Genentech

FDA extends PDUFA date for Genentech’s cobimetinib NDA

Thursday, July 2, 2015 09:17 AM

Exelixis has been informed by partner Genentech, a member of the Roche Group, that, in order to accommodate its review of a supplemental data submission, the FDA has extended the Prescription Drug User Fee Act (PDUFA) action date for its review of Genentech's NDA for cobimetinib by the standard extension period of three months, from Aug. 11 to Nov. 11.

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FDA grants Breakthrough designation for Actemra in Systemic Sclerosis

Thursday, June 11, 2015 12:59 PM

Genentech, a member of the Roche Group, has announced that the FDA has granted Breakthrough Therapy designation status to Actemra (tocilizumab) for systemic sclerosis, also known as scleroderma. This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech also has initiated a phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.

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Denali Therapeutics launches to study neurodegenerative disease treatments

Friday, May 15, 2015 02:23 PM

Denali Therapeutics, a new California-based biotechnology company focused on developing effective therapies for neurodegenerative diseases, has launched with an initial investment commitment of $217 million. Denali is based on the collaboration of world-class scientists, industry experts and investors. Recent scientific insights into the genetic causes and biological processes underlying neurodegenerative disease, together with new translational medicine tools, offer an unprecedented opportunity to discover and develop effective medicines for Alzheimer's disease, Parkinson's disease, ALS and other neurodegenerative diseases.

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AbbVie’s Venetoclax receives FDA Breakthrough Therapy designation for CLL

Thursday, May 7, 2015 12:54 PM

AbbVie has announced its investigational medicine venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation.

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Roche becomes majority shareholder in Foundation Medicine

Thursday, April 9, 2015 01:41 PM

Roche has become a majority shareholder of Foundation Medicine, a molecular information company based in Cambridge, Mass. Roche purchased approximately 15.6 million shares of common stock through a tender offer from Foundation Medicine stockholders at a price of $50 per share.

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Broad Institute, Calico collaborate on aging

Friday, March 20, 2015 01:56 PM

The Broad Institute of MIT and Harvard has entered into a partnership with Calico around the biology and genetics of aging and early-stage drug discovery. The partnership will support several efforts at the Broad Institute to advance the understanding of age-related diseases and to propel the translation of these findings into new therapeutics.

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First U.S. biosimilar approval opens floodgates for lower-priced competition to blockbuster biologics

Monday, March 16, 2015 08:00 AM

The FDA’s approval this month of the first U.S biosimilar, Zarxio from Sandoz, has formally opened the floodgates for sponsors seeking approval of lower-cost biologics to compete with expensive brand-name prescription drugs.

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23andMe to create therapeutics group, names Richard Scheller CSO

Thursday, March 12, 2015 01:03 PM

23andMe, a personal genetics company based in Mountain View, Calif., has created a new therapeutics group and has named Richard Scheller, Ph.D., to lead it as chief science officer and head of therapeutics. Scheller retired in December 2014 from a 14-year career at Genentech, where he was executive vice president of research and early development.

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Dr. Anita J. Chawla joins CytRx board of directors

Thursday, March 12, 2015 12:46 PM

CytRx, a biopharmaceutical R&D company specializing in oncology, has appointed Anita J. Chawla, Ph.D., to its board of directors. Chawla brings over 25 years of experience as an economist in the health care industry to CytRx, with a proven track record helping pharmaceutical, biotechnology, medical device and diagnostic companies achieve their product development and commercialization objectives.

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Patients’ increased sharing of clinical trial experiences through social media can help sponsors improve outcomes, enrollment

Monday, March 2, 2015 08:00 AM

Social media continues to play a major role in clinical trial patient recruitment and participation, according to former trial patients who still share information about their experiences with friends and others online—conversations that can influence whether prospective patients join a trial.

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CWWeekly

June 29

FDA and PatientsLikeMe collaborate to test social media adverse event reporting

Boston-area teaching hospitals launch web portal to attract life science companies

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The CenterWatch Monthly

July

Integrated research partnerships build momentum
Research function provides infrastructure, leverages large pool of health systems' patients and data

'Right to Try' laws challenge clinical trial process
20 states pass, 20 more pending allowing access to study drugs without FDA and IRB approval

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The CenterWatch Monthly

June

TransCelerate Biopharma turns three
High-profile consortium has made inroads fixing wasteful practices, but it still has more work ahead

Pharma industry improves its tarnished reputation
Delivering innovation, social responsibility will help rebuild trust

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