Brian Buntz

The European Medicines Agency (EMA) has begun an evaluation of a conditional marketing authorization application for the Skycovion (GBP510) COVID-19 vaccine candidate from SK Chemicals GmbH. Skycovion is a recombinant protein-based vaccine with adjuvant from GSK. In its filing, SK Chemicals provided data on how efficacious the vaccine is at creating antibodies against ​wild-type COVID-19.…

The Biden administration is in the process of transferring responsibility for COVID-19 vaccines to the healthcare industry, according to media reports.   To date, the federal government has footed the bill for the shots, but the Trump and Biden administrations have intended to eventually cease that practice as the pandemic shifts to an endemic phase.  Confirmed COVID-19…

The Administration for Strategic Preparedness and Response (ASPR) will make 50,000 courses of the small-molecule drug Tpoxx (tecovirimat) from SIGA Technologies (Nasdaq: SIGA) available to help fight the monkeypox outbreak. There have been 13,517 confirmed monkeypox/orthopoxvirus cases in the U.S. to date, according to the CDC. In 2018, Tpoxx became the first drug to win an…

Pfizer (NYSE:PFE) and BioNTech SE (Nasdaq:BNTX) have released positive data regarding two omicron-specific COVID-19 vaccine candidates. One is monovalent, and the other is bivalent, combining the companies’ original BNT162b5 COVID-19 vaccine with mRNA based on the BA.1 omicron variant. A Phase 2/3 study found that a booster dose of the next-gen Pfizer-BioNTech vaccine candidates led…

FDA announced that it had approved Zynteglo (betibeglogene autotemcel), a novel cell-based gene therapy for adult and pediatric patients with beta-thalassemia who need regular red blood cell transfusions.  Zynteglo, developed by Bluebird Bio (Nasdaq: BLUE), is administered as a single dose.  The product is indicated for adult and pediatric patients who need regular red blood…

Approximately two-thirds of Americans have received at least one dose of a COVID-19 vaccine.  But COVID-19 cases remain elevated following the spread of a series of omicron sublineages, which pose a threat to those vaccinated and naturally infected with various lineages of the coronavirus.  A variety of companies are developing next-generation COVID-19 vaccines that could potentially…

COVID-19 is an emerging focus for EpicentRx, a private biotech focused on multiple immune-mediated disorders. The La Jolla, California–based company is developing a next-gen COVID vaccine for SARS-CoV-2 based on nucleocapsid rather than spike protein.  The recombinant replication-competent adenoviral vaccine that expresses the SARS-CoV-2 nucleocapsid protein could be more resistant to COVID-19 variants.  The real-world…

It’s clear that drug discovery and development costs have rapidly increased in recent decades. That said, estimates vary widely. For example, a 2020 article in JAMA noted that estimates range from $314 million to $2.8 billion. A high drug discovery failure rate exacerbates the problem. Part of the challenge of making such calculations is the…

Yvonne Duckworth, CRB’s director of digital technology, says she was fortunate to enter the pharmaceutical industry straight out of college. “My first job, 31 years ago, was a wonderful opportunity as an automation engineer with an engineering company servicing the pharmaceutical industry,” she said. Duckworth has maintained her pharma focus at CRB, where she has…

The Galien Foundation has rounded up its picks for the most innovative biotech products for its 2022 Prix Galien USA Awards, showcasing advances in biotechnology and health products. The foundation does not include financial information in its nomination process. Consequently, its biotech roundup included few products that have reached blockbuster status. The Galien Foundation will announce the…

Be The Match BioTherapies now offers cryopreserved cord blood units (CBU) as allogeneic cell therapy starting material. Potential applications of the CBUs include non-clinical, clinical and commercial use. The company’s registry has more than 266,000 fully-characterized CBUs from domestic cord blood banks. Be The Patch offers comprehensive characterization information about CBUs to identify therapy-matched units.…

Pfizer (NYSE:PFE) said it is planning on filing a supplemental Biologics License Applications (sBLA) for its 20-valent pneumococcal conjugate vaccine candidate in infants by the end of the year. After announcing positive data from a pivotal U.S. Phase 3 study (NCT04382326), the company said the 20vPnC vaccine candidate, if approved, would offer the broadest serotype…

