Drug Discovery

FDA’s Antimicrobial Drugs Advisory Committee narrowly concluded that the benefits of Merck’s (NYSE:MRK) COVID-19 pill molnupiravir outweigh the risks. A total of 13 members of the panel voted in favor of the drug candidate, while 10 voted against it. There were no abstentions. FDA generally follows the advice of its advisory committees. “This was clearly…

Pfizer (NYSE:PFE) and Moderna (NSDQ:MRNA) are planning to research their vaccines’ effectiveness against the highly mutated Omicron variant (B.1.1.529), which is behind a surge in infections in Johannesburg, South Africa. If needed, they plan to create new versions of their vaccines. The Omicron variant has more than 30 changes to the SARS-CoV-2 spike protein. “I…

Hutchmed (HKG:0013) and AstraZeneca (LON:AZN) have announced the launch of the SACHI Phase 3 study to test the combination of Orpathys (savolitinib) and Tagrissso (osimertinib) as a treatment for locally advanced or metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small-cell lung cancer (NSCLC). Specifically, the study will focus on patients with amplification of the MET…

Pfizer (NYSE:PFE) accused a former employee Chun Xiao (Sherry) Li of uploading 12,000 documents from a company-issued laptop to a personal Google Drive account and various personal devices. In a complaint filed in the U.S. District Court for the Southern District of California, Pfizer also accuses Li of misleading the company about what she did with…

FDA has approved Takeda Pharmaceutical’s (NYSE:TAK) Livtencity (maribavir) for use in patients at least 12 years old with post-transplant cytomegalovirus (CMV) infection or disease that does not respond to available antiviral therapy. The indication covers patients weighing at least 35 kilograms. Livtencity blocks virus replication by blocking the activity of the human cytomegalovirus enzyme pUL97.…

Two months after receiving a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), Janssen has won approval from the European Commission for Byannli, a six-month formulation of paliperidone palmitate. Indicated as a maintenance treatment for adults with schizophrenia, Byannli won approval based on results from the Route 6 study, which found…

Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) shared new data from their Phase 3 study of the Comirnaty vaccine, concluding that two 30-µg doses were 100% effective against COVID-19 between seven days and four months after the second dose. The safety profile of the vaccine in the study was broadly consistent with other clinical safety data. In…

The research data platform Flywheel has announced that Roche (OTCMKTS:RHHBY) and its subsidiary Genentech are using its cloud-scale informatics platform to ingest, standardize and analyze medical imaging data to streamline drug discovery. Minneapolis-based Flywheel says the process provides a swifter and more efficient means to curate data at the terabyte and petabyte scales. Specifically, Roche and…

PerkinElmer (NYSE:PKI) announced today that it launched its PKeye workflow monitor for remotely managing and monitoring workflows. Waltham, Massachusetts–based PerkinElmer’s cloud-based PKeye workflow monitor enables laboratory personnel to remotely handle PerkinElmer instruments and workflows in real-time through 24/7 access and visibility into laboratory operations. Get the full story at our sister site, MassDevice.

FDA has informed Bristol Myers Squibb (NSDQ:GILD) that it has extended its review of mavacamten, an allosteric modulator of cardiac myosin. Bristol Myers Squibb aims to win an FDA nod for the drug as a treatment for obstructive symptomatic hypertrophic cardiomyopathy (oHCM), a disease associated with heart muscle thickening. Mavacamten addresses the molecular defect involved…

A life sciences real estate developer announced today that BD (NYSE:BDX) selected its property as a new facility for its biosciences business. Through a joint venture with Tishman Speyer and Bellco Capital, Breakthrough Properties confirmed that BD chose its Torrey View by Breakthrough property for an expanded San Diego reagent innovation center within its biosciences segment. Get…

GlaxoSmithKline (NYSE:GSK) will present 11 abstracts on Blenrep (belantamab mafodotin blmf) at the American Society of Hematology (ASH) Annual Meeting and Exposition on December 11–14. Presentations will include new data from the DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial program and two collaborative studies focused on Blenrep. The drug won FDA approval…

Bruker (NSDQ:BRKR) announced today that it acquired Molecubes, a maker of benchtop preclinical nuclear molecular imaging (NMI) systems. Ghent, Belgium-based Bruker said in a news release that the acquisition, for which financial terms were not disclosed, will strengthen its position as a leading NMI solutions provider in preclinical and translational imaging research. The acquisitions will…

