Brian Buntz

Gilead Sciences’ (NSDQ:GILD) Veklury (remdesivir) became the first FDA-approved COVID-19 drug when it was approved in October 2020. Now, the company has announced that the FDA has granted expedited approval of a supplemental new drug application (sNDA) for the drug to treat non-hospitalized adult and adolescent patients with a high risk of progression to severe…

FDA first approved AbbVie’s (NYSE:ABBV) interleukin-23 inhibitor Skyrizi (risankizumab-rzaa) for moderate to severe plaque psoriasis in 2019. Now, the agency has extended the approval to include adults with active psoriatic arthritis (PsA), which affects almost one out of three people with psoriasis. To win the new indication, AbbVie provided data from the KEEPsAKE-1 and KEEPsAKE-2 pivotal studies.…

Biogen’s (NSDQ:BIIB) Alzheimer’s drug Aduhelm (aducanumab) continues to be a source of contention. Advocates cite the need for a new therapy for the memory-robbing disease while skeptics remain unconvinced about the benefit-risk profile of the drug.  Most recently, Alzheimer’s disease advocates have criticized Medicare’s proposal to constrain coverage for the drug to clinical trial participants.  The…

IntelGenx Corp. (TSX:IGX/OTCQB:IGXT) has dosed the first patient in a resumed Phase 2a clinical trial involving an oral film of montelukast for Alzheimer’s disease (AD).  The COVID-19 pandemic previously interrupted the study for more than one year.  In 2019, IntelGenx initially announced that the study would enroll roughly 70 individuals with mild-to-moderate AD and test a…

The self-proclaimed “spatial biology company” Akoya Biosciences (NSDQ:AKYA) has appointed Marilee Moy as its chief people officer. Moy has more than three decades of experience in human resources and has worked for several life science companies, including Questcor, Counsyl, Tails Biomedical, Genentech and Johnson & Johnson. Akoya, which went public last year, had raised more…

Soon after taking the reins of Zymeworks (NYSE:ZYME), new Chair and CEO Kenneth Galbraith has decided to sharpen the company’s focus and reduce the firm’s headcount. To free up cash, the company plans to lay off at least one-quarter of its staff, including 10 members (50%) of its senior management team. The Vancouver–headquartered company also intends to…

The biotech Altos Labs has exited stealth mode with top-tier talent and $3 billion in funding with a broad mission of promoting homeostasis in cells to reverse disease, injury and disability. In other words, the company aims to use biotechnology to fight aging and disease, as early media reports have suggested. In a press release, Altos…

Beckman Coulter Life Sciences (Indianapolis) has received an EU Quality Management System Certificate under the In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) for more than 200 flow cytometry reagents manufactured at its Marseille, France facility. In May 2022, IVDR 2017/746 will replace the In Vitro Diagnostics Directive (98/79/EC) (IVDD), which has been in place…

Valneva SE (NSDQ:VALN) announced promising preliminary lab results involving recipients of its inactivated VLA2001 COVID-19 vaccine. In a pseudovirus neutralization assay involving sera from 30 volunteers in the Phase 1/2 trial VLA2001-201, all samples had neutralizing antibodies against the ancestral virus and the delta variant. In addition, 87% (26 samples) had neutralizing antibodies to omicron.…

Sorrento Therapeutics (NSDQ:SRNE) has received the go-ahead from the Brazilian Health Regulatory Agency (ANVISA) for a Phase 2a study involving its COVI-MSC allogeneic adipose-derived mesenchymal stromal cells. The company hopes the experimental treatment will benefit patients with so-called “long COVID,” a syndrome linked with a variety of symptoms ranging from fatigue to pulmonary compromise. The…

FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY). The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen. FDA also granted priority review to the…

The use of decentralized clinical trials (DCTs) exploded during the pandemic, but quantifying their financial benefits has been elusive.  Medable (Palo Alto, California), the maker of a cloud-based DCT platform, has announced that DCTs can accelerate clinical trial timelines and lead to significant cost savings.  Medable and its research partner, the Tufts Center for the Study…

Janssen (NYSE JNJ) and Leyden Labs (Amsterdam) have signed a licensing agreement that gives the latter rights to develop CR9114, an antibody protecting against influenza A and B. Leyden hopes to commercialize CR9114 as a nasal spray. Under the terms of the deal, Janssen will get an upfront payment and could receive milestone payments tied…

