Amgen Reports sNDA Submission of Otezla (apremilast) to The US FDA’s for Adults with Mild to Moderate Plaque Psoriasis

Shots:

  • The sNDA filing is based on P-III ADVANCE trial data, assessing Otezla (30 mg, bid) vs PBO in 595 patients in a ratio (1:1) with mild-to-moderate plaque psoriasis
  • The P-III ADVANCE study results: @16wks., improvement in its 1EPs of sPGA score; achieve 2EPs i.e, 75% improvement in BSA, change in PASI score
  • Otezla is a selective PDE4 inhibitor, approved therapy for mod. to sev. plaque psoriasis who are candidates for phototherapy or systemic therapy, for active PsA, and for with oral ulcers associated with Behçet’s Disease

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Conejo Valley Guide

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Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer

Shots:

  • The first BLA submission is based on P-III EV-301 trial which involves assessing of Padcev vs CT in 600 patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based CT and a PD-1/L1 inhibitor. The 1EP of the study was OS
  • The second BLA submission is based on P-II cohort 2 of EV-201 trial which involves assessing of Padcev in 128 patients with locally advanced or metastatic urothelial cancer who had received prior immunotherapy treatment but not eligible for cisplatin. The 1EP’s study was ORR
  • The submissions will be reviewed under RTOR for both the trials and results were presented at the ASCO GU’ 2021

Click here ­to­ read full press release/ article | Ref: Astellas | Image: Astellas

The post Astellas and Seagen Reports Submission of Two BLA to the US FDA for Padcev (enfortumab vedotin) in Locally Advanced or Metastatic Urothelial Cancer first appeared on PharmaShots.

Johnson & Johnson Reports EUA Submission to US FDA’s for its Single Shot COVID-19 Vaccine Candidate

Shots:

  • The EUA submission is based on P-III ENSEMBLE trial assessing the safety and efficacy of the COVID-19 vaccine in protecting adults aged ≥18yrs. against both mod. and sev. COVID-19 disease with assessment of efficacy as of day 14 and as of day 28 as co-1EPs
  • The study demonstrated that single-dose vaccine met all 1EPs & 2EPs. The company has initiated rolling submissions with several health agencies outside the US, and will submit a cMAA with the EMA in the coming weeks
  • The company intends to distribute vaccine to the US government imminently, following the authorization, and expects to supply 100M doses to the US in the H1’21

Click here ­to­ read full press release/ article | Ref: J&J | Image: Yahoo Finance

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Janssen Reports CHMP’s Acceptance for Accelerated Assessment of Cilta-cel’s MAA to Treat Patients with Heavily Pretreated Multiple Myeloma

Shots:

  • The MAA submission is based on a P-Ib/II CARTITUDE-1 study assessing the safety and efficacy of cilta-cel in adults with r/r MM. The company is expected to submit MAA to EMA in H1’21
  • The accelerated approval milestone in EU follows the rolling submission for cilta-cel to the US FDA in Dec’2020
  • Cilta-cel is an investigational BCMA-directed CAR-T therapy in development for the treatment of adults with r/r MM. CHMP’s accelerated assessment can reduce the review timelines to evaluate an MAA

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Businesswire

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Novo Nordisk Report Submission of label Expansion Application to US FDA’s for Ozempic (semaglutide) for T2D

Shots:

  • The approval is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg dose achieved significant and superior reduction in HbA1c, both doses are safe and well-tolerated profiles
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the US for 0.5 mg and 1.0 mg doses to treat T2D in adults and to reduce the risk of MACE in adults with T2D mellitus and established CV disease

Click here ­to­ read full press release/ article | Ref: GlobeNewswire| Image: Business Medical Dialogues

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Provention Bio Reports Submission of BLA and Priority Review to the US FDA for Teplizumab to Prevent T1D

Shots:

  • The BLA for teplizumab to delay or prevention of clinical T1D in at-risk individuals has been filed to the US FDA. The FDA has also granted Provention’s request for Priority Review and assigned anticipated PDUFA date as Jul 02, 2021
  • The company is actively working with the FDA to support their review while planning to launch the therapy in Q3’21
  • Teplizumab is an investigational anti-CD3 mAb and has previously received the US FDA’s BT designation. If approved, teplizumab will be the first disease-modifying therapy for T1D

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: ProventionBio

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Antengene Reports NDA Submission for ATG-010 (selinexor) to Treat RRMM and RR DLBCL in South Korea

Shots:

  • The NDA is based on STORM and SADAL studies. The P-IIb STORM study involves assessing of ATG-010 + low-dose dexamethasone in patients with rrMM prior treated with at least 4 prior therapies and whose disease is refractory to at least 2 proteasome inhibitors, 2 immunomodulatory agents, and an anti-CD38 mAb
  • The P-II SADAL study involves assessing ATG-010 in patients with rrDLBCL, including DLBCL arising from FL, who have received at least 2 prior therapies. The studies demonstrated efficacy with a manageable safety profile for ATG-010
  • ATG-010 (Xpovio) is a first-in-class oral SINE and is the first FDA approved drug for use in both MM and DLBCL

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PRNewswire

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Sorrento Reports Submission of MAA to COFEPRIS for COVI-STIX Rapid Detection Test

Shots.

