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Just hours after J&J’s oncology team bragged about scoring a breakthrough therapy designation for their BCMA CAR-T drug, they pulled the wraps off the multiple myeloma data for JNJ-4528 that impressed the FDA. Following up on some attention-grabbing data initially presented by their Chinese development partners at Legend 2 years…

The first girl in the trial came in with chronic diarrhea and the immune system of an untreated HIV patient. Born with a rare genetic disease that impeded her ability to make B and T cells, she had once been given a stem cell transplant but it didn’t take. Back in the hospital, she was injected with a new experimental antibody and then given a new stem cell transplant. Soon, she gained weight. The diarrhea stopped. “She has normal T cells now, she’s in school,” Judith Shizuru, the Stanford scientist who pioneered the antibody, told Endpoints News . “It’s a wonderful thing.”It’s the kind of medical story you’d love to launch your biotech with, so that’s what Shizuru is doing. Today, her company Jasper Therapeutics is emerging out of stealth.

→ Antibiotic developer Summit Therapeutics has scored a cool in funding from biotech billionaire Robert Duggan — the former chief of Pharmacyclics , the company behind Imbruvica that was sold to AbbVie for $21 billion in 2015 — as it steers its lead drug through late-stage development.

Terrie Curran. → Gastrointestinal disease-focused. Phathom Pharmaceuticals. its leadership team. The company has tapped former. Celgene. exec. Terrie Curran. as CEO, succeeding. David Socks ,. who is transitioning to interim CFO. Curran was president of Celgene’s global inflammation and immunology franchise — helping with the sale of. Otezla. for $13.4 billion to. Amgen. — and has held a previous stint at. Merck. . In addition to Curran, the company also welcomed former. Omeros. CMO. Eckhard Leifke. as CMO, ex-Celgene exec. Joseph Hand. as chief administrative officer, and former general counsel for. Cyclerion Therapeutics Larry Miller. as general counsel. They also replaced. Chris Slavinsky. on the board with. Takeda. exec. Asit Parikh. . Martin Williams. →. Martin Will.

Just weeks after boasting head-to-head victories over first placebo and then J&J’s IL-23 contender in clearing psoriasis, the results are in for UCB’s last Phase III trial, in which bimekizumab went up against the world’s best-selling drug. Only topline results are provided for today’s readout of the BE SURE study, so we won’t find out just how superior bimekizumab proved against Humira on the co-primary endpoints — standard scores known as PASI90 and IGA measuring the impact and severity of the disease — until a scientific conference in 2020. Iris Loew-Friedrich. UCB added that its dual IL-17 inhibitor (which blocks both IL-17A and IL-17F) beat Humira in terms of total skin clearance at weeks 16 and 24, as well as achieving rapid response b.

Having made its marketing pitch to the EU regulator, Novartis on Thursday unveiled positive pivotal study data supporting the use of its inhaled asthma treatment. The therapy, QMF149, consists of the long-acting beta-agonist, or LABA, called indacaterol acetate and the corticosteroid mometasone furoate.

Nearly a year after raising $85 million from investors, Black Diamond Therapeutics has raised another $85 million to help push its allosteric therapies into the clinic in the next few months. The Series C round was led by Boxer Capital. Black Diamond last December as the first company to come out of Versant’s Ridgeline discovery engine in Basel. They had two former developers of the cancer drug Tarveca as co-founders in David Epstein and Elizabeth Buck and a relatively new approach to oncology. Within a month of their full launch, they also had in backing. Elizabeth Buck. Allosteric therapies are essentially like other oncogenetic therapies, such as kinase drugs, that inhibit a protein fueling cancer. But rather than try to inhibit the prote.

FerGene was born ready. By the time Ferring the biotech with a gene therapy licensed from FKD Therapies Oy and $400 million in cash from Blackstone, they had secured a priority review on their BLA and pointed to an imminent date for the pivotal Phase III readout in bladder cancer. The date came yesterday, and FerGene said its experimental drug did not disappoint. In a single arm trial of 157 patients with high-grade non-muscle invasive bladder cancer, investigators zeroed in on a subgroup — 103 patients with carcinoma in situ, ie bladder cancer that is confined to the superficial layer, with or without concomitant high-grade Ta or T1 papillary disease — for the primary endpoint. Three months after receiving one intravesical injection of nad.

The 31 staffers left at German biotech Mologen are now working for a liquidator. And the focus now is on finding buyers for anything it has left that can be sold. Mologen filed for insolvency a few days ago, months after its lead drug — the TLR9 agonist lefitolimod — failed badly in Phase III. Back in August the company reported that their drug produced a near mirror image result for median overall survival in comparison to the control group in a Phase III. Their OS rate was 22 months when the drug was used as a second-line therapy for colorectal cancer. That compared to 21.9 months for the comparison group. And secondary endpoints didn’t provide any reason to hope for something better. Mologen — which had partnered on the drug with China-b.

