Invitae (NYSE: NVTA), a leading medical genetics company, today announced that its Personalized Cancer Monitoring (PCM™) assay, which helps detect minimal residual disease (MRD) in patients, has obtained its first commercial coverage in all solid tumors by Blue Shield of California. The policy, effective as of March 1, 2023, considers the test medically necessary for patients with stage I-IV cancer after surgical intervention for adjuvant or targeted therapy and/or monitoring for relapse or progression.
Monday, March 6, 2023
Clene: CNM-Au8® Preserved ALS Patient Function, Slowed Disease Progression in Phase 2
- Significant preservation of function (ALSFRS-R) from randomization to 48 weeks (p=0.0159)
- Significant preservation of function (ALSFRS-R) during the long-term open-label extension (OLE) week 24 to 120 weeks from randomization (p=0.0057)
- Significantly reduced risk of ALS clinical worsening by 52% over 120 weeks (HR: 0.478, p=0.0494)
- CNM-Au8 treatment was well-tolerated without long term safety concerns
RallyBio: Proof-of-Concept Achieved for Antibody to Prevent Thrombocytopenia
RLYB212 Showed Rapid Elimination of Transfused, HPA-1a Positive Platelets in HPA-1a Negative Subjects --
-- Clinical Findings and Safety Profile Consistent with Previously Reported Data; Continue to Support the Potential for RLYB212 as a Prophylactic Treatment for FNAIT --
-- Company Expects to Present Results at a Scientific Conference in 2023 --
Aclaris drug fails to treat skin disorder in mid-stage study
Aclaris Therapeutics Inc said on Monday its experimental drug failed to meet the main goal of a mid-stage study to treat a type of skin disorder.
The company said the drug, zunsemetinib, did not meet the main goal of reducing abscess count in patients with hidradenitis suppurativa, compared with placebo at week 12, and added that the study failed to meet its secondary goals.
The study for zunsemetinib in people with moderate to severe forms of the disease enrolled 95 patients. Hidradenitis suppurativa is a chronic inflammatory skin condition that causes abscesses and scarring on the skin.
Aclaris is also developing zunsemetinib as a potential treatment for rheumatoid arthritis and psoriatic arthritis.
https://finance.yahoo.com/news/aclaris-therapeutics-drug-fails-mid-121113144.html
FDA Approves Intramuscular Administration for Merck’s MMRV Family of Vaccines
Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved the addition of the intramuscular (IM) route of administration to the United States Product Insert (USPI) for Merck’s MMRV family of vaccines: M-M-R®II, VARIVAX®, and ProQuad®.
While these vaccines have a long history in the U.S., until now they have only been administered via subcutaneous (SC) injection.
Adaptimmune and TCR2 Therapeutics to Merge
Compelling clinical data with clear paths to products and multiple near‐term value-creating catalysts
Complementary technology platforms designed to treat solid tumors which represents a substantial market opportunity largely unaddressed by cell therapies
Following closing of the transaction, cash runway extended into 2026
Following the all-stock transaction, currently expected to close in Q2 2023, Adaptimmune shareholders will own ~75% and TCR² Therapeutics stockholders will own ~25% of the combined company
Companies to host a joint Webcast today, March 6, 2023, at 8:00 a.m. EST (1:00 p.m. GMT)
A joint webcast will be held at 8:00 a.m. EST (1:00 p.m. GMT) on March 6, 2023. A live webcast of the conference call and replay can be accessed at https://api.newsfilecorp.com/redirect/e4WKKsxwna. Call in information is as follows: (800)-319-4610 (US or Canada) or +1 (416)-915-3239 (International and additional options available HERE). Callers should dial in 5-10 minutes prior to the scheduled start time and simply ask to join the Adaptimmune call.
https://finance.yahoo.com/news/adaptimmune-tcr2-therapeutics-announce-strategic-110000040.html
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