The FDA greenlit multiple new drugs this month and issued some notable label expansions, including for Eli Lilly’s Kisunla. Meanwhile, the regulator turned away a cell therapy for Duchenne muscular dystrophy and a gene therapy for the rare disease Sanfilippo syndrome.
Bristol Myers Squibb tested Cobenfy as an adjunctive treatment with atypical antipsychotics for schizophrenia in the Phase III ARISE study, which earlier this year failed to demonstrate significant symptom improvement.
For now, Sanofi’s U.S. inventory is insulating the company from a potential 15% tariff on drugs shipped from the EU.
Move over Humira, Skyrizi and Rinvoq are expected to beat the former megablockbuster’s peak sales by the end of this year.
Rumors of Biogen’s disagreements with Eisai have been greatly exaggerated, CEO Chris Viehbacher said during a second quarter earnings call. The partnered Alzheimer’s drug Leqembi saw sales climb 20% for the period.
The announced reduction of hundreds of staff came a day ahead of Moderna’s Q2 earnings report.
FEATURED STORIES
After a busy first half of 2024, several companies are expecting key data readouts in the neuropsychiatric and neurodegenerative disease spaces during the next six months.
Why I advocated on Capitol Hill this month for the renewal of the FDA’s Priority Review Voucher program
Halia Therapeutics, NodThera and Gain Therapeutics target neuroinflammatory processes in hopes of modifying the course of Parkinson’s progression.
The Federal Trade Commission criticized the business practices of pharmacy benefit managers this week, but drugmakers are also at fault for the high costs of medicines.
Artificial intelligence is making it faster to get drug candidates to the clinic, but to gain a competitive advantage, companies must have a strong foundation of data.
Investment in the development of new antimicrobials is falling rapidly, even as the global public health threat of antimicrobial resistance is growing increasingly severe worldwide.
LATEST PODCASTS
In this episode presented by Slone Partners, Leslie Loveless, Co-CEO and Managing Partner discusses how hiring and the building of executive teams has responded to the current biotech environment.
Pfizer seals the deal with Metsera for $10 billion after Novo Nordisk bowed out; President Donald Trump welcomes executives from Novo and Eli Lilly to the White House to announce that the companies’ GLP-1 medicines would be sold at a reduced cost; and the FDA grants the second round of priority review vouchers—primarily to already marketed drugs.
In this episode presented by PII, BioSpace’s head of insights discusses how to relieve clinical trial patients of technological burden to improve compliance with guests Oliver Eden and Travis Webb.
Job Trends
Alnylam Pharmaceuticals, Inc., the leading RNAi therapeutics company, reported its consolidated financial results for the fourth quarter and full year ended December 31, 2023 and reviewed recent business highlights.
Subscribe to GenePool
Subscribe to BioSpace’s flagship publication including top headlines, special editions and life sciences’ most important breaking news
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
-
The acquisition will bring gene therapy company Decibel Therapeutics into Regeneron’s fold after a six-year partnership, targeting different forms of congenital and monogenic hearing loss. -
Following difficult recent months for EQRx, the biotech is being bought by Revolution Medicines in an all-stock transaction that secures $1 billion in additional capital for the oncology company. -
Biogen’s $7.3 billion Reata acquisition and layoffs dominated this week’s news, while BMS and Roche reported second-quarter earnings and BioSpace looked at 12 late-stage neuro companies. -
Following a sweeping cost-cutting plan announced earlier this week, including an 11% workforce reduction, Biogen is acquiring Reata Pharmaceuticals to bolster its neurological and rare disease pipeline. -
The British drugmaker’s rare disease subsidiary Alexion will take on a number of Pfizer’s preclinical gene therapy programs and technologies to advance its genomic medicines pipeline.
WEIGHT LOSS
-
The recent FDA decision will likely mean more Medicare patients gain access to the blockbuster weight loss drug, experts say. Meanwhile, results continue to roll in for GLP-1 agonists for conditions beyond diabetes and obesity. -
Novo Nordisk’s investment of more than half a billion dollars is meant to expand its production capabilities in China and help it meet the global drug demand. -
Heather, Greg and Tyler discuss a busy news week including Wegovy’s label expansion, biosimilars, surprise donanemab delays for Eli Lilly and speculate on election impact. -
Eli Lilly has partnered with Amazon Pharmacy to help fill online orders of its obesity drug Zepbound—as well as migraine and diabetes medicines—placed through the pharma’s online portal LillyDirect. -
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.
POLICY
-
The combination therapy is one step closer to becoming a potential new first-line standard of care for patients with unresectable or metastatic urothelial carcinoma in Europe. -
Despite their initial kicking and screaming, drugmakers seem confident the Inflation Reduction Act’s Medicare Drug Price Negotiation Program will not greatly impact their bottom lines. -
Executives from the three largest pharmacy benefit manager companies testified Tuesday before Congress that rising drug prices in the U.S. are due to pharma companies taking advantage of market exclusivities and excessive charges. -
Allarity Therapeutics announced Monday that the Securities and Exchange Commission has made a preliminary determination recommending an enforcement action against the company for alleged violations of federal securities laws. -
The Department of Health and Human Services’ Office of the Inspector General found that bluebird bio’s fertility support program for its gene therapies could potentially violate federal anti-kickback statutes.
Have you ever wondered why some life science professionals seem very happy at work, and appear to love their jobs? At the same time, their co-workers in an identical position are miserable.
Arguments in the workplace are often unavoidable. There will be differences in opinion, strategy and planning efforts. To help, here are some tips on how to avoid arguments at work.
A recent BioSpace survey found that health insurance is one of the top considerations of life science professionals willing to relocate for a job. To learn more, we interviewed Carrie Richards Leary, a health insurance benefits professional.
According to a BioSpace poll, over half (56%) of respondents are not happy with their current life sciences position. Are you one of the 56%? You deserve to be happy! Start working towards your happiness and check out job opportunities at these top companies!
You want to take every opportunity you can find to incorporate resume action verbs. The main way to do that is to replace any weak verbs you’ve written.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2019. We want to know your if you have ‘work-life balance’ with your job.
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
-
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. -
AbbVie’s antibody-drug conjugate Elahere, developed by ImmunoGen, elicited a nearly 52% objective response rate in heavily pretreated patients with folate receptor-alpha-positive, platinum-sensitive ovarian cancer.
NEUROSCIENCE
-
While the trial was designed to test safety and not efficacy, patients treated with Araclon Biotech’s experimental ABvac40 vaccine saw a 38% drop in disease progression compared to placebo. -
While sensitive and specific biomarkers for Alzheimer’s disease have recently taken a leap forward, the Parkinson’s space has lagged behind. Neurofilament Light Chain could change that. -
The biopharma’s data manipulation controversy continues with a recently leaked City University of New York report, which found signs of “egregious” and “deliberate” misconduct by a company advisor. -
Data from the Mayo Clinic shows limited eligibility for the anti-amyloid treatment. However, Michael Irizarry, Eisai’s deputy chief clinical officer, says some patients could still be eligible. -
After a groundbreaking year in the Alzheimer’s space, Parkinson’s disease researchers express renewed hope based on a greater biological understanding of neurodegeneration.
CELL AND GENE THERAPY
-
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation. -
The plausible mechanism pathway “could accelerate gene therapy/editing development,” analysts at William Blair said Thursday, while adding that additional clarity is needed. -
MeiraGTx Holdings is licensing a genetic eye disease medicine to Eli Lilly in a deal worth up to $475 million. -
The FDA previously placed two clinical studies on hold, including the Phase III trial in which the liver toxicity occurred. Intellia is working with experts to create a risk management program for nex-z. -
Pfizer and Novo Nordisk continue to fight for ownership of obesity startup Metsera; CDER Director George Tidmarsh leaves his position amid an ongoing probe into his “personal conduct”; FDA reverses course on approval requirements for uniQure’s Huntington’s gene therapy; Sarepta’s exon-skipping Duchenne muscular dystrophy drugs fail confirmatory study.