While Novartis is battling to weaken the challengers vying to market copycat versions of its blockbuster multiple sclerosis treatment Gilenya — the US drug regulator on Thursday approved a trifecta of the drug’s first knockoffs. When they will launch is another question altogether. Known chemically as fingolimod, Gilenya was approved by the FDA in 2010 for relapsing-remitting multiple sclerosis. It generated sales of about $2.4 billion in sales in the first nine months of this year. Geoffrey Porges SVB Leerink. The MS field is crowded, with a range of oral, injectable and infused treatments. Despite new approvals, such as Merck KGaA’s and Biogen’s , neurologists continue to favor Roche’s , Biogen’s and Sanofi’s Aubagio, SVB Leerink’s Geoffre.

Just 9 months after buying Clementia for to acquire its lead rare disease drug palovarotene, the FDA has forced Ipsen to slam the brakes on treating children in late-stage studies underway for the therapy. Officially this is a partial hold, says Paris-based Ipsen, as the feds are ordering a halt to dosing of patients 14 and under in Phase II trials and a Phase III study for fibrodysplasia ossificans progressiva (FOP) and multiple osteochondromas (MO).

Sue Desmond-Hellmann, the longtime researcher and executive who helped lead Genentech to develop the first gene-targeted cancer therapies, is stepping down after 5 years as CEO of the Bill & Melinda Gates Foundation. ". Stepping down as CEO of. is, without a doubt, the toughest decision of my career," she wrote in the first of a series of tweets announcing and reflecting on her departure.

“Exhilarating.” “A major advance.” “A milestone achievement.” If one had just tuned into the panel comments on Biogen’s presentation at CTAD, it would seem that the biotech had an impressive, disease-modifying Alzheimer’s drug in aducanumab. But off the stage, reactions to their admittedly complicated dataset and the biotech’s explanation for resurrecting a drug that failed its futility analysis were a lot more mixed, with analysts continuing to question whether the evidence is substantial enough to warrant an FDA approval and raising new doubts on the safety side. Biogen had a theory going into the Clinical Trials on Alzheimer’s Disease meeting. Once they took into account patients who were consistently exposed to a high dose of aducanumab.

→ As they continue to scoop up for their PARP juggernaut Lynparza, AstraZeneca — along with their partners at Merck — have scored approval in as a first-line maintenance treatment for a form of ovarian cancer. Regulators based their decision on results from the SOLO-1 trial, in which the drug lowered the risk of disease progression or death by 70% when compared to placebo. It marks a major addition to the list of 65 countries in which Lynparza is approved to treat platinum-sensitive relapsed ovarian cancer, the companies said. → Regeneron from a small, Phase II trial on a rare blood disorder. Six patients were given Regeneron’s anti-C5 antibody pozelimab for paroxysmal nocturnal hemoglobinuria, or PNS, a chronic and life-threatening conditi.

It was supposed to be Vivek Ramaswamy’s first drug approval, but the regenerative med company he set up to advance a new tissue-based approach to treating an ultra-rare condition in newborns has been hit with a complete response letter from the FDA. Rachelle Jacques. The FDA...

A few months back, Illumina VP Serafim Batzoglou got an invite from the woman who had first hired him at Stanford two decades prior: Daphne Koller. Koller had been searching for months for a chief data officer for her new artificial intelligence biotech insitro.

As one of the biggest spenders in biopharma R&D, Novartis execs love to tout the scope of its late-stage pipeline, spotlighting the winners most likely to create blockbuster revenue streams in the near future. Building on the 5 drug approvals the pharma giant expects to end the year with, Novartis…

When Michael Ehlers at Biogen to become a venture partner and CSO at Apple Tree, he also got a new job as CEO of a gene therapy startup named Limelight Bio. The stealthy biotech is now ready to shed some — though not much — of its veils. Jean Bennett. As ATP managing partner Seth Harrison tells it, the new venture grew out of a strong relationship with the co-founders, Jean Bennett and Phil Johnson. Bennett, who steered the early research on the landmark gene therapy eventually known as Luxturna alongside Spark Therapeutics CSO Kathy High, now leads Penn’s Center for Advanced Retinal and Ocular Therapies. Meanwhile, Johnson left his role at the Children’s Hospital of Philadelphia to become Limelight’s CSO. “Initially we were focused on backi.

Two years ago, Deerfield writing large checks to prestigious research institutes as part of a strategy to get in on the ground floor of top translational work and, they said, possibly spinout biotechs. One of those biotechs has now emerged from one of the biggest recipients. Eric Fischer. Civetta Therapeutics announced $53 million in Series A funding to apply protein degradation technology from the Dana Farber Cancer Institute to cancer and neurodegenerative diseases, among other targets. The scientific founders were Eric Fischer, head of the Center for Protein Degradation at Dana Farber, and William Sellers, who led oncology research at Novartis for 11 years before to Harvard and Dana-Farber. No investor besides Deerfield was named. The new.

Acadia Pharmaceuticals has broken out the numbers propping up Nuplazid’s surprise early win in a Phase III dementia study and, according to one analyst, it’s “as good as we could have hoped for.”The biotech stunned investors three months ago when they they’re halting the HARMONY trial, having obtained enough positive data at an interim readout to make a pitch to the FDA. It came as a surprise and stirred up a rally around Acadia’s stock , which has suffered from previous at expanding the controversial Parkinson’s disease psychosis drug beyond the approved patient population. Serge Stankovic. Presenting at the Clinical Trials on Alzheimer’s Disease meeting — although they also enrolled patients with other types of dementia — Acadia investiga.

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