BioCentury | Feb 26, 2020
Product Development

Regulatory Roundup: FDA reviewing GSK, Takeda applications for earlier lines of cancer treatment; plus Novartis, Halozyme-Genentech, MacroGenics, CSL, Lilly

FDA is reviewing four earlier or additional indications for a slate of cancer drugs, plus a first-time application for MacroGenics’ anti-HER2 mAb. The agency also approved the first quadrivalent flu vaccine and a CV application...
BioCentury | Jan 25, 2020
Product Development

A milestone year for Roche’s CNS gambit could kick off its plan for the decade

A ramped up focus on CNS that has been long in the making could start to pay off this year for Roche, which has two programs slated for launch and four others with late-stage readouts...
BioCentury | Nov 1, 2019
Product Development

Novartis, Merck KGaA see opportunity in select pockets of MS patients

As companies continue to pile into the multiple sclerosis market with new therapies, Novartis and Merck KGaA are dissecting the landscape to define populations for their newly launched drugs. While the former is staking out...
BioCentury | Oct 25, 2019
Product Development

Deciding factors in the shifting MS treatment landscape

The efficacy and convenience advantages that established oral medicines as the go-to therapy in multiple sclerosis are the same factors now squeezing them out. Two years post-launch, the success of injectable Ocrevus ocrelizumab from Roche...
BC Extra | Sep 13, 2019
Clinical News

Novartis’ ofatumumab data comparable to Ocrevus in RRMS

Roche’s blockbuster MS therapy Ocrevus ocrelizumab could soon have company in relapsing-remitting multiple sclerosis as Phase III data presented Friday for ofatumumab by Novartis show the two anti-CD20 mAbs could have comparable efficacy. Data from...
BC Extra | Aug 30, 2019
Clinical News

Aug. 30 Clinical Quick Takes: Pharnext falls on FDA request for second Phase III study, plus Genentech, Novartis and Seqirus

Pharnext shares sag on regulatory slowdown  Shares of Pharnext S.A. (Euronext:ALPHA) lost €4.99 (41%) to €7.16 on Friday after the company said FDA advised it to conduct a second Phase III study of PXT3003 prior...
BC Extra | Jul 19, 2019
Financial News

Genmab’s plans after $500M NASDAQ debut

European bellwether Genmab plans to use a large chunk of the $505.9 million it raised through its listing on NASDAQ Thursday to fuel clinical development and commercialization of antibody-drug conjugate tisotumab vedotin (HuMax-TF-ADC). Two other...
BioCentury | Jun 14, 2019
Product Development

Despite senior management shake-up, Novartis’ pipeline is primed to deliver

A string of departures at Novartis AG and strategic shifts by new CEO Vasant Narasimhan have produced a fairly thorough makeover of the executive committee he inherited in 2018. The team gains a pipeline that...
BC Extra | May 28, 2019
Financial News

May 28 Financial Quick Takes: Alphamab Oncology raises $60M; plus $180.5M for Panacea healthcare fund and more

Hudson Bay leads Alphamab Oncology's $60M series B Alphamab Oncology (Cayman) raised $60 million in a series B round led by Hudson Bay Capital, with participation from new investor and entrepreneur Adrian Cheng and existing...
BioCentury | Jan 5, 2019
Finance

Ready to launch

  The proposed $74 billion takeout of Celgene Corp. by Bristol-Myers Squibb Co. will not shift buysider attention away from upcoming and maturing drug launches heading into 2019, with plenty to track following a record...
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