End points poll: Janet Wood cock takes the helm at the FDA. And a large ma jor i ty of our read ers want her to ...


2021-01-22 07:00:17 ENDPOINTS NEWS


It’s official: Janet Woodcock is now the acting chief of the FDA. And — according to an Endpoints poll — most industry readers would like her to stay there, although a significant minority is strongly opposed. To recap: Joe Biden is reportedly choosing between Woodcock and former deputy FDA commissioner Joshua Sharfstein as his nominee for the permanent position. Given their respective track records, the decision is set to determine the agency’s lodestar for years to come. By RBC Capital Markets With Andy Schwab, Co-Founder and Managing Partner at 5AM Ventures Key Points Prescription Digital Therapeutics, cell therapy technologies, and in silico medicines will be a vital part of future treatment modalities. Unlocking the potential of the microbiome could be the missing link to better disease diagnosis. Growing links between academia, industry, and venture capital are spinning out more innovative biotech companies. Biotech is now seen by investors as a growth space as well as a safe haven, fuelling the recent IPO boom. GlaxoSmithKline’s HIV unit ViiV was dealt a stinging loss back in late 2019 when the FDA slammed the brakes on its application for a once-monthly injection based on manufacturing issues. Now, with that roadblock in the rearview, ViiV has finally made good on its promise to change the HIV game. The FDA on Thursday approved ViiV’s Cabenuva (cabotegravir and rilpivirine) as a long acting, once-monthly therapy for HIV-positive adults who are virologically suppressed and on a stable antiviral regimen. The firehose of biopharma news is gushing these days. That’s why broader and deeper is the theme for 2021 at Endpoints. You can expect new coverage outside our core R&D focus, with deeper reporting in some key areas. When John Carroll and I launched Endpoints nearly five years ago, we were wading in waist-high waters. Now we’re a team of 25 full-time staffers (and growing) with plans to cover the flood of biopharma news, Endpoints-style. Tony Coles’ team at Cerevel Therapeutics is adding two high-profile board members, including an ex-governor that has lots of connections to the Boston area where the biotech is based. Former Massachusetts Gov. Deval Patrick is hopping on Cerevel’s board of directors, the company announced Thursday, joining less than three months after Cerevel went public on the backs of Perceptive’s ARYA II SPAC. And in a twist, Pfizer’s new business development chief Deborah Baron is joining the board as well, about three years after the Big Pharma shuttered the neuroscience pipeline that Cerevel is seeking to revive. Close to 2 years ago, GSK’s R&D team eagerly agreed to pay up to $4 billion-plus to ally itself with Merck KGaA on a mid-stage bispecific called bintrafusp alfa, which intrigued them with the combination of a TGF-β trap with the anti-PD-L1 mechanism in one fusion protein. But today the German pharma company says that their lead study on lung cancer was a bust, as independent monitors said there was no reason to believe that the experimental drug — targeting PD-L1/TGF-Beta — could beat Keytruda. It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years. As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama. Eli Lilly says bamlanivimab lowered the risk of contracting symptomatic Covid-19 in a first-of-its-kind trial involving nursing home residents and staff, paving the way for a new option to protect against the virus. But how big of an impact it might have, and what role it will play, at a time vaccines are being rolled out to the exact population it is targeting still remains unclear. Among 965 participants in the study — all of whom tested negative for the coronavirus at baseline — the number of symptomatic cases reported in the bamlanivimab arm was 57% lower than that in the placebo arm (odds ratio 0.43, p=0.00021). In addition to that primary endpoint, all secondary endpoints reached statistical significance. The biopharma industry, on the whole, had a red-letter year in 2020 amid Covid-19, with fundraising at an all-time high and major players speeding vaccines ahead to approval. But for BIO, the industry’s leading trade organization, the pandemic has prompted a reconsideration of the game plan. BIO will pivot to digital as the Covid-19 pandemic continues to rage, making “some staff reductions” as it looks to bring its roughly 37,000 in-person meetings each year to the web, the organization said Thursday. The results for Merck’s leading heart drug fell short of what some cardiologists had hoped for, but they proved more than enough to convince the FDA, which handed down an approval Wednesday. The agency OK’d vericiguat, now marketed as Verquvo, for patients with heart failure, offering one of the first new pharmaceutical tools to tackle a hard-to-treat group of patients at high risk for what remains the leading cause of death in the US and Europe. It’s also a notable win for Merck, who rolled the dice on the molecule in 2016, paying Bayer $1 billion for US rights to the then-experimental drug and ex-US rights for the approved CV drug Adempas.
