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J&J loses talc cancer case; Merck's Keytruda gets EU nod in NSCLC

Top news

* Johnson & Johnson was hit with another verdict in its talc litigation after a California jury awarded $29 million to a woman alleging that the company's products caused her cancer, Reuters reported. The lawsuit was filed by Terry Leavitt, who sued the company claiming that she was diagnosed with mesothelioma after using the company's baby powder and shower to shower powder.

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* Merck & Co. Inc. said the European Commission approved its blockbuster drug Keytruda — in combination with Bristol-Myers Squibb Co.'s chemotherapy drug Paraplatin and either Bristol-Myers' Taxol or Celgene Corp.'s Abraxane — for the first-line treatment of adults with squamous non-small cell lung cancer whose disease has spread to another site in the body.

* Roche Holding AG said the EC approved its drug Hemlibra for preventing bleeding episodes in patients with severe hemophilia A without factor VIII inhibitors, an essential blood-clotting protein.

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Richard Francis
Source: Sandoz

* Novartis AG said Richard Francis is stepping down as CEO of Sandoz, the Swiss drugmaker's generics business, effective March 31. Francesco Balestrieri, Sandoz's region head for Europe, was named ad-interim CEO of the unit.

On the policy front

* Rep. Tom Cole, R-Okla., the top Republican on the House Appropriations Subcommittee on Labor, Health and Human Services, Education and Related Agencies, said President Donald Trump's plan to cut about $5 billion from the National Institutes of Health in the administration's fiscal 2020 budget, would "send the wrong signals to young scientists." At a March 13 hearing, Cole said the administration's proposal to slice about $1 billion from the Centers for Disease Control and Prevention's spending is "literally a risky mistake," and he expected his congressional colleagues — Republicans and Democrats — to reject the proposed cuts.

* Lawmakers at a Capitol Hill hearing heard an array of advice on how to delve into the patent issues involved in trying to lower U.S. drug prices — from being aggressive in adopting a package of recently introduced bills to approaching some of the measures with caution. At issue before the House Energy and Commerce Health Subcommittee on March 13 were seven bills, three of which are bipartisan — authored by Democrats and Republicans together — that are aimed at getting lower-cost versions of brand-name medicines to the market quicker.

* New York Gov. Andrew Cuomo's budget director, Robert Mujica, and Cuomo's top aide, Melissa DeRosa, said Trump's budget proposal for fiscal 2020 would result in the state receiving a 20% reduction in federal aid for Medicaid and other health services, The Wall Street Journal reported. Last month, the Democratic governor proposed cutting the state's spending on Medicaid by about $550 million in the fiscal year commencing April 1, a proposal that was met with resistance from hospitals and healthcare providers as the cuts would lead to reduced services.

* A group of scientists is calling for a global moratorium on the clinical editing of DNA in human sperm, eggs or embryos to create genetically modified babies after Chinese biophysicist He Jiankui reportedly edited embryos to create twin babies. In a paper published in the journal Nature, the researchers said the proposed moratorium would not apply to germline editing for research purposes or for genome editing of nonreproductive cells to treat diseases in humans.

* Chinese regulators will start negotiating with pharmaceutical companies to add new medicines to the national drug reimbursement list, according to the National Healthcare Security Administration. The regulators said they will prioritize adding drugs for cancer, chronic diseases, rare diseases, and other severe and acute illnesses to the list.

Drug and product pipeline

* Stamford, Conn.-based Purdue Pharma LP said the U.S. Food and Drug Administration granted fast-track designation to its nalmefene hydrochloride injection, an investigational opioid antagonist for the emergency treatment of a known or suspected opioid overdose. The injection has a longer-lasting effect than naloxone, another opioid antagonist approved for the same indication, and is intended to help address overdose deaths in an ongoing opioid epidemic in the U.S.

Operational activity

* Insys Therapeutics Inc. said its auditor has raised "substantial doubt" about the company's ability to continue as a going concern. In a regulatory filing, the specialty drugmaker said it is seeking to raise capital but could provide no assurances that it would resolve the company's liquidity issues or eliminate operating losses.

* Canada's Aurora Cannabis Inc. appointed activist investor and consumer industry veteran Nelson Peltz as a strategic adviser to assist the company in its global expansion. Aurora Cannabis will work with Peltz to explore potential partnerships to enter its targeted market segments.

* The U.S. FDA issued a warning letter to Pfizer Inc.'s Indian manufacturing plant, which is about to be shut down, citing violations of product quality and data integrity issues. The agency said the methods and facilities for manufacturing, processing and packing at Pfizer's manufacturing plant in Irungattukottai, in the state of Tamil Nadu, did not conform to Current Good Manufacturing Practice regulations.

The day ahead

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

In Asia, the Hang Seng was up 0.15% to 28,851.39. The Nikkei 225 fell 0.02% to 21,287.02.

In Europe around midday, the FTSE 100 was up 0.48% to 7,193.54 and the Euronext 100 was 0.53% higher at 1,033.03.

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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