  • The company has submitted MAA to COFEPRIS (the health regulatory authority for Mexico) for its COVI-STIX rapid diagnostic test to detect SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients
  • The test provides results in 15min. with positive detection as quickly as 2min for patient samples with high viral load.
  • Additionally, Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVI-GUARD, COVI-AMG, COVI-SHIELD, Gene-MAb, COVI-MSC and COVI-DROPS and diagnostic test solutions, including COVI-TRACK, COVI-STIX and COVI-TRAC

Click here ­to­ read full press release/ article | Ref: Sorrento | Image: Sorrento

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Vertex Reports Health Canada’s Acceptance of Trikafta’s NDA for Priority Review to Treat Cystic Fibrosis

Shots:

  • Vertex’ new drug submission for Trikafta has been accepted for Priority Review by Health Canada for the treatment of CF in people aged ≥12yrs.
  • With PR, the conventional review timeline of 300 days is reduced to 180 days. The expected Health Canada’s approval is in H1’21
  • Trikafta is a triple combination regimen used to treat CF in patients aged ≥12yrs. who have at least one copy of the F508del mutation in the CFTR gene

Click here ­to­ read full press release/ article | Ref: Businesswire | Image: Vertex

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Novo Nordisk Reports Submission of Label Extension Application to the EMA for Semaglutide (once weekly, 2.0 mg) for T2D

Shots:

  • The submission is based on SUSTAIN FORTE trial assessing Ozempic (2.0mg, qw) vs Ozempic (1.0mg) in 961 people with T2D in need of treatment intensification
  • Result: 2.0 mg of dose achieved significant and superior reduction in HbA1c @40wks., both the doses are safe and well-tolerated
  • Ozempic is a glucagon-like peptide-1 (GLP-1) analogue and is currently approved in the EU for 0.5 mg and 1.0 mg doses to treat T2D in adults

Click here ­to­ read full press release/ article | Ref: GlobeNewswire | Image: Facebook

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Chi-Med Initiates Rolling Submission of NDA to the US FDA of Surufatinib to Treat Advanced Neuroendocrine Tumors

Shots:

  • Chi-Med initiated the filing of NDA to the US FDA for surufatinib to treat pancreatic & non-pancreatic NET & plans to complete the NDA submission in the H1’21
  • The NDA is based on two P-III studies that demonstrated a reduction in risk of progression or death by 67% & 51%, extending PFS of non-pancreatic NET & pancreatic NET patients with an acceptable risk/benefit ratio
  • Surufatinib is an oral angio-immuno kinase inhibitor that selectively inhibits the tyrosine kinase activity associated with VEGFR and FGFR. The US FDA has granted FTD to surufatinib for pancreatic and non-pancreatic NET in Apr’2020 and ODD for pancreatic NET in Nov’2019

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: PMLive

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Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations

Shots:

  • The EMA Submission is based on P-l CHRYSALIS study to evaluate the safety and efficacy of Amivantamab as a monotherapy and in combination with Lazertinib in adult patients for the treatment of advanced NSCLC
  • Result of CHRYSALIS Study assessed efficacy using overall response rate per Response Evaluation Criteria, CBR, DOR and PFS as well as the safety profile of amivantamab
  • Amivantamab is an investigational, fully – human EGFR-MET bispecific antibody with immune cell – directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications

Click here ­to­ read full press release/ article | Ref: Janssen | Image: Law.com

The post Janssen Report MAA Submission of Amivantamab to EMA for Metastatic Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations first appeared on PharmaShots.

Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma

Shots:

  • Janssen Initiates Rolling Submission of BLA to US FDA is based on P-lb/ll CARTITUDE-1 Study involve evaluating the safety and efficacy of Autoleucel (cilta-cel) in adults for the treatment of relapsed and refractory Multiple Myeloma
  • The FDA granted BTD for cilta-cel and agreed to BLA’s rolling review includes completed portions of the application to be submitted and reviewed on an ongoing basis and the data were presented at the 62nd (ASH) Annual Meeting
  • Cilta-cel is a unique, structurally differentiated CAR-T cell therapy containing a 4-1BB co-stimulatory domain and 2 BCMA-targeting single-domain antibodies with a preferential CD8+ T-cell expansion

Click here ­to­ read full press release/ article | Ref: Janssen  | Image: Apotheke Adhoc

The post Janssen Initiates Rolling Submission of BLA to US FDA of Autoleucel (cilta-cel) to Treat Multiple Myeloma first appeared on PharmaShots.

