Brian Buntz

Founded in 2016, PolarityTE (Nasdaq:PTE), a company focused on developing regenerative tissue products to address unmet medical needs in chronic wounds, has recently commenced a Phase 3 pivotal study involving patients with diabetic foot ulcers (DFUs).  In addition, the FDA granted its investigational SkinTE product Regenerative Medicine Advanced Therapy (RMAT) designation.  PTE shares, however, skidded…

The Pfizer-BioNTech vaccine booster had been previously limited in the U.S. to individuals at least 12 years old, but now children as young as 5 are eligible, thanks to an expanded emergency use authorization related to the vaccine. The agency agreed to expand the vaccine’s use in children to “provide continued protection against COVID-19,” said…

The U.S. government is planning to establish the Advanced Research Projects Agency for Health (ARPA-H) to accelerate biomedical research. The new federal research agency will not be based alongside its NIH parent in Bethesda, Maryland. After winning authorization to create the agency, Sen. Edward J. Markey (D-Mass.) and several colleagues in Massachusetts are asking the…

The popularity of CRISPR-based non-viral gene insertion techniques is fueling interest in CRISPR/Cas genome-editing technology that uses the homology-directed repair (HDR) pathway to insert DNA sequences. To respond to that demand, biotech services firm GenScript has introduced GMP-compliant single-stranded DNA (ssDNA) and closed-end linear double-stranded DNA (dsDNA) services. The company’s GenExact ssDNA services support up to…

Blockchain may be arguably one of the most hyped technologies in recent memory, but the distributed ledger technology better known for its role in cryptocurrency may have significant potential in the pharma supply chain, clinical trials and beyond. A blockchain-based initiative known as PharmaLedger has won support from prominent companies like Pfizer, Novartis, Merck &…

FDA has approved Mounjaro (tirzepatide), the first glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) for treating adults with type 2 diabetes. Developed by Eli Lilly and Co., tirzepatide could quickly become a mega-blockbuster. Annual sales of the drug could approach $14 billion by 2030, according to Mizuho Securities. To win approval, Lilly provided data…

On the heels of announcing a restructuring plan that reduces its workforce by 30%, Black Diamond Therapeutics (Nasdaq:BDTX) has announced that its discovery engine was featured in the peer-reviewed Cancer Research journal. The journal is published by American Association for Cancer Research (AACR). A paper highlighted in the journal explained how the company’s Mutation-Allostery-Pharmacology (MAP) discovery…

Focused on developing peripheral nerve regeneration and repair products, Axogen (Nasdaq:AXGN) announced that the Phase 3 RECON study met its primary endpoint in comparing its Avance nerve graft to conduits in digital nerve injuries. The primary endpoint was the return of sensory function based on static two-point discrimination. This test measures the ability to detect…

The Biden-Harris administration has announced that the NIH has licensed COVID-19 research technologies and vaccine candidates to the Medicines Patent Pool (MPP). Working with the WHO’s COVID-19 Technology Access Pool (C-TAP), the NIH will provide licenses to enable manufacturers to use the technologies to develop COVID-19 vaccines, treatments and diagnostics. In total, NIH is providing…

A recent physician survey found that 89% of neurologists in the U.S. have concerns about the efficacy of the controversial Alzheimer’s drug Aduhelm (aducanumab) from Biogen (Nasdaq:BIIB) and Eisai Co. (TYO:4523). Nearly as many — 87% — were concerned about the drug’s safety profile. The survey from the physician social media network Sermo (New York City) asked more than…

Seagen (Nasdaq:SGEN) has tapped a law firm to lead an investigation into its CEO Clay Siegall, who was charged with misdemeanor assault against his wife on April 23. Siegall maintains his innocence. A police report related to the incident reported that Siegall’s wife called 911 after he allegedly forced her to the ground. Siegall was…

AbbVie (NYSE:ABBV) has revealed positive topline results from the U-ENDURE Phase 3 study investigating 15- and 30-mg doses of Rinvoq (upadacitinib) in adults with moderate to severe Crohn’s disease. Recipients who received either dose met the co-primary endpoints of endoscopic response and clinical remission, AbbVie announced. More than one-third (36%) of participants who received 15…