FDA has authorized booster shots of the Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) and Moderna (NSDQ:MRNA) vaccines for everyone 18 and older. Assuming CDC backs the decision, tens of millions of American adults who received two doses of the two mRNA COVID-19 vaccines at least six months ago will be eligible for boosters. “Authorizing the use of a single…

South San Francisco–based biopharma Fountain Therapeutics has pulled in $15 million in Series A-2 financing, bringing its total Series A funding to $26 million. The company focuses on drug development for chronic degenerative diseases. Eli Lilly and Company (NYSE:LLY), Alexandria Venture Investments and R42 Group joined as new investors in the funding round. Prior investors…

The FDA reportedly is planning to authorize the ​​Pfizer-BioNTech (NYSE:PFE/NSDQ:BNTX) COVID-19 vaccine booster for all adults in the coming days. FDA could make an announcement on the subject as soon as tomorrow, according to The New York Times. CDC’s Advisory Committee on Immunization Practices (ACIP) plans on discussing the Pfizer-BioNTech booster data on November 19.…

Atea Pharmaceuticals (NSDQ:AVIR) has announced the termination of a joint venture with Roche involving the development of the COVID-19 antiviral AT-527. In October, the two companies revealed that the Phase 2 MOONSONG trial focusing on AT-527 did not meet its primary endpoint. Atea will retain rights to AT-527 after the strategic collaboration with Roche ends…

Founded in late 2020, Acelyrin has closed a $250 million Series B financing led by AyurMaya, an affiliated fund of Matrix Capital Management, Surveyor Capital and Westlake Village BioPartners. Other investors joining the funding round included Cowen Healthcare Investments, Decheng Capital, Marshall Wace, OrbiMed, RTW Investments, LP, Samsara BioCapital, Tybourne Capital Management and venBio Partners.…

In late October, Merck (NYSE:MRK) and its partner Ridgeback Biotherapeutics agreed to make the COVID-19 antiviral molnupiravir available in the developing world. Now, Pfizer (NYSE:PFE) is taking a similar approach for its investigational antiviral cocktail Paxlovid, which contains PF-07321332 and ritonavir. Pfizer, like Merck, struck an agreement with the Medicines Patent Pool (MPP) related to…

Privately-held ConcertAI has formally integrated with TeraRecon, a provider of advanced visualization services, including 3D and 4D medical imaging post-processing.  Cambridge, Massachusetts–based ConcertAI says the integration will expand its offerings for life science companies, which now can integrate data from electronic medical records, genomic data and medical imaging. As a result, the company can offer…

RedHill Biopharma Ltd. (NSDQ:RDHL) has randomized the last patient in Part A of an ongoing Phase 2/3 study focused on RHB-107 (upamostat), an investigational antiviral. The Tel Aviv–based company anticipates that RHB-107, a serine protease inhibitor, would be broadly effective against emerging SARS-CoV-2 variants. RedHill Biopharma expects top-line data for Part A of the trial,…

World Diabetes Day — Nov. 14 — centers around raising awareness for those with diabetes. This year, that aim remains the same, and medical technology companies continue to look for ways to continue improving the management of the metabolic disease. Some of those treatments involve insulin, which was discovered as a treatment for diabetes in…

Johnson & Johnson’s Janssen division (NYSE:JNJ) was among the first drug companies to prioritize oncology research. The company has more than three decades of experience in the domain. Recently, Chimeric antigen receptor (CAR) T therapy has become one of the most exciting areas of research for cancer and other diseases for the company, said Mathai Mammen, global…

Former FDA Commissioner Dr. Robert Califf could return to his old job if President Joe Biden has his way. Biden today announced his intention to nominate Califf to serve as FDA commissioner — a job he previously held during the Obama administration from 2016-17. A cardiology professor at Duke University and a member of the…

Athira Pharma (NSDQ:ATHA) announced that its lead development candidate, ATH-1017, had balanced baseline characteristics to date in two ongoing late-stage Alzheimer’s studies. Presenting the data at the 2021 Clinical Trials on Alzheimer’s Disease (CTAD) conference in Boston, the company’s chief medical officer Dr. Hans Moebius said that the baseline characteristics are consistent between the ACT-AD…