Chemical compounds

FibroGen Announces Outcome of FDA Advisory Committee Review of Roxadustat for Treatment of Anemia of Chronic Kidney Disease

Retrieved on: 
Thursday, July 15, 2021

Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD.

Key Points: 
  • Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by the FDA for review for the treatment of anemia of CKD.
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia of chronic kidney disease (CKD).
  • Roxadustat is also in clinical development for anemia associated with myelodysplastic syndromes (MDS) and for chemotherapy-induced anemia (CIA).

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AcelRx, Ocugen, Tarena, and DraftKings and Encourages Investors to Contact the Firm

Retrieved on: 
Thursday, July 15, 2021

The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.

Key Points: 
  • The Company's lead product candidate is DSUVIA, a 30 mcg sufentanil sublingual tablet for the treatment of moderate-to-severe acute pain.
  • misbrand Dsuvia within the meaning of the Federal Food, Drug and Cosmetic Act (FD&C Act) and make its distribution violative.
  • For more information on the DraftKings class action go to: https://bespc.com/cases/DKNG
    About Bragar Eagel & Squire, P.C.
  • The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country.

Wolf Haldenstein Adler Freeman & Herz LLP: Benzene in Sunscreen Investigation Alert

Retrieved on: 
Thursday, July 15, 2021

Today, Johnson & Johnson announced that it is voluntarily recalling some spray aerosol sunscreen from the market amid concerns that the products could be contaminated with a cancer-causing chemical.

Key Points: 
  • Today, Johnson & Johnson announced that it is voluntarily recalling some spray aerosol sunscreen from the market amid concerns that the products could be contaminated with a cancer-causing chemical.
  • The company said in astatement that it is recalling all lots of five Neutrogena and Aveeno brand aerosol sunscreen product lines after testing identified low levels of benzene in some samples.
  • Wolf Haldenstein is investigating claims of high levels of benzene in the following sunscreens and gels:
    HAVE YOU PURCHASED ONE OF THESE PRODUCTS?
  • Wolf Haldenstein Adler Freeman & Herz LLP has extensive experience in the prosecution of consumer rights litigation in state and federal trial and appellate courts across the country.

Prostate Cancer Clinical Landscape Research Report 2021 - ResearchAndMarkets.com

Retrieved on: 
Thursday, July 15, 2021

In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.

Key Points: 
  • In the US, prostate cancer is the most common non-cutaneous malignancy diagnosed in men, and is the second-leading cause of cancer mortality in men behind lung cancer.
  • Prostate cancer drugs, on average, take 9.0 years from Phase I to approval, compared to 9.6 years in the overall oncology space.
  • Pfizer's next-generation androgen receptor (AR) inhibitor Xtandi is the market leader in prostate cancer due to its established efficacy across prostate cancer segmentations and a lack of near-term generic competition.
  • Future expansion opportunities include potential use in combination with PARP inhibitors Talzenna or Rubraca in metastatic castration-resistant prostate cancer (mCRPC) patients.

Incyte Announces Positive Phase 3 REACH3 Study Data Published in NEJM for Ruxolitinib (Jakafi®) in Chronic Graft-Versus-Host Disease

Retrieved on: 
Wednesday, July 14, 2021

Results from the REACH3 study published in NEJM are extremely compelling and underscore the potential benefits ruxolitinib can offer appropriate patients facing the serious complications associated with chronic GVHD, said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte.

Key Points: 
  • Results from the REACH3 study published in NEJM are extremely compelling and underscore the potential benefits ruxolitinib can offer appropriate patients facing the serious complications associated with chronic GVHD, said Peter Langmuir, M.D., Group Vice President, Oncology Targeted Therapies, Incyte.
  • BAT arms were thrombocytopenia (15.2% vs. 10.1%), anemia (12.7% vs. 7.6%), neutropenia (8.5% vs. 3.8%) and pneumonia (8.5% vs. 9.5%).
  • Mortality rates were similar across treatment arms (18.8% in the ruxolitinib arm vs. 16.5% in the BAT arm)1.
  • Deaths reported as primarily due to chronic GVHD complications and/or its treatment were higher in the ruxolitinib vs.

Navitas Described as "The Power and the Glory" of Top Tech Companies to Watch

Retrieved on: 
Friday, July 16, 2021

Navitas has performance and reliability for a $13B GaN market that goes beyond chargers to datacenters, solar and EV.

