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AstraZeneca to discontinue phase 3 heart drug trial; biopharma M&A in 2020

Top news

* AstraZeneca PLC said it will discontinue a phase 3 trial of its heart disease medicine Epanova to treat patients with mixed dyslipidaemia — an abnormal amount of lipids — who are at increased risk of cardiovascular disease. The U.K.-based pharmaceutical giant took the decision after an independent committee recommended that there was a low likelihood of the drug benefitting the patients. AstraZeneca added that a write-down of up to $100 million related to the drug is expected to hit its core earnings for the fourth quarter of 2019.

* As the J.P. Morgan Healthcare Conference kicks off in San Francisco on Jan. 13, the biopharma industry is looking to innovative cancer therapies and dealmaking to propel sales in the new year while drug pricing and litigation continue to add strain, S&P Global Market Intelligence has a report.

* The European Medicines Agency recommended 66 new medicines for marketing authorization in 2019, its lowest total in five years, data compiled by S&P Global Market Intelligence showed. The year 2019 was marked by several first-of-their-kind therapies, with Merck & Co. Inc.'s Ebola vaccine Ervebo being one of them.

* A panel formed by the U.S. Food and Drug Administration recommended that mineral particles that are found in talc products and are small enough to enter the lungs should also be considered as potentially harmful, even though the industry would not refer to these materials as asbestos, Reuters reported, citing a report from the FDA. The recommendation endorsed views held by public health authorities and plaintiffs who over the years have alleged that contamination in talc products causes cancer, the report added.

* California Governor Gavin Newsom plans to propose that the state launch its own prescription-drug label to help lower healthcare costs for residents, The Wall Street Journal reported.

* An analysis of U.S. death certificate data carried by an agency under the National Institutes of Health showed that alcohol-related deaths have been rising in the country, doubling from 35,914 in 1999 to 72,558 in 2017. Rates of death involving alcohol increased more for women than men over the study period.

On the policy front

* After repeatedly arguing the Affordable Care Act was unconstitutional, the Trump administration and a group of Republican state attorneys general now say they are not in any hurry for the U.S. Supreme Court to decide if the decade-old law should be invalidated. Waiting would mean the Supreme Court would be unlikely to render a decision until after the U.S. 2020 elections.

M&A and capital markets

* Eli Lilly and Co.'s $1.1 billion cash deal to acquire dermatological medicines developer Dermira Inc. aligns with the pharmaceutical giant's strategy of acquiring clinical phase assets to supplement existing development expertise and commercial infrastructure. The deal is also being seen as an effort to help fill gaps that would be left after the expiry of patents of certain drugs from Lilly.

* Sorrento Therapeutics Inc.'s stock soared Jan. 10 after the company announced that it received a nonbinding offer from a private equity fund to acquire a majority or all of the issued and outstanding shares of the company for up to $7 per share. Sorrento noted that its board was reviewing the proposal.

Drug and product pipeline

* AstraZeneca and Merck & Co. said their medicine Lynparza was granted priority review status by the U.S. FDA as maintenance therapy for patients with advanced ovarian cancer who are in complete or partial response to first-line platinum-based chemotherapy with Roche's bevacizumab.

* Alnylam Pharmaceuticals Inc. began a rolling submission of a new drug application to the U.S. FDA seeking approval of its experimental therapy lumasiran to treat a rare kidney disorder called primary hyperoxaluria type 1.

* ViiV Healthcare Ltd., which is majority-owned by GlaxoSmithKline PLC, filed an application with the European Medicines Agency seeking approval of its drug fostemsavir to treat HIV-1 patients who no longer respond to other therapies.

* Bristol-Myers Squibb Co. and Nektar Therapeutics have revised a collaboration to advance their cancer therapies into new clinical trials in melanoma and bladder cancer.

* Roche Holding AG will pay Amunix Operating Inc. $40 million upfront to license the privately held company's Xten technology platform for developing non-cancer treatments. Roche may also pay up to $1.5 billion in development and sales-based milestones, plus royalties on sales of commercialized products.

* LogicBio Therapeutics Inc. entered a research collaboration with Tokyo-based Takeda Pharmaceutical Company Ltd. to further develop an experimental therapy called LB-301 for a rare genetic disease in children.

Operational activity

* Johnson & Johnson said it will expand the presence and capabilities of its research unit, Janssen Research & Development LLC, in South San Francisco, Calif.

* Endo International PLC reached an $8.75 million settlement with Oklahoma officials to resolve the company's role in ongoing litigation over the U.S. opioid epidemic. A number of companies have reached settlements with states to resolve claims that certain marketing practices fueled the opioid crisis, which kills about 200 Americans each day.

The day ahead

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

In Asia, the Hang Seng increased 1.11% to 28,954.94, while the Nikkei 225 was closed.

In Europe, around midday, the FTSE 100 was up 0.23% to 7,605.06, and the Euronext 100 was down 0.04% to 1,156.90.

Click here to read about today's financial markets, setting out the factors driving stocks, bonds and currencies around the world ahead of the New York open.

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