Drug Discovery and Development Archives - Page 69 of 158

Details emerge from incident that led Seagen’s CEO to take a leave of absence

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 later charged with fourth-degree domestic violence, according to police reports obtained by Endpoints News.

Siegall’s wife also filed a temporary restraining order against him. The couple is going through divorce proceedings.

The police report alleges that Siegall (61) pushed his wife Nellie to the ground and dragged her along the floor, causing bruises and abrasions.

Founded in 1997, Bothell, Washington-based Seagen is a leading biotechnology company focused on antibody-drug conjugates. Its 2021 revenues were $1.6 billion.

Siegall is a co-founder of the company.

Following the r…

AbbVie’s Rinvoq supports clinical remission in Phase 3 Crohn’s disease study

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 mg of upadacitinib achieved clinical remission at week 52. A total of 46% of those receiving the 30-mg dose achieved the same benchmark, compared with 14% of placebo recipients.

Subjects also achieved the secondary endpoint of endoscopic remission at 52 weeks compared to placebo.

Study participants were poor candidates for conventional or biologic therapy.

The study defined clinical remission using the Crohn’s Disease Activity Index (CDAI) or by stool frequency and abdominal pain score (SF/AP).

Rinvoq first won FDA approval in 2019 for rheumatoid ar…

Janssen’s company group chairman dishes on growth strategy

By 2025, Janssen could be a $60 billion pharmaceutical company, projected Tom Cavanaugh, company group chairman, global commercial strategy organization at Janssen, in a recent interview.

To get there, Janssen will rely heavily on R&D. The company invested $11.9 billion in R&D in 2021. “That’s a 24% increase versus the previous year,” Cavanaugh said.

The company spends more on R&D than sales and marketing. To choose where to invest the funding, the company looks across six core therapeutic areas to find areas with the greatest unmet medical need.

Drugs helping fuel current growth

Tom Cavanaugh

When asked which drugs stand out in its current portfolio, Cavanaugh first singled out Darzalex (daratumumab), which first won FDA approval in 2015 for patients with previously treated multiple myeloma. Licensed from Genmab, Darzalex binds to a protein known as CD38 on r…

FDA approves Olumiant for treating some hospitalized COVID-19 patients

[Olumiant image courtesy of Lilly]

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 rheumatoid arthritis.

Lilly began testing the drug in hospitalized COVID-19 patients in June 2020. It won emergency use authorization (EUA) for such patients in November of that same year when used with remdesivir.

FDA broadened the EUA in July 2021 to allow its use with or without remdesivir.

Olumiant is the first immunomodulatory therapy to score FDA approval for a COVID-19 indication.

The drug continues to be avail…

Genanscence raises $10.5 million in Series A financing

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 development of GNSC-001, an adeno-associated vector with a coding sequence for interleukin-1 receptor antagonist (IL-1Ra), which inhibits interleukin-1 (IL-1) signaling.

GNSC-001 is Genascence’s lead program in osteoarthritis. Inhibiting IL-1 is an attractive target in osteoarthritis because IL-1 is involved in cartilage degeneration and inflammation.

Osteoarthritis affects approximately 13% of adults according to data from CDC.

“Osteoarthritis affects more than 30 million Americans and is the leading cause of disability and chronic pain…

Athira Pharma to continue open-label Alzheimer’s extension studies

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 board.

ATHA shares fell about 3% to $8.89 in early afternoon trading.

Last October, the company’s former CEO, Leen Kawas, stepped down amidst research misconduct allegations, and Athira’s then-chief operating officer, Mark Litton, assumed the mantle of CEO.

In June 2021, the company announced they had put Kawas on leave. After the announcement, its stock dipped 39%.

In the recent news announcement, Athira said that participants in the LIFT-AD or ACT-AD studies could elect to join the open-label extension that provides up to …

How Karius aims to transform the diagnosis of infections with a non-invasive liquid biopsy

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 Karius Test, a liquid biopsy for infectious diseases that can detect more than one thousand pathogens from a single blood draw.

Dr. Bradley Perkins [Image courtesy of Karius]

The test works by detecting microbial cell-free DNA (mcfDNA) in the bloodstream from likely pathogens causing an infection.

“If we can accelerate and improve diagnosis while making it safer, the notion is that clinicians will ultimately be better able to treat infectious diseases,” Perkins said.

Karius says its tech…

AstraZeneca’s Farxiga met primary endpoint in Phase 3 heart failure trial

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 disease.

AstraZeneca now says that data from the DELIVER and DAPA-HF Phase 3 studies show its efficacy in heart failure regardless of ejection fraction.

In the two studies, the safety profile of Farxiga was consistent with prior data.

Farxiga’s biggest competitor is Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly, first approved in 2014 for type 2 diabetes. Jardiance now has two FDA indications related to heart failure.

Another competitor is the heart failure drug Entresto (sacubitril/valsartan) from Novartis, which had $2.8 billion in sales in …

FDA and Pfizer differ on reports of viral rebounds after Paxlovid treament

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.”

Paxlovid is currently authorized under emergency use authorization “for longer than 5 consecutive days.”

In a clinical trial, between 1% and 2% of COVID-19-infected participants taking Paxlovid experienced a relapse, which was a similar rate to placebo recipients.

In a recent article, Dr. John Farley, director of the FDA’s Center for Drug Evaluation and Research, said the agency was aware of reports of some patients developing COVID-19 symptoms after completing a five-day course of Paxlovid.

Farley concluded that “there is no evidence of benefit at this time for a longer course of treatment (e.g., 10 days rather than the…

Curebase raises $40 million in Series B funding round

Decentralized clinical trial specialist Curebase has secured $40 million in Series B funding thanks to the support of Industry Ventures and others.

Other investors contributing to the funding round include Acrew Capital, World Innovation Lab, Positive Sum, Gilead Sciences and existing investors GGV Capital, Bold Capital and Xfund.

The San Francisco–based company has worked to popularize the concept of “BYOP” — “bring your own physician” to make clinical trials available to patients regardless of location.

“Traditional clinical trials at big hospitals tend to be slower, more expensive, less diverse,” said Tom Lemberg, CEO of Curebase. “Our objective as a company is to bring the trial to the patient both at home and with their own physician.”

Tom Lemberg

Curebase says its decentralized approach can accelerate recruiting, facilitate clinical t…

Imfinzi with chemotherapy gets FDA priority review for locally advanced or metastatic biliary tract cancer

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.

FDA has set a Prescription Drug User Fee Act date for the third quarter of 2022.

Roughly 23,000 people in the U.S. receive a BTC diagnosis annually. Of those, approximately 5% to 15% survive five years after diagnosis.

“People with advanced biliary tract cancer have faced poor outcomes and limited treatment options for too long, and today’s news for the TOPAZ-1 trial underscores the urgency to deliver new, effective therapies in this setting,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca: “We are working close…

Psilocybin holds therapeutic promise — but tapping its potential could be a challenge

Communication between brain networks in people given psilocybin (right) or a non-psychedelic compound (left). [Image courtesy of Wikimedia Commons]

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, who has experience working in the pharmaceutical, cosmetic and cannabis industries.

“The mental health segment needs to be readdressed from the ground up” to make the most of psychedelics, Chase said. With psychedelics, the mental health industry should strive to find a “true linking of medication with therapy.”

Psychedelics such as psilocybin should …