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ENDPOINTS 09/22/2020 08:14
With the clock all but up, the FDA accepted and handed priority review to Bristol Myers Squibb and bluebird bio’s BCMA CAR-T, keeping a narrow window open for Celgene investors to still cash in on the $9 CVR from the $63 billion Celgene merger. The acceptance comes five months after the two companies weres slammed with a surprise refuse-to-file that to foreclose the CVR entirely.
ENDPOINTS 09/22/2020 07:12
In what they’re billing as a first for biotech, David Grainger, Francesco De Rubertis and their team at Medicxi have put down a €200 million to sweep up stakes in six companies from their predecessor VC and pump new money into them. Medicxi didn’t disclose which companies it was investing in but the portfolio draws from Index Ventures Life VI, one of the last funds the Medicxi team launched while they were still part of the multinational, tech-focused VC firm Index Ventures.
ENDPOINTS 09/22/2020 07:01
Scripps Research Institute has settled a case with the Justice Department alleging claims of misappropriated funds, the US attorney for the district of Maryland late last week. Prosecutors said the institute improperly used NIH-funded research grants for non-grant related activities, including working on new grant applications, teaching activities and other administrative tasks.
ENDPOINTS 09/21/2020 18:23
President Donald Trump, who seems intent on announcing a COVID-19 vaccine Election Day, could over the objections of , officials at the FDA and even , who have pledged not to release any vaccine unless it’s proved safe and effective. In , , and , a growing number of prominent health leaders say they fear that Trump — who has repeatedly signaled his desire for the swift approval of a vaccine and his displeasure with perceived delays at the FDA — will take matters into his own hands, running roughshod over the usual regulatory process. It would reflect another attempt by a norm-breaking administration, opposed to existing abortion rights and the Affordable Care Act, to inject politics into sensitive public health decisions.
ENDPOINTS 09/21/2020 16:35
William B Crews had been a public affairs specialist at the NIH’s National Institute of Allergy and Infectious Diseases. That ended today when he informed the agency of his decision to retire, after he was as the managing editor at RedState, a prominent Trump loyalist website. Crews’ RedState duties are performed under the alias streiff.
ENDPOINTS 09/21/2020 13:51
Moving into earlier and earlier treatment lines, Bristol Myers Squibb is reporting that adjuvant treatment with Opdivo has doubled the time that esophageal or gastroesophageal junction cancer patients stay free of disease. Samit Hirawat. With the CheckMate-577 data at ESMO, CMO Samit Hirawat said, the company believes it can change the treatment paradigm. While a quarter to 30% of patients typically achieve a complete response following chemoradiation therapy and surgery, the rest do not, said Ronan Kelly of Baylor University Medical Center.
ENDPOINTS 09/21/2020 11:15
For the blockbuster potential of Novartis’ Tafinlar and Pfizer’s Braftovi, all the BRAF inhibitors on the market so far only target V600 mutations — which accounts for roughly 50% of patients. Israeli biotech Novellus now has $57 million to develop a drug that they say can help the other 50% who have everything else. The Series C will fund a Phase II trial for PLX-8394, a "paradox breaker" that could block RAF without activating MAPK signaling.
ENDPOINTS 09/21/2020 11:02
Does Seattle Genetics have another approval on its hands? The last 12 months, not so great for the world, has been great for Seattle Genetics. The company landed two separate FDA approvals, signed a $4.5 billion with Merck and watched antibody-drug conjugates — the technology they spent years developing to broad industry skepticism — emerge suddenly as one of the most popular approaches in oncology. And on Monday at ESMO, the company and their partners at Genmab unveiled the data behind the ADC it hopes will provide its next major FDA approval. In a pivotal Phase II study of their experimental drug tisotumab vedotin, 101 patients with recurrent or metastatic cervical cancer had an objective response rate of 24%, with that response lasting a.
ENDPOINTS 09/21/2020 10:53
Three drug developers announced plans to go public on Friday, a sign that the IPO window for biopharma is . First up is Daly City, CA-based Spruce Biosciences. They filed for an $86 million IPO to develop their pipeline for classic congenital adrenal hyperplasia (CAH). Currently, only steroids are available to treat the condition, which affects the adrenal glands above the kidneys. Spruce’s tildacerfont, a non-steroidal option, is in a Phase IIb trial in adults with classic CAH and poor disease control. The company expects a topline readout here in the next 12 to 15 months. The small molecule is also in a Phase IIb study in adults with classic CAH and good disease control. Spruce expects topline data here in the first half of 2022. The comp.
ENDPOINTS 09/21/2020 10:27
Bausch Health is closing in on a that would allow it to buy out all of Allegro Ophthalmics’ eye-related assets — including the rights to lead candidate risuteganib — for $50 million. The payment would be made in two tranches: $10 million at signing, and $40 million in 2021. Risuteganib is in clinical development for intermediate dry Age-related Macular Degeneration (AMD).
ENDPOINTS 09/21/2020 09:03
Regeneron entered the PD-(L)1 game late, so they devised a two-pronged strategy to catch up with Big Pharma rivals: They would push it into cancers where PD-1s had yet been tested, and they would prove that it’s as powerful in the big indications as any other on the market. They a hurdle on the first goal Friday, showing a 31% response in patients with the rare skin cancer basal cell carcinoma.
ENDPOINTS 09/21/2020 07:32
Following in the steps of Moderna and Pfizer, the other two American drugmakers currently in Phase III trials for their Covid-19 vaccines, AstraZeneca posted its own study protocols over the weekend. The move is the latest in a series of rare peeks behind the curtain, as such blueprints are typically shared once such trials are completed. “Given the unprecedented global impact of the Coronavirus pandemic and the need for public information, AstraZeneca has published the detailed protocol and design of our AZD1222 clinical trial. As with most clinical development, protocols are not typically shared publicly due to the importance of maintaining confidentiality and integrity of trials. AstraZeneca continues to work with industry peers to ensur.
ENDPOINTS 09/21/2020 05:50
Roche is gambling on a new way of discovering drug targets and, ultimately, promising to infuse more than $375 million into a small biotech if all goes well. A spinout of the Netherlands Cancer Institute and Oxford University, Scenic Biotech set out to pioneer a field that’s gaining some traction among top VCs in the US: to harness the natural protecting powers of genetic modifiers — specific genes that suppress a disease phenotype. Oscar Izeboud. After each getting a PhD from the prestigious Dutch research center and spending time in the Boston/Cambridge biotech hub, Thijn Brummelkamp and Sebastian Nijman built their functional genomics platform and named it Cell-Seq.
ENDPOINTS 09/20/2020 15:44
AstraZeneca has unveiled the final, mature overall survival data that cemented Lynparza’s first approval in prostate cancer approval — touting its lead against rivals with the only PARP inhibitor to have demonstrated such benefit. But getting the Merck-partnered drug to the right patients remains a challenge, something the companies are hoping to change with the new data cut. José Baselga. The OS numbers on the subgroup with BRCA1/2 or ATM-mutated metastatic castration-resistant prostate cancer are similar to the first look on offer when the FDA expanded the label in May: Lynparza reduced the risk of death by 31% versus Xtandi and Zytiga.

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