Alkermes schizophrenia drug gets U.S. FDA approval

 Alkermes Plc said on Tuesday the U.S. Food and Drug Administration (FDA) had approved its treatment, Lybalvi, for schizophrenia and bipolar I disorder.

The company said it expects to commercially launch the drug in the fourth quarter.

The FDA in November had declined to approve the drug, citing concerns related to a tablet coating process at its manufacturing site.

Lybalvi is a once-daily, oral antipsychotic drug composed of olanzapine, an established antipsychotic agent, and samidorphan, a new chemical entity, the company said.

Schizophrenia is a severe mental disorder and affects 20 million people worldwide, according to the World Health Organization.

The company also has FDA-approved antipsychotic and alcohol-dependence treatments in the market. 

https://finance.yahoo.com/news/1-alkermes-schizophrenia-drug-gets-112818741.html

Seres: FDA Clears IND for SER-155 Investigational Microbiome Therapeutic

 – SER-155 aims to prevent mortality in immunocompromised patients due to gastrointestinal infections, bacteremia and GvHD –

– In collaboration with Memorial Sloan Kettering Cancer Center, Seres will now advance SER-155 into a Phase 1b clinical study –

https://finance.yahoo.com/news/seres-therapeutics-announces-fda-clearance-120000118.html

Immutep In New Collaboration With Merck KGaA LAG-3 Therapy, Efti

 

• Collaboration with Merck KGaA, Darmstadt, Germany to evaluate eftilagimod alpha in combination with bintrafusp alfa

• New investigator-initiated explorative, multi-centre, open-labelled Phase I/IIa trial in 12 previously treated patients with different solid tumours, called INSIGHT-005

• First patient is expected to be enrolled and dosed in H2 of calendar year 2021

https://finance.yahoo.com/news/immutep-enters-collaboration-merck-kgaa-120000889.html

CTI BioPharma Gets Priority Review of Pacritinib for Treatment of Myelofibrosis

 CTI BioPharma Corp. (Nasdaq: CTIC) today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L), with the NDA being granted Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is November 30, 2021. The FDA is not currently planning to hold an advisory committee meeting to discuss the NDA.

"We are pleased that the FDA's acceptance of our NDA brings us one step closer to our goal of providing myelofibrosis patients with severe thrombocytopenia a new treatment option," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "With commercial preparation underway, we believe we will be well positioned for a potential U.S. launch later this year. We look forward to working with the FDA during its review of our application."

The NDA was accepted based on the data from the Phase 3 PERSIST-2 and PERSIST-1 and the Phase 2 PAC203 clinical trials, with a focus on the severely thrombocytopenic (platelet counts less than 50 x 109/L) patients enrolled in these studies who received pacritinib 200 mg twice a day, including both frontline treatment-naive patients and patients with prior exposure to JAK2 inhibitors. In the PERSIST-2 study, in patients with severe thrombocytopenia who were treated with pacritinib 200 mg twice a day, 29% of patients had a reduction in spleen volume of at least 35%, compared to 3% of patients receiving the best available therapy, which included ruxolitinib.; 23% of patients had a reduction in total symptom scores of at least 50%, compared to 13% of patients receiving the best available therapy. In the same population of patients treated with pacritinib, adverse events were generally low grade, manageable with supportive care, and rarely led to discontinuation. Platelet counts and hemoglobin levels were also stabilized.

https://finance.yahoo.com/news/cti-biopharma-announces-acceptance-nda-110000462.html

CareDx Starts Enrollment in MAPLE, a Multi-modal, Multi-center, Prospective Study of LiverCare

 CareDx, Inc. (Nasdaq: CDNA), a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers, today announced the enrollment of the first patient in the Molecular Assessment and Profiling of Liver Transplant Recipients (MAPLE) Study at Mount Sinai Hospital in New York.

