January 27, 2020 Acad, Gov/Utilities

Roche submits supplemental Biologics License Application to the FDA for Tecentriq in combination with Avastin for the most common form of liver cancer

Basel, 27 January 2020 Application is being reviewed under FDA’s Real-Time Oncology Review pilot programme Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the completion of a supplemental Biologics License Application (sBLA) submission to the US Food and Drug Administration (FDA) for Tecentriq® (atezolizumab) in combination with Avastin® (bevacizumab), for the treatment of people with... Read more

January 24, 2020 Bio/Pharma/CRO

Roche provides an update on Phase III study of Tecentriq in people with muscle-invasive urothelial cancer

Basel, 24 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the Phase III IMvigor010 study evaluating Tecentriq® (atezolizumab) as an adjuvant (after surgery) monotherapy treatment did not meet its primary endpoint of disease-free survival (DFS) compared to observation in people with muscle-invasive urothelial cancer (MIUC). Safety for Tecentriq appeared consistent with... Read more

January 23, 2020 Licensing, IP, and Legal

Roche’s Risdiplam meets primary endpoint in pivotal FIREFISH trial in infants with type 1 spinal muscular atrophy

Risdiplam demonstrated statistically significant and medically meaningful motor milestone improvement in infants with Type 1 SMA No treatment related safety findings leading to withdrawal seen in any risdiplam trial to date Data will be shared with health authorities globally              Basel, 23 January 2020 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive topline results... Read more

January 21, 2020 PAI Top-10

European Commission approves Roche’s Polivy for people with previously treated aggressive lymphoma

Basel, 21 January 2020 Novel combination regimen includes first-in-class antibody-drug conjugate that specifically targets CD79b Targeted off-the-shelf treatment provides much-needed new option for people with relapsed or refractory diffuse large B-cell lymphoma Polivy approval is based on a phase Ib/II study, the first and only study showing improved response rates and overall survival in patients... Read more

January 15, 2020 Clinical Research/Diagn. Product Launch

Roche helps further reduce risk of severe illness for transplant patients by expanding the portfolio to include Adenovirus Test on the cobas 6800/8800 Systems

●  Immunocompromised transplant recipients are at risk of major complications when infected with adenovirus, a common and highly contagious virus ●  Healthcare professionals can use this new test to determine whether transplant patients are at risk of developing severe illness from adenovirus infection ●  The Adenovirus Test leverages the flexibility, automation, and reliability of the cobas omni Utility... Read more

January 13, 2020 M&A, Partnerships

Roche and Illumina partner to broaden patient access to genomic testing

Partnership to leverage Illumina’s extensive decentralised installed base with Roche’s expertise in assay development and to provide broad access to clinical oncology next-generation sequencing Comprehensive genomic testing improves clinical decision making by genomically defining a patient’s unique cancer and matching optimal treatment Collaboration agreement builds upon Roche’s sequencing strategy to accelerate clinical research, streamline workflows... Read more

December 23, 2019 Clinical Research/Diagn. Licensing, IP, and Legal M&A, Partnerships

Roche enters licensing agreement with Sarepta Therapeutics to improve the lives of patients living with Duchenne muscular dystrophy

Roche obtains the exclusive right to launch and commercialize SRP-9001, Sarepta’s investigational micro-dystrophin gene therapy for Duchenne muscular dystrophy (DMD) outside the United States At closing, Roche will pay an upfront of $750million in cash and $400million worth in equity Sarepta is eligible to receive up to $1.7billion in regulatory and sales milestones, plus royalties... Read more

December 17, 2019 Atomic Spectroscopy Clinical Research/Diagn.

Roche concludes acquisition of Spark Therapeutics, Inc. to strengthen presence in gene therapy

Spark will continue its operations in Philadelphia as an independent company within the Roche Group             Basel, 17 December 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced the completion of the acquisition following the receipt of regulatory approval from all government authorities required by the merger agreement. Commenting... Read more

December 17, 2019 Atomic Spectroscopy Clinical Research/Diagn.

Roche purchases shares in tender offer for Spark Therapeutics, Inc.

Roche intends to complete Spark acquisition today Basel, 17 December 2019 – Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that Roche’s wholly owned subsidiary 022019 Merger Subsidiary, Inc. has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all... Read more

December 16, 2019 Atomic Spectroscopy Clinical Research/Diagn.

Roche and Spark Therapeutics, Inc. announce closing of investigation and unconditional clearance by the FTC and expiration of Hart-Scott-Rodino waiting period for acquisition of Spark Therapeutics, Inc

All antitrust approvals required to close the transaction received. Basel, 16 December 2019  – Roche (SIX: RO, ROG; OTCQX: RHHBY) and Spark Therapeutics, Inc. (NASDAQ: ONCE) (“Spark”) today announced that the Federal Trade Commission closed its investigation and granted unconditional clearance and termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976... Read more