ITS官员:珍妮特·伍德科克现在是FDA的代理局长。 根据Endpoints的一项民意调查,大多数行业读者都希望她留在那里,尽管有相当一部分人强烈反对。 重述一下:据报道,乔·拜登正在伍德科克和前FDA副专员约书亚·沙夫斯坦之间选择他的永久职位提名人。鉴于它们各自的成绩记录,这一决定将确定原子能机构今后几年的方向。 加拿大皇家银行资本市场 与5AM Ventures联合创始人兼管理合伙人安迪•施瓦布合作 要点 处方数字治疗技术,细胞治疗技术和硅胶药物将是未来治疗模式的重要组成部分。 开发微生物组的潜力可能是更好地诊断疾病所缺少的一环。 学术界,工业界和风险投资之间日益紧密的联系正在催生出更多创新的生物技术公司。 生物技术现在被投资者视为一个增长空间,同时也是一个安全的避风港,推动了最近的IPO热潮。 葛兰素史克公司HIV病毒第VIV单元在2019年末遭受了惨痛的损失,当时FDA基于生产问题对其每月注射一次的申请急刹车。现在,有了这个障碍,ViiV终于兑现了改变HIV游戏的承诺。 FDA周四批准VIIVS Cabenuva(卡博特格拉韦和利匹韦林)作为长期的,每月一次的治疗方案,用于病毒学受抑制且使用稳定的抗病毒方案的HIV阳性成人。 这几天生物制药新闻的火龙喷涌而出。 这就是为什么2021年的主题更广泛,更深入。你可以期待我们的核心研发重点之外的新报道,在一些关键领域有更深入的报道。大约五年前,当约翰·卡罗尔和我推出Endpoints的时候,我们正趟着一条不起眼的水路。现在我们有一个由25名全职员工组成的团队(并且还在不断增长),计划覆盖生物制药新闻的洪流,终点式的。 Cerevel Therapeutics的Tony Colesteam将增加两名高知名度的董事会成员,其中包括一名前州长,他与该生物技术公司所在的波士顿地区有很多联系。 Cerevel公司周四宣布,前马萨诸塞州州长德瓦尔•帕特里克将加入该公司董事会,而在不到三个月前,Cerevel公司在艾雅二世公司的支持下上市。此外,Pfizer新的业务发展主管黛博拉·巴伦也加入了董事会,大约三年前,这家大型制药公司关闭了Cerevel正在寻求重振的神经科学项目。 将近两年前,GSKS的研发团队急切地同意支付高达40多亿美元与默克集团联合研制一种名为bintrafusp alfa的中期双特异性药物,该药物将TGF?陷阱与一种融合蛋白中的抗PD-L1机制结合在一起,引起了他们的兴趣。 但今天这家德国制药公司表示,他们在肺癌方面的领先研究是失败的,因为独立的监督员说,没有理由相信靶向PD-L1/TGF-beta的试验性药物能够打败Keytruda。 现在是时候让一位新的FDA专员上任了,这是乔·比登政府的一个成人仪式,这将有助于确定新总统在未来4年中寻找专家来领导政府的代表。 到目前为止,最高职位的竞争似乎已经缩小到了两个人:长期担任CDER主席的珍妮特·伍德科克和曾在佩吉·汉堡领导下担任FDA首席副手的约书亚·夏夫斯坦(Joshua Sharfstein)。两人都是由巴拉克·奥巴马任命的。 礼来公司表示,在一项涉及疗养院居民和工作人员的首次同类试验中,班拉尼单抗降低了感染有症状的柯维19病毒的风险,为预防病毒的新选择铺平了道路。 但在疫苗正向其针对的确切人群推出之际,它可能会产生多大影响,以及它将发挥何种作用,目前仍不清楚。 在965名基线冠状病毒检测呈阴性的研究参与者中,班拉维单抗组报告的有症状病例数比安慰剂组低57%(优势比0.43,P=0.00021)。除主要终点外,所有次要终点均达到统计学意义。 总体而言,生物制药行业在2020年的Covid-19中迎来了喜人的一年,筹资达到了历史最高水平,各大公司加快了疫苗的审批速度。但对于该行业的主要贸易组织BIO来说,这场大流行促使他们重新考虑自己的游戏计划。 该组织周四表示,随着Covid-19疫情的持续肆虐,BIO将转向数字化,并将裁减一些员工,以实现每年约37,000次面对面会议的网络化。 Mercks的主要心脏药物的研究结果没有达到一些心脏病专家的预期,但是这些结果足以说服FDA,FDA于周三批准了这项研究。 OKD vericiguat,现在以Verquvo的名字上市,是治疗心力衰竭患者的第一批新型药物工具之一,用于治疗难以治疗的高危患者,心力衰竭仍然是美国和欧洲的主要死因。这对默克公司来说也是一个显著的胜利,2016年默克公司在该分子上掷骰子,向拜耳支付了10亿美元,购买了当时正在试验的药物在美国的使用权,以及获得批准的CV药物Adempas在美国境外的使用权。