In anticipation of Aduhelm’s approval for Alzheimer’s in June, Biogen employees were directed to identify and guarantee treatment centers would administer the drug through a program called “Javelin,” a senior Biogen employee told Endpoints News.
The program identified 800 centers for use, he said, and Biogen now pays for the use of bioassays to identify beta amyloid in potential patients having undergone a lumbar puncture procedure, the employee said — and one center preparing to administer the drug confirmed its participation in the bioassay program.
Always remember just how risky it is to gamble big on small studies.
A little more than 4 years ago, Novartis reportedly put up a package worth up to $1 billion for the dry eye drug ECF843 after a small biotech called Lubris put it through its paces in a tiny study of 40 moderate to severe patients, tracking some statistically significant markers of efficacy.
By last fall, the program had risen up to become one CEO Vas Narasimhan’s top “wild card” programs in line for a potential breakthrough year in 2021. These drugs were all considered high-risk, high-reward efforts. And in this case, risk won.
Earlier this summer, Magenta Therapeutics was forced to say goodbye to its head of R&D at a pivotal time as the biotech read out data for its lead stem cell conditioning hopeful. Just weeks later, the company’s second drug is facing a clinical hold from the FDA as the agency demands more info on how the candidate works in humans.
Magenta will be required to submit an additional bioassay to help determine the best path forward on dose escalation for the biotech’s Phase I/II study of MGTA-117, an antibody-drug conjugate used to deplete hematopoietic stem cells prior to a transplant of HSC-based gene therapy, the biotech said Wednesday.
The manufacturing expansion into Africa continued Wednesday with Pfizer and BioNTech’s announcement that the two companies signed on with the Biovac Institute to manufacture its Covid-19 vaccine to distribute throughout Africa. But while the continent is in dire need of doses, vaccines from the expansion won’t be available until the start of next year.
Biovac will only handle distribution and fill-finish duties. Drug substance for these batches will come from European facilities. When fully operational, the facility will pump out 100 million doses a year, set to be evenly distributed among the 55 member states of the African Union.
With the recent and unexpected discovery of probable human carcinogen impurities prompting recalls of popular heartburn drugs like Zantac and nizatidine, as well as metformin diabetes medicines, ARBs and more, the FDA has made clear the need for an industry-wide risk assessment for the so-called nitrosamines in even more drugs that may be at risk.
But industry groups are pushing back on the need for such widespread testing, arguing that the FDA should be more consistent and collaborative with other regulators in its approach, and that the timelines for such testing are too constricted and may lead to serious drug shortages.
With the wind of the pandemic at its back, the biopharma industry saw a surging tide of fundraising in 2020 that has only exponentially grown this year. But with VC dollars flowing like never before, are there some cracks showing in biopharma’s gold-tinted façade?
In the first half of 2021, total healthcare venture spending in the US has already outstripped 2020’s record-breaking totals across biotech, healthtech and beyond, putting the industry on a funding pace that could be hard to match in coming years, according to a new report from Silicon Valley Bank released Wednesday.
As the saga over how to pay for Aduhelm plays out, biopharma companies are now looking closely at how Biogen was able to keep such a special relationship with FDA officials ahead of the drug’s accelerated approval, and whether or not they might be able to leverage those takeaways into their own relationships with the agency.
What makes Biogen unique, however, is how deep its relationship with the FDA ran, and the way in which FDA’s neuroscience head Billy Dunn worked alongside the company for years prior to Aduhelm’s quick OK. For instance, back in 2017, Dunn co-chaired a data sharing initiative at the nonprofit C-Path Institute alongside Biogen SVP Samantha Budd Haeberlein, as first reported by the New York Times. In 2018, Dunn and Budd Haeberlein also jointly presented on strengthening communication across the Alzheimer’s drug development community.
As clinical trial transparency and the sharing of positive and negative trial results slowly become the norm rather than the exception, a new study published in the BMJ revealed struggles from smaller companies to keep up with their larger rivals when it comes to transparency.
AbbVie, Amgen, Bayer, Merck KGaA/EMD Serono, Novartis, Roche and Takeda all tied for the top spot as the most transparent biopharma companies, the study found.
Like so many people around the world, my life has been profoundly shaped by cancer. Those personal experiences, along with a deep love of clinical laboratory science and a passion to apply the power of genomics in medicine, motivated me to launch a company that would improve cancer care through better diagnostics. Thirteen years later, I am proud that we are delivering more accurate information at multiple points along the patient journey, with a focus on eight of the 10 cancers that are most commonly diagnosed in the United States.
Albireo $ALBO CEO Ron Cooper is getting his long-awaited shot at marketing the first drug approved for pruritus in all subtypes of progressive familial intrahepatic cholestasis.
The biotech put out word Tuesday afternoon that the FDA came through with the approval right on deadline, something that had been expected since the agency handed the company a priority review for the drug. That now gives them a green light to see how much of a head start they can get before Mirum finds out about the ultimate fate of its own PFIC program.
硅谷银行（Silicon Valley Bank）周三发布的一份新报告显示，2021年上半年，美国的医疗保健风险投资总额已经超过了2020年生物技术、医疗技术及其他领域的创纪录总额，使该行业的融资速度在未来几年可能很难跟上。
然而，Biogen的独特之处在于它与美国食品和药物管理局的关系有多深，以及在Aduhelm的《快速确定》之前，美国食品和药物管理局神经科学负责人比利·邓恩（Billy Dunn）与该公司合作多年的方式。例如，据《纽约时报》首次报道，早在2017年，邓恩就与生物技术高级副总裁萨曼莎·巴德·海伯莱一起在非营利组织C-Path研究所共同主持了一项数据共享倡议。2018年，Dunn和Budd Haeberlein还联合介绍了加强阿尔茨海默氏症药物开发社区的沟通。