The United Kingdom today approved its first COVID-19 vaccine, created through a partnership between Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX). The Medicines and Healthcare products Regulatory Agency (MHRA) approval came after a “rolling review” in which assessment takes place as the packages of data become available from ongoing studies on a staggered basis. The idea is to…
BREAKING: Moderna is filing for a COVID-19 vaccine EUA
Moderna (NSDQ:MRNA) announced today that it will apply for emergency authorization from U.S. FDA and the European Medicines Agency for its COVID-19 vaccine candidate. The company said it has already initiated the rolling review process with the EMA, Health Canada, SwissMedic, the United Kingdom Medicines and Healthcare products Regulatory Agency, Ministry of Health in Israel, and…
Merck to buy OncoImmune and its potential COVID treatment for $425M
Merck (NYSE: MRK) recently announced that it will pay $425 million in cash to acquire privately-held biopharmaceutical company OncoImmune and its potential COVID-19 treatment. OncoImmune’s CD24Fc is a first-in-class recombinant fusion protein that targets the innate immune system. OncoImmune recently announced positive top-line findings from an interim efficacy analysis of a Phase 3 study evaluating…
BREAKING: Pfizer, BioNTech submit FDA EUA request for COVID-19 vaccine
Pfizer (NYSE:PFE) and its partner BioNTech (NSDQ:BNTX) announced that they will submit a request today with FDA for an EUA of their mRNA vaccine candidate, BNT162b2, against SARS-CoV-2. If all goes as planned, the companies predict that high-risk populations in the U.S. could start receiving the vaccine by mid- to late-December. Vaccine distribution could start within…
Qosina offering SmartSite swabbable needle-free injection sites
Qosina (Ronkonkoma, N.Y.) is touting the variety of SmartSite swabbable needle-free injection sites that it offers. The needle-free injection sites feature an ergonomic design and a smooth, flat top that can be easily disinfected, according to Qosina. Said the company: ” These components are equipped with a valve, that when activated, forms an airtight seal […]
Trump administration paying Eli Lilly $375M for experimental COVID-19 therapy
U.S. HHS and DoD will pay $375 million to buy 300,000 doses of bamlanivimab 700 mg from Eli Lilly and Co. (NYSE:LLY) as part of Operation Warp Speed initiatives to stockpile experimental COVID-19 treatments for distribution, pending FDA authorization. HHS plans to allocate 300,000 doses of the monoclonal antibody immediately, according to an announcement from…
Are Stephen Hahn’s days numbered at FDA?
HHS Secretary Alex Azar has been reportedly discussing the removal of Dr. Stephen Hahn as FDA commissioner, according to Politico. The Politico report cited a half dozen current and former administration officials. FDA spokesperson Michael Felberbaum in an email to Drug Discovery‘s sister site MassDevice denied an Azar-Hahn feud: “Commissioner Hahn enjoys a good relationship…
Biogen beats The Street on tough Q3, cuts 2020 outlook
Biogen (NASDAQ:BIIB) posted third-quarter results today that beat the consensus forecast on Wall Street — but cut its outlook for the rest of the year, citing the emergence of generic versions of its Tecfidera drug for multiple sclerosis. The Cambridge, Mass.–based neurological therapies company reported profits of $702 million, or $4.46 per share, on sales…
Purdue Pharma reaches $8B federal settlement over opioid abuse crisis
The U.S. Department of Justice today announced a roughly $8 billion resolution with Purdue Pharma relating to its role in the U.S. opioid abuse crisis. The agreement — which is pending approval in bankruptcy court in Southern New York as part of Purdue’s ongoing Chapter 11 process — has the company paying a criminal fine…
U.K. to reportedly conduct human challenge trials with COVID-19 vaccines
British researchers plan to deliberately infect healthy volunteers with lab-grown COVID-19 viruses in order to test potential vaccines, according to a report today in The Washington Post. U.S. researchers have seen so-called human challenge trials as too risky, but U.K. scientists think it’s worth the risk if the challenge trials speed up the development of…
Teknova is distributing COVID-19 transport media
Teknova (Hollister, Calif.) announced today that it has completed the FDA notification process for its CDC formulation viral transport medium (VTM). Notification process compilation means the VTM is in compliance with FDA’s COVID-19 Transport Media Policy, July 2020 guidelines. Teknova is now offering the VTM for commercial distribution after scaling up manufacturing within six months.…
Moderna CEO sees EUA for COVID-19 vaccine in December
The CEO of Moderna (NSDQ:MRNA) thinks the FDA could grant an EUA for its COVID-19 vaccine candidate in December, depending on whether it sees positive interim clinical results in November. Moderna CEO Stéphane Bancel’s comments — made during The Wall Street Journal’s annual Tech Live conference yesterday and reported in the newspaper — suggest that the…
FDA’s Hahn insists a COVID-19 vaccine approval will not be rushed
FDA Commissioner Dr. Stephen Hahn used a virtual conference appearance today to repeat that a COVID-19 vaccine approval will be up to the agency’s scientists — not political pressure. “We want to make sure that any vaccine we approve is safe and effective according to our criteria,” Hahn said during The Virtual Medtech Conference held…
How could holographic displays boost drug discovery?
