| With 45 new drugs receiving the FDA’s green light in 2019, it looks like the agency’s rate of approvals has bounced back. Though not a record, last year continues a trend up from 2016’s 22 new therapies. Novartis emerged as a big winner, with six approvals across multiple disease areas, including its gene therapy Zolgensma. And with the agency’s OK coming faster and more frequently, some are wondering if this is a sign of a “friendlier” FDA. Our special report is below. | |
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Featured Story | | | It looks like drug approvals have well and truly bounced back. 2019’s total of 45 approvals may not have hit the record high posted in 2018, but it fits into a general upward trend. Some pin that on a “friendlier” FDA, while others think it is the natural outcome of the maturation of new treatment approaches. |
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Top Stories Of The Week Friday, December 27, 2019 Parker Institute-backed biotech Xyphos has been bought out by Japanese pharma Astellas as it looks to bolster its cancer pipeline. Thursday, December 26, 2019 The FDA touted approvals for the first two copycats to blockbuster blood thinner Eliquis, a major growth driver for Bristol-Myers Squibb and partner Pfizer as well as the overall biopharma sector. But ongoing patent lawsuits might prevent their launch until 2026. Sunday, December 29, 2019 One of AstraZeneca’s top research leaders has been knighted in the U.K.’s New Year 2020 Honours list. Monday, December 23, 2019 HIV patients looking for relief from the burden of daily pills will have to wait a little longer. Saturday, GlaxoSmithKline’s ViiV Healthcare said that the FDA had rejected its long-acting HIV injection, known under the working title Cabenuva. The statement is thin on details, only that the complete response letter is related to chemistry manufacturing and controls. Friday, December 20, 2019 Gilead emerged from a meeting with the FDA this summer confident it would file for approval in the U.S. by the end of 2019: With just over a week to spare, it’s delivered on that promise. Monday, December 23, 2019 For metastatic breast cancer patients who try and fail on multiple treatments, finding options to manage disease is a difficult proposition. AstraZeneca and Daiichi Sankyo hoped their antibody-drug conjugate could help that tough-to-treat population––and the FDA agreed to give it a shot despite a shaky safety profile. Friday, December 20, 2019 Blood testing is ubiquitous, but it’s clear its possibilities are unfulfilled. The field has seen setbacks, with Theranos’ well-known rise and fall, but a steady march of clinical data, engineering successes and FDA backing have shown that these ideas can work when they're done right. Monday, December 23, 2019 The CGRP migraine prevention field already has three meds from Amgen, Eli Lilly and Teva vying for market share, and now Allergan has scored the first approval for an oral CGRP to treat migraines as they happen. The med is expected to face 2020 competition from Biohaven’s rimegepant. Monday, December 23, 2019 Researchers at MD Anderson Cancer Center discovered that a macrophage expressing the immune-suppressing enzyme CD73 is abundant in glioblastoma tumors and may be responsible for resistance to drugs that inhibit the checkpoints PD-1 and CTLA-4. Blocking CD73 in mouse models of the disease improved survival among animals given checkpoint inhibitors. Thursday, December 26, 2019 UCB, which recently pulled off a $2.5 billion deal for an autoimmune drug candidate, says it sees the need for more biopharma production. To fill it, it will build a €300 million ($333 million) facility and staff it with 150 new workers. Monday, December 23, 2019 Light in the darkness. It’s a common theme this time of year. At their best, biotech and pharma are like the candles in Vermont windows, visible from a half-mile away. For patients with rare, deadly and chronic diseases, new treatments offer the hope of relief, or even a cure. Monday, December 23, 2019 As we reach the end of the year, we look back on the most read stories of the last 12 months as we also look ahead not just to a new year, but a new decade. So, what were the most read stories that you, dear reader, sought to end the 2010s with? Monday, December 23, 2019 As we close out this decade, our biggest medtech stories of the past year have all looked toward what’s coming next—whether it’s new treatments or renewed companies, the common thread running through our most popular reads is that people are eager to see these advancements realize their promise. Enrollment Showcase | | | Sponsored by: Drexel University Online Drexel University’s online graduate programs in biomedicine, clinical research, drug discovery, and molecular medicine were developed with working professionals in mind, providing you with the education, practical skills, and competitive edge you need to be successful in your career. Learn more. |
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