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Novartis CAR-T therapy gets Japanese nod; UK drugmakers brace for hard Brexit

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Novartis CAR-T therapy gets Japanese nod; UK drugmakers brace for hard Brexit

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Top news

* Japan's Ministry of Health, Labour and Welfare approved Novartis AG's chimeric antigen receptor T cell, or CAR-T, therapy Kymriah for treating CD19-positive relapsed or refractory B-cell acute lymphoblastic leukemia and CD19-positive relapsed or refractory diffuse large B-cell lymphoma — two types of blood cancer. CAR-T therapies work by taking immune cells from a patient's blood, re-engineering them to attack cancer cells and infusing them back into the person's body.

* The U.K.'s largest drugmakers, GlaxoSmithKline PLC and AstraZeneca PLC, are leading the industry's preparations for a so-called hard Brexit — an increasingly likely outcome whereby the U.K. exits the EU without a withdrawal deal in place — by stockpiling medicines and spending a minimum of £120 million to secure supplies. GSK said it has set aside £70 million to implement changes required for Brexit. It has also increased inventory in the U.K. and in Europe, without disclosing specific levels, in a move mirrored by other large suppliers of medicines in Britain including Novo Nordisk A/S and Sanofi.

* The U.S. Justice Department said it now wants an appeals court to strike down the entire Affordable Care Act, changing a position the Trump administration held earlier when it said only certain portions of the law, such as its preexisting conditions protections, should be nixed. In a letter to the U.S. Court of Appeals for the 5th Circuit, Justice Department officials said the administration has decided that a district judge's ruling deeming the ACA unconstitutional should be affirmed.

In an appeals brief filed with the court March 25, Democratic state attorneys general said that if O'Connor's ruling were implemented, it would "wreak havoc on the entire American healthcare system and risk lives in every state." The 133 million Americans with preexisting health conditions would be put at risk of losing their coverage, they argued, adding that insurers also could again put lifetime caps on Americans' coverage.

* About 11.4 million consumers signed up for ACA plans in 2019 across the U.S., down from 11.8 million in 2018, according to the Centers for Medicare and Medicaid Services.

M&A and capital markets

* NGM Biopharmaceuticals Inc. plans to raise net proceeds of about $89.5 million in an IPO and will conduct a separate private placement with Merck & Co. Inc. in which the pharmaceutical giant will acquire a nearly 20% stake in the biotech firm. The biotechnology company will offer 6,666,667 common shares in the IPO at $15 apiece, the midpoint of the IPO's estimated price range of $14 to $16 per share.

* Private biotechnology companies in the U.K. raised £182 million between December 2018 and February 2019, up £50 million from the same period a year earlier, according to the UK BioIndustry Association.

* The U.S. Federal Trade Commission requested more information from Bristol-Myers Squibb Co. and Celgene Corp. regarding the agency's review of the $74 billion union between the two drugmakers. The FTC's review is focused on the pipeline products of the companies for the treatment of psoriasis.

* Merck KGaA started a tender offer to acquire all outstanding shares of Versum Materials Inc., a supplier of specialty materials to the semiconductor and display industries, for $48 per share. Tempe, Ariz.-based Versum had previously agreed to combine with Billerica, Mass.-based Entegris in a $3.9 billion all-stock merger, until Germany's Merck issued its $6 billion counteroffer.

Drug and product pipeline

* Celgene Corp. has again filed an application with the U.S. Food and Drug Administration seeking approval for its multiple sclerosis treatment ozanimod just over a year after the agency rejected the therapy due to lack of certain data. The New Jersey company based the newest filing on data from two late-stage studies called Sunbeam and Radiance, both of which reached their primary goals.

* Novartis unit Sandoz Inc. said it launched the first generic version of United Therapeutics Corp.'s pulmonary arterial hypertension drug Remodulin in the U.S. Sandoz said the copycat launched with 180 days of marketing exclusivity, which is part of the U.S. Food and Drug Administration's effort to encourage competition for generic drugs.

The exclusivity is granted to the first generic-drug applicant to submit a substantially complete generic application that includes a challenge to the brand-name drug's patents.

* AbbVie Inc. said Skyrizi received its first Japanese approval to treat plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. Psoriasis is a chronic, immune-mediated disease characterized by raised, red, scaly patches on the skin.

The approval was supported by the effectiveness and safety data from mid- and late-stage trials — sustaIMM, ultIMMa-1 and IMMspire — which evaluated Skyrizi in Japanese patients with the disease.

* PharmaMar AG's lurbinectedin was shown to shrink tumors in a phase 2 trial in patients with small-cell lung cancer whose diseases recurred.

* Japan also approved Lupin Ltd. and YL Biologics Ltd.'s biosimilar — a lower-cost version of biologic therapies — of Amgen Inc.'s Enbrel, or etanercept. YL Biologics is a joint venture between Lupin and Japan's Yoshindo Inc.

Operational activity

* The Oklahoma Supreme Court declined to postpone a trial in May accusing drugmakers Purdue Pharma LP, Johnson & Johnson and Teva Pharmaceutical Industries Ltd. of playing a part in the opioid epidemic in the U.S. state by deceptively marketing their painkillers, Reuters reported. Oklahoma is seeking more than $20 billion in damages in the lawsuit.

Purdue Pharma — maker of the opioid painkiller OxyContin — agreed to settle the lawsuit with Oklahoma Attorney General Mike Hunter, Reuters reported, citing people familiar with the matter. Earlier this month, Purdue was reported to be considering filing for bankruptcy amid allegations that the company contributed to the U.S. opioid crisis.

The day ahead

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

In Asia, Hang Seng rose 0.15% to 28,566.91, while the Nikkei 225 gained 2.15% to 21,428.39.

In Europe, around midday, the FTSE 100 climbed 0.24% to 7,194.64, and the Euronext 100 lifted 0.68% to 1,030.09.

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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