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ENDPOINTS 12/06/2019 07:49
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.
ENDPOINTS 12/06/2019 06:46
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.
ENDPOINTS 12/06/2019 04:39
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).
ENDPOINTS 12/05/2019 15:57
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.
ENDPOINTS 12/05/2019 14:58
“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.
ENDPOINTS 12/05/2019 10:27
→ 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.
ENDPOINTS 12/05/2019 08:30
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.
ENDPOINTS 12/05/2019 07:36
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.
ENDPOINTS 12/05/2019 07:11
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.
ENDPOINTS 12/05/2019 06:56
After a checkered mid-stage program marred by drug-related , Aurinia emerged victorious on Wednesday with phase III lupus nephritis data that demonstrated its lead drug is safe and effective for a patient population that has few options. Peter Greenleaf CEO, Aurinia. Aurinia’s shares skyrocketed in Thursday morning premarket trading, as the Canadian biotech unveiled plans to submit a marketing application next year. The 357-patient placebo-controlled tested the company’s drug, voclosporin, in combination with mycophenolate and low-dose corticosteroids to evaluate whether the therapy could improve the speed of and overall renal response rates in patients with lupus nephritis, where the autoimmune disease ravages the kidneys, triggering inflam.
ENDPOINTS 12/05/2019 06:29
Josh Bilenker, Jake Van Naarden and Nisha Nanda came out of Eli Lilly’s $8 billion Loxo Oncology buyout with a bundle of cash and plenty of choices on what they could do next. Start a new company, go public. Live on the beach in 5-star luxury. Contemplate the stars — in their own observatory. So what are they doing? They formed a new executive team that is taking over the management of Eli Lilly’s hundreds-strong oncology R&D group — essentially using Loxo as a base for a bold new experiment in Big Pharma R&D in an attempt to create a true biotech environment with the deep pockets of a . They’ve recruited David Hyman from Memorial Sloan Kettering to join the team as chief medical officer. And the mandate includes culling out the oncology pi.
ENDPOINTS 12/04/2019 11:38
As last Christmas approached, analysts anticipated a potential blockbuster from Immunomedics. Instead they got pharma coal: a CRL. Now, nearly a year after the FDA first , the ADC biotech is returning to plead their case again. They have resubmitted their BLA, seeking accelerated approval for sacituzumab govitecan for triple-negative metastatic breast cancer. Immunomedics said the FDA noted manufacturing issues in their rejection. Soon after, it emerged that the agency had previously cited them for a breach of in the months leading up to their PDUFA, although the publicly released report is heavily redacted and it remains unclear if the data breach was directly connected to the FDA rejection. The rejection triggered upper-level changes at a.
ENDPOINTS 12/04/2019 11:36
Tech giants have penetrated the realm of healthcare. Meanwhile, the biopharmaceutical industry has embraced the promise of digital drug development and medicine as it ushers in the era of telemedicine, wearables, cloud computing, machine learning and artificial intelligence. Novartis, which was one of the pioneering large drugmakers to hire a chief digital/technology officer in 2017, has now with the widely used cloud platform Amazon Web Services to streamline its manufacturing, supply chain, and delivery operations. The technology will be used to give Novartis scientists and researchers real-time visibility into the Swiss drugmaker’s manufacturing and distribution apparatus, enabling teams to track production lines, diagnose potential bott.
ENDPOINTS 12/04/2019 11:32
→ Celgene and Acceleron ‘s Reblozyl ( luspatercept ) from the FDA last month to treat anemia in adults who require regular transfusions, but still had a pending review with regulators about using the drug for myelodysplastic syndromes (MDS). Now, Bristol-Myers — which completed its $74 billion takeover of Celgene — and Acceleron said the FDA’s Oncologic Drugs Advisory Committee will meet to their supplemental biologics license application to to cover the treatment of adult patients with very low- to intermediate-risk MDS-associated anemia who have ring sideroblasts and require red blood cell (RBC) transfusions. The PDUFA date is set for April 4, 2020. → David Meeker’s KSQ Therapeutics — which earned a from a financing round last year — cell.
ENDPOINTS 12/04/2019 11:15
When Merck was hit with a ransomware attack in 2017, the pharma giant was in fact just collateral damage from a virus Russia aimed at Ukraine, and the company is struggling to recoup its losses because its $1.75 billion insurance plan doesn’t cover acts of war. Those are details from a richly reported story out yesterday exploring how a geopolitical fight in Eastern Europe accidentally entangled a New Jersey-based pharmaceutical company and sparked lawsuits with major ramifications for the future of insurance and cybercrime. Merck employees logging on to their computers on June 27, 2017 were greeted with a polite message in pink letters: "Ooops, your important files are encrypted.
ENDPOINTS 12/04/2019 10:46
Omeros has brought some stellar pivotal data to the FDA to build a case for its blood clot drug, narsoplimab. They just can’t say exactly how they got to the conclusion yet. Gregory Demopulos. Reporting preliminary data from its single-arm, open-label trial, the Seattle-based biotech said 56% of the patients — who were experiencing thrombotic microangiopathy following hematopoietic stem cell transplants — receiving at least one dose of narsoplimab achieved complete responder status. Among the subset who received at least four weeks of dosing, 68% met the criteria. So what separates a responder from a non-responder? That will have to “remain confidential for competitive business reasons,” the company said in a statement, stressing that FDA re.

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