Regulatory actions and licensing and collaboration agreements were the key highlights this week with companies like Loxo Oncology (LOXO) remaining in the limelight.
Bristol-Myers (BMY) Q3 earnings miss estimates while revenues beat the same. Opdivo's label was expanded to two more indications.
The FDA approves Amgen-Allergan's biosimilar version of Roche's Avastin for treating multiple types of cancers, to be marketed by the trade name of Mvasi.
Kite Pharma (KITE) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
Nektar Therapeutics (NKTR) reported first-quarter 2017 loss of 42 cents per share, wider than the Zacks Consensus Estimate of a loss of 40 cents.
Kite Pharma, Inc. (KITE) reported wider-than-expected loss in the first quarter of 2017.
Exelixis, Inc. (EXEL) is scheduled to report first-quarter 2017 results on May 1, after the market close.
Amgen, Inc. (AMGN) announced that its biosimilar version of AbbVie Inc.'s (ABBV) rheumatoid arthritis (RA) drug Humira has been approved by the European Commission (EC).
Glaxo carries a Zacks Rank #2 (Buy).
Donald Trump will nominate Scott Gottlieb, a conservative drug industry insider and former FDA and CMS official, to serve as FDA commissioner, industry sources close to the White House tell POLITICO.Gottlieb, a physician, is a far more traditional pick to lead the Food and Drug Administration than other candidates Trump had considered. One, Silicon Valley investor Jim O’Neill, had shocked public health advocates with his comments that the FDA should approve drugs without proof they worked. However, Gottlieb’s close ties with industry are likely to draw Senate scrutiny. A classic Washington insider who has occupied conservative turf in the health care debate for two decades, Gottlieb is a board member or adviser to various drug companies and plays a role in funding the industry through a venture capital firm, New Enterprise Associates.If confirmed, Gottlieb would play a major role in the Trump’s administration’s efforts to speed up the regulatory approval of drugs. Trump, who’s been critical of high drug prices, has often argued that shortening the FDA approval process and cutting regulations would bring prices down.The White House could announce Gottlieb's nomination as soon as Friday.The FDA, which oversees the review and approval of drugs, vaccines and medical devices, and the regulation of tobacco, food and cosmetics, has an annual budget of $5 billion, close to 15,000 employees, and plays a regulatory role in about a fifth of the economy. A slew of FDA user fee programs, in which industry essentially funds half the FDA budget, are up for reauthorization in the fall; it would fall upon Gottlieb, if approved, to shepherd the agreements — negotiated under his predecessor — through Congress.Gottlieb has broad experience in regulating health care and working for the industry. He received nearly $200,000 in payments in 2015 from eight pharmaceutical companies, according to federal database tracking drug industry payments. All were classified as “general” payments, meaning they were for things like travel and lodging, consulting or speaking fees. In 2014, he received more than $160,000 in general payments from companies.Gottlieb has been on GlaxoSmithKline’s research and development board since 2010, according to his résumé, and previously served on its oncology board. He advises Bristol Meyers Squibb on its cancer drugs and Cell Biotherapy, an oncology start-up. Gottlieb was a senior adviser to Vertex Pharmaceuticals, maker of expensive cystic fibrosis drugs, from 2009 through 2016. He holds seats on the boards of drug companies Daiichi Sankyo and Tolero Pharmaceuticals; medical lab company American Pathology Partners; MedAvante, a contract research organization, and Glytech, which makes an FDA-approved insulin dosing support system. He also has served on the board of insurance and medical diagnostic companies.Gottlieb was the FDA’s deputy commissioner for medical and scientific affairs from 2005 to 2007, and chief policy adviser to the CMS administrator in 2004, during implementation of Medicare Part D. Earlier, he was a senior adviser and director of medical policy development at the FDA, where he worked on issues like orphan drugs and combination products. Gottlieb has long been a resident fellow at the right-leaning American Enterprise Institute. He serves on the Federal Health IT Policy Committee, which makes recommendations to the Department of Health and Human Services Office for Healthcare Information Technology. He practices medicine at New York University where he is a clinical assistant professor. Gottlieb's free-market health policy positions are well known, thanks to regular op-eds in The Wall Street Journal and Forbes, and FDA-related testimony to Congress. This past fall, he gave testimony criticizing the FDA’s regulation of generic drugs, during a hearing on pharmaceutical industry competition occasioned by the rising prices of the EpiPen.
Nektar Therapeutics (NKTR) reported loss of 28 cents per share in the fourth quarter of 2016, wider than the Zacks Consensus Estimate of loss of 26 cents.
Exelixis, Inc. (EXEL) is scheduled to report fourth-quarter 2016 results on Feb 27, after the market close.
Kite Pharma (KITE) announced that it has entered into a strategic partnership with Daiichi Sankyo to develop and commercialize axicabtagene ciloleucel (KTE-C19) in Japan.