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Merck & Co. wins 1st US nod for Ebola vaccine; EU approves J&J depression drug


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Merck & Co. wins 1st US nod for Ebola vaccine; EU approves J&J depression drug

Top news

* Merck & Co. Inc.'s Ervebo became the first vaccine to be approved in the U.S. for the Ebola virus disease. The contagious disease is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people, as well as with surfaces and materials contaminated with the fluids. Ervebo has already received a conditional approval in the EU.

* The European Commission approved Johnson & Johnson's esketamine nasal spray Spravato for treatment-resistant major depressive disorder. Earlier in the year, Spravato was approved in the U.S. for the same use, which is to treat patients who have shown a lack of response to at least two different antidepressant treatments.

* Johnson & Johnson said it is acquiring the remaining stake in robotics and data science company Verb Surgical Inc. following a strategic collaboration with Verily Life Sciences LLC, the life sciences arm of Google LLC. Financial terms of the deal were not disclosed.

* Merck & Co.'s blockbuster drug Keytruda was approved in Japan for expanded use to treat certain patients with advanced renal cell carcinoma — a type of kidney cancer — and head and neck cancer.

* Bristol-Myers Squibb Co. said the European Commission approved the expanded use of its medicine Revlimid in combination with Roche Holding AG's Rituxan to treat certain adults who have been previously treated for follicular lymphoma — a type of blood cancer.

* With some of the largest acquisitions in pharmaceutical industry history in 2019 and a focus on anticompetitive behavior that drives up drug prices, the U.S. Federal Trade Commission signaled a shifting strategy on deal oversight, experts say.

The largest deal of 2019 — Bristol-Myers' $95 billion acquisition of Celgene — was delayed as the agency investigated an overlap in its immunology portfolio. The company was ultimately required to divest the arthritis and psoriasis drug Otezla for $13.4 billion to Amgen Inc. The divestiture was the largest ever required by the FTC or the U.S. Department of Justice involving a merger, according to the agency.

On the policy front

* Four Republican lawmakers have authored new legislation to permit drugs for critically ill patients to enter the market before completing late-stage trials, saying the bill was necessary because the U.S. Food and Drug Administration's regulatory process was too slow and burdensome. The bill would create a time-limited conditional approval pathway in the U.S. similar to a system that has long been used by European regulators.

M&A and capital markets

* Achillion Pharmaceuticals Inc.'s shareholders approved the company's $930 million acquisition by Boston-based Alexion Pharmaceuticals Inc. Under the merger agreement, Alexion agreed to pay $6.30 for every Achillion share it acquires and will make further payments if the latter meets certain clinical and regulatory milestones.

* Cambridge, Mass.-based Biogen Inc. said its board authorized a program to buy back up to $5 billion of its common stock.

* Bausch Health Cos. Inc. issued a conditional redemption notice for $1.24 billion of its outstanding 5.875% senior notes due 2023.

Drug and product pipeline

* Amgen Inc. and Allergan PLC filed an application with the U.S. FDA seeking approval of ABP 798, a biosimilar to Roche and Biogen's blockbuster drug Rituxan. The companies' application for their biosimilar drug is backed by data from two separate studies evaluating the therapy against Rituxan in treating a type of blood cancer called non-Hodgkin lymphoma, and rheumatoid arthritis.

* Gilead Sciences Inc. and Galapagos NV's submitted an application with the FDA seeking approval of their medicine filgotinib to treat adult patients with rheumatoid arthritis — an autoimmune disorder characterized by the immune system mistakenly attacking healthy tissues, resulting in pain and swelling, among other things.

* Rockville, Md.-based MacroGenics Inc. filed an application with the FDA seeking approval of its medicine margetuximab to treat certain patients with breast cancer.

* Adamis Pharmaceuticals Corp. submitted its answers to the FDA's concerns after the regulator rejected the company's opioid overdose injection Zimhi in November. The company has also requested a meeting with the U.S. regulator.

Operational activity

* AstraZeneca PLC is selling rights to its breast cancer medicine Arimidex and prostate cancer drug Casodex in parts of Europe, Africa and certain other countries to Laboratoires Juvise Pharmaceuticals SAS for $181 million up front.

* Merck KGaA entered a license agreement to provide Promega Corp. access to its intellectual property relating to CRISPR gene-editing technology to create research products and services.

* Catalyst Biosciences Inc. is licensing its experimental eye disease therapy pegylated CB 2782 to Biogen for a $15 million up-front payment. Catalyst may also be eligible to receive an additional $340 million in certain milestone and royalty payments.

* The U.S. government agreed to give Paratek Pharmaceuticals Inc. up to $285 million in a contract to develop its oral medicine Nuzyra for treating anthrax inhalation. The Biomedical Advanced Research and Development Authority is providing the funding as part of its Project Bioshield, which was introduced by the U.S. government to buy and support the development of products that protect against biological weapons.

* Pharma Mar SA is licensing its lung cancer drug Zepsyre, or lurbinectedin, to Jazz Pharmaceuticals PLC in the U.S. for an upfront fee of $200 million and up to $250 million if certain regulatory milestones are achieved.

* Ionis Pharmaceuticals Inc. licensed its experimental Alzheimer's disease therapy IONIS-MAPTrx to Biogen. Ionis earned $45 million from the licensing fee, with the possibility of receiving an additional $155 million in milestone payments.

* Selecta Biosciences Inc. is licensing its immune tolerance platform called ImmTOR for treating Pompe disease to Asklepios BioPharmaceutical Inc. in exchange for over $240 million in up-front and milestone payments.

* Genmab A/S is partnering with CureVac AG for the research and development of messenger RNA-based antibody products in a deal worth $10 million upfront. CureVac will also receive a €20 million equity investment from Genmab, among other potential payments.

The day ahead

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

In Asia, the Hang Seng was up 0.25% to 27,871.35, and the Nikkei 225 slid 0.20% to 23,816.63.

In Europe, around midday, the FTSE 100 inched up 0.19% to 7,588.55, and the Euronext 100 gained 0.61%% to 1,149.96.

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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