Focusing on insights based on real-world data (RWD) related to drug lifecycle and medical practice, Verana Health (San Francisco) has just hauled in $150 million Series E funding. Verana Health’s current fundraising total is $288.8 million, according to CrunchBase. Johnson & Johnson Innovation (JJDC) and Novo Growth led the most recent funding round. Also joining…

Pfizer (NYSE:PFE) has announced that the FDA has approved the oral Janus kinase 1 inhibitor Cibinqo (abrocitinib) for adults with refractory, moderate-to-severe atopic dermatitis (AD). In 2020, Pfizer CEO Dr. Albert Bourla projected that Cignqo would generate $3 billion in peak sales. In 2021, SVB Leerink projected the drug would generate $2 billion in sales…

FDA has approved Rinvoq (upadacitinib) from AbbVie (NYSE:ABBV) to treat moderate to severe atopic dermatitis in individuals at least 12 years old. AbbVie anticipates 2025 risk-adjusted sales for Rinvoq to top $7.5 billion. The most common type of eczema, atopic dermatitis, can be managed with various therapies, including corticosteroids, topical calcineurin inhibitors and immunosuppressants. Nevertheless, the…

​​Vir Biotechnology (NSDQ:VIR) with its partner GSK (LSE/NYSE:GSK) recently announced growing traction for the investigational COVID-19 monoclonal antibody sotrovimab. Now, San Francisco–based Vir has expanded its partnership with the Bill & Melinda Gates Foundation to focus on developing broadly neutralizing antibodies intended to provide a “vaccinal effect” for treating HIV and preventing malaria. Vir Biotechnology…

While the present adoption of real-world data (RWD) and real-world evidence (RWE) remains early, such data promise to accelerate regulatory decision-making and support the approval of new indications for drugs already on the market.  “We’re now seeing real-world data being used and consulted almost 100% of the time to design a protocol for a study,”…

GlaxoSmithKline (LSE/NYSE GSK) and Vir Biotechnology (NSDQ:VIR) are seeking to expand the use of the investigational monoclonal antibody sotrovimab. Intravenous sotrovimab is currently authorized to treat mild-to-moderate COVID-19 in patients at least 12 years of age, weighing at least 40 kg (88 pounds). The authorization is constrained to patients who face a high risk of…

Denali Therapeutics (NASDAQ:DNLI) has announced that the FDA has placed a clinical hold on the Investigational New Drug (IND) application for DNL919. The large-molecule drug candidate targets TREM2 or triggering receptor expressed on myeloid cells 2. South San Francisco–based Denali said it received an email from FDA stating that the agency had placed the IND…

The pharmaceutical industry appears to have addressed a decade-long decline in R&D productivity, according to a recent analysis from Deloitte. In 2021, the projected R&D return on investment (ROI) rose 7%. For comparison, the ROI level in 2010 was 2.7%. Forecast peak sales per asset hit $521 million, up more than 23% over the $422 million…

U.S. researchers have found that cannabinoid acids extracted from cannabis sativa prevented infection of human epithelial cells. They conclude cannabinoids may also have the potential to treat COVID-19. Using a pseudovirus expressing the SARS-CoV-2 spike protein, the scientists found that cannabigerolic acid (CBGA) and cannabidiolic acid (CBDA) effectively blocked infection from the alpha (B.1.1.7) and beta…

Bharat Biotech (Hyderabad, India) and its partner Ocugen (NSDQ:OCGN) have announced that their Covaxin (BBV152) COVID-19 vaccine candidate generated a strong neutralizing antibody response to the omicron (B.1.529) and delta (B.1.617.2) variants. The data comes from a study at Emory University involving sera from participants who received three doses of the vaccine with a 28-day…

Last December,’s (NYSE:JNJ) blockbuster blood thinner Xarelto (rivaroxaban) won FDA approval for two new indications for pediatric indications. The drug now has 11 indications in the U.S., more than any other direct oral anticoagulant (DOAC). In 2020, the drug generated nearly $6.5 billion in revenue globally. To learn more about the new indications, we spoke…

BioNTech (NSDQ:BNTX) and the enterprise AI company InstaDeep have announced that they have created an early warning system to improve the monitoring of potentially dangerous SARS-CoV-2 variants. The companies claim that the system spotted more than 90% of WHO-designated variants an average of two months before the organization officially classified them. For example, the system…