Tags : Sarepta

Sarepta Signs an Exclusive Worldwide License with Hansa to Develop

Shots: Hansa to receive $10M up front, up to $397.5M as development, regulatory & commercial milestones. Hansa will book all sales of therapy and will get royalties on gene therapy sales that arises from treating Ab-positive patients enabled through imlifidase pre-treatment Sarepta get an exclusive WW license to develop and promote imlifidase as a pre-treatment […]Read More

PharmaShots Weekly Snapshot (Jun 22- 26, 2020)

 1.  EMA’s CHMP Recommends the Approval of Two Biosimilar Referencing Lilly’s Forsteo (teriparatide) for the Treatment of Osteoporosis Published: Jun 26, 2020 | Tags: EMA, CHMP, Recommend, Approval, Two, Biosimilar, Referencing, Lilly, Forsteo, teriparatide, Osteoporosis 2.  Medtronic Receives the US FDA’s Approval for its Percept PC Neurostimulator with BrainSense Technology Published: Jun 25, 2020 | Tags: Medtronic, […]Read More

Sarepta Signs a Two-Year Research and Option Agreement with Codiak

Shots: Codiak to receive up to $72.5M upfront, near-term license payments along with research funding and is eligible to receive development and regulatory milestone payments and tiered royalties on future sales of therapies emerges during the collaboration Sarepta gets an exclusive option to license Codiak’s technology to develop and commercialize engineered exosome therapies for up […]Read More

PharmaShots Weekly Snapshot (April 27 -May 01, 2020)

WuXi Biologics and Aravive Collaborate to Develop Novel High-Affinity Bispecific Antibodies for Cancer and Fibrosis Published: Apr 30, 2020 | Tags: WuXi Biologics, Aravive, Collaborate, Develop, Novel, High-Affinity Bispecific Antibodies, Cancer,  Fibrosis  Novartis’ Enerzair Breezhaler (QVM149, IND/GLY/MF) Receives CHMP’s Recommendation for Approval as a Treatment for Uncontrolled Asthma Published: May 01, 2020 | Tags: Novartis, Enerzair, […]Read More

Insights+: COVID-19 Healthcare News Monthly Updates

Our planet is facing a major pandemic outbreak due to COVID-19 and health agencies are taking every measure to stop it. The COVID-19 virus has been named “SARS-CoV-2” (severe acute respiratory syndrome coronavirus 2) and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). The outbreak of the respiratory disease was first detected […]Read More

Sarepta Signs a Research Agreement with the US Department of

Shots: Sarepta and USAMRIID have entered into a CRADA to jointly identify antisense oligonucleotides utilizing Sarepta’s phosphorodiamidate morpholino oligomer (PMO) platform with activity against SARS-CoV-2 for the potential treatment of COVID-19 Sarepta will design, synthesize and manufacture multiple peptide-conjugated PMO (PPMO) constructs based on genetic sequencing of SARS-CoV-2 while USAMRIID will assess the constructs on […]Read More

Insights+: The US FDA New Drug Approvals in December 2019

The US FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have approved 48 new products so far in 2019. In 2018, FDA approved 59 novel products including 42 New Chemical Entity and 17 Biologics while breaking its past year’s records of approval. However, there is a significant […]Read More

Roche Signs a License Agreement with Sarepta for its Gene

Shots: Sarepta to receive $1.15B up front including $750M in cash $400M in Sarepta stock, priced at $158.59/share of common stock, up to $1.7B regulatory and sales milestones plus royalties on sales. Sarepta will be responsible for SRP-9001’s clinical development and manufacturing with global clinical cost equally shared Roche to get exclusive rights to commercialize […]Read More

Sarepta Receives the US FDA’s Approval for VYONDYS 53 (golodirsen)

Sarepta’s VYONDYS 53 is an antisense oligonucleotide derived using phosphorodiamidate morpholino oligomer (PMO) platform targeting DMD patients in patients with a confirmed mutation amenable to exon 53 skipping In Aug 2019, the company received a CRL for VYONDYS 53 from Drug Evaluation 1 following the New Drug Application (NDA) submission to and review by the […]Read More

PharmaShots Weekly Snapshot (November 11-15, 2019)

Roche’s Kadcyla (trastuzumab emtansine) Receives CHMP’s Recommendation for Approval as an Adjuvant Treatment for Patients with HER2+ eBC with Residual Invasive Disease After Neoadjuvant Treatment Published: Nov 15, 2019 | Tags: Roche, Kadcyla, trastuzumab emtansine, Receives, CHMP, Recommendation, Approval, Adjuvant, Treatment, HER2+ Early Breast Cancer 2. Stanford Medicine Reports Results of Apple Heart Study for Detecting […]Read More