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ENDPOINTS 04/06/2020 16:21
It turns out that even sending everyone from the CEO to rank-and-file staffers home to work in the middle of a Category 5 wasn’t enough to in the flow of . And even dealmaking held its own against the howling winds of misfortune — largely because a group of savvy players was quick to adjust to the new reality. Chris Dokomajilar. Our deal expert Chris Dokomajilar ran the numbers for us on a month-to-month basis and found that not only was venture money flowing during the panicky month of March, but it was also hitting home in record sums compared to the last 26 months of deal flow. Say what? As you can see in the top chart below, Dokomajilar outlined how the industry racked up $2.41 billion in total for March, just barely ahead of one other t.
ENDPOINTS 04/06/2020 11:19
More than a year ago, hit by a surprise complete response letter from the FDA, Immunomedics bid its then-CEO, Michael Pehl, and began a 15-month quest to resolve the manufacturing issues cited in the CRL and seek a new leader — all the while moving forward with a Phase III study on its lead drug for metastatic triple-negative breast cancer. Harout Semerjian. Today the biotech said their stars are finally aligning.
ENDPOINTS 04/06/2020 10:41
The biotech dollars just keep rolling in. Even as the world economy faces an economic contraction unprecedented in nature, biotech venture capital firms are announcing huge new investment pots. The latest? Deerfield Management Co. The firm, known for its aggressive and unique push into universities, has raised $840 million for a new fund, focused on medical technology, digital health and drug development. The announcement comes days after Flagship Pioneering and ARCH Ventures – two of the largest VC firms in biotech – funds worth a combined $2.6 billion, before venBio with a $394 million raise. The five-day total now stands at around $3.8 billion. Like the firms before them, Deerfield emphasized the crucial role biotech and healthcare playe.
ENDPOINTS 04/06/2020 10:02
Four months after an merger, Menlo Therapeutics is counting yet another pair of trial failures — ones with significant consequences for the companies, their shareholders, and the drug. In two pivotal Phase III trials, Menlo’s lead drug serlopitant failed to treat pruritus associated with prurigo nodularis — basically itchiness from a particular skin disease that causes red lesions on a person’s arms or legs.
ENDPOINTS 04/06/2020 07:36
Reblozyl, the anemia drug Celgene paid a modest $25 million upfront to partner on 9 years ago, brought Bristol Myers Squibb one of only two new in 2019. Merely five months later, it’s taking home another supplemental OK expected to catapult sales into blockbuster territory. The FDA has approved Reblozyl (luspatercept) as a treatment for anemia in a subset of adults with lower-risk myelodysplastic syndromes. Specifically, it’s limited to patients who have failed an erythropoiesis stimulating agent and require 2 or more red blood cell units over 8 weeks. These MDS patients are further characterized by ring sideroblasts, where iron accumulates in the mitochondria of red blood cells, rendering them dysfunctional. Bristol Myers and partner Accel.
ENDPOINTS 04/06/2020 06:41
“Each generation needs a new music,” Francis Crick wrote in 1988, reflecting back on his landmark discovery. Crick was 35, then, in 1953, when he began working with a 23-year-old named James Watson, and 37 when the pair unveiled the double helix. Rosalind Franklin, whose diffraction work undergirded their plastic model, was 32. The model would become the score for a new era in biology, one devoted to cracking the basic structures turning inside life. Subsequent years would bring new conductors and new rhythms: Robert Swanson, 29 when he convinced a 39-year-old Herb Boyer to build a company off his work and call it Genentech; Phillip Sharp, 29 when he discovered RNA splicing and 34 when he co-founded Biogen; Frances Arnold, 36 when she pione.
ENDPOINTS 04/06/2020 06:40
A few days ago the FDA touted a procedure for Covid-19 meds that committed the agency to immediate action for developers, formalizing a high-speed response that’s been promised for weeks. Bioregnum Opinion Column by John Carroll. Decisions that once required months would be measured in hours under the "In many cases" trial protocols could be hammered out in less than a single day.
ENDPOINTS 04/05/2020 15:11
Gilead is still some days away from turning the card on its first round of data on remdesivir’s ability to fight severe cases of Covid-19, but the big biotech is ramping up an emergency supply of a million courses of therapy as it starts free distribution of the drug to tens of thousands of patients under their compassionate use program and in clinical trials. In his latest posted over the weekend, Gilead CEO Dan O’Day outlined how the company has been successful in cutting production time on remdesivir while repurposing some of their own facilities and turning to contract manufacturers to build a near-term supply of 1.5 million doses.