MAPLE is a multi-center, prospective study of the LiverCare platform, a novel multi-modality approach to assess the status of liver allografts. LiverCare will include the following:

• AlloSure® Liver — donor-derived cell-free DNA-based measure of organ injury

• AlloMap® Liver — gene expression profiling assessment of recipient immune system activity

• AlloHeme™ Liver — blood-based micro-chimerism surveillance solution

• HistoMap Liver — tissue-based gene expression profiling assessment of allograft rejection and injury

• AlloID™ — blood-based metagenomic infectious disease identification
  

In addition, LiverCare includes a proprietary machine learning algorithm to predict allograft outcomes based on clinical parameters.

The study, which was first announced earlier this year, will enroll 1500 liver transplant recipients and marks the beginning of CareDx’s work in liver transplant. The first enrolled patient demonstrates the continued momentum behind the study and CareDx’s commitment to patient care across transplant organ types.

“MAPLE will help us define the application of multi-modality testing in liver transplant,” said Dr. Sham Dholakia, Senior Vice President of Medical Affairs at CareDx. “As leaders in transplantation, CareDx was first to market with surveillance tests supported by clinical data in kidney and heart, and we are leading in lung. We will continue to invest in clinical data development and follow the science in support of transplant patients.”

https://finance.yahoo.com/news/caredx-starts-enrollment-maple-multi-120900903.html

Sanofi, Merck's 6-in-1 pediatric combo vaccine available in US

 Vaxelis™ (Diphtheria and Tetanus Toxoids and Acellular Pertussis, Inactivated Poliovirus, Haemophilus b Conjugate and Hepatitis B Vaccine), developed as part of a partnership between Sanofi Pasteur, the global vaccines business unit of Sanofi, and Merck (NYSE: MRK),* known as MSD outside the United States and Canada, is now available in the U.S.

Vaxelis is the first and only hexavalent (six-in-one) combination vaccine available in the U.S. Vaxelis is a vaccine given to protect your child from getting diphtheria, tetanus (lockjaw), pertussis (whooping cough), polio, Hib (Haemophilus influenzae type b), and hepatitis B. Your child cannot get any of these diseases from Vaxelis. Vaxelis may not completely protect your child from these diseases. Vaxelis is given to children from 6 weeks through 4 years of age (up to the 5th birthday) and is given as 3 shots, one at 2 months, one at 4 months and one at 6 months of age.

https://finance.yahoo.com/news/sanofi-mercks-first-only-six-104500757.html

Spectrum: FDA Rolontis preapproval inspection started

 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced that the U.S. Food and Drug Administration (FDA) is "on site" for the ROLONTIS® (eflapegrastim) manufacturing facility inspection. Spectrum previously received notification from the agency that it would defer its decision on the BLA for ROLONTIS because an inspection of the Hanmi Bioplant in South Korea could not be conducted due to restrictions on travel related to the COVID-19 pandemic.

"I would like to confirm that the FDA has initiated its inspection of the ROLONTIS manufacturing facility," said Joe Turgeon, President and CEO of Spectrum Pharmaceuticals.

About ROLONTIS

ROLONTIS is a novel, long-acting granulocyte colony-stimulating factor (G-CSF) seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive anti-cancer drugs. The BLA for ROLONTIS is supported by data from two identically designed Phase 3 clinical trials, ADVANCE and RECOVER, which evaluated the safety and efficacy of ROLONTIS in 643 early-stage breast cancer patients for the treatment of neutropenia due to myelosuppressive chemotherapy. In both studies, ROLONTIS demonstrated the pre-specified hypothesis of non-inferiority (NI) in duration of severe neutropenia (DSN) and a similar safety profile to pegfilgrastim. ROLONTIS also demonstrated non-inferiority to pegfilgrastim in the DSN across all 4 cycles (all NI p<0.0001) in both trials.

https://finance.yahoo.com/news/spectrum-pharmaceuticals-announces-rolontis-eflapegrastim-110000519.html