A consumer-driven weight loss market could put pharma at greater risk if a recession hits; the continued turmoil at FDA and other HHS agencies magnifies the uncertainty facing the industry; Lilly files a lawsuit against a med spa selling its drugs; and more.
The company is dropping its former lead molecule in favor of another antibody, RLYB116, which is being developed for a variety of rare autoimmune disorders.
Merida is working on a selective therapy for Graves’ disease, leveraging targeted therapies that can deplete disease-causing autoantibodies.
Last week, The Trump administration reversed a Biden-era proposal for Medicare coverage of anti-obesity treatments. But on Monday, HHS suggested it is open to future policy considerations toward this end.
Stifel analysts said that Lexeo’s data showing reduced size and thickness of the heart’s left ventricle are “supportive of a drug effect” for the company’s gene therapy in Friedreich’s ataxia cardiomyopathy.
Senators Bill Cassidy and Bernie Sanders asked HHS Secretary Robert F. Kennedy, Jr. to make good on a pledge to appear before the committee regularly. It is not clear if or when the hearing, which was scheduled for Thursday, will take place.
FEATURED STORIES
Following a series of clinical failures, optimism builds for the first disease-modifying treatment.
Since taking the helm in 2023, Anderson has embarked on a radical departure from the traditional structure of large pharma companies. Will getting rid of management layers fix Bayer?
While biopharma professionals cited age discrimination as an issue in a new BioSpace report, it’s not the only factor affecting older and younger people’s job searches.
The weight-loss drug bonanza continued in the first quarter of 2024 for Novo Nordisk and Eli Lilly, as Amgen also posted strong results, while Biogen and BMS struggled early in the financial year.
Applications of the technology range from data collection to drug design to raising the alarm on product safety, but its adoption is also creating some anxiety.
Crackdowns on drug pricing have forced one major insulin out of the market. Are more to come?
FROM BIOSPACE INSIGHTS
In a year when eradicated diseases are on the uptick in America, how will American children survive RFK Jr.’s vaccine scrutiny and inconsistency? Two experts call on pharma and regulatory bodies to rebuild trust.
LATEST PODCASTS
In this episode of Denatured, BioSpace’s Head of Insights Lori Ellis discusses key themes from BIO and DIA, including the funding environment, with Rich Daly, CEO of Catalyst Pharmaceuticals, Peter Ronco, CEO of Emmes Corporation, and Phil Vanek, founder of Redline Bio Advisors.
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines.
HHS Secretary Robert F. Kennedy Jr. made waves this week, firing the remaining members of the CDC’s Advisory Committee on Immunization Practices; Metsera’s amylin drug produced weight loss of 8.4% at 36 days; and FDA leaders gathered last week to discuss the future of cell and gene therapy, a sector that has been in turmoil since the ousting of CBER Chief Peter Marks.
Job Trends
FDA Advisory Committee Votes in Favor of Bristol Myers Squibb’s and 2seventy bio’s Abecma for Triple-Class Exposed Multiple Myeloma in Earlier Lines of Therapy.
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SPECIAL EDITIONS
BioSpace did a deep dive into executive pay, examining the highest compensation packages, pay ratios and golden parachutes—what a CEO would get paid to leave.
A new generation of checkpoint inhibitors is emerging, with some showing more promise than others. From recent TIGIT failures to high-potential targets like VEGF, BioSpace explores what’s on the horizon in immuno-oncology.
Peter Marks, the venerable head of the FDA’s Center for Biologics Evaluation and Research, has been forced out. In this special edition of BioPharm Executive, BioSpace takes a deep dive into the instability of the HHS.
DEALS
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Though data became an issue in two separate meetings, the FDA’s Oncologic Drugs Advisory Committee made a potentially precedent-setting decision by voting in favor of US WorldMeds’ neuroblastoma treatment. -
Following a Phase III failure and the departure of its CEO, Mirati Therapeutics is rumored to be engaged in acquisition discussions with French pharma giant Sanofi, according to Bloomberg. -
After finally getting the green light from the Federal Trade Commission last month, Amgen has completed the buyout and expects to provide updated fiscal year 2023 guidance during its third-quarter earnings call. -
The Japan-based pharma is acquiring Orchard Therapeutics for approximately $477.6 million, if all conditions are met. Orchard’s pediatric gene therapy has a PDUFA date set for March 2024. -
AbbVie, Amgen, Gilead, Merck and Novartis are among the 31 members that have formed the Partnership for the U.S. Life Science Ecosystem to push back against federal antitrust reforms.
