Tags : Alkermes

Weekly Snapshot

PharmaShots Weekly Snapshot (January 27-31, 2020)

ProQR’s QR-421a Receives FDA’s Rare Pediatric Disease Designation for Retinitis Pigmentosa Published: Jan 30, 2020 | Tags: ProQR, QR-421a, Receives, FDA, Rare Pediatric Disease Designation, Retinitis Pigmentosa 2. Eli Lilly’s Fast-Acting Insulin Lispro Receives CHMP’s Positive Opinion in Patients with Diabetes Published: Jan 31, 2020 | Tags: Eli Lilly, Fast Acting Insulin Lispro, Receives, CHMP, Positive Opinion, […]Read More

Regulatory

Alkermes Reports the US FDA Acceptance of NDA for ALKS

Shots: The NDA is based on ENLIGHTEN-1 & 2 studies assessing the antipsychotic efficacy & weight gain with ALKS 3831 (olanzapine/samidorphan) vs PBO & Zyprexa (olanzapine) for 4 & 6wks. in patients with schizophrenia and bipolar I disorder respectively Alkermes is seeking approval for FD of ALKS 3831 consisting samidorphan (10mg) co-formulated with 5/10/15/20 mg […]Read More

M&A

Alkermes to Acquire Rodin Therapeutics for $950M

Shots: Alkermes acquires Rodin in all cash transaction, making the total deal value as $950M which include $100M upfront in cash and up to $850M as clinical, regulatory and commercial milestones. The transaction is expected to be completed by the end of Nov’2019 The acquisition will lead to the expansion of Alkermes’ Presence in CNS […]Read More

Weekly Snapshot

PharmaShots Weekly Snapshot (October 28 – November 01, 2019)

1. Medtronic Reports MHLW’s Shonin Approval and Launches Valiant Navion Thoracic Stent Graft System in Japan Published: Oct 31, 2019 | Tags: Medtronic, Reports, MHLW, Shonin Approval, Launches, Valiant Navion Thoracic Stent Graft System, Japan  2. Beam Therapeutics Signs Exclusive License Agreement with Prime Medicine for Prime Editing Technology Published: Oct 31, 2019 | Tags: Beam […]Read More

Regulatory

Biogen and Alkermes’ Vumerity (diroximel fumarate) Receive FDA’s Approval for

Shots: The FDA’s approval is based on NDA submitted under the 505(b)(2) filing pathway and contain data from P-III EVOLVE-MS-1 study assessing Vumerity in patients with relapsing-remitting MS In Nov’2017, Biogen and Alkermes collaborated to develop & commercialize Vumerity under which Alkermes to receive $150M and royalties on WW sales of Vumerity for the 5yrs. […]Read More

Pharma

Biogen and Alkermes Report Results of Diroximel Fumarate in P-III

Shots: The P-III EVOLVE-MS-2 study assessing the GI tolerability of Diroximel Fumarate (462mg, bid) vs Tecfidera (dimethyl fumarate, 240 mg, bid) in 506 patients with RRMS The P-III EVOLVE-MS-2 study results demonstrated superiority in gastrointestinal (GI) tolerability with a symptom intensity score ≥2 on the IGISIS rating scale and low discontinuation rates of <1% due […]Read More