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Thermo Fisher to buy gene, cell therapy maker; AstraZeneca's Forxiga gets EU nod

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Thermo Fisher to buy gene, cell therapy maker; AstraZeneca's Forxiga gets EU nod

Top news

* Thermo Fisher Scientific Inc. agreed to buy Brammer Bio LLC, a company focused on viral vector manufacturing for gene and cell therapies, for about $1.7 billion in cash. The deal will expand Waltham, Mass.-based Thermo Fisher's capabilities in the high-growth gene and cell therapy market, which has recently seen a flurry of M&A activity. Cell and gene therapies feature an innovative method of treating diseases from cancer to rare disorders.

Thermo Fisher, a provider of analytical instruments and laboratory equipment, said the deal will be accretive to adjusted EPS by 10 cents in the first full year of ownership.

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* AstraZeneca PLC said the European Commission approved Forxiga as a supplementary treatment to insulin for patients with type 1 diabetes and with a body mass index of at least 27 kilograms per meter square, when insulin alone does not provide enough blood sugar control. The nod was based on results from a late-stage study, dubbed Depict, which showed Forxiga improved glucose control without increasing the risk of hypoglycemia, or very low blood sugar levels, when along with insulin in patients with type-1 diabetes. The medicine is known as Farxiga in the U.S.

On the policy front

* All five of the pharmacy benefit manager companies summoned to appear before the Senate Finance Committee to explain the industry's role in the high costs of U.S. prescription medicines have agreed to send executives to testify in April 9. PBMs — often called middlemen — have been a particular target of the Trump administration, which has proposed ending the safe harbor protections that allow those companies to secure lucrative rebates from drugmakers under secret deals.

* The White House Office of Management and Budget is reviewing a final rule by the U.S. Centers for Medicare and Medicaid Services that would require drugmakers to include the list prices of their medicines in television advertisements aimed at consumers.

* One of U.S. Food and Drug Administration Commissioner Scott Gottlieb's last duties at the agency will be implementing a restructuring plan he outlined for his office — a reorganization that takes effect on March 31, just days before he departs on April 5. In a March 21 memo to employees, Gottlieb said the reorganization would elevate the role of the FDA's drug and device and other centers in support of the agency's science-driven culture and would consolidate the work in the operations office to more effectively support regulators' mission and strengthen staffing and recruiting functions.

* Rep. Elijah Cummings, D-Md., the chairman of the House Oversight and Reform Committee, demanded certain documents from Purdue Pharma LP about the Sackler family's involvement in promoting the company's powerful opioid medicine OxyContin and the FDA's expansion of the drug's labeling in 2001. Raymond Sackler was an American physician and billionaire entrepreneur, who, along with his brother Mortimer Sackler, was the owner of Purdue Pharma.

* The U.S. FDA issued a draft guidance detailing the potential uses of natural history studies in the development of therapies for rare diseases.

M&A and capital markets

* Biogen Inc.'s board authorized a $5 billion repurchase program of the company's common stock. The authorized program is in addition to about $1.7 billion remaining under the share buyback program authorized by the drugmaker's board in August 2018.

* Sorrento Therapeutics Inc. unit SCILEX Pharmaceuticals Inc. will merge with fellow pain management drug developer Semnur Pharmaceuticals Inc., Sorrento said March 22. Both California-based drugmakers develop non-opioid medications for pain.

* TWi Pharmaceuticals Inc. founder and Chairman Chen Chih-ming plans to take the generic-drug developer private, Taipei Times reported, citing a regulatory filing. The going-private deal, which will be done through a tender offer and a share swap, is intended to strengthen the company's financial structure and adjust its product development strategy, according to the report.

Drug and product pipeline

* The U.S. FDA rejected for the second time Recro Pharma Inc.'s application for approval of its intravenous meloxicam for the management of moderate to severe pain. The reason for the latest complete response letter from the regulatory agency was the delayed onset of the non-opioid drug, which did not meet expectations for intravenous treatments.

* Ovoca Bio PLC plans to file for Russian approval of its medicine Libicore after the drug improved the number of sexually satisfying events in women in a late-stage study.

Operational activity

* Eli Lilly and Co. said the price it was paid for its Humalog insulin dropped 8.1% over the last five years after accounting for rebates and discounts, The Wall Street Journal reported yesterday, citing information from the company. The Indianapolis-based company said the net price for the widely used insulin drug — the price after discounts and rebates — fell to an average of $135 per patient per month in 2018 from $147 in 2014, while the product's average list price rose 51.9% to $594 per patient monthly, the Journal reported.

* Bayer AG's management retains the backing of its supervisory board despite the fact that a second jury in the United States ruled its glyphosate-based Roundup weed killer caused cancer, Bayer CEO Werner Baumann said in an interview with German newspaper. Baumann made the comments to Frankfurter Allgemeine Sonntagszeitung, according to a March 24 Reuters report reprising the interview.

Our features

Merck's Keytruda eclipses Herceptin, Opdivo as cancer meds lead 2018 drug sales: Overall, the biggest cancer drugs made $36.37 billion in 2018, up from $31.35 billion in 2017. Merck & Co. Inc.'s Keytruda led the pack with sales of $7.17 billion.

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The day ahead

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

In Asia, the Hang Seng Index was down 2.03% to 28,523.35. The Nikkei 225 retreated 3.01% to 20,977.11.

In Europe, around midday, the FTSE 100 was down 0.26% to 7,188.88, and the Euronext 100 fell 0.29% to 1,023.84.

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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