Gilead Sciences Inc.’s recent decision to acquire Immunomedics Inc. looks even smarter now in light of the full data in a phase III study of Trodelvy (sacituzumab govitecan-hziy) released at the European Society for Medical Oncology (ESMO) over the weekend.
Antibody-drug conjugates (ADCs) are making a comeback. After a relatively slow start with Adcetris (brentuximab vedotin, Seattle Genetics Inc.) and Kadcyla (ado-trastuzumab emtansine, Roche Holding AG) approved by the FDA in 2011 and 2013, respectively, the regulatory activity has swelled with four FDA approvals over the last nine months.
In the company’s largest acquisition and potentially the fifth biggest biotech M&A ever, Gilead Sciences Inc. will acquire Immunomedics Inc. for $21 billion in a move that substantially transforms Gilead’s oncology portfolio.
LONDON – CEOs of five leading biopharma companies have hit back against any suggestion COVID-19 vaccines and therapies could be approved in advance of phase III data, saying it is imperative the highest standards of quality, safety and efficacy are upheld everywhere. The most important thing is to reinforce to the public the commitment to safety as the number one priority, said Kenneth Frazier, CEO of Merck & Co. Inc.
The massive deal Jounce Therapeutics Inc. has cut with Gilead Sciences Inc., an agreement that could eventually add up to about $805 million, will strengthen Jounce’s ability to develop its pipeline and choose new partners, the company’s CEO and president told BioWorld.
As of Aug. 13, more than 90,000 patients hospitalized in the U.S. with COVID-19 already had been given access to convalescent plasma through a national expanded use protocol (EAP) sponsored by the Mayo Clinic. The FDA’s decision Sunday to grant emergency use authorization (EUA) for the potential therapy will further expand access to convalescent plasma for hospitalized patients throughout the country at a time when fully approved COVID-19 treatments are nonexistent and even EUAs are few and far between.
Avoiding the political overtones that seem to be more viral than COVID-19 these days, Anand Shah, deputy commissioner for medical and scientific affairs at the FDA, stressed that even though the agency is making decisions in real time in response to the urgency of the pandemic in the U.S., its decisions are being driven by scientific integrity, regulatory independence and the FDA’s historic commitment to ensuring the safety and efficacy of the products it regulates.
An FDA rejection of Galapagos NV's rheumatoid arthritis (RA) drug filgotinib, announced Aug. 18, was "disappointing and unexpected," CEO Onno van de Stolpe said, adding that "there is so much more" to his company's story and pipeline. Gilead Sciences Inc., the Belgian company's partner and a substantial backer of both the drug and the pipeline, said it would "evaluate the points raised" by the CRL, but continued to believe in the drug.
Tango Therapeutics Inc. CEO Barbara Weber told BioWorld that Gilead Sciences Inc.’s decision to greatly expand their 2018 deal in oncology – a pact then valued as high as $1.7 billion – was based on brisker than expected progress in the original, five-target effort.
According to an analysis conducted by BioWorld of the second-quarter 2020 financial reports filed by 120 public biopharmaceutical companies with market caps greater than $1 billion, and excluding big pharma companies, the amount that was invested in research and development during the period increased by 14% compared to the same six-month period last year.