ENDPOINTS 04/03/2020 10:43
Can a Chinese biotech deliver the first new lupus drug in decades? A high-profile group of VCs are betting on it. Lilly Asia Ventures and Lake Bleu Capital are the co-headliners for RemeGen’s , which brought in more than $100 million. Hudson Bay Capital and Vivo Capital — which, like LAV, also invested in a pre-IPO round for Legend Biotech unveiled today — chimed in, as did Janchor Partners and OrbiMed. Jianmin Fang. RemeGen got going in 2008 when Jianmin Fang, a Canada-educated scientist who trained at Harvard Medical School, convinced his friends at a traditional Chinese medicine company to launch a biologics player with him, the founder told Endpoints News . He’s served as the CEO and CSO since then. Initially focused on antibodies and fu.
ENDPOINTS 04/03/2020 10:34
Months after GSK’s Nucala cleared in a , the asthma biologic has scored in a late-stage trial in chronic rhinosinusitis patients with nasal polyps. The British drugmaker on Friday disclosed data from the SYNAPSE study, which tested Nucala (also known as mepolizumab) against a placebo on top of standard-of-care in more than 400 patients, all of whom had a history of previous surgery (approximately one in three had ≥3 surgeries) and required surgery due to severe symptoms and bigger polyps. Nucala met both the main goals demonstrating statistically significant improvements in both the size of nasal polyps (p <0.001) at week 52 and in nasal obstruction (p <0.001) during weeks 49 to 52.
ENDPOINTS 04/03/2020 10:30
Whatever Servier learned about Symphogen during their 2-year development alliance must have significantly whetted their appetite for an acquisition. Paris-based Servier announced Friday that it has struck a deal to buy out the antibody expert. The acquisition comes 2 years after Servier acquired Shire’s cancer business for $2.4 billion. They’ve…
ENDPOINTS 04/03/2020 09:55
Sue Desmond-Hellmann. → Rip Ballou, who until very recently led vaccine research and development at GlaxoSmithKline, is the International AIDS Vaccine Initiative (IAVI) to lead its USAID-funded ADVANCE program. The program uses a network of researchers and institutions in Africa to help develop a vaccine for HIV. Ballou had worked at GSK since 2010 and led global vaccine R&D once 2015. Prior to that he held posts at the Bill & Melinda Gates Foundation, a different post at GSK, Medimmune, and Walter Reed Army Institute of Research. IAVI is led by Mark Feinberg , the former CSO of Merck Vaccines. → As we yesterday, Sue Desmond-Hellmann to Pfizer ’s board of directors alongside a veritable who’s-who that includes Coca-Cola CEO James Quincey and.
ENDPOINTS 04/03/2020 09:50
Last month Nanjing Legend Biotech that it sees, and was quietly planning for, a future as a public company in the US, separate but still tied to its former parent, Chinese CRO GenScript. It’s evidently a vision that enticed investors, drawing marquee names for a pre-IPO round. The Series A a whopping $150.5 million from Hudson Bay Capital Management, Lilly Asia Ventures, Vivo Capital, RA Capital Management and JJDC, the venture arm of J&J. The pharma giant has helped fund Legend’s CAR-T work with the $350 million upfront payment it handed over to partner on the lead BCMA program. Known as JNJ-4528 or LCAR-B38M, the therapy immediately became the biggest star in J&J’s armamentarium for relapsed/refractory multiple myeloma, just after the ant.
ENDPOINTS 04/03/2020 09:44
The FDA on Thursday updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation. The updated listings for five manufacturers note an increased demand for midazolam and may just be the beginning of what’s to come for other sedation drugs too. Michael Ganio. Michael Ganio, senior director of pharmacy practice and quality at the American Society for Health-System Pharmacists, told Focus via email: "We have multiple reports of increases in purchases and utilization of sedatives like midazolam, fentanyl, and propofol to treat COVID-19 patients who require mechanical ventilation.".
ENDPOINTS 04/03/2020 09:33
How could a small, largely unknown biotech that emerged from stealth mode just months ago with early-stage cancer programs jump onto Wall Street in the middle of a Force 5 financial hurricane and sail through with a $165 million IPO? Bioregnum Opinion Column by John Carroll. And what does that mean for the rest of the industry waiting to see just how much damage global lockdowns will wreak on clinical development? The biotech is a company called Zentalis.

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