WEIGHT LOSS
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Novo Nordisk’s blockbuster weight-loss drug Wegovy was approved on Friday by the FDA to reduce the risk of cardiovascular death, heart attack and stroke in adults who have cardiovascular disease and are obese or overweight. -
Novo Nordisk’s early-stage amylin and GLP-1 co-agonist elicited a 13.1% reduction in body weight, with an overall favorable safety profile, the Danish drugmaker reported Thursday at an investor event. -
After stopping the study early due to strong efficacy, Novo Nordisk released data from the FLOW study showing significant benefits of semaglutide in patients with type 2 diabetes and chronic kidney disease. -
Eli Lilly is planning to launch its blockbuster diabetes drug Mounjaro next year in India, the world’s most populous nation, ahead of its main competitor Novo Nordisk which is eyeing an Indian launch of Wegovy in 2026. -
Viking Therapeutics announced Tuesday that its GLP-1/GIP receptor dual agonist helped patients lose up to nearly 15% of their weight over about three months in a Phase II study.
POLICY
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Eli Lilly on Thursday said it is again suing spas and clinics over compounded and counterfeit forms of tirzepatide, the active ingredient in blockbusters Mounjaro and Zepbound, which the pharma says can cause harmful side effects. -
The Federal Trade Commission is supporting the U.S. Patent and Trademark Office’s proposed new rules requiring parties to a patent dispute to disclose all settlement agreements, including pharmaceutical drug settlements. -
National Institutes of Health researchers in a Phase Ib/II study found a five-drug combination elicits strong remission rates in diffuse large B-cell lymphoma patients without using chemotherapeutic agents. -
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others. -
Following two deaths due to presumed sepsis, the FDA has placed a partial clinical hold on three trials for Zentalis’ azenosertib including a Phase I in solid tumors, Phase II in platinum-resistant ovarian cancer and Phase II in uterine serous carcinoma.
Questions about the future are not uncommon in job interviews and represent an opportunity for careful preparation.
It’s common to feel overwhelmed or stressed about a major career change. There are a few things you can do to position yourself as the right person for the job.
Once you have your job search spreadsheet organized and the hunt is officially underway, complete the tasks that come up with this method in mind.
Two effective focal components – deployed separately or together – are the resume headline and resume branding statement.
Going into an interview knowing that it’s OK to be yourself and perfection isn’t the goal can help alleviate that self-imposed pressure.
In order to play the “cat and mouse” game with poise, we’ve provided a breakdown of the steps to take to negotiate properly. Read on for tips to help you successfully negotiate a job offer.
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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Bucking its recent winning streak in oncology, AstraZeneca reported Tuesday that its AKT inhibitor Truqap failed to significantly boost overall survival in patients with triple-negative breast cancer. -
The FDA is facing four big target action dates in the final week of June, including one label expansion for a bispecific antibody and another for an investigational gene therapy. -
The hold on BioNTech and MediLink’s antibody-drug conjugate candidate BNT326/YL202 has halted enrollment in a Phase I U.S. trial in patients with non-small cell lung cancer or breast cancer, following multiple deaths. -
Coherus BioSciences and Junshi Biosciences’ PD-1 inhibitor Loqtorzi significantly boosted progression-free and overall survival in a late-stage study of patients with advanced hepatocellular carcinoma. -
The use of artificial intelligence in the development of cancer vaccines allows for individualized therapy, but the prospect of an ever-changing product poses new challenges for drug developers and regulators.
NEUROSCIENCE
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For forms of Alzheimer’s, frontotemporal dementia and Parkinson’s caused by genetic defects, gene therapy could change the treatment landscape. -
To protect the central nervous system, the blood-brain barrier bars entry to around 98% of molecules—but approaches like Roche’s trontinemab could spell new hope in Alzheimer’s and beyond. -
While the biotech’s third-quarter revenue beat Wall Street expectations, its $7.3 billion acquisition of Reata Pharmaceuticals—which closed in September—negatively impacted 2023 per-share earnings. -
After winning traditional approval from the U.S. regulator, Eisai’s Alzheimer’s disease therapy Leqembi has seen a sharp increase in patient uptake, with a target of 10,000 patients by March 2024. -
A third-party audit found no integrity and reliability problems with data from BioXcel Therapeutics’ Phase III trial. The company intends to file a supplemental New Drug Application for its candidate BXCL501.
CELL AND GENE THERAPY
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While BMO Capital Markets said that zimislecel is “highly encouraging” for type 1 diabetes, questions regarding its target population and Vertex’s execution hang over the cell therapy’s commercial potential. -
The well-respected director of the FDA’s cell and gene therapy office was seen as a stabilizing and trustworthy voice inside the quickly reshaping FDA, especially since the late-March exit of CBER Director Peter Marks. -
Another patient has died from acute liver failure after receiving Sarepta’s gene therapy for DMD ; After a quiet start to the year, M&A is back with one deal for a gene editing biotech reinvigorating that sector; and RFK Jr. installs a suite of new vaccine board members who share his skeptical views on vaccines. -
The pending deal was rumored overnight after a report from the Financial Times, spurring analysts to speculate that if true, the entire gene editing space would see a boost at the markets. -
Analysts at Truist Securities called J&J’s CAR T readout “compelling,” noting that the efficacy figures could position the cell therapy as a formidable competitor to the current standard of care, Gilead’s Yescarta.