Holographic displays company Looking Glass Factory in the early summer integrated its displays with drug discovery software from Schrödinger. The combination, according to Looking Glass Factory officials, enables drug designers to view molecular structures and compositions in true 3D right on their desktops, without having to wear VR or AR headsets. Looking Glass Factory CEO…
UC San Diego team claims it’s built a better microscope
A UC San Diego research team claims it’s developed a microscope that gives them a thorough view of molecular systems — not just single traits of molecules. The researchers recently published their findings in the Proceedings of the National Academy of Sciences. Wei Xiong and other members of the Xiong Group at UC San Diego…
Illumina may buy back Grail
Illumina (NSDQ:ILMN) may acquire Grail for more than $8 billion — four years after it spun out the cancer detection startup. That’s according to a Bloomberg report out yesterday, which cited people familiar with the matter. Analysts told Bloomberg that the acquisition would put Illumina — a giant in the DNA sequencing space — in direct…
AstraZeneca resumes COVID-19 vaccine trial
AstraZeneca (NYSE:AZN) has resumed its COVID-19 vaccine trial in the U.K. following confirmation from the Medicines Health Regulatory Authority (MHRA) that it was safe to proceed. The news of the trial resumption, announced Sept. 12, came six days after a voluntary pause so that an independent committee could review safety data surrounding a single event of…
BioAscent spending £1M to boost drug discovery service offering
BioAscent (Newhouse, U.K.) recently announced that it will spend £1 million ($1.3 million) on new instrumentation and equipment. The investment is meant to further enhance the company’s offerings in integrated drug discovery and compound management. The new instrumentation will include a FLIPR Penta screening system and a Biacore 8k Surface Plasmon Resonance (SPR) system, as…
The top digital health startups in the world
CB Insights’ second annual Digital Health 150 list includes 26 startups seeking to improve drug research and development, an area hard-hit as the COVID-19 pandemic interrupts clinical trials. Drug discovery companies include Healx (rare diseases) and ProteinQure (quantum computing). (Download the full report here.) Get the full story on our sister site Medical Design & Outsourcing. …
Russia claims to have first COVID-19 vaccine
Russian officials announced today that they will make a COVID-19 vaccine available to its citizens on a voluntary basis, with President Vladimir Putin saying the vaccine has gone through all necessary tests. The vaccine, developed at by the Gamaleya Institute in Moscow, will first become available to medical workers, teachers and at-risk groups. Kirill Dmitriev,…
The hottest life science hubs in the U.S.
Boston, San Francisco and San Diego remain the leading U.S. life science hubs — hauling in 70% of all the venture capital in the space last year, according to a new report from commercial real estate services company JLL. Venture capital funding matters, according to JLL, because it fuels innovative companies that then require more…
Hackers targeted pharma and other IP for Chinese government, indictment claims
A federal grand jury in Spokane, Wash. has indicted two Chinese nationals on charges that they hacked into pharma companies and hundreds of other businesses, governments and organizations — in some cases on behalf of the Chinese Ministry of State Security. The 11-count indictment, which the U.S. Department of Justice announced today, alleges that Li…
Johnson & Johnson Q2 results beat The Street amid pharma sales uptick
Johnson & Johnson (NYSE:JNJ) posted second-quarter results today that beat the consensus forecast on Wall Street — boosting its outlook for the year even as its medical device sales took a big hit from the COVID-19 pandemic. The New Brunswick, N.J.–based medical device and pharmaceutical giant reported profits of $3.6 billion, or $1.36 per share, on…
Boston Sci reportedly looking to sell snake antivenom business
Boston Scientific (NYSE:BSX) is exploring selling its snake antivenom products business, according to Bloomberg, which cited anonymous sources. A Boston Sci spokesperson told MassDevice via email that the company has a practice of not commenting on speculation. Boston Scientific acquired the antivenom business during its $4 billion acquisition of BTG, which closed last year. Its products include CroFab, touted as the…
Biopharmaceutical companies pledge more than $1 billion to develop new antibiotics
More than 20 biopharmaceutical companies around the world have pledged more than $1 billion toward the Antimicrobial Resistance (AMR) Action Fund that launched today. Pledges include $100 million from Pfizer and $50 million from Boehringer Ingelheim. An initiative of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the fund’s goal is to bring two to four…