Merck & Co. (NYSE:MRK) could pay more than $1 billion to the Boston-based biotech startup Cerevance to develop potential drugs for Alzheimer’s disease. The collaboration will center around Cerevance’s Nuclear Enriched Transcript Sort sequencing (NETSseq) technology platform. The platform’s origins trace back to research at the Howard Hughes Medical Institute. Under the terms of the…

The Jynneos vaccine from Bavarian Nordic A/S (OMX:BAVA), the most widely used vaccine to protect against monkeypox, tends to have generally mild side effects according to clinical trial data. It is also clear that the Jynneos vaccine can help reduce the severity of monkeypox infections. Researchers are uncertain, however, about how the vaccine’s potential to…

Not long ago, diversity in clinical research seemed like an obscure topic. Ben Enejo, a partner at Arthur D. Little, recalls mentioning the theme in the past and getting blank stares. But the pandemic and the murder of George Floyd helped highlight the importance of diversity on multiple fronts, including in clinical research. As a result, there are…

Decades after compounds like LSD and psilocybin were made illegal , psychedelic medicine appears poised to go mainstream in the coming years, potentially treating conditions ranging from anxiety to PTSD. In the interim, however, hurdles remain. The American Psychiatry Association (APA) recently released a conservative position statement on psychedelics and empathogens such as MDMA. In…

Scholar Rock recently announced Q2 results, highlighting continued progress in its Phase 3 SAPPHIRE trial for the selective myostatin-inhibitor apitegromab in spinal muscular atrophy (SMA). SAPPHIRE is a randomized, double-blind, placebo-controlled study. The Cambridge, Massachusetts–based company also shared new data from its Phase 2 TOPAZ trial focused on apitegromab that showed significant and sustained improvement…

FDA has authorized emergency use of the Jynneos monkeypox vaccine for individuals who face an elevated risk of infection from the virus. The authorization specifically allows the intradermal use of vaccine from Bavarian Nordic A/S (OMX:BAVA, OTC:BVNRY) in those 18 and older with a high risk of monkeypox infection. The agency notes that the intradermal…

The electronic clinical outcome assessments (eCOA) firm THREAD has appointed Kim Boericke to be its first chief delivery officer. In her role, Boericke (pronounced “Berica”) will focus on supporting customers in implementing the THREAD platform to support decentralized clinical trial data collection. In addition, she will assist THREAD with decentralized clinical trials, working to include patients…

Over the past few months, healthcare leaders have been working on identifying vaccines to prevent the spread of monkeypox. One such development is the use of Bavarian Nordic’s (OMX:BAVA) Jynneos vaccine for the prevention and treatment of the fast-spreading disease. The Jynneos vaccine won approval in the U.S. in 2019 for the prevention of monkeypox…

The HER2-directed antibody-drug conjugate Enhertu (trastuzumab deruxtecan) has won FDA approval for patients with unresectable or metastatic HER2-low breast cancer. Enhertu, a HER2-directed antibody drug conjugate, is now the first approved therapy for patients with the HER2-low breast cancer subtype. The recent approval covers patients with HER2-low breast cancer if they have had chemotherapy for…

New York City-based Kallyope is one of the few biotechs focused solely on the gut-brain axis.  The privately-held company has built a cross-disciplinary team that weaves together advanced technologies in sequencing, bioinformatics, neural imaging, human genetics, and cellular and molecular biology to interrogate the hormonal and neural signaling pathways that comprise the gut-brain axis.  The…

Amgen (Nasdaq:AMGN) announced that it would purchase the San Carlos, California–based ChemoCentryx (Nasdaq:CCXI) for $52 per share in cash, which equates to a total of approximately $3.7 billion. The centerpiece of the proposed acquisition is Tavneos (avacopan), which scored FDA approval last year for the adjunctive treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The disease…

Axcella Therapeutics (Nasdaq:AXLA) has announced positive topline results from a Phase 2a randomized, double-blind, placebo-controlled study of the metabolism-modulator AXA1125 in patients with fatigue from long COVID. The biotech’s Phase 2a study was among the first drug studies to focus on long COVID. In February, FDA granted a Fast Track Designation to AXA1125 to treat…

Kansas City, Missouri–based engineering, construction and consulting company CRB has named Valerie Silva as director of procurement. With experience in cost optimization, project management and supply chain issues in the automotive and pharmaceutical industries, Silva will work within CRB’s innovative Global Technical Operations team. Silva will help the company’s clients address challenges related to speed…