Top Pharma News of the Week – September 24th

All The Most Important Pharmaceutical News Stories Of The Week – September 2018 – Week # 4

FDA Issues Statement Reaffirming the Positive Benefit-Risk Profile of NUPLAZID® (pimavanserin) for Patients with Hallucinations and Delusions Associated with Parkinson’s Disease Psychosis

September 20, 2018

ACADIA Pharmaceuticals Inc. has announced that the FDA has completed a postmarketing review and issued a clear statement reaffirming the positive benefit-risk profile of NUPLAZID (pimavanserin) for patients with Parkinson’s disease psychosis. NUPLAZID is the only medicine approved in the United States to treat hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). NUPLAZID was approved by the FDA based on a pivotal Phase 3 study that demonstrated clinically robust and highly statistically significant efficacy, combined with other supportive studies.

Merck Receives Positive CHMP Opinion for DELSTRIGO™ (doravirine/ lamivudine/ tenofovir disoproxil fumarate) and PIFELTRO™ (doravirine) in the European Union for the Treatment of HIV-1 Infection

September 20, 2018

Merck, known as MSD outside the United States and Canada, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending granting of marketing authorization for two HIV-1 medicines: DELSTRIGO™, a once-daily fixed-dose combination tablet of doravirine (100 mg), lamivudine (3TC, 300 mg) and tenofovir disoproxil fumarate (TDF, 300 mg); and PIFELTRO™ (doravirine, 100 mg), a new non-nucleoside reverse transcriptase inhibitor (NNRTI) to be administered in combination with other antiretroviral medicines. DELSTRIGO and PIFELTRO are currently under EMA review for the treatment of adults with HIV-1 infection without past or present evidence of resistance to the non-nucleoside reverse transcriptase class, lamivudine or tenofovir. These two recommendations will now be reviewed by the European Commission for marketing authorization in the European Union. Marketing authorization applications for DELSTRIGO and PIFELTRO are also under review in other countries, including Canada, Australia, and Switzerland.

Novartis announces positive CHMP opinion for one-time gene therapy Luxturna® to treat children and adults with rare inherited retinal disease

September 21, 2018

Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for the approval of voretigene neparvovec, a one-time gene therapy for the treatment of patients with vision loss due to a genetic mutation in both copies of the RPE65 gene. Luxturna was developed and is marketed in the US by Spark Therapeutics. If approved, voretigene neparvovec will be commercialized by Novartis in markets outside the U.S.

St. Jude Children’s Research Hospital and Tessa Therapeutics Announce Strategic Collaboration

September 21, 2018

St. Jude Children’s Research Hospital (St. Jude) together with Tessa Therapeutics (Tessa), a clinical stage biopharmaceutical company, today announced the establishment of a strategic collaboration focusing on the development of novel cellular immunotherapies that could lead to new treatment options for children with brain cancer.

Trelegy Ellipta receives positive CHMP opinion supporting expanded COPD indication in Europe

September 21, 2018

GlaxoSmithKline plc and Innoviva, Inc. have announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion today supporting the use of Trelegy Ellipta (fluticasone furoate/umeclidinium/ vilanterol ‘FF/UMEC/VI’) in a broader group of patients with moderate to severe chronic obstructive pulmonary disease (COPD) and that labelling, if approved, will be updated to further reflect its effect on exacerbations of COPD.

Takeda Receives Positive CHMP Opinion Recommending ALUNBRIG® (brigatinib) for the Treatment of ALK+ Non-Small Cell Lung Cancer in Patients Previously Treated with Crizotinib

September 21, 2018

Takeda Pharmaceutical Company Limited has announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the full approval of ALUNBRIG® (brigatinib) as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase-positive (ALK+) advanced non-small cell lung cancer (NSCLC) previously treated with crizotinib. ALUNBRIG is a tyrosine kinase inhibitor (TKI) designed to target and inhibit the ALK mutation in NSCLC. Approximately three to five percent of NSCLC patients globally have the ALK mutation. If the CHMP opinion is affirmed, and the European Commission approves ALUNBRIG, it will become the only ALK inhibitor available in the European Union as a one tablet per day dose that can be taken with or without food.

Sandoz receives positive CHMP opinion for proposed biosimilar pegfilgrastim

September 21, 2018

Sandoz, a Novartis division and global leader in biosimilars, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for marketing authorization of its proposed biosimilar pegfilgrastim, a long-acting version of supportive oncology care medicine filgrastim.

Takeda Obtains Additional Indication and Dosage & Administration for ADCETRIS® as a Frontline Treatment for CD30-positive Hodgkin Lymphoma in Japan

September 21, 2018

Takeda Pharmaceutical Company Limited has announced that it has obtained an additional indication and dosage & administration for the use of ADCETRIS® (brentuximab vedotin; “ADCETRIS”) in combination with doxorubicin, vinblastine and dacarbazine as a frontline treatment option for CD30-positive Hodgkin lymphoma patients in Japan.

New analysis of Novartis Phase III brolucizumab (RTH258) data reinforces superior reduction of retinal fluid, a key marker of disease activity in nAMD

22 September 2018

Novartis announced a new data analysis showing that retinal fluid was detected less often in patients treated with brolucizumab (RTH258) 6 mg versus aflibercept over four visits between weeks 36 to 48. Retinal fluid is a key marker of disease activity in neovascular age-related macular degeneration (nAMD). The data, from pre-specified secondary endpoints of the Phase III HAWK and HARRIER trials, were presented at EURETINA 2018 as a follow-up to data presented in November 2017.

Top Pharma News of the Week – September 24th last edit: 2018-09-25T20:33:27+00:00 da Luca

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