharmaceutical will become a privately held entity and will no longer trade on the New York Stock Exchange. -
The bladder cancer-focused biotech is looking to be one of the first companies out of the gate with an initial public offering in 2024. -
Taiwanese contract development and manufacturing organization Bora will purchase Minnesota-based Upsher-Smith Laboratories, expanding operations into the U.S. for the first time. -
Alto Neuroscience and Kyverna Therapeutics are following in the footsteps of CG Oncology, Metagenomi and Arrivent in seeking initial public offerings this year. -
Following the J.P. Morgan Healthcare Conference and other parallel meetings in San Francisco, it’s time to reflect on some of the significant deals secured last week.
WEIGHT LOSS
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Novo Nordisk on Monday announced it is boosting its manufacturing capabilities with a $4.1 billion commitment to construct a second fill and finishing facility in Clayton, North Carolina. -
Data showed that Eli Lilly’s Zepbound could resolve obstructive sleep apnea in at least 43% of patients, solidifying the pharma’s case for label expansion. -
Altimmune’s obesity candidate pemvidutide strongly preserved lean muscle mass, with fat accounting for more than 78% of weight lost by participants in a Phase II study. -
Novo Nordisk’s Wegovy elicited greater weight loss in women than in men with heart failure, according to data presented Sunday at the American Diabetes Association’s 2024 Scientific Sessions. -
Zealand Pharma’s petrelintide cut body weight by more than 8% on average, with a good overall safety and tolerability profile.
POLICY
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Former president and CEO of CytoDyn Nader Pourhassan along with Kazem Kazempour, former CEO of the CRO running CytoDyn’s trials, are awaiting sentencing but could face up to 20 years in prison for each count of securities and wire fraud and insider trading. -
The EPIC Act has been proposed with bipartisan and industry support to give small molecule drugs the same protection against price negotiation as biologics, but concerns over how to balance the federal budget could prevent a short-term fix to the IRA. -
In the U.S., the chorus of opposition against the proposed buyout continues to grow and now includes the CEOs of Roche and Lilly, a broad coalition of unions and consumer groups and at least one senator. -
Iskra Reic will continue to serve as the pharma’s senior vice president for Vaccines and Immune Therapies as she steps in for Leon Wang, who was detained by Chinese authorities in November. -
Novartis is seeking to prevent the entry of generics for its blockbuster heart failure drug Entresto, its top-selling asset that brought in more than $6 billion in net global sales last year.
If you’ve been furloughed, it’s normal to feel some apprehension, fear and/or doubt about your employment. These are four ways to stay productive if you’ve been furloughed.
Most job applicants don’t know about questions that they should ask at the end of an interview. Here are some not-so-common interview questions that you must remember to ask.
Once you do land your next job interview, you’ll want to address your layoff in the right way. Here’s how.
Finding common ground and making small talk are both skills that help you build that rapport with someone.
Of the resumes submitted to employers that use Applicant Tracking Systems (ATS), 75% are never seen by human eyes.
The global COVID-19 pandemic may not seem like the best time to accelerate your career, but some characteristics of this unusual time actually lend themselves to career-boosting activities. Whether you are still working from home or are back in your workplace, this article offers suggestions for pumping up your career.
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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Despite meeting the primary endpoint in a Phase III study, two patients treated with Merck and Daiichi Sankyo’s experimental antibody-drug conjugate died in a Phase III non-small cell lung cancer study, though the deaths have not been linked to patritumab deruxtecan. -
Bristol Myers Squibb presented the positive Phase III results on its already approved Opdivo-Yervoy combo at ESMO over the weekend, while separately announcing that it was returning Immatics’ bispecific T cell engager. -
The result comes months after an FDA advisory committee flagged the risk of potential overtreatment with perioperative regimens.
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High response rates reported by GSK and iTeos at the 2024 European Society for Medical Oncology Congress offer a ray of light for anti-TIGIT therapies after a string of failures. -
The FDA has six target action dates ahead to round out September as drugs for gastroparesis, Niemann-Pick disease type C and more await decisions.
NEUROSCIENCE
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While Sage Therapeutics’ drug candidate showed a slight difference compared to placebo in a mid-stage Huntington’s disease trial, William Blair analysts in a Tuesday note to investors said they “remain cautious” on dalzanemdor and “do not view the small numerical changes as definitive.” -
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks. -
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes. -
In this deep dive BioSpace analyzes the neuropsychedelic therapeutics pipeline, which grabbed headlines in February when the FDA accepted the New Drug Application for Lykos Therapeutics’ MDMA capsules for PTSD. -
While more programs now involve candidates with different targets, experts say anti-amyloid therapies will remain a primary player in treating the memory-robbing disease.
CELL AND GENE THERAPY
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Investors were disappointed in data from a mid-stage study of Enlivex Therapeutics’ Allocetra cell therapy for the treatment of sepsis. The Israeli company is considering a follow-on trial in sepsis caused by urinary tract infection. -
The approvals, third line for BMS and 2seventy Bio’s Abecma and second line for J&J and Legend Biotech’s Carvykti, represent a new class of therapy for these blood cancer patients. -
Gamida Cell, whose cell therapy for blood cancer was approved last year by the FDA, is being taken private and restructuring due to liquidity constraints. -
Nanoscope Therapeutics nabbed a victory on the changed primary endpoint of its Phase IIb vision loss gene therapy trial Tuesday, teeing the biotech up to file for FDA approval of the candidate this year. -
With several recent approvals in the space and more on the horizon, BioSpace looks at some of the key decisions and their larger significance both for patients and science.
