Albert Bourla, Pfizer CEO (John Thys, Pool/AFP via Getty Images)
Pfizer on Friday unveiled statistically significant efficacy data for its potential Covid-19 pill among people who haven’t been hospitalized with the virus. The data will likely lead to a quick EUA from the FDA and add to a growing field of effective, easy-to-use treatments.
Data from a scheduled interim analysis showed an 89% reduction in risk of Covid-related hospitalization or death from any cause compared to placebo in patients treated within three days of symptom onset. Pfizer said it halted enrollment in the trial because of the positive results, and in consultation with the FDA.
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The COVID-19 pandemic has made society very aware of the need to be flexible in the approach to daily life. Every part of ‘normal’ day-to-day life has been disrupted. Clinical trials and the traditional way of conducting them has been no different. Flexibility became an immediate need for sponsors, CROs, clinical sites, and patients. Quick adjustments had to be made, along with finding new ways to make sure that patients had the appropriate care, oversight of the clinical sites continued to be managed, and drug supply and accountability were maintained. Many clinical sites found themselves acting as a shipping department, trying to make sure all of their patients received their drug safely and on time. CRAs performed remote oversight visits, virtual site tours, and virtual accountability audits. Sponsors quickly began to rethink their Direct-to-Patient (DTP) approach as patients increasingly requested that their study drugs be shipped to their homes.
The US government’s $1.8 billion investment into Novavax’s Covid-19 vaccine may soon pay off as the company floated some positive comments around the issues surrounding the manufacturing of its recombinant protein vaccine, which could be added early next year to the world’s arsenal of shots.
The company has struggled with its vaccine candidate’s potency and purity, pushing back the timing of submitting its application to the FDA all summer, and in June the US government had to steer Novavax, instructing the company to prioritize alignment with the FDA on its analytic methods before conducting additional US manufacturing, and ‘further indicated that the US government will not fund additional US manufacturing until such agreement has been made,’ the company said.
After a fiasco surrounding the contamination of Covid-19 vaccine doses in its facilties — during a time in which vaccinating residents was dire to America’s return to normalcy — Emergent BioSolutions’ $600 million manufacturing deal with the US government has come to an end.
CEO Bob Kramer said that the two parties ‘mutually agreed’ to terminate the contract in an earnings call with investors Thursday, evaporating about $180 million in deal value.
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For the past 20 years, Novartis and Roche were more than cross-town rivals reigning over towering pharmaceutical dynasties. Novartis also holds a sizable chunk of Roche’s shares — amounting to a nearly one-third voting stake.
Now, Roche is buying that stake back for $20.7 billion.
‘After more than 20 years as a shareholder of Roche, we concluded that now is the right time to monetize our investment,’ Novartis CEO Vas Narasimhan said in a statement, adding that the cash will go toward purposes in line with current capital allocation.
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Site of bluebird’s new headquarters at 455 Grand Union Blvd, Assembly Row (Photo credit to Aram Boghosian)
Recouping from a series of setbacks for its gene therapy business, bluebird bio successfully bisected itself earlier this week as part of a big rebrand around genetic disease. Now, with its future still in the wind, bluebird has found a new nest.
Bluebird has signed a lease for a new 61,000-square-foot headquarters at Assembly Row in Somerville, MA, that the newly stripped-down biotech envisions as its hybrid home base of the future after spinning off its oncology business earlier this week.
DeepMind CEO Demis Hassabis
Last summer marked a major breakthrough in drug discovery when DeepMind, a predictive modeling startup from Google parent company Alphabet, offered the most accurate picture yet of the ‘protein folding’ problem. The Alphabet team is now propping up a unit focused solely on drug discovery, and it will look to leverage lessons learned from DeepMind’s example.
Alphabet has launched Isomorphic Labs, a London-based drug discovery startup leveraging the company’s AI and machine learning work, and lessons from DeepMind’s AlphaFold breakthroughs, CEO Demis Hassabis said in a blog post Thursday.
Sam Rasty, PlateletBio CEO (Oxford Biomedica, via Website)
More than two years after PlateletBio landed its first round of fundraising and a contract with the US government, the company announced its Series B round Thursday.
The preclinical stage biotech out of Watertown, MA announced it raised $75.5 million. The round was led by new investors SymBiosis, K2 HealthVentures, and Oxford Finance, and already-existing investors.
The financing will go toward preclinical development of its lead platelet-like cell program as a therapy for the autoimmune disease immune throbocytopenia. It will help further develop its platform and manufacturing capabilities, and as a result, the managing partner of SymBiosis, Chidozie Ugwumba, will join the board of directors.
As Nitrome Biosciences — a biotech founded in 2017 to focus on a class of enzymes called nitrases — rebrands to Nitrase Therapeutics, the company is also bringing on a new CEO: Pierre Beaurang.
In Nitrase’s statement earlier this week announcing its new CEO, the biotech said that the founder and now-former CEO — Irene Griswold-Prenner — will stay on with Nitrase as the new CSO. And this new appointment comes in tandem with the biotech’s Series A expansion, where Bristol Myers Squibb became an investor alongside AbbVie and Sofinnova Partners, bringing the total amount raised to $45 million.
Bob Bradway, Amgen CEO (Scott Eisen/Bloomberg via Getty Images)
Amgen announced back in June that it would spend $365 million to build its manufacturing plant of the future in New Albany, OH, complete with self-driving vehicles and data-gathering tools to ensure efficiency. Today, that journey begins.
The California-based biotech will break ground today on its new assembly and packaging plant, which is estimated to create 400 new jobs in the area just 18 miles northeast of Columbus, according to a report by the Columbus Dispatch. The new facility will further Amgen’s capabilities to make medicines set for distribution in the US, it said in a statement a few months ago.
https://endpts.com/breaking-pfizers-covid-19-antiviral-reduces-hospitalizations-by-89-could-prove-a-formidable-foe-for-mercks-pill/