Key Points: 
  • Navitas has performance and reliability for a $13B GaN market that goes beyond chargers to datacenters, solar and EV.
  • Navitas' proprietary GaN power ICs integrate GaN power (FET) and GaN drive plus control and protection in a single SMT package.
  • The Silicon 100 demonstrates the commitment of EE Times and its distinguished reporters to recognize the critical role that innovative companies play in technological progress."
  • Live Oak II and Navitas anticipate that subsequent events and developments will cause Live Oak II's and Navitas' assessments to change.

Keller Lenkner LLC Files Class Action Against Johnson & Johnson Subsidiary

Retrieved on: 
Thursday, July 15, 2021

CHICAGO, July 15, 2021 /PRNewswire/ -- National plaintiffs' law firm Keller Lenkner LLC today filed a class action against Johnson & Johnson subsidiary Johnson & Johnson Consumer, Inc. (J&J) on behalf of purchasers of certain Aveeno and Neutrogena sunscreens that have dangerous and unacceptable levels of the known cancer-causing chemical, benzene.

Key Points: 
  • CHICAGO, July 15, 2021 /PRNewswire/ -- National plaintiffs' law firm Keller Lenkner LLC today filed a class action against Johnson & Johnson subsidiary Johnson & Johnson Consumer, Inc. (J&J) on behalf of purchasers of certain Aveeno and Neutrogena sunscreens that have dangerous and unacceptable levels of the known cancer-causing chemical, benzene.
  • "Johnson & Johnson continued to market these sunscreen products as safe and healthy for consumers after being alerted to dangerous levels of a known, cancer-causing chemical," said Keller Lenkner Partner Warren Postman .
  • The action is Dominguez et al v. Johnson & Johnson Consumer, Inc., No.
  • ABOUT KELLER LENKNER:Keller Lenkner LLC represents plaintiffs in complex litigation matters in federal and state courts throughout the nation.

NCCN Announces Selected Projects to Study Neratinib in Collaboration with Puma Biotechnology, Inc.

Retrieved on: 
Thursday, July 15, 2021

Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert medical oncologists from NCCN Member Institutions.

Key Points: 
  • Proposals were peer reviewed by a Scientific Review Committee, which consisted of leading expert medical oncologists from NCCN Member Institutions.
  • Puma is providing $1.4 million in funding and will also supply the neratinib tablets for use in the studies.
  • In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database .
  • Visit NCCN.org for more information and follow NCCN on Facebook @NCCNorg , Instagram @NCCNorg , and Twitter @NCCN .

Acadia Pharmaceuticals to Present New Scientific Data on Pimavanserin in Neurodegenerative Diseases at the Alzheimer’s Association International Conference 2021 (AAIC)

Retrieved on: 
Wednesday, July 14, 2021

Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.

Key Points: 
  • Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that three scientific presentations in dementia-related psychosis (DRP) will be shared at the Alzheimers Association International Conference 2021 (AAIC), being held July 26-30, 2021 in Denver, Colo., and virtually.
  • The poster presentations include two analyses of patients who have neurodegenerative disease taking pimavanserin while also receiving other antidementia medication.
  • In vitro, pimavanserin demonstrated no appreciable binding affinity for dopamine (including D2), histamine, muscarinic, or adrenergic receptors.
  • Contraindication: NUPLAZID is contraindicated in patients with a history of a hypersensitivity reaction to pimavanserin or any of its components.

FDA lifts Partial Clinical Hold on Phase Ib Clinical Trial of RVU120 (SEL120) in Acute Myeloid Leukemia and Myelodysplastic Syndrome

Retrieved on: 
Wednesday, July 14, 2021

Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.

Key Points: 
  • Following the completion ofthe75mg cohort, the data generated will be reviewed by the agency and a further dose escalation strategy will be established.
  • The partial clinical hold was issued following Ryvu's recent report to the FDA of a Serious Adverse Event (SAE) involving a patient death that may possibly be related to RVU120.
  • RVU120 is a selective CDK8/CDK19 kinase inhibitor with potential for the treatment of hematological malignancies and solid tumors currently in Phase 1b clinical development for the treatment of acute myeloid leukemia and myelodysplastic syndrome.
  • SEL24 (MEN1703) is a dual PIM/FLT3 kinase inhibitor licensed to the Menarini Group, currently in Phase II clinical studies in acute myeloid leukemia.