In 2021, Johnson & Johnson’s (NYSE:JNJ) pharmaceutical segment Janssen reported revenue of more than $50 billion in fiscal 2021 and operational growth of 13.1%. Janssen exec Tom Cavanaugh’s next big goal for Janssen is ensure Janssen is a $60 billion pharmaceutical company by 2025. Heavy reliance on R&D will get them there, said Cavanaugh — Janssen’s…

The JAK inhibitor Olumiant (baricitinib) from Incyte (Nasdaq:INCY) and Lilly (NYSE:LLY) has scored FDA approval to treat hospitalized COVID-19 patients who need help breathing. In particular, the new indication covers adult patients needing supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation. Olumiant first won FDA approval in 2018 for treating moderately-to-severely active…

The clinical-stage biotech Genascence has closed a Series A financing led by Pacira BioSciences, generating $10.5 million. The funding round included investors Polymerase Capital, DeepWork Capital and University of Florida Research Foundation. The Palo Alto, California–based company is focused on treating musculoskeletal diseases with gene therapy. The company plans on using the funding for continued…

The biopharma Athira Pharma (Nasdaq: ATHA) has lengthened the current open-label extension (OLEX) study for its Phase 3 LIFT-AD and Phase 2 ACT-AD trials of fosgonimeton (ATH-1017, NDX-1017), hepatocyte growth factor receptor agonist, focused on mild-to-moderate Alzheimer’s disease. The Bothell, Washington–based company made the decision based on feedback from its independent data and safety monitoring…

The startup Karius aims to help establish a world where infectious disease is no longer a major threat to human health. “It’s an audacious vision,” said Dr. Brad Perkins, chief medical officer at Karius. “But I think it’s commensurate with the platform we’ve developed and continue to evolve.” The Redwood City, California-based company has developed…

AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study.  First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney…

Pfizer CEO Dr. Albert Bourla recently said that patients who relapse after completing a course of the COVID-19 antiviral Paxlovid (nirmatrelvir and ritonavir) could continue taking the drug.   “Paxlovid does what it has to do: it reduces the viral load,” Bourla told Bloomberg. “Then your body is supposed to do the job.”   “While the…

Decentralized clinical trial specialist Curebase said today that it has secured $40 million in Series B funding. The lead investor in the round was Industry Ventures. Other investors contributing to the round include Acrew Capital, World Innovation Lab, Positive Sum, Gilead Sciences (Nasdaq:GILD) and existing investors GGV Capital, Bold Capital and Xfund. The San Francisco–based…

AstraZeneca (LON:AZN) has announced that its supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) has received Priority Review from FDA when used with chemotherapy in patients with locally advanced or metastatic biliary tract cancer (BTC). The company had submitted data from the TOPAZ-1 Phase 3 study indicating an improvement in overall survival compared to standard-of-care chemotherapy.…

A growing number of small studies indicate that psilocybin, a psychoactive compound in hallucinogenic mushrooms, holds promise for treating depression, addiction and anxiety. But while traditional psychedelics like psilocybin may have broad potential, making effective therapeutic use of them at scale is likely to be challenging in the near term, said psilocybin advocate Derek Chase,…

Compass Pathways (Nasdaq:CMPS) announced positive data from two early studies focused on using psilocybin therapy for anorexia nervosa and severe treatment-resistant depression. The London-based company presented the results at the Society of Biological Psychiatry Annual Meeting in New Orleans. In the anorexia nervosa study, 10 patients received a single 25 mg of the company’s COMP360…

With the blockbuster dreams of the Alzheimer’s drug Aduhelm (aducanumab) dashed for the foreseeable future, Biogen has announced that its CEO Michel Vounatsos will depart. Vounatsos began his tenure as CEO in 2017. Vounatsos’ plans to exit the company came out on the same day that Biogen reported Q1 adjusted earnings per share of $3.62,…

Sage Therapeutics (Nasdaq:SAGE) and Biogen (Nasdaq: BIIB) have begun a rolling submission of a New Drug Application (NDA) to FDA for zuranolone to treat major depressive disorder (MDD). The two companies plan on submitting additional clinical data for the NDA in the second half of the year. Biogen entered into a $1.5 billion licensing agreement…