The pressure builds for Emma Walmsley as GlaxoSmithKline misses Q1 projection, drops more cancer drugs
Nicole DeFeudis
Editor
GlaxoSmithKline CEO Emma Walmsley is staying focused on the company’s split as earnings slide and Elliott Management lurks on the sidelines, threatening to launch one of its notorious activist attacks aimed to shake things up. And in a Q1 marked by a couple of major setbacks on the oncology side, R&D chief Hal Barron is doing some fine tuning of the pipeline that includes dropping two early stage candidates for cancer and Duchenne muscular dystrophy (DMD).
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January 17, 2022 06:00 AM EST
ZS Perspective: 3 Predictions on the Future of Cell & Gene Therapies
Ben Hohn
The field of cell and gene therapies (C>s) has seen a renaissance, with first generation commercial therapies such as Kymriah, Yescarta, and Luxturna laying the groundwork for an incoming wave of potentially transformative C>s that aim to address diverse disease areas. With this renaissance comes several potential opportunities, of which we discuss three predictions below.
Allogenic Natural Killer (NK) Cells have the potential to displace current Cell Therapies in oncology if proven durable.
Despite being early in development, Allogenic NKs are proving to be an attractive new treatment paradigm in oncology. The question of durability of response with allogenic therapies is still an unknown. Fate Therapeutics’ recent phase 1 data for FT516 showed relatively quicker relapses vs already approved autologous CAR-Ts. However, other manufacturers, like Allogene for their allogenic CAR-T therapy ALLO-501A, are exploring novel lymphodepletion approaches to improve persistence of allogenic cells. Nevertheless, allogenic NKs demonstrate a strong value proposition relative to their T cell counterparts due to comparable response rates (so far) combined with the added advantage of a significantly safer AE profile. Specifically, little to no risk of graft versus host disease (GvHD), cytotoxic release syndrome (CRS), and neurotoxicity (NT) have been seen so far with allogenic NK cells (Fig. 1). In addition, being able to harness an allogenic cell source gives way to operational advantages as “off-the-shelf” products provide improved turnaround time (TAT), scalability, and potentially reduced cost. NKs are currently in development for a variety of overlapping hematological indications with chimeric antigen receptor T cells (CAR-Ts) today, and the question remains to what extent they will disrupt the current cell therapy landscape. Click for more details.
What lured Hal Barron away?; Top FDA minds on accelerated approval reforms; ‘Dead wrong’ Aduhelm ad blitz; and more
Amber Tong
Senior Editor
Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.
Nothing can really compete with Hal Barron’s departure from GlaxoSmithKline as the news of the week, but we do have plenty of original reporting and analysis from the Endpoints team in this edition. Enjoy and have a nice weekend.
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Merck wins legal battle over insurance coverage after ransomware attack
Nicole DeFeudis
Editor
Merck has emerged victorious from a years-long legal battle with insurers over the coverage of more than a billion dollars in losses from the malware NotPetya, with a New Jersey Superior Court judge concluding that the responsibility is on insurers to clarify their policies around cyber attacks.
The pharma giant was one of several victims of a global cyber attack back in 2017 that also hit Danish shipping company Maersk, American food company Mondelēz, French construction giant Saint-Gobain and even the systems monitoring the Chernobyl nuclear power stations, Bloomberg reported back in 2019.
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Critics push back on Alzheimer’s Association ad blitz to get Medicare to change its Aduhelm ruling: 'Dead wrong'
Beth Snyder Bulik
Senior Editor
The latest Alzheimer’s Association advertising campaign encourages people to fight.
Not against the disease or for more research or treatments, but against the Centers for Medicare and Medicaid Services. More specifically, CMS’ recent reimbursement decision to only pay for Biogen and Eisai’s controversial Alzheimer’s drug Aduhelm for patients in clinical trials.
With CMS’ preliminary decision now in a 30-day comment period, patient advocates’ goal is to convince CMS to reverse its decision with a marketing blitz and public pressure.
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Dan O'Day, Gilead CEO (Jim Watson/AFP via Getty Images)
Failing to confirm clinical benefit, Gilead pulls 2 accelerated approval indications for cancer drug
Zachary Brennan
Senior Editor
Gilead recently decided to pull two indications for its cancer drug Zydelig — in relapsed follicular B-cell non-Hodgkin lymphoma (FL) and relapsed small lymphocytic leukemia (SLL) — after failing to complete the confirmatory trials required as part of the accelerated approvals from 2014.
“As the treatment landscape for FL and SLL has evolved, enrollment into the confirmatory study has been an ongoing challenge,” Gilead said in a statement, noting it formally notified the FDA of its decision to voluntarily withdraw these indications.
Executive Director of the EMA Emer Cooke (AP Photo/Geert Vanden Wijngaert)
European Parliament signs off on strengthening drug regulator's ability to tackle shortages
Zachary Brennan
Senior Editor
The European Parliament on Thursday endorsed a plan to increase the powers of the European Medicines Agency, which will be better equipped to monitor and mitigate shortages of drugs and medical devices.
By a vote of 655 to 31, parliament signed off on a provisional agreement reached with the European Council from last October, in which the EMA will create two shortage steering groups (one for drugs, the other for devices), a new European Shortages Monitoring Platform to facilitate data collection and increase transparency, and on funding for the work of the steering groups, task force, working parties and expert panels that are to be established.
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Secondary patents prove to be key in biosimilar blocking strategies, researchers find
Zachary Brennan
Senior Editor
While the US biosimilars industry has generally been a disappointment since its inception, with FDA approving 33 biosimilars since 2015, just a fraction of those have immediately followed their approvals with launches. And more than a handful of biosimilars for two of the biggest blockbusters of all time — AbbVie’s Humira and Amgen’s Enbrel — remain approved by FDA but still have not launched because of legal settlements.
Another day, another xenotransplant, as United Therapeutics looks to beat competitors to sci-fi-esque breakthrough
Max Gelman
Editor
Xenotransplantation is having a moment.
Last October, a team from NYU successfully transplanted a kidney from a pig into a brain-dead patient, although observers cast doubt on the importance of the experiment. Then, earlier this month, surgeons at the University of Maryland transplanted a pig heart into a dying human, who appears to still be stable.
Now, another group is planting a flag in the xenotransplantation field. Surgeons at the University of Alabama at Birmingham said Thursday they have achieved the first kidney transplant from a pig to a brain-dead patient, publishing their peer-reviewed findings online. The team, aiming to differentiate itself from the others through the genetic modifications used, is hoping there’s now enough research to soon begin clinical xenotransplantation studies.
Time limits on accelerated approvals? FDA's oncology chief Rick Pazdur eyes potential reforms via international approaches
Zachary Brennan
Senior Editor
The spotlight on the accelerated approval pathway continues to shine bright, with the FDA’s top oncology official writing in an opinion that the pathway may be strengthened with bits and pieces of what other regulators in Europe and elsewhere have done with their expedited approval pathways, such as adding expiration dates for these faster approvals to ensure they confirm clinical benefit in a timely manner.
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