Amgen Reports NDA Submission of Sotorasib to the US FDA for Advanced/Metastatic NSCLC With KRAS G12C Mutation

Shots:

  • The NDA submission is based P-II CodeBreaK 100 study assessing Sotorasib in patients with KRAS G12C-mutated NSCLC prior treated with CT and immunotherapy
  • The study provided durable anticancer activity with a positive benefit-risk profile
  • The US FDA has reviewed the NDA under RTOR pilot program, which aims to explore efficient review process that ensures safe and effective treatments are made available to patients as early as possible

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Axios

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Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension

Shots:  

  • The NDA submission is based on P-III UPTRAVI IV study he safety and tolerability of 20 patients with PAH temporarily switching from oral UPTRAVI to UPTRAVI IV, and then transitioning back to the initial oral dose
  • Results demonstrated that Uptravi IV is suitable to maintain continuous dosing for short periods of time when the oral formulation is not feasible. Both the formulation was well tolerated with no unexpected safety findings
  • Uptravi is a selective, prostacyclin IP receptor agonist, approved in IV formulation for PAH, WHO Group I in adults with WHO functional class (FC) II–III, who are currently prescribed oral Uptravi but are temporarily unable to take oral therapy

Click here ­to­ read full press release/ article | Ref: PRNewswire | Image: Penn Today

The post Janssen Reports the NDA Submission to the US FDA for Uptravi (selexipag, IV) to Treat Pulmonary Arterial Hypertension first appeared on PharmaShots.

Bayer Reports the NDA Submission to NMPA for Vericiguat to Treat Chronic Heart Failure in China

Shots:

  • The NDA submission was submitted to NMPA’s CDE and is based on P-III VICTORIA study, seeking regulatory approval of vericiguat in China
  • In Oct’2014, Bayer and MSD signed a WW agreement for sGC modulators. The therapy is being jointly developed by both the companies as per the collaboration and has received the US FDA’s PR in Jul’2020
  • Vericiguat (BAY 1021189/ MK-1242) is an sGC-stimulator being developed to treat patients with symptomatic CHF with an ejection fraction less than 45% who have had a previous worsening HF event in combination with available HF therapies

Click here ­to­ read full press release/ article | Ref: Bayer| Image: Berkeleyside

BioMarin Reports NDA Submission to the US FDA for Vosoritide to Treat Children with Achondroplasia

Shots:

  • BioMarin has submitted an NDA to the US FDA for vosoritide to treat children with achondroplasia
  • The company also reported that EMA has begun validation of MAA for the therapy on 13 Aug, 2020
  • Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) and is potentially the first treatment for achondroplasia in the US

Click here ­to­ read full press release/ article | Ref: Biomarin | Image: Fierce Biotech

Gilead Reports NDA Submission to the US FDA for Veklury (Remdesivir) to Treat COVID-19

Shots:

  • The NDA filing is based on P-III studies evaluating Veklury vs PBO, conducted by NIAID. The studies demonstrated that Veklury led to faster time to recovery and that a 5-day or 10-day treatment duration led to similar clinical improvement
  • Across multiple studies, Veklury was generally well-tolerated in both the 5-day and 10-day treatment groups, with no new safety signals identified
  • Veklury (remdesivir) is an investigational nucleotide analog with broad-spectrum antiviral activity both in vitro/ in vivo in animal models against multiple emerging viral pathogens. The therapy has been approved by multiple regulatory authorities across the globe, including the EU and Japan

Click here ­to­ read full press release/ article | Ref: Gilead  | Image: The Wire Science

BioMarin Reports the Submission of MAA to EMA for Vosoritide to Treat Children with Achondroplasia

Shots:

  • The MAA is based on P-III study assessing the efficacy and safety of vosoritide, further supported by the long-term safety and efficacy from the ongoing P-II and P-III extension studies and extensive natural history data
  • Following the completion of EMA’s validation, BioMarin expects the initiation of the MAA review to commence in Aug’2020. The company is planning to file NDA to the US FDA in Q3’20
  • Vosoritide is an investigational, once-daily injection analog of C-type Natriuretic Peptide (CNP) for children with achondroplasia and has received FDA’s and EMA’s ODD

Click here to read full press release/ article | Ref: BioMarin | Image: BioMarin




MorphoSys Reports Submission of Tafasitamab’s BLA to the US FDA to Treat Relapsed or Refractory Diffuse Large B Cell Lymphoma (r/r DLBCL)

Shots:

  • The BLA submission is based on L-MIND P-II trial data results assessing Tafasitamab + lenalidomide in patients with r/r DLBCL and retrospective observational matched control cohort Re-MIND evaluating efficacy outcomes of r/r DLBCL patients who received Tafasitamab + lenalidomide vs lenalidomide monothx
  • Re-MIND has met its 1EPs and has shown improved ORR of the tafasitamab/lenalidomide combination vs lenalidomide monothx. In Oct 2017, Tafasitamab + Lenalidomide received the US FDA’s Breakthrough Therapy Designation
  • Tafasitamab (MOR208) is an investigational Fc-engineered mAb directed against CD19 and is being evaluated in B-MIND P-III trial in combination with bendamustine vs rituximab + bendamustine in patients with r/r DLBCL

Click here to read full press release/ article | Ref: MorphoSys | Image: Behance