Otsuka and Lundbeck’s data are insufficient to establish significant efficacy of Rexulti plus sertraline in PTSD, according to the FDA’s outside experts.
In light of recent patient deaths, the FDA has also revoked its platform designation for Sarepta’s AAVrh74 technology. The designation, granted last month, was the first of its kind to be announced publicly.
Roche and Genentech were unable to sufficiently demonstrate the benefit of using Columvi in an earlier treatment setting for DLBCL in a U.S. population, according to the FDA.
The rollercoaster week for Sarepta Therapeutics continued, with shares of the embattled gene therapy-turned-siRNA biotech down 37% Friday afternoon as media outlets reported FDA plans to request a stop to all shipments of the Duchenne muscular dystrophy therapy Elevidys following a third patient death linked to the underlying platform.
Despite the failure, BMS remains “encouraged” by Reblozyl’s clinical activity in myelofibrosis-associated anemia and will approach regulators to discuss potential submissions for this indication, for which few treatment options exist.
The panelists flagged safety concerns with Blenrep and GSK’s failure to optimize its dosing regimen for the antibody-drug conjugate in multiple myeloma.
FEATURED STORIES
Through substantial leadership turnover and workforce cuts, the FDA has continued to support the advanced therapy sector, actively working to remove obstacles to innovation.
Unpredictable communication and a lack of transparency are eroding the industry’s and the public’s trust. The FDA, experts agree, needs to take control of the narrative.
One of the FDA’s potential approvals this month could break an existing monopoly in the treatment space for a rare growth disorder.
With immunology and inflammation blockbusters like AbbVie’s Skyrizi and Rinvoq reeling in nearly $7 billion combined in the third quarter, the pipeline-in-a-product strategy has never been more attractive.
With pricing pressures climbing, Pfizer, Eli Lilly and other major drugmakers are looking to sell their products directly to patients. Analysts are skeptical that these efforts, including those announced to much fanfare from the White House, will result in meaningful reductions in drug spending.
Representatives from companies such as Sanofi and Forge Biologics point to the potential for PreCheck to drive activation of idle production capacity and help companies that are already building plants.
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
Enigma Biomedical Group - USA (EBG-USA) today announced it has signed an exclusive license and option agreement with AbbVie for the development and potential commercialization of AbbVie’s next-generation F18 PET imaging biomarkers to assess the presence of four-repeat (4R) tau protein in patients with suspected neurodegenerative disease.
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
-
Elicio Therapeutics entered into a merger agreement as a wholly-owned subsidiary of Angion Biomedica Co. on Tuesday, becoming a Nasdaq-listed company. -
If the letter of intent to acquire your company has been signed, you might be asking what happens next. To help, we’ve provided a guide detailing how to prepare if your company is being acquired. -
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week. -
In a presentation led by Robert J. Bradway, Amgen chairman and chief executive officer, the company covered recent acquisitions, Repatha and Lumakras updates, biosimilars and its broader financial outlook. -
Stay on top of what’s happening at JPM. BioSpace is covering all the key announcements all week.
WEIGHT LOSS
-
Speaking at a conference this morning, Pfizer CEO Albert Bourla suggested that Metsera’s therapies could begin hitting the market in 2028. -
The decision to pause dapiglutide will help Zealand focus investment into assets that have “the greatest potential for clinical differentiation” in obesity. -
Altimmune’s pemvidutide showed “class-leading signals” in non-invasive assessments and has “potentially best-in-class tolerability,” according to analysts at H.C. Wainwright. -
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. -
The White House may have struck a deal with Eli Lilly and Novo Nordisk last week to lower the costs of their weight loss drugs for patients, but knockoff versions of Zepbound and Wegovy still permeate the obesity market.
POLICY
-
Based on promising response data from the Phase I/II TRIDENT-1 study, the FDA on Thursday granted Bristol Myers Squibb’s Augtyro accelerated approval for NTRK-positive locally advanced or metastatic solid tumors. -
Shifts in the FDA’s approach present an unprecedented opportunity to solve problems with patient access and trial design. -
The BIOSECURE Act, which seeks to protect U.S. national security from Chinese biotech companies, will not be part of the House of Representatives vote on the 2025 fiscal year National Defense Authorization Act. -
The FDA has a packed calendar this week, with six decisions on the docket, including ones for Merck’s Keytruda, BMS’s Krazati and Sarepta’s Elevidys. -
Teva Pharmaceuticals lost its patent row with Amneal Pharmaceuticals on Monday as a New Jersey court ruled that some of Teva’s claims over its inhaler product ProAir HFA were improperly listed on the FDA’s Orange Book.
Many job seekers take it for granted that the holidays are not the best time to be on the job market, so they suspend their job hunt until after the new year. Others get distracted by all of the holiday hullabaloo and don’t put as much time and effort into their search as they need to.
Building an “Internal Network” is much the same as regular professional networking. Look at some of the reasons why it is important in contemporary times.
Sometimes you don’t have days or weeks to prepare for a job interview. Sometimes, you may only have a few hours… Here are some quick interview tips for moments like this.
Your employment or work history section of your resume is likely the single most important category in the entire document and, when done well, can make a powerful case to your potential employer about how and why you’re well qualified for their open position.
Going into a job interview, especially when you really want the job or don’t have much experience on the job market, can be a nerve-wracking few hours for many candidates.
If you’re considering a future in life science, there’s a good chance a lucrative salary isn’t the biggest draw. For many who choose science careers, the opportunity to satisfy an innate curiosity is more important than a stellar income.
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
-
At Thursday’s Oncology Innovation Day, Pfizer laid out its business strategy which includes building up its biologics business, specifically antibody-drug conjugates and bispecific antibodies. -
Janux Therapeutics on Monday announced positive updated clinical data for both of its clinical programs in prostate cancer advanced or metastatic solid tumors. -
The cancer space has been aflutter with notable approvals so far this year, but there are several more candidates with significant data expected over the next four months. BioSpace takes a closer look. -
A year after Roche returned Gavreto’s global rights to Blueprint Medicines, Rigel Pharmaceuticals has acquired the U.S. rights to the FDA-approved treatment for non-small cell lung cancer. -
The biotech will use the oversubscribed Series C financing to advance its next-generation KRAS blocker FMC-376, which saw its first patient dosed in a Phase I/II clinical trial on Thursday.
NEUROSCIENCE
-
Eli Lilly’s investigational antibody donanemab met all of its primary and secondary endpoints in the Phase III TRAILBLAZER-ALZ 4 study, the company announced Wednesday. -
BioSpace sat down with Roche Global Head of Neurodegeneration Rachelle Doody, Ph.D. and Alzheimer’s Drug Discovery Foundation Co-founder Howard Fillit, M.D. to discuss the highlights. -
Full data from the Phase III Clarity AD trial show Eisai and Biogen’s lecanemab has a favorable safety profile in patients with Alzheimer’s disease. -
With $96 million in Series A financing, Cajal Neuroscience launched Tuesday to develop drug candidates to target neurodegeneration in Alzheimer’s and Parkinson’s diseases. -
A second patient death has been linked to the Phase III clinical trial of Eisai and Biogen’s investigational Alzheimer’s drug lecanemab, according to the journal Science.
CELL AND GENE THERAPY
-
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.
-
The potential approval of Vertex’s IgAN therapy povetacicept in 2026 comes amid launch headwinds for the company’s non-opioid pain medicine Journavx and gene therapy Casgevy.
