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Gottlieb's recusal; drugmakers' opioid problem; Trump's healthcare vows


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Gottlieb's recusal; drugmakers' opioid problem; Trump's healthcare vows

* Republican leaders sent mixed messages about whether repealing and replacing the Affordable Care Act was a priority for the party after their bill failed to garner enough votes to pass the House. "I know that we are going to make a deal on healthcare; that's such an easy one," President Donald Trump declared to a room full of U.S. senators at a bipartisan White House evening reception.

* Scott Gottlieb plans to temporarily recuse himself from taking decisions on more than 20 companies if he is confirmed to lead the U.S. FDA, including those where he has held positions or received compensation from, The Wall Street Journal reports. The Trump nominee has worked with the likes of GlaxoSmithKline PLC and Bristol-Myers Squibb Co.

* U.S. Senator Claire McCaskill, D-Mo., launched an investigation into the top five opioid manufacturers' business practices. McCaskill sent letters to Purdue Pharma, Johnson & Johnson's Janssen Pharmaceuticals Inc., Insys Therapeutics Inc., Mylan NV and Depomed Inc., requesting information about their sale, marketing and education practices in promoting their opioid products.

* Despite opposition from Gov. Sam Brownback, the Kansas Senate voted 25-13 to give early approval to a proposal that would expand the state's privatized Medicaid program, The Kansas City Star reported. The Affordable Care Act allows states to expand Medicaid, which provides health coverage to disabled and low-income people.

Drug and product pipeline

* The U.S. FDA approved Roche Holding Ltd.'s Ocrevus for the treatment of relapsing and primary progressive forms of multiple sclerosis. The treatment, developed by Genentech Inc., is slated to be available in the U.S. within two weeks from March 28.

* The U.S. FDA also approved Sanofi and Regeneron Pharmaceuticals Inc.'s Dupixent injection for the treatment of atopic dermatitis, the most common form of eczema. The drug is expected to be available at a listed price of $37,000 per year, but Regeneron CEO said it will be in the "low $30,000s range" for payers due to discounts, rebates and patient assistance programs such as co-pay assistance.

* Vertex Pharmaceuticals Inc.'s tezacaftor/Kalydeco combination therapy met its primary endpoints in two phase 3 trials in patients with cystic fibrosis. The company plans to submit a new drug application to the U.S. FDA and a marketing authorization application to EMA in the third quarter of 2017 on the basis of the results.

* Indian pharma major Lupin Ltd. launched abacavir and lamivudine tablets in the U.S. indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. The tablets are the AB-rated generic equivalent of ViiV Healthcare Co.'s Epzicom tablets.

* Aceto Corp.'s Rising Pharmaceuticals launched Capecitabine tablets, the AB-rated generic version of Roche Holding Ltd.'s Xeloda tablets, for the treatment of metastatic breast cancer.

* AXIM Biotechnologies Inc. plans to develop a bioequivalent of AbbVie Inc.'s Marinol to help treat patients with chemotherapy-induced nausea and vomiting, and AIDS patients experiencing appetite and weight loss. AXIM entered into a term sheet agreement with a U.S.-based controlled-substances active pharmaceutical ingredient production company to develop the controlled-release chewing gum product.

Operational activity

* Mylan NV appointed former U.S. SEC Commissioner Daniel Gallagher as its chief legal officer, effective April 17.

* The European Patent Office upheld BioTime Inc.'s key patents to develop OpRegen, a treatment for retinal degenerative diseases.

* Depomed Inc. appointed Arthur Higgins to the positions of president, CEO and board member after the resignation of James Schoeneck.

* AstraZeneca PLC's Japanese unit will reorganize its business structure into oncology, cardiovascular/metabolic, and respiratory therapeutic areas, effective April 1, Pharma Japan reported.

* Astellas Pharma Inc. will sell a portfolio of long-listed ex-patent drugs to Tokyo-based LTL Pharma Co. Ltd. for ¥20.1 billion, the Nikkan Kogyo Shimbun reported. Astellas will use the proceeds for the development of more promising new drugs.

Now featured on S&P Global Market Intelligence:

* Moving from botanics to pharma, China MediTech pegs success on new cancer drug: In an interview with S&P Global Market Intelligence, Hutchison China MediTech Ltd. CEO Christian Hogg spoke about the company's oncology pipeline, which includes eight drug candidates in over 30 clinical trials around the world.

The day ahead

Early morning futures indicators pointed to a mixed opening for the U.S. market.

In Asia, the Hang Seng rose 0.19% to 24,392.05, and the Nikkei 225 was up 0.08% to 19,217.48.

In Europe, as of midday, the FTSE 100 was down 0.19% to 7,329.57, and the Euronext 100 had fallen 0.06% to